medical research volunteers

• Clinical Trials

Volunteering

Volunteers are an integral part of the research process. People with a particular disease as well as healthy people both can play a role in contributing to medical advances. Without volunteers, clinical studies simply would not be possible.

People volunteer for clinical studies for many reasons. They may have a:

• Desire to improve medical care for future generations
• Connection to a certain disease or illness, whether through personal experience or through friends or family
• Personal interest in science

Participating is a choice

Volunteering for a clinical study is a personal choice. You have no obligation to do so, and participation is not right for everyone. After enrolling in a study, you may leave at any time for any reason.

Getting involved

• Participate in a clinical study at Mayo Clinic. By better understanding how to diagnose, treat, and prevent diseases or conditions, we help people live longer, healthier lives. Researchers need volunteers for a broad range of clinical studies. Find a clinical study .
• Connect with us. Eligibility requirements vary for each study and determine the criteria for participation. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Connect with the study staff directly as they are in the best position to answer questions and provide specific information regarding eligibility and possible participation. Contact information is found in each study listing.
• Join a national research volunteer registry. Health research changes peoples’ lives every day, but many studies end early because there are not enough volunteers. Researchers need both healthy people and those with all types of conditions. Funded by the National Institutes of Health, ResearchMatch is a first-of-its-kind registry that connects research volunteers with researchers across the country. Sign up at ResearchMatch.org .

Making an informed decision

• Informed consent. Before deciding to participate in a study, you will be asked to review an informational document called an informed consent form. This form will provide key facts about the study so that you can decide if participating is right for you. You must sign the informed consent form in order to participate in the study, though it is not a contract — you may still choose to leave the study at any time.
• Risks and benefits. All medical research involves some level of risk to participants. Risks and benefits vary depending on the particular study. To help you make an informed decision, the study team is required to tell you about all known risks, benefits and available alternative health care options.
• Ask questions. If you have questions when deciding to join a research study or at any time during it, ask a member of the study team. If your questions or concerns are not satisfactorily addressed, contact the study's principal investigator, the Mayo Clinic research subject advocate or the Mayo Clinic Institutional Review Board (IRB).

Protecting rights and safety

An independent group, the Mayo Clinic IRB , oversees all Mayo clinical studies that involve people, ensuring research is conducted safely and ethically. Members of the Mayo Clinic IRB include doctors, scientists, nurses and people from the local community.

In addition, Mayo Clinic has a research subject advocate who is independent of all clinical studies and is a resource for research participants. Contact the research subject advocate by email or at 507-266-9372 with questions, concerns and ideas for improving research practices.

Participation costs

Clinical studies may involve billable services and insurance coverage varies by provider.

Clinical studies questions

• Phone: 800-664-4542 (toll-free)
• Contact form

Cancer-related clinical studies questions

• Phone: 855-776-0015 (toll-free)

International patient clinical studies questions

• Phone: 507-284-8884
• Email: [email protected]

Clinical Studies in Depth

Learning all you can about clinical studies helps you prepare to participate.

Diversity in Clinical Trials

Mayo Clinic is keeping diversity and inclusion in focus for all clinical trials and addressing barriers to enrollment.

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The Institutional Review Board protects the rights, privacy, and welfare of participants in research programs conducted by Mayo Clinic and its associated faculty, professional staff, and students.

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Participate in Clinical Research

Millions of people volunteer to take part in clinical research every year. Their participation helps the medical community learn what works best in preventing and treating diseases. If you’re serious about volunteering, it’s important for you and your family to understand the process and your part in it.

Clinical trials are medical research studies performed with the help of patients who volunteer to try new diagnostic techniques or new therapies, or to be observed as part of a group of people with a specific health issue. The doctors conducting the research seek to answer specific medical questions — ultimately to improve health and patient care. Diversity in clinical trial participation helps ensure new treatments are safe and effective for all people. Learn more about why diversity in clinical research matters here .   

Researchers can gather information for clinical trials using a variety of methods, including:

Interventional

Participants receive experimental treatment — which can include a drug, device, surgical procedure or an existing therapy used in a new way — to determine whether it’s safe and effective.

Observational

Participants receive diagnostic or therapeutic care through their regular care providers and researchers observe and note the health outcome, sometimes through review of patient medical charts.

Chart review

Doctors use data from existing patient health charts to answer the research question.

Researchers study a specific patient population by observing participants with a particular disease, condition or exposure to something that may be affecting their health.

Specimen collection and research repository

Participants donate biologic samples for analysis, including blood, solid tissues, cells, cell cultures or molecules derived from tissues — such as DNA, RNA and proteins — and body fluids. Participants may consent to use of their samples for a particular study or for unspecified future research or testing.

Before joining a clinical trial, you must meet the specific qualifications of the study. Each study has a different set of criteria to help ensure that researchers can answer the health question they plan to investigate. Trial criteria may include age, sex, the type and stage of the disease, and previous treatment history.

Types and Phases of Clinical Trials

Clinical trials can be used for much more than testing new drugs. Types of clinical trials include:

• Treatment trials  – Test new drugs, devices, therapies or surgical techniques.
• Prevention trials  – Look for ways to prevent disease.
• Diagnostic or screening trials  – Find better tests for identifying or screening for certain health conditions.
• Quality of life trials (or supportive care trials)  – Explore ways to improve quality of life for people living with chronic disease.

Drug Trial Phases

For the study of new drugs, or of existing drugs used in new ways, pre-clinical and clinical trials are divided into different phases, numbered from 0 to 4. The earliest phases may look at safety or side effects. A later phase may test whether a new treatment is better than existing treatments:

Pre-Clinical

Research using In Vitro (i.e., test tube or petri dish) or In Vivo (i.e., live organism/animals) to find out if a drug, procedure, or treatment is likely to be useful. Preclinical studies take place before any testing in humans is done.

An exploratory study that requires very limited human exposure to the drug and has no therapeutic or diagnostic goals.

Conducted with an emphasis on safety, the goal is to discover how the drug is processed, toxicity and any side effects.

Gathers preliminary data on effectiveness — whether the drug works in participants with a certain condition, compared with participants receiving a different treatment or a placebo (a medicine that has no effect). 

Measures safety and effectiveness by examining different populations taking different dosages of the drug or in combination with other drugs.

Phase 4 

Occurs after the Federal Drug Administration (FDA) has approved a drug, but researchers want more information about its safety, efficacy or best use.

Medical Device Trial Phases

Clinical trials are also used to test medical devices — healthcare products that don't achieve results through chemical action or by being metabolized. A device can range from something as simple as a tongue depressor or thermometer to a complex instrument, such as a specialized heart valve or robotic surgical device. Device trial phases include:

• Pilot/Feasibility  – May be used to answer basic research questions or provide support for a future study. It's an initial, exploratory stage to determine whether the potential benefit justifies any risk.
• Pivotal  – Evaluates the safety and effectiveness of the device for the intended use, which may require one or more studies. 
• Post-market  – Assesses safety of the device after it’s been used commercially, such as investigating rare adverse events or long-term effectiveness. 

Observational Studies

Some studies do not involve receiving a treatment as part of the study. Instead, they are meant to identify individuals belonging to specific groups and assess them for health outcomes. These studies may involve responding to questionnaires and/or providing biologic samples (such as blood). They may involve a single study visit or multiple visits, such as following up with you at different times throughout a treatment you’re receiving from your regular doctor.

Research Study Funding and Leadership

The people or organizations that initiate studies are known as research sponsors. Doctors, medical institutions, foundations, voluntary groups, device and pharmaceutical companies sponsor medical studies. Federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD) and the Department of Veterans Affairs (VA) also sponsor research. Trials can take place in hospitals, universities, doctors’ offices or community clinics.

Every study has a principal investigator, or lead researcher, who takes direct responsibility for completion of a clinical trial. The principal investigator directs the research and reports to the sponsor.

Informed Consent: Know Your Risks and Costs

Clinical trials aren’t always free and may include risks, even though they’re carefully controlled. Every trial is different. When it comes to cost, some studies will be fully funded, while others will be billed to your insurance company; a combination of both is also a common occurrence.

“Informed consent” is a process of learning key facts about a trial before participating. It’s also a document. Once your doctors and nurses are certain you fully grasp the details — a study’s purpose, procedures, risks, costs, potential benefits and how long it will take — you’ll be asked to sign an informed consent document. It’s not a contract and it’s not binding . You may withdraw from a trial at any time .

How to Find a Clinical Trial

The Center for Information and Study on Clinical Research Participation (CISCRP) educates and informs the public, patients, medical and research communities, the media, and policymakers about clinical research and the role each party plays in the process. They offer a free search service to help you  find a trial that’s right for you .

How to Express Interest in a Study

Trial listings often include a “Contact Us” option to submit contact information if you or a loved one is interested in learning more about whether a clinical trial is right for you/them.  A few tips:

• Expressing interest should include basic contact information (“Dear Study Team - Please contact me to determine if this study is a good fit for me/my loved one.”).
• When coordinating a follow-up call with the study team, they may ask you to discuss medical history that can be found in your health records.  Being prepared to discuss this information is helpful.
• In some cases, you may be asked to authorize access to your medical records to enable the study team to confirm eligibility.  They will ask you to sign a “Medical Records Release Form” or “Authorization for the Release and/or Discussion of Protected Health Information.”  Please read these forms carefully.

Email: [email protected] Phone: 617.414.7090

Participating in a Clinical Trial or Study

Clinical research and trials offer hope for many people and a chance to help researchers find better treatments for others in the future. However, they wouldn't exist without the people who volunteer to participate. By volunteering you may help researchers:

• Help other people who are sick.
• Find safer or better treatments.
• Find ways to improve medical care.
• Learn more about how the human body and mind work.

Clinical Research Participants

Clinical trials require different types of people. Each type chooses to participate for different reasons.

• Healthy Volunteers Healthy volunteers play an important role in research because they help define “normal” ranges. While they may receive no direct benefit, healthy volunteers may choose to participate in clinical research because they want to help others and contribute to advancing science.
• Patient Volunteers People with a health condition or disease may take part in a research study to gain access to a new therapy; take a more active role in their health; or contribute to better understanding, diagnosing, or treating that disease or condition. While some patient volunteers may receive a direct benefit from participating, the overall goal of the clinical trial may be to understand the risks and benefits of a treatment and to scientifically prove whether it is effective.

Who Can Participate?

Researchers use a list of rules called eligibility criteria to decide who is eligible to be in the study. These criteria ensure it is safe for you to participate. They also ensure the study results are due to the treatment being studied and not other factors or chance.

“Inclusion criteria” are factors that allow someone to be included in the study. “Exclusion criteria” are factors that disqualify someone from being in a study. These factors can include:

• Type and stage of a disease
• Previous treatment history
• Other medical conditions

Deciding to Volunteer

There are different ways to participate in clinical research. You may need to visit the hospital, medical or research office, or nursing home. Or you may participate in a classroom, in your own home, or through an online survey or questionnaire. Types of participation can include:

• Completing a questionnaire about health or behaviors, or answering questions in an interview with researchers.
• Donating a tube of blood or a tissue sample.
• Taking part in a clinical trial to find out if new therapies are safe and effective.
• Helping researchers understand how the healthy body works.

Our doctors and providers offer many opportunities for you to participate in clinical research.

Understanding the Risks

Clinical research can have risks, just like routine medical care and the activities of daily living. While some of the risks are minor, other risks are more serious. Some clinical research participants may experience complications that require medical attention. It is rare for people to be seriously injured or die from complications related to clinical trial participation. When considering whether to participate in a clinical trial, it’s important to understand:

• The possible risks of being in the study.
• The level of risk or harm.
• The chance of that risk or harm happening.

Where to Find the Risks

The risks of a specific research study are described in detail in the informed consent form and will be explained to you by the study team. The study team will also explain the purpose of the study and what will happen while you are in it and will answer any questions you have.

Questions to Consider Before Volunteering to Be in a Study

Educating yourself about the study and its risks and benefits will help you determine if participation in a clinical trial is right for you. The research team should be able to answer your questions before you decide.

While every study is different, here are some general questions you will want answers to before you decide. Most of this information will also be in the informed consent document you will need to sign before you join a study. You can also download a PDF of the questions below and print it before you meet the study team.

• What’s the condition being studied?
• Why is this study being done?
• Why is it important?
• Why is the study needed and what important questions will it answer?
• If this is a clinical trial, what phase is it?
• Has it been tested before?
• What were the results of earlier studies of this treatment?
• How likely are those results to apply to me?
• How do they compare with what I would receive if I don’t join the study?
• What alternatives are available to me?
• Will my doctor know?
• Is there a placebo in this study?
• How could the study treatment affect my daily life?
• Will I have to be hospitalized for any of the tests, procedures, or treatments?
• Who can be in the study?
• How long will the study last?
• What will happen to my samples (blood, tissue, etc.) that you collect for the study?
• How do they compare with standard treatment?
• What are the possible benefits of participation?
• Are there reasons I might be removed from the study?
• Who will be in charge of my care?
• Will this study require extra time or travel from me?
• Who is sponsoring the study?
• Will I be paid for participating?
• What will my health insurance cover?
• How will you protect my privacy and the confidentiality of my health and research records?
• What happens if I become sick while participating in the study?
• Can I choose to remain on this treatment after the study is over?
• How are the study data and patient safety being monitored?
• When and where will study results and information go?
• Will you tell me about my personal results?
• Will you tell me the overall study results when it is completed?
• How long do I have to decide whether or not I want to participate?

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• National Institutes of Health

Patient Recruitment

Healthy volunteers.

Clinical research and medical discovery depend on volunteers who participate in clinical research studies.

What's a "healthy volunteer"

Someone with no known significant health problems who participates in research to test a new drug, device, or intervention is a "healthy volunteer" or "Clinical Research Volunteer".

Research participants include healthy volunteers and patient volunteers

Healthy volunteers provide researchers with crucial data because their health information can be used as a comparison. In some studies, researchers need to compare healthy volunteers with people who have a specific disease or condition. Research with healthy volunteers is designed to develop new knowledge, not to provide direct benefit to study participants.

Healthy volunteers have always played a vital role in medical research. When developing a new technique such as a blood test or imaging device, we need clinical research volunteers to help us define the limits of "normal."

These volunteers are recruited to serve as controls for patient groups. They are often matched to patients on such characteristics as age, gender, or family relationship. They are then given the same test, procedure, or drug the patient group receives. Investigators learn about the disease process by comparing the patient group to the clinical research volunteers.

Why are healthy volunteers needed for clinical research?

There are many reasons. When developing a new technique such as a blood test or imaging device, we need clinical research volunteers to help define the limits of "normal." Healthy volunteers are often matched to patients so that certain characteristics such as age, gender, or family relationship, are similar. Healthy volunteers are given the same test, procedure, or drug that the patient group receives. Investigators learn about the disease process by comparing the patient group to the clinical research volunteers.

How can I volunteer?

One way to volunteer is to join the registry for the Clinical Research Volunteer Program. The program, created in 1995, is a resource that helps match potential research volunteers to clinical research studies at the NIH Clinical Center. To participate in the registry, we'll ask you to provide some basic information and give us permission to share that information with the research teams. If you are a potential match to a study's requirements, the study team will contact you.

How do I enroll myself or my child?

You can contact us at 301-496-4763. Parents or guardians must call to register anyone under 18 years of age.

How do I find studies for healthy volunteers?

To find studies for healthy volunteers go to http://clinicalstudies.info.nih.gov/ and search for studies using the word healthy . When you select individual studies, carefully review the study overview and eligibility requirements. If you meet the eligibility requirements, call 1-800-411-1222 (TTY 1-866-411-1010). We can provide participation details on up to three studies a day.

Ask about joining our Clinical Research Volunteer Program registry. To participate in the registry, we'll ask you to provide some basic information and give us permission to share that information with the research teams. If you are a potential match to a study's requirements, the study team will contact you.

Choosing to participate in a clinical trial is an important personal decision. For more information and answers to frequently asked questions about participating in clinical research, visit http://www.cc.nih.gov/participate.shtml . Compensation may be provided.

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Clinical Studies: Information for the Public and Potential Volunteers

Find studies seeking volunteers.

• Studies on the NIH Campus in Bethesda, Maryland (Intramural)
• Studies Across the Country (Extramural)

On this page:

What is a clinical study?

Who can participate in a clinical study, how can i find studies seeking volunteers.

A clinical study is a research study (sometimes called a trial or protocol) in which people agree to participate after providing informed consent. These are carefully designed studies that aim to uncover better ways to prevent, diagnose, or treat conditions, or to better understand specific conditions or processes.

One of the most common types of clinical studies is a clinical trial, in which researchers work with volunteers to find out how a substance or action, also called an intervention, affects a person. Interventions are, for example, drugs, therapies or procedures, medical devices, or lifestyle changes (behaviors), such as changes in diet or level of physical activity. Clinical trials are often designed to see if the intervention prevents, finds, or improves a disease or condition. 

Clinical trials may compare experimental interventions with existing products or processes, or with a product or process that appears to be identical to the intervention being studied but which has no known effect, such as a dummy pill (called a placebo). Clinical trials can also compare two or more existing approaches to determine which is safer or more effective.

In randomized clinical trial, neither the volunteer nor the researcher know which intervention the volunteer is receiving. This ensures that the results are not impacted by any assumptions or preconceived notions of how the intervention will affect the volunteer.

Before being tested on people during in clinical trials, the drug, device, or other approach being studied has been shown to be safe and helpful in a laboratory (such as in studies of cells or tissues in test tubes) and, sometimes, in animals.

Another type of clinical study is an observational study. Observational studies are key to learning about the incidence, prevalence, and prognosis of a disease or condition. Population-based research studies—which are a type of observational study—are critical for estimating how many people are affected by specific conditions and the burden those conditions have on society.

Like clinical trials, researchers collect information about participants, including how treatments or other factors affect the volunteers; however, in observational studies, researchers do not play a role in assigning  the interventions. Observational studies therefore enable researchers to gain key insights into factors (sometimes called determinants) that may be linked to another condition or health outcome. In addition to medicines and other treatments, these factors may include, for example, behaviors, age, gender, and health conditions.  

Clinical studies enroll people— volunteers —who are alike in certain ways, depending on the study's purpose. The study's protocol tells who can join the study and spells out the characteristics that volunteers should have. These are called eligibility criteria . They may include age, gender, general health, and other risk factors. Many studies include healthy volunteers—people with no known significant health problems—as well as people with certain conditions or risk factors for a disease or illness.

Eligibility criteria are a key part of medical research. They help produce results we can trust. After those results are known, the information can help researchers find out who will be helped by the approach being studied—if it's shown to work. For example, a new drug might not work for people with one type of risk factor, or it may work better for men than for women. Eligibility criteria also help protect study participants. They help make sure that if a volunteer is likely to be harmed by something in the study, he or she is not exposed to that risk.

Researchers study only individuals who volunteer to participate in their study. A person who is interested in volunteering is informed about the risks and benefits of taking part in the study, including details about the study approach and any tests that may be performed. When a person decides to participate, he or she signs a consent form. This process is called informed consent, and it lasts as long as the person is in the study. In other words, a volunteer can change his or her mind and leave a study at any time.

Most research funded by the National Institutes of Health (NIH)—which includes the NIDCD—is conducted at universities, medical schools, and other institutions nationwide and around the world. This includes research conducted in laboratories as well as clinical research. Similarly, clinical research studies are conducted in sites throughout the United States.

ClinicalTrials.gov , a website maintained by the NIH, provides current information about clinical studies for potential volunteers, family members, health providers, and others. You can search the entire database or go directly to a list of NIDCD-supported clinical studies .

ResearchMatch.org  is another tool to connect volunteers with appropriate studies. This free, confidential registry was developed in part through NIH funding. After you register on the site, you will receive emails about any studies that appear to be relevant, with instructions about how you can get more information about participating.

NIDCD scientists who work at the NIH in Bethesda, Maryland, also conduct clinical research in communication disorders, primarily in hearing and balance. These scientists and their staff are part of the NIDCD Division of Intramural Research . Most of their clinical studies are conducted at the NIH Clinical Center , the world’s largest complex devoted to clinical research. Here are the current NIDCD clinical studies at the NIH .

OHSU Visitors and Volunteers

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Volunteer Opportunities in Research

Shadow opportunities restricted.

Currently, high school students and undergraduates who want to observe clinical operations and/or visit clinical areas must be a part of vetted and approved through established OHSU programs. See a list of approved programs.

Summary of duties:  The Psychology team within the Autism Diagnostic Clinic is seeking volunteers to help primarily with clinical data entry, while also becoming familiar with standardized autism assessment measures and diagnostic procedures. This data will be used to further our understanding of best practices in the diagnostic assessment of Autism Spectrum Disorder in children and adolescents. Volunteers will also observe autism and neuropsychological assessments with children and teens. Volunteers would work directly with licensed psychologists and psychologist residents (Dr. Rachel Greene and Dr. Susanne Duvall) as part of this opportunity. Volunteers may work remotely (e.g., data entry, optional participation in neuropsychology didactic series), but there will also be some expectation for in-person opportunities such as shadowing clinical assessments. This volunteer position may or may not include being involved on an abstract or manuscript submission based on the volunteer’s interest, experience, and time availability. This will be negotiable with the research team. 

Commitment Requirements and Length of Opportunity : We ask that those that are interested to commit to a minimum of 8-10 hours per week for a minimum of 12 months. 

Eligibility:  Those interested in pursuing graduate study in clinical psychology or a related field may benefit greatly from this opportunity.

Contact Information:  Please send a brief self-introduction along with a resume or CV and availability to  [email protected] . 

The Clinical Research Investigative Studies Program (CRISP) exposes vetted pre-health students to the world of clinical research in emergency medicine through prospective ED research projects at the Marquam Hill campus. The CRISP program will give students considering potential health related careers hands on experience in the Emergency Department (ED) helping facilitate the completion of clinical research studies. The students will interact with both Emergency Department patients and research investigators. Since 2004, CRISP students have successfully screened, consented, and enrolled thousands of patients into multiples studies of varying complexity, including FDA drug and device trials, and cross-sectional and prospective survey studies.

Our CRISP students undergo hours of rigorous fundamental concepts of clinical research, confidentiality, consent and procedural skills, practice informed consent, continuous learning that provides ongoing research education including the CITI modules on Human Subjects Protection, GCPs, and HIPAA. Once trained, the CRISP student will use EPIC (the electronic health record system at OHSU) to proficiently screen all patients who come into the OHSU Emergency Department for each active study protocol.  If a patient is deemed eligible for the study, the CRISP student will inform the patient and/or the patient’s legal guardian (LAR) about the study, and proceed with the informed consent process if the patient is willing to participate.  Once the patient is consented, the CRISP students will move forward with enrollment procedures which can range clinical data abstractions, patient surveys, and/or work with the ED treatment team to collect necessary patient samples and imaging such as ECGs, blood, urine, or stool.

For more details, www.ohsu.edu/crisp  or view the CRISP information Flyer .

Commitment Requirements:

• Pre-health students, highly disciplined and motivated
• Able to commit to 2-four hour shifts (8 hours) per week for 12 weeks -then after 12 weeks able to commit to one-four hour (4 hour) shift per week – 1 year commitment
• Able to commit to 4h of mandatory office auditing shift

Eligibility :

• Pre-health students who can commit to the program for 1 year
• Excellent written and verbal communication skills
• Pre-health students who are highly motivated and detailed-oriented

Interested ? Please email [email protected] to get on the list. We will be hosting information sessions Quarterly throughout the year. To apply, www.ohsu.edu/applycrisp

The Division of Gastroenterology and Hepatology is looking for a volunteer to assist with clinical trials conducted by the division. Current studies include research on monitoring and treatment of pancreas divisum, pancreatic cysts, colon adenomas, abdominal pain, non-alcoholic fatty liver disease, chronic pancreatitis and ulcerative colitis. 

• Primary Duties:  Volunteers will assist with recruitment and eligibility screening, consenting and enrolling participants, conducting study visits and entering data. Additional responsibilities will depend on the volunteer’s interests and the needs of the research team. 
• Commitment:  Minimum of 10 hours per week for 6 months.
• Eligibility : V olunteers should be an undergraduate student, post bac, graduate student, or medical student interested in gaining clinical-translational research experience. Must be detail oriented, organized, timely, and professional. Basic knowledge of computer application software preferred.
• Interested?   Please apply by sending a CV and cover letter explaining your interest to Heather Katcher .

The Novel Interventions in Children’s Healthcare (NICH) program serves youth with a range of complex medical conditions and psychosocial vulnerabilities (e.g., insufficient access to resources, mental health issues, involvement with foster care system). The NICH research team, under direction of Drs. David Wagner and Michael Harris, is evaluating the ability of NICH to meet the triple healthcare aim: improving health, improving care, and reducing medical costs. Currently we are looking for research volunteers to help with a new study assessing risk factors of poor health outcomes in youth with type 1 diabetes who would be most likely to benefit from the program. This is a great educational and training opportunity for those interested in pursuing graduate study in psychology, social work, public health, pediatrics, emergency medicine, and related fields.

• Primary Duties: Research volunteers will primarily assist with participant recruitment, scheduling and tracking completion of study tasks, and medical chart review. There is also opportunity for volunteers to contribute to scientific posters and complete their own independent research project in a lab-related topic.
• Eligibility:  Must be a college junior, senior, or post bac. Must be comfortable interacting with individuals with diverse backgrounds in the hospital and community. Previous experience with adolescents and families, as well as access to reliable transportation, a plus, but not required.  
• Commitment:  Requesting a minimum commitment of 10 hours/week for 9-months.
• Interested?   Please send Sydney Melnick ( [email protected] ) and Dr. David Wagner, PhD ( [email protected] ) a letter of interest, a resume and/or vita, and the names and contacts of 2 individuals who can provide professional references.

For more information about NICH, go to: https://www.ohsu.edu/xd/health/child-development-and-rehabilitation-center/clinics-and-programs/cdrc-portland-programs/nich/

The OHSU Innovation and Commercialization internship program is an educational experience for individuals interested in technology transfer, business development, and/or patent law. Get real-world experience assisting with innovation development and the transition of technology from laboratory to market. Eligible interns can receive a monthly stipend and/or academic credit for program participation. Please note that this program is primarily remote/virtual, but interns in the Portland metro area may have the opportunity for to attend some in-person meetings.

• Commitment: An average of 8 to 10 hours per week for at least six months time. Intern performance will be assessed every three months. The program length may be extended for interns in good standing, per a formal review process.
• Eligibility: Applicants must hold a bachelor's degree in a life science, a physical science, and/or engineering; be pursuing or have received a graduate-level degree in science, medicine, engineering, business, or law; and have an interest in intellectual property, technology transfer, and/or business development as a career goal.
• Interested? Please see the OHSU Innovation and Commercialization Internship Website for application instructions. Contact Nicole Garrison ( [email protected] ) with questions.

The Oregon POLST Registry is a secure electronic record of patient’s end-of-life treatment preferences (POLST- Portable orders for life-sustaining treatment). The Registry relies on the hard work of our generous volunteers to process communication with POLST patients via mailed registration confirmation. Registry confirmation packets include a letter confirming the registrant’s information, medical orders, and other printed materials. The Registry also sends out notifications when a registrant updates their POLST orders and notifications for POLST forms that are about to expire. Volunteers will gain experience handling PHI, diversify knowledge of HIPAA compliance in a non-clinical setting, and support emergency services. The Registry team is truly grateful for the time and energy that volunteers contribute to the Registry’s mission.

• Primary Duties : Preparation of registrant confirmation packets, update letters, and 10 year expiration letters. Volunteers will additionally verify that the content of the mail is being sent to the correct person.
• Commitment : Between 2-4 hours a week for a minimum of 3 months.
• Eligibility : Volunteers must be at least 16 years old. The hours are flexible but must be completed within The Registry’s business hours – Monday through Thursday 7:30 to 4:00 PM.
• Interested? Contact: [email protected] for more information.

The Pediatric Nephrology Department is actively involved with many ongoing national clinical trials including longitudinal observation studies, rare diseases, pharmacokinetics, and investigator initiated research.

• Primary Duties: Volunteers will assist research coordinators with study visits, data collection, data entry, and other scholarly activities with opportunities for networking and participation in publications. We are recruiting volunteers who are enthusiastic about research and would like to gain experience in working with pediatric clinical trials.
• Eligibility: Completion of bachelor degree in science field is preferred but will consider exceptionally qualified applicants. Pre-medical students are encouraged to apply. Must be detail oriented, organized, timely, and professional. Basic knowledge of computer application software preferred.
• Commitment: 6-16 hours per week for least 6 months.
• Interested? Please e-mail Kira Clark at [email protected] with a CV and cover letter.

The Prenatal Environment And Child Health (PEACH) Study, under the direction of Dr. Elinor Sullivan and Dr. Joel Nigg are looking for volunteers to aid in their study. The PEACH Study is a longitudinal research study that will follow mothers from the second trimester of pregnancy until the child is 5 years of age. The purpose of this study is to learn more about how prenatal factors, such as nutrition, influence infant and toddler behavior and risk of neurodevelopmental disorders such as ADHD. This study will determine which prenatal factors are the strongest predictors of alterations in infant and toddler behavior associated with neurodevelopmental disorders, and set the stage for new approaches to prevent or treat child mental health problems.  

• Primary Duties : Volunteers may assist the lab with recruitment, eligibility screening, participant visits, data collection and scoring, data entry, cleaning of physiological data, coding of video taped visits, transcription of audio files and other general laboratory and administrative duties in support of the study. Specific responsibilities wi ll depend on each volunteer’s interests and strengths.  
• Com mitment : A minimum of 4 -15 hours p er week for at least 1 year.
• Eligibility : Must be a junior, senior or post bac (or have exceptional qualifications). Coursework in nutrition, infant and early life development, neurophysiology, and infant and child behavior is preferred/ beneficial. Preferred minimum G PA of 3.0. Must have some availability during the workday with the possibility of working over weekends. Must have strong interpersonal skills, be detail oriented, organized, timely , and professional. Experience working with infants and young children is preferred but not required . Previous experience of behavioral coding if preferred but not required . Basic knowledge of computer application software (SPSS, Excel) is preferred.  
• Interested? Please send your CV, your availability (days/times that you are available to volunteer) to [email protected] . If you have any questions, please contact Jessica Tipsord at [email protected] .  

PRISM research team performs phase II-IV clinical trials in pulmonary clinics and hospital settings. We have multiple ongoing clinical trials in conditions like pulmonary artery hypertension, COPD, and acute respiratory distress syndrome. We accept highly disciplined volunteers to conduct chart reviews of study subjects/patients using electronic medical records (EPIC) and enter the information in a secure database and support research coordinators. Our offices are located on the 1st floor of Emma Jones Hall, Room 121. Shadowing opportunities will be offered to our volunteers after completion of 6 months of volunteering with PRISM.

• Primary Duties : Conduct chart reviews of study subjects/patients using electronic medical records (EPIC) and enter the information in a secure database and support research coordinators.
• Commitment : Volunteers are expected to be available at least two half days (8 hours) a week for a period of 12 months.
• Eligibility : Intended for pre-medical students interested in gaining research experience before applying to medical school. International medical graduates interested in gaining experience in phase 2 and phase 3 clinical trials in pulmonary critical care and sleep medicine may also apply.
• Interested ? Contact: [email protected] with your resume, and a statement of interest/goals for PRISM.

For more information, visit the Division ( https://www.ohsu.edu/school-of-medicine/pulmonary-critical-care-medicine ) and the study team ( https://www.prismtrials.com/ ) websites.

Intermittent research volunteer opportunities available for motivated graduate students or advanced undergraduate students interested in conducting research with transgender and gender diverse youth and their families. Example research projects include retrospective medical chart review, measurement development (e.g., gender euphoria measure), and quality improvement related to transition from pediatric to adult healthcare. The position would be directly supervised by Danielle Moyer, PhD, assistant professor in the OHSU Department of Pediatrics and Division of Psychology.

• Must have excellent interpersonal skills
• Comfortable working in a professional and clinical environment
• Strong writing skills
• Preferably detail oriented and organized
• Familiarity with psychology, medicine, or public health
• Prior experience with youth and/or the transgender community is a plus
• Lived experience or strong allyship preferred
• Commitment: Availability for volunteering for specific projects is subject to change, and specific volunteer duties and required hours will depend on the specific project and current project status. An individualized research training experience will be established based on availability as well as volunteer’s interests and goals. Publication opportunities and/or opportunities to observe clinical care may also be available. Please note that onboarding for non-OHSU affiliated volunteers may take up to 2 months, and therefore may not be a good fit for those looking for short-term experiences. Those affiliated with OHSU may also need additional onboarding.
• Contact Information:  To inquire about current opportunities, please email Dr. Danielle Moyer at [email protected] with a brief statement of interest, availability to volunteer, and any current affiliation with OHSU. If an appropriate opportunity is available, you will be asked to provide your CV/resume and a professional/academic reference. Feel free to email for any qualifying questions or to learn more.

Pre-health (pre-nursing, pre-med, pre-PA, pre-pharmacy, etc.) undergraduate or graduate student volunteers are needed to assist the VirtuOHSU Simulation & Surgical Training Center, team in OHSU Simulation. OHSU Simulation is the health care simulation program at OHSU responsible for training a variety of health care providers in controlled and simulated environment, outside of the clinical setting. There are 3 major simulation centers on the OHSU, Portland, campus: VirtuOHSU Simulation & Surgical Training Center and Multnomah Pavilion Simulation on Marquam Hill as well as the Mark Richardson I Simulation Center in CLSB. This volunteer work would be up on Marquam Hill. 

• Primary Duties:  Duties include assisting with lab events, facilitating set up and break down of training sessions, maintenance of simulation models, administrative duties, organization of supplies, and assisting with the outreach events for surgical simulation. Volunteers work closely with medical students, residents, faculty, and OHSU Simulation Staff to accomplish the mission of OHSU Simulation. 
• Volunteer Schedule:  Flexible, Monday-Friday with variable hours between 0800-1700. Estimated 4-6 hours per week, no less than 2 hours for a day. 
• High School Diploma or equivalent 
• Must be at least 21 years of age for VirtuOHSU Simulation & Surgical Training Center 
• Must be able to show current enrollment as an undergraduate or graduate student 
• Must demonstrate excellence in verbal and written, communication, professionalism, motivation, reliability, organization, time management, and customer-service focus 
• Candidate should be able to work independently and as part of a team, effectively multi-task, be attentive to detail, and possess an aptitude for problem-solving 
• Individual must be able to lift and move 30 pounds easily as needed 
• The volunteer will be willing to work within the same lab space as animal and cadaveric tissues occasionally 
• Professional interest in medicine, health care, simulation, life sciences, and/or medical research 
• Course work in pre-health, pre-medicine or life sciences 
• Professional interest surgery (specifically for VirtuOHSU)  
• Experience in event planning 
• Interested?  Please email Cover Letter, resume, include current GPA, references, and letter of recommendation to: VirtuOHSU Simulation Center: Elena An, Operations Director OHSU Simulation at [email protected]  

Additional Details 

• Parking access on Marquam Hill/OHSU campus is extremely limited. Please be prepared to walk, bike, or use public transit to and from OHSU 
• See more information at http://www.ohsu.edu/xd/education/simulation-at-ohsu/ 
• It is expected that all volunteers dress in business casual attire (collared shirt, no jeans or shorts, no tennis shoes) or clean, well fit scrubs and closed toed shoes.  

Please note: In compliance with Oregon law, OHSU’s COVID-19 Immunization and Education policy will go in effect Oct. 18, 2021. Visitors and volunteers who have an in-person assignment must be fully vaccinated (defined as having received both doses of an original two-dose COVID-19 vaccine, or one dose of an original single-dose COVID-19 vaccine, and at least 14 days have passed since the individual's final dose of COVID-19 vaccine) or adhere to any requirements set forth by OHSU's Occupational Health Clinic for unvaccinated individuals.

Home » What to Expect From Our Volunteer Research Opportunities » Volunteer And Get Paid For Clinical Trials

Volunteer And Get Paid For Clinical Trials

Seize the chance to serve, while getting paid.

If you’re a student or a young individual who wants to earn extra income while finding purpose in service, becoming a volunteer of a paid clinical trial is a great way to achieve both objectives. Being a participant in a medical research study will surely add a sense of fulfillment and purpose to your life.

Biotrial offers a meaningful way to spend your time while earning money. Becoming a paid clinical trial volunteer is easy! Just register to be a participant for one of our online research studies and you can start getting paid during your first screening appointment.

By participating in our healthy studies, you offer hope for many people as you contribute to medical advancement. Our volunteers not only get involved in medical trials for money, they are also here for a purpose – an opportunity to help researchers find better treatments for diseases. In return, we provide compensation as a reward for your courage and contribution to the betterment of our medical state.

Why become a volunteer?

Get compensated for your time.

There are no out of pocket costs to participate in a study, instead, you get paid for doing them. All costs – from your travel expenses to your examination and medication, are covered by the sponsoring organization or individual. You will also get paid for studies as compensation for your time and service. The amount of payment you receive depends on several factors, including the type of trial, the length of your stay, and the number of times you visit the ambulatory. All participants will get paid for the studies they are involved in. Payment details, as well as other pertinent information, will be sent in an informed consent document.

Know that your safety comes first

Biotrial conducts Phase 1 and sometimes first-in-human studies with the highest standards of safety. Clinical trials have always been the cornerstone of medical research under the utmost condition that the safety of participants is ensured at all time. Since most of our clinical studies are in phase 1, we welcome healthy volunteers. A healthy volunteer is someone with no known illness and who is not taking any medication. It is their contribution that greatly impacts the future recipients for which these medicinal products and devices are intended.

Get the reward of helping others

At Biotrial, we consider our volunteers as modern research heroes. When you participate in a medical trial, you are doubly compensated. You get a monetary benefit, and you allow medical research to advance. In a few words, you take part in significant, life-saving causes. You might have a relative with a disease and want to help them. By joining Biotrial trials, you’ll gain a unique and empowering experience. Many of our volunteers report a sense of compassion and fulfillment after participating in our medical studies.

Learn about your health

Every year, hundreds of volunteers complete our onsite medical studies and get to know their medical condition much better. These individuals get frequent health check-ups and close monitoring of their body metabolism. During their stay, they have easy and frequent access to medical doctors and can ask all the questions they want. It is an opportunity to learn about a healthy diet and better understand medical diseases. Our clinical studies also offer the opportunity to better understand science and get more knowledge about diabetes, cancer, heart disease, and other illnesses that plague humanity.

We are looking for healthy volunteers who want to make a difference and get paid for research studies.

We need healthy men and women 18 to 80 all year round to become volunteers for our Phase I paid clinical trials.  Our medical research studies compensate your time and effort. Register now to participate.

Sign up to become a clinical volunteer!

Complete the registration form and call us at 844-246-8459 . Our recruiters will be happy to help you, and it will take 5 minutes of your time to know if you are eligible. Your information will be kept strictly confidential.

Volunteering at UW Medicine

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Experience caring in action

Volunteers are an essential part of our healthcare team. Their dedicated service helps us achieve our mission to improve the health of the public. Their care and commitment makes an indelible impact on our diverse group of patients, families and medical staff.

Our volunteers get to see world class healthcare in action while they learn new skills. Volunteers also find that working with patients gives them the meaningful satisfaction of helping others while learning customer service and professional skills at the same time.

Volunteers help create a welcoming environment for patients and visitors alike by supporting a variety of vital activities within the immediate community. The services offered by our volunteers enrich the overall community and each unique individual within it.

Volunteering at University of Washington Medical Center - Montlake Campus

Thank you for your interest in the UW Medical Center Volunteer Program. Since 1959, University of Washington Medical Center patients, families, guests and staff have benefited tremendously from the commitment of community members and individuals who volunteer at the UW Medical Center.

Volunteers add to the quality of care and service provided to our patients by supporting our "UW Medicine Patients Are First" culture and providing more than 60,000 hours of service each year in more than 70 roles throughout UW Medical Center and UW Medical Center - Roosevelt Clinics.

Volunteer opportunities

Opportunities are currently available four our patient Escort position.  We expect more positions to open in the near future. Volunteers are required to complete a one-month term (16 hours of service) pre-requisite as a patient escort before they are eligible for new assignments.

Patient Escorts

Be a part of our highly regarded team who transport, greet and welcome visitors and patients to UW Medical Center. Our patient escort volunteers are stationed in the dispatch area and work directly with resource team and patient transport staff to assist with the following tasks: Level Green wheelchair transport, specimen deliveries, wheelchair rounding, patient discharges, delivering patient flowers and mail, and creating a warm and welcoming environment for our patients and visitors.

Volunteers receive training on safe wheelchair handling and patient transport, customer service and patient confidentiality. The escort role provides volunteers with an opportunity to work directly with patients while also experiencing the hospital environment in a leading regional and metropolitan acute care facility. In these roles, volunteers become familiar with the diversity of care and services provided at the hospital while experiencing the highest level of patient contact of any volunteer position offered at UW Medical Center. This role provides excellent baseline training to prepare volunteers for other patient care volunteer opportunities.

Retired Adult Volunteers

Please contact Volunteer Services at  [email protected]  to inquire about upcoming opportunities.

Summer Teen Program

The 2024 UW Medical Center Summer Teen Volunteer Program is now open for applications.

The 2024 Summer Teen Volunteer Program takes place July 8th-August 30th . The program is open to teenagers aged 16 through 18, who have not yet graduated from high school. Teenagers who participate in the program build leadership, teamwork and customer service skills and gain valuable exposure to the hospital environment in a nationally recognized academic medical center.

Summer teen volunteers greet and direct visitors, transport patients in wheelchairs, deliver specimens to the lab, deliver flowers and mail to patients, round up wheelchairs, and assist staff with special projects.

Due to the critical healthcare environment at UW Medical Center, candidates for this program must be mature, reliable, self-directed, motivated, confident, approachable, emotionally intelligent, and able to work independently. They must also demonstrate excellent customer service and communication skills and be comfortable working with diverse populations.

2024 Program Deadlines

Our application process contains layers of items that are due. All items must be completed and submitted by Friday, March 15th at 5:00pm . Please make sure all application materials are submitted by this deadline. No exceptions.

To be considered for the program, all applications must be complete. The applicant must meet the age requirements, and all required documents must be received by the stated deadline. Late or incomplete applications will not be considered. Everything is required to be turned in electronically by Friday, March 15th at 5:00pm.

Step 1: Complete the online application

The application is available online and will be delivered to us electronically upon submission. There are required written responses in this application, so please allow yourself time to complete it once you start it. You will not be able to save it and return back to it to complete it. Once the application is submitted you will receive automated email instructions with subsequent requirements that are due by the deadline.

Step 2: Turn in the Reference Form and Background Check

In the automated email mentioned above there are two additional forms that are required to make your application complete. Applications will not be considered complete until these forms are received electronically via email on or before the deadline on Friday, March 15th by 5:00pm. These forms must be received TOGETHER, not separately.

All applications must be received by 5:00pm on Friday, March 15th.

Please Note the Following:

• There are a limited number of positions available; an application does not guarantee
• placement in the program. We usually get four to six times as many applications than there are available placements. Priority placement will be given to Returning Summer Teen Volunteers and applicants that live in the immediate Seattle area.
• Participation in this volunteer program will not give you any preference for admission to the UW . If you live farther away than the immediate Seattle area, volunteering at your local hospital will provide you with the same level of experience and admission consideration as volunteering at UWMC. • If you are 18 years old and graduating high school in June 2024, you can apply for summer volunteering as an adult volunteer after graduation.

Returning Summer Teen Volunteers

Please complete the new online application. Under 'Demographic Information' returning Summer Teen Volunteers can select 'Yes' that you are a returning volunteer.

Returning Summer Teen Volunteers DO NOT have to complete another reference form or background check. Please ignore the email that asks you to submit these two documents (it is sent automatically to any new applicant). All returning volunteers will receive instructions in a few weeks that will tell you what your next steps are. Returning Volunteers also need to get your application in by the deadline, Friday, March 15th 5:00pm.

Requirements for Summer Teen Volunteers 

• Minimum age requirement: 16 at the time of application . No exceptions. You will be required to show identification in person as part of the onboarding process. 
• Commitment: Must be available to attend required interviews, orientations, and trainings in May/June. Minimum total of 24 hours of service completed during the summer months (July/August). Minimum of four hours of service per week, with a maximum of 12 hours per week (Per extra shift availability). 
• A minimum of five weeks participation is required within the seven-week run of the program. 
• No break in service longer than two weeks during the duration of the program. No exceptions. Please do not apply if you know you will be gone for longer than two weeks this summer. 
• Pass Washington State Background Check (provided by UW Medical Center, if accepted). 
• Purchase and wear volunteer uniform polo shirt and follow UW Medical Center Professional Image Policy .
• Follow and abide by UW Medical Center Service Culture Guidelines . 
• Ability to work independently with confidence. 
• Ability to demonstrate excellent critical thinking skills and emotional intelligence. 
• Must provide required documentation of immunization history. 

Required immunizations prior to application (responsibility of volunteer): 

Measles, Mumps, Rubella (MMR). 

Varicella (Chicken Pox) - completed 2 shot series. 

If you have had Chicken Pox and no Varicella vaccine, a blood titer to confirm is required. 

Tetanus, Diphtheria, and Acellular Pertussis (Tdap) within last 10 years. 

Please note: 

Your application will not be considered unless you have official documentation of the immunizations, tests and/or a blood titer for immunizations required BEFORE application. 

You will be asked to provide medical records for these specific immunizations as part of the application process, and these documents will be reviewed by our Employee Health Department. 

How to Apply 

SUMMER TEEN VOLUNTEER APPLICATION

Reference Form/Background Check Form 

• Who may complete the Reference Form? Teacher/Counselor 
• Supervisor/Boss 
• Neighbor or adult family friend that can speak to your character (not a peer) 
• Coach or group leader (i.e. from an organization such as Boy Scouts), church leader or community leader 
• Who may not complete the Reference Form? Relative 
• Peer / Friend 
• Please remember that the completed Reference Form and the Background Check Form must be submitted by the deadline. Your Reference Form should be emailed in with your Background Check form, not separately. All forms must include the original signature and the reference’s contact information. 
• Please note that space is limited. Application does not guarantee placement in the program. 
• Late paperwork will not be accepted. 
• Submit all documents through [email protected] with your name and “Summer Teen” in the subject. 

Applicants will be informed of application status within two weeks after the deadline. 

Questions? 

Please contact UW Medical Center Volunteer Services at [email protected]  

Getting started

Thank you for your interest in the UWMC Volunteer Program at Montlake. Applications are temporarily closed until further notice. Please check back in the winter for availability. Thank you for your patience.

Questions? Please email the Volunteer Services team at [email protected]

Contact information

If you have further questions about the UWMC Volunteer Programs at Our Montlake and Northwest campuses, please email us at  [email protected]  and a Volunteer Services team member will respond to you. Thank you.

Eligibility and time commitment

Adult/College Program: All applicants must be 18 or over and a high school graduate.  All eligible volunteers must complete an application, attend an interview, be screened by Employee Health and comply with all required immunizations, and complete all required training, both written and practical.   Volunteers are required to make a minimum commitment of four hours per week for three months.

Summer Teen Program: This is a summer only program that provides exposure to healthcare careers and service for our community high school students.

Please note: Our volunteer program does not accommodate job shadowing, internships, court ordered service, or job training programs.​ In addition, our program is not intended for those with medical training above a CNA.

Current Volunteers

 Look for updates here soon.

Frequently asked questions

Discover the answers to common questions asked about volunteering at UW Medical Center.

Volunteering at Harborview Medical Center

The care and dedication of our volunteers has a great impact on our diverse group of patients, families and staff. Volunteers at Harborview Medical Center have the chance to:

• Gain experience in a hospital setting, working side by side with leading healthcare professionals
• Observe patient care in a high-volume medical center
• Gain satisfaction from helping others
• Build meaningful relationships
• Give back to the community

As an academic medical center, Harborview promotes a culture of education. If you are considering a career in healthcare, volunteering at Harborview is one of the best experiences you can have.

Harborview volunteers are an essential part of the Harborview community.   Volunteer placement is dependent on the applicant's work history and volunteer experience, as well as the needs of the hospital. Applicants with no prior work or volunteering experience in a healthcare setting will usually be required to complete a 3-month term of 50 hours of service at our Information Desk. Opportunities are variable but generally are available between 8 a.m. and 5 p.m. weekdays. Please refer to our Opportunity Directory for a list of commonly available departments. Please keep in mind that we will place volunteers based primarily on the needs of the hospital and that we cannot guarantee any applicant a position in a certain department. Typical volunteer duties include:

• Restocking supplies in inpatient units
• Providing non-medical comfort to patients
• Preparing rooms for new patients
• Providing administrative support in medical offices
• Reading to patients
• Changing bed linens
• Answering patient calls
• Socializing with patients, speaking with patients in another language
• Escorting non-critical patients to clinic appointments
• Directing patients' families and friends to hospital units, clinics, or other destinations
• Distributing books, magazines and activities to patient rooms and waiting areas

Thank you for your interest in the Harborview Medical Center Volunteer Program. Applications are temporarily closed until further notice. Please check back in April for availability.

Questions? Please email the Volunteer Services team at  [email protected] .

Volunteer Services Harborview Medical Center 325 Ninth Ave Seattle, WA 98104  Box 359788

Email: [email protected] Phone: 206.744.3547

Program applicants must be at least 16 years old to volunteer at the Information Desk and 18 or older for inpatient units and in clinical areas.

The commitment for our program is four hours per week for at least six months. Volunteers may continue beyond six months, if they maintain at least 4 hours per week of service.

Discover the answers to commonly asked questions about volunteering at Harborview.

University of Washington Medical Center – Northwest Campus

Have you ever had to wait while a loved one has surgery? Then you know how comforting it is to have a volunteer keep you company in the waiting room. Have you ever gotten lost on your way to treatment or another area of the hospital? Then you know what a relief it is to see the friendly face of a volunteer who took the time to take you where you were going. Have you ever been hospitalized? Then you know how uplifting it is when a volunteer comes by with magazines, flowers or just a hello. 

Every day, everywhere in the hospital, volunteers add to the caring environment at University Medical Center - Northwest, helping patients and their families at a stressful and sometimes frightening time in their lives. By volunteering your time, you help give back to your community and make University Medical Center - Northwest a friendlier, more welcoming place to everyone who steps foot on our campus.

More than 150 active volunteers of all ages perform a wide variety of tasks at the hospital. For example, volunteers work in the hospital’s gift shop, bring the library cart to patients’ rooms, escort discharged patients and provide information and comfort to families of inpatients and those undergoing surgery. In fact, volunteers can be found in departments throughout the hospital.

While most volunteers work during the weekdays between 8 a.m. and 5 p.m., some volunteers choose to work evenings and weekends.

Thank you for your interest in the UWMC Volunteer Program at Northwest. Applications are temporarily closed until further notice. Please check back in the winter for availability. Thank you for your patience.

If you have any questions, please email  [email protected]  and a Volunteer Services team member will respond to you. Thank you for your patience and we look forward to working with you all again soon!

More information coming soon.

Volunteering at Valley Medical Center

Valley Medical Center volunteers are an integral part of its healthcare team and valuable contributors. Volunteer opportunities are available within different departments and roles throughout the organization.

Volunteer for medical research

By volunteering to participate in medical research, you help researchers learn more about specific medical conditions and the effectiveness of treatments. Studies usually focus on diagnosing, preventing, treating or improving symptoms of a disease, injury or condition. Both healthy volunteers and participants with specific health conditions are needed.

Requirements for volunteering in our hospitals

All UW Medicine volunteers are required to be immunized, screened for tuberculosis and pass a background check.  In addition, volunteers must maintain the highest level of patient confidentiality.

Health Screening

• All volunteers need to provide evidence of immunity against varicella (chickenpox), measles, mumps and rubella (MMR), and tetanus, diphtheria and pertussis (Tdap).  This may be in the form of vaccinations or lab testing.
• Hepatitis B vaccination is not required for volunteers.
• Annual flu vaccination is required for all volunteers.
• TB skin testing is required at orientation and annually. Some volunteers may need two TB skin tests (an initial test and a repeat test) when first starting their volunteer orientation.
• Health screenings, flu vaccinations and TB skin testing are provided free of charge to volunteers. 

Background Check

• All volunteers are required to pass a Washington state criminal conviction history background check before volunteering. To complete the background check, potential volunteers must complete a criminal conviction history form at the time of obtaining their volunteer badge, along with submitting a photocopy of a government issued ID (driver’s license, state ID, passport).
• If you have any prior criminal convictions, please contact the appropriate volunteer services office at the time of application so we can discuss this with you, as it may or may not disqualify you depending on the type of conviction and how long ago it occurred.

Patient Confidentiality

Volunteers must comply with patient confidentiality and HIPAA compliance standards. Training is provided during volunteer orientation. Volunteers who violate HIPAA guidelines will be subject to termination.

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Medical Research Volunteer Program (MRVP): innovative program promoting undergraduate research in the medical field

Michael m. dagher.

Department of Psychology, American University of Beirut, Beirut, 1107-2020 Lebanon

Jessica A. Atieh

Department of Biology, American University of Beirut, Beirut, 1107-2020 Lebanon

Marwa K. Soubra

Department of IT Academic Core Processes & Systems, American University of Beirut, Beirut, 1107-2020 Lebanon

Samia J. Khoury

Abu Haidar Neuroscience Institute, American University of Beirut, Beirut, 1107-2020 Lebanon

Department of Internal Medicine, American University of Beirut, Beirut, 1107-2020 Lebanon

Bilal R. Kaafarani

Department of Chemistry, American University of Beirut, Beirut, 1107-2020 Lebanon

Associated Data

Data are accessible by contacting the corresponding authors.

Most educational institutions lack a structured system that provides undergraduate students with research exposure in the medical field. The objective of this paper is to describe the structure of the Medical Research Volunteer Program (MRVP) which was established at the American University of Beirut, Lebanon, as well as to assess the success of the program.

The MRVP is a program that targets undergraduate students interested in becoming involved in the medical research field early on in their academic career. It provides students with an active experience and the opportunity to learn from and support physicians, clinical researchers, basic science researchers and other health professionals. Through this program, students are assigned to researchers and become part of a research team where they observe and aid on a volunteer basis. This paper presents the MRVP’s four major pillars: the students, the faculty members, the MRVP committee, and the online portal. Moreover, details of the MRVP process are provided. The success of the program was assessed by carrying out analyses using information gathered from the MRVP participants (both students and faculty). Satisfaction with the program was assessed using a set of questions rated on a Likert scale, ranging from 1 (lowest satisfaction) to 5 (highest satisfaction).

A total of 211 students applied to the program with a total of 164 matches being completed. Since the beginning of the program, three students have each co-authored a publication in peer-reviewed journals with their respective faculty members. The majority of the students rated the program positively. Of the total number of students who completed the program period, 35.1 % rated the effectiveness of the program with a 5, 54.8 % rated 4, and 8.6 % rated 3. A small number of students gave lower ratings of 2 and 1 (1.1 % and 0.4 %, respectively).

The MRVP is a program that provides undergraduate students with the opportunity to learn about research firsthand as they volunteer and aid in different research projects. This program also provides faculty members with the help to conduct their research projects and opportunity to influence future generations. It was shown that so far the MRVP has been successful in reaching its goals, for both students and faculty.

Research is an integral part of science that develops not only the field itself, but also the researcher. Without it, there could be no progress. As such an important part of the field, it comes as a surprise to find that its value is not better highlighted during students’ undergraduate education. Research is a process that must be mastered to ensure the continuity of any science. It follows that students should be exposed to research as soon as possible, providing them with enough time to become truly proficient [ 20 ]. Research exposure at such an early academic level serves more than just to engender an interest in research. Several studies have shown an increase in student interest and involvement in their academic field after exposure to research [ 7 , 10 , 11 ]. It also provides them with a platform from which to begin their professional socialization [ 6 , 14 , 15 ]. Research exposure also serves as a means by which to clarify a specific career path [ 6 , 8 , 17 , 18 ]. Students, who engaged in research, reported increased development of their critical thinking [ 3 , 16 , 21 ], specific research skills [ 3 , 5 ], communication [ 6 , 9 , 13 , 20 ], self-confidence in their abilities [ 3 , 7 , 17 ] and sense of self-efficacy [ 1 , 4 , 19 ]. Research also provides the student with the chance to move beyond simple textbook learning and to learn in a more hands-on environment. This experience greatly enriches the education of these individuals.

Exposing undergraduate students to research not only benefits them but also the faculty and researchers who provide this exposure [ 21 ]. By working with undergraduate students, faculty members get the chance to refine and shape the scientific minds of the future. In fact, this is often listed as one of the top motivating factors for faculty to invest in students and their education [ 20 ]. Another highly prominent benefit to the researchers themselves is the added input and contribution that the students bring to the research project. As expected, the longer a student can contribute to a project, the more meaningful the contribution can become. As such, many faculty members encourage research exposure from as early on as Freshman year [ 21 ].

Although all the aforementioned benefits apply to all students, it holds true for undergraduates interested in pursuing a career in the medical sciences more than most. With the dominant wave of evidence-based learning and practice in the medical field, the ability to understand and appreciate research is crucial. Research exposure in the medical field provides students with vital skills such as the ability to understand, interpret and evaluate evidence, research methodology and medical experimental results. These skills allow undergraduates to become active members of the professional medical research community and not just passive spectators.

Most educational institutions lack a structured system that provides students with this highly valuable research exposure in the medical field. This lack constitutes a major shortcoming of the undergraduate education leading up to the medical profession. This paper details a solution to this limitation: the Medical Research Volunteer Program (MRVP). This program aims to systematically and reliably provide research experience to undergraduate students interested in entering the field of medicine. The primary objective of this paper is to describe the structure and function of the MRVP and to promote and facilitate its replication in other universities around the world. Moreover, the secondary objective is to assess the success of the program by analyzing data about participation and satisfaction with the program.

Following is the description of the methodology followed for each of the two primary and secondary objectives of this paper.

Primary objective

The MRVP is a program that targets undergraduate students interested in becoming involved in the field of medical research early on in their academic career. It provides these students with an active experience and the opportunity to learn from and support physicians, clinical researchers, basic science researchers and other health professionals. Through this program, students are assigned to researchers and become part of a research team where they observe and aid on a volunteer basis. For many students, the MRVP will provide their first exposure to the field of research. As students help in the various tasks assigned to them, they will witness first-hand the extensive work that goes into scientific research.

The MRVP was established at the American University of Beirut (AUB) in Lebanon. AUB is one of the leading universities in the region, founded in 1866. AUB has a diverse population of students. There are 8712 students enrolled at AUB (September 2015). Almost one quarter of these students are internationals.

The stages of the MRVP development

The MRVP has passed through three major stages as it developed. Each of these stages is described below.

• The Dormant Phase

The dormant phase of the MRVP was initiated in the Fall of 2013 by one of the authors. It entailed matching students who showed outstanding potential to faculty members who were willing to welcome undergraduate student volunteers into their research teams. Although at the time there was no structured program guiding these matchings, this phase served as a major stepping stone for the program.

• b. The Pilot Study

Following the successful experience of the dormant phase, the pilot phase was conducted by the authors of this paper during the summer of 2014. It entailed the development of the program’s guidelines and procedures. It was in this phase that both the MRVP website and the accompanying portal were developed. The pilot study marked the official inauguration of the MRVP.

• c. The Current Stage

After the base of the MRVP had been firmly established, the current phase of the program began in the Fall semester of 2014. This program relies on four major pillars: the students, the faculty members, the MRVP committee, and the online portal. The following four sections provide more details about each of the four pillars.

The MRVP is open to undergraduate students at AUB who are interested in pursuing a career in the medical field. This is not a program that can cater to the needs of all students. As such, certain inclusion criteria were developed.

One criterion for admission to the MRVP is that the student must be interested in medical research and willing to commit to the requirements of the program. Students from a variety of majors (Biology, Chemistry, Chemical Engineering, Environmental Health, Medical Lab Technology, Nutrition, and Physics) are eligible to apply. In addition, all premedical students, regardless of major, are eligible to join the MRVP. All applicants must have completed a minimum of 24 credits at the sophomore level and have a cumulative average of 78 % or above. Finally, the applicants must provide at least 8 h/week.

Students’ cooperation and adherence to the instructions given to them is vital to the success of the program. Although each research project is governed by its own specific set of rules based on the nature of the research, there are certain guidelines that every student participating in the MRVP should follow. Upon starting work on a research project, students are expected to contribute to the best of their ability in a committed and ethical manner.

All faculty members in the Faculty of Medicine with professorial rank and active ongoing research projects are eligible to participate in the MRVP. The faculty members take the role of mentors to the students and facilitate the students’ learning process by providing supervision, guidance, and support. As such, participating faculty members must have sufficient time to invest in the program. In addition, members should allocate suitable tasks for each student based on their skills, expertise, interests, and background.

The MRVP is headed by a committee that is responsible for overseeing the program. The committee is composed of a combination of faculty members (from both the undergraduate level and the Faculty of Medicine) and student representatives. The roles of the MRVP committee include, overseeing the process and ensuring the success of the program, recruiting students and faculty members to the program and matching students and faculty members based on interests and needs of both. The committee is also responsible for following up on the students’ progress in their volunteer work, resolving any arising conflicts throughout the process and continuously evaluating and developing the program.

Developed in coordination with the Information Technology (IT) department at AUB, the portal is an online program that aids in the compilation of the needed data and facilitates the management of this data. It provides an efficient way for both faculty and students to provide their information. The portal grants the MRVP committee access to this information and allows it to be easily managed and manipulated during matching.

The MRVP process

The MRVP process includes the following steps.

• Student Orientation

The MRVP committee holds a 2 h student orientation before the beginning of each MRVP call. Any student may attend this orientation session although the target audience is primarily those students who have successfully fulfilled all the inclusion criteria previously discussed. It serves to inform students of the program’s procedure and their roles and responsibilities. This orientation also serves to dispel any misconceptions about the program and provides students with an open floor where their questions and concerns can be addressed. Students are also provided with important dates and deadlines for the MRVP. The orientation also serves to teach the students how to interact with the online portal. A live demonstration is included to ensure that all the functions of the portal are explored.

• 2. Student Application

The next step of the process is to collect enough information about the student to understand what type of research he/she is looking for and what role they wish to play. The application form gathers basic personal information as well as information about applicants’ academic records, research experiences, research interests, and time availability. The data gathered through the applications are used to construct a regularly updated database of student profiles allowing students to be promptly assigned to the right research projects. Students apply to the program by creating an online profile that contains all the required information. Applications are time restricted so students only have access to this function at specific predetermined times.

• 3. Faculty Information

Faculty members are prompted to fill out an online form by a mass email and announcements on the institution’s website. This form collects information including contact information such as specialty, current research projects as well as the number of students they are willing to work with and any specific background requirements they wish these students to have. Some faculty members may have more than one active project at any given time and some projects can accommodate more than one student volunteer. Similar to students, each faculty member also provides this information via the generation of an online profile on the portal. This information is also compiled into a database.

• 4. Matching

Matching is the process through which students get paired with projects. Using the information available in the compiled database, the portal generates suggestions of potential student-project matches based on different factors, mainly: research interests, number of proposed interests, availability of projects, as well as time of student’s profile creation. Students are prioritized on a first-come-first-served basis. The portal also assigns alternative matches: cases in which students are available but their research interests are different than the ones needed. The system does not automatically match the students to the projects, it only suggests potential and alternative matching. The matching must be made by members of the MRVP committee via the portal. Both the students and researchers are informed of the details of the match, via an automated email notification. Matching is completed in a timely manner, usually within two days after the application deadline. In this way, students can begin their MRVP experience with a minimal wait between applying and getting matched.

• 5. Work Initiation

Students are expected to initiate contact with the faculty member after being notified via email that they have been matched to a project. Faculty members and students must discuss the research project and the roles and responsibilities which will be delegated to them. Upon finalizing the agreement between the two parties, the student is required to fill out the “MRVP Initiation” form on the portal. This form includes information about the study and the terms of the volunteer work such as the number of hours of work per week and the role of the student in the research project.

• 6. Follow-Up

A “Follow-up” form is submitted, via the portal, to the MRVP office every two months. These reports give the students a platform to voice their suggestions, comments and complaints as well as the chance to inform the committee of what responsibilities have been allocated to them. The report serves to document what students have been doing and the challenges they are facing. It is also used to inform the MRVP committee of any modifications to the initial agreement between the student and the faculty member. This form contains both open-ended and Likert-type questions that aim to assess the satisfaction of the participating students.

• 7. End of Agreement

Students are required to submit a “Student End of Volunteering” form when they finish their volunteer work. This form is a more detailed version of the reports that students have been submitting to the MRVP office bimonthly. The “Student End of Volunteering” form evaluates both the student’s personal experience and the MRVP in general. Although faculty members are not required to submit a “Follow up” form every two months, they are asked to submit a “Faculty End of Volunteering” form at the end of each student’s volunteering period. This gives the researcher an opportunity to evaluate both the student’s performance and the MRVP in general.

• 8. Evaluation and updating the program

The data from the “Follow-Up” and “End of Agreement” forms are used to assess the success of the program after each MRVP call. Any issues that are brought to the committee’s attention through the feedback are addressed before the beginning of the next MRVP call. In addition, the committee continuously evaluates the program in an attempt to enhance and refine it.

Secondary objective

To address the second objective about the outcome of the program, a sub-study was carried out to assess student and faculty participation as well as their evaluation of and satisfaction with the MRVP. Data was collected from the portal for students who joined between the summer of 2014 and the summer of 2015 (all stages of the program excluding the dormant phase). Data from the dormant phase was not included as it was a preparatory stage that was used to develop the program. The data collected fell into two main categories of information: student and faculty. Student information included basic demographics, major, application rates, dropout rates and satisfaction with the program. For the faculty, the information collected was limited to the number of participating researchers and the number of projects each researcher was currently accepting students on. The data was analyzed by generating and comparing means. Trends across calls were also analyzed and interpreted.

Data collection and measures

Data was collected from both students and faculty members. For students, this information included total number of student applicants and demographics such as gender, major, date of enrollment in the MRVP, and academic year at the time of initial registration. This data was collected from the student profiles found on the MRVP portal. For faculty members, information including total number of faculty profiles and projects was also extracted from the MRVP portal. To measure satisfaction, the “Follow-Up” and “End of Volunteering” forms were used. The “Follow-Up” form, administered to students, contains six questions measured on a 5-point Likert scale to assess satisfaction with the program in general. Similarly, seven questions of similar format assessed the students’ satisfaction with the project they had been matched to. Two open-ended questions allowed the students to summarize the role they had played in the research team and allowed them to voice any additional comments. A final question asked students to rate their overall satisfaction with the program on a five-point Likert scale. The student version of the “End of Agreement” form is comparable to the “Follow-Up” form. Data was collected from the faculty members using the faculty “End of Volunteering” form. This form includes seven questions assessing the researchers’ satisfaction with the program and nine questions assessing their satisfaction with the student volunteer. All these questions are measured on a five-point Likert scale. Open ended questions allow the researchers to voice any additional comments.

Data analysis

The data collected from the portal and various forms were analyzed using IBM’s Statistical Package for the Social Sciences (SPSS) version 22.0 (IBM, Inc, Chicago, IL). The data was summarized by generating numbers and percentages. Trends were assessed across time.

Table  1 summarizes the characteristics of the volunteers who were involved in the MRVP. A total of 211 students applied to the program, with more than half of the applicants being female (55.5 %). The highest number of applicants was in the Summer 2014 call ( N =  83), while the lowest was in the Summer 2015 call ( N =  36). The vast majority of the applicants were from the Faculty of Arts and Sciences (82.9 %), followed by the Faculty of Health Sciences (13.7 %), and the minority were from the Faculty of Engineering and Architecture (0.5 %) and Hariri School of Nursing (0.5 %). Within the Faculty of Arts and Sciences, Biology (78.9 %) and Chemistry (12.0 %) students comprised most of the applicants, while Philosophy (0.6 %) students were the least. Regarding the class breakdown, application rates were the highest for juniors (50.7 %) and lowest for sophomores (19.8 %).

Characteristics of volunteers who were involved in the MRVP

a The data found in this subsection under “Number of Students Applied” include those who have applied to more than one call. The total number of students in this subsection is thus greater than 211, the total number of students who applied to the program

The number of matches within each call since the beginning of the MRVP is also presented in Table  1 . A total of 164 matches have been completed. There appears to be no significant difference between the numbers of female (48.2 %) and male (51.8 %) students matched. The highest number of matched students was in the Summer 2014 call (45.7 %), while the lowest was in the Fall 2014–2015 call (15.9 %). Similar to the application rates, the Faculty of Arts and Sciences (86.0 %) has the highest matching rate among the faculties, and Biology (83.0 %) has the highest matching rate among the majors within its faculty. The rates of students matched with respect to class is similar to the rates of students applied.

More than half of the students successfully completed the volunteering period in each call (Table  1 ). Of the total 60 dropped students, the highest was in the Summer 2014 call (50.0 %), followed by Summer 2015 call (20.0 %), and Fall and Spring 2014–2015 calls (15.0 %). The student dropout rates for males (53.3 %) are higher than those for females (46.7 %). With regard to faculty, the majority of dropped students are in the Faculty of Arts and Sciences (83.3 %), of which most are Biology students (88.0 %). In addition, juniors (51.7 %) experienced the highest rates of dropped students, with the lowest rates belonging to sophomores (8.3 %).

Table  2 provides the numbers of registered faculty members and projects in each call. A total of 102 projects were registered in the MRVP. 48.0 % of projects were registered in the Summer 2014 call, 16.7 % in the Fall 2014–2015 call, 20.6 % in the Spring 2014–2015 call, and 14.7 % in the Summer 2015 call. Regarding the faculty member registration, 49.3 % were registered in the Summer 2014 call, 16.0 % in the Fall 2014–2015 call, 22.7 % in the Spring 2014–2015 call, and 12.0 % in the Summer 2015 call, amounting to a total of 75 faculty member registrations. Since the beginning of the dormant phase of the MRVP, three students have each co-authored a publication in peer-reviewed journals with their respective faculty members.

Number of projects and faculty members registered in each MRVP call a

a Each registered project can continue over more than one call. The numbers of projects and faculty members displayed under each call may include both newly registered and continuing ones from previous calls

Response to the “End of Volunteering” form

Figure  1 illustrates the ratings of the effectiveness of the program as reported by the students. The majority of the students provided positive responses and high ratings throughout all the calls. Of the total number of students who completed the program period, 35.1 % rated the effectiveness of the program with a 5, 54.8 % rated 4, and 8.6 % rated 3. A small number of students gave lower ratings of 2 and 1 (1.1 % and 0.4 %, respectively). In the Summer 2014 call, the “End of Volunteering” form was filled out by 63 students, yielding a response rate of 94.0 %. The results showed that 46.0 % of students rated the effectiveness of MRVP with a 5, 49.2 % rated 4, 3.2 % rated 3, and only 1.6 % rated 1. In the Fall 2014–2015 call, none of the students rated the effectiveness of the program with 2 and 1. The response rate was 100.0 %. Twenty-three percent of students rated 5, 58.8 % rated 4, while only 17.6 % rated 3. The overall response rate of the Spring 2014–2015 call was also 100.0 %. More than a third (39.1 %) rated 5, 52.2 % rated 4, and 4.4 % rated 3. Only 4.3 % responded with a 2. Similar positive responses were reported in the Summer 2015 call. Of the total number of students who completed the volunteering period, 66.7 % ( N  = 22) filled out the “End of Volunteering” form, where 31.8 % rated the effectiveness of the program with a 5, 59.1 % rated 4, and 9.1 % rated 3.

Percentage of the student responses to the question about the effectiveness of the MRVP, with 1 being not effective at all and 5 being extremely effective.*

Figure  2 portrays the faculty member response rates concerning the effectiveness of the MRVP. In the Fall 2014–2015 call, the “End of Volunteering” form was filled by seven faculty members, yielding a response rate of 58.3 %. 13.3 % of the respondents rated the effectiveness with a 5, 60.0 % rated 4, and 26.7 % rated 3. The response rate of the subsequent spring semester (58.8 %) was comparable to that of the Fall 2014–2015 call. However, more positive responses were reported, with 40.0 % responding with a 5, 40.0 % responding with a 4, and 20.0 % responding with a 3.

Percentage of the faculty responses to the question about the effectiveness of the MRVP, with 1 being not effective at all and 5 being extremely effective.*

The MRVP is a program that provides to many undergraduate students their first exposure to medical research. Since its launch, the program has directed four calls and matched hundreds of students to projects in need of volunteers. The development of the portal is one of the MRVP’s many milestones that helped the program meet its goals and objectives. The progress and support of the program are dependent on its constant evaluation.

The MRVP was designed to serve the needs of both students and faculty members. Undergraduate students require proper exposure to research and mentorship in the medical field. On the other hand, faculty members require access to a constant supply of assistance to aid them in their research projects. Thus, the MRVP is a program that mutually benefits both parties.

For students, the MRVP provides them with an environment in which they will learn a subject matter in-depth from a hands-on experience and build long-term connections with physicians and researchers. By providing opportunities to participate in every phase of research, the MRVP allows students to learn how to apply scientific methodology and techniques, acquire laboratory skills and improve social skills such as teamwork and oral communication, and strengthen academic credentials. A recent study conducted in 2010 supports the aforementioned based on interviews with students who have engaged in undergraduate research in liberal colleges [ 12 ]. Laursen et al. found that the students who participated in research reported gains that can be grouped into six categories: “Personal/professional gains; Gains in thinking and working like a scientist; Gains in becoming a scientist; Gains of skills; Enhanced preparation for career and graduate school; and Clarification, conformation, and refinement of career and educational goals and interests”.

The MRVP is a signature program that provides more than just research opportunities for undergraduates. The program views research as the exploration of the unknown, whether in scientific or in personal terms. Decisions in the scientific community are as important as decisions taken in a career pursuit. Along with academic excellence, a career in the medical field requires life-long commitment and dedication to achieve success. A recent literature review has shown that completing undergraduate research programs may impact the student’s choice of future occupation [ 2 ]. Yet, many students follow a career path based largely on academic requirements and minute work experience. The MRVP realizes this lack of experience and works to foster intellectual maturity necessary for career decisions.

Faculty members participating in the MRVP are prestigious physicians whose projects reflect the type of work found in medical research. The MRVP emphasizes the significance of working with physicians at an early stage, allowing undergraduates to capture the reality of the work and dispel any misconceptions about this specific career path. The MRVP also allows students to contact faculty members in our committee for advice on academic and professional pursuits. In addition, a recent review on scholarly activity programs revealed that the students’ work in such programs influences their choice in career paths and interest in research [ 2 ]. The program thus highly values the discovery of oneself and works to initiate it at an early stage.

For faculty members, the MRVP provides a constant access to a wide pool of interested students willing to participate and contribute to research projects. It also provides faculty members with the opportunity to impact the minds of future generations by helping talented young students grow professionally and academically. Zydney et al. [ 21 ] conducted a study on faculty perception of undergraduate research at the University of Delaware. Results of surveys filled by faculty members showed that 75 % of the respondents perceive their desire to influence young students’ careers to be “important” or “very important” [ 20 ]. In addition, an undergraduate student’s fresh point of view can sometimes influence the faculty member’s thinking about the research project. Faculty members have an opportunity to communicate their subject with joy and passion, and, in the long-run, entice new students to their fields.

Finally, the MRVP is a program that aims to improve the overall quality of life at AUB and Lebanon. It contributes to the development of the research culture and promotes an interactive scientific community at AUB by inspiring passion for research in young talented minds. The program also helps researchers to be more productive in their research by providing support. This will ultimately translate into an increase in the productivity and impact of research conducted locally and nationally.

The gender demographics presented in Table  1 show the female to male ratio of students applied to the MRVP to be higher than that of the student population in AUB (1 male:1 female). A significantly higher percentage of male students dropped out of MRVP is also depicted. No previous studies have been found to explain such differences in gender demographics in terms of undergraduate research participation.

A decrease in the number of participating students during the calls following the pilot study is also evident in Table  1 . The decrease may reflect the increased difficulty of working on a research project in addition to maintaining high academic performance during the semester. Moreover, after registering for their first call, many volunteers matched with faculty members resume working during the following calls without updating their profiles on the portal, resulting in false negatives. In addition, due to their little experience in conducting research, some volunteers are not clear about what research is. A common misconception held by many students, especially school-leaver entrants, is that medical research always occurs in a lab. The faulty equation of research to lab work has led many students to express dissatisfaction when matched to a project that requires data analysis, proposal writing or manuscript writing. Though dissatisfied, the program evidently served one of its purposes of reflecting to students the possible tedious nature of research projects.

The aforementioned reasons may also explain the student drop out incidence in every call. Table  1 shows no significant difference in the number of students dropped among the calls, as the number dropped is proportional to the number matched in every call. In any case, the high number of students dropping out or disappearing from the program has proved to be a pressing challenge. It generates a decreased tendency of faculty members to participate in the MRVP and ask for more student volunteers in the future, as depicted by the decrease in number of faculty members and projects in Table  2 .

The results in Table  1 also show the Biology and Chemistry undergraduates comprising the highest percentages of students applied and matched. These high proportions are comparable to those of Biology and Chemistry pre-medical students at AUB. In addition, junior students constitute the highest number of profiles registered on the portal (Table  1 ). This may suggest that most students who are interested in the program are those who have found stability in their major and wish to gain better perspective on their academic or professional pursuit.

Like any novel program, it is crucial to objectively assess the success of the MRVP. Since the program is still in its early stages, measuring success in terms of publications will be unreliable. In addition, using the number of participating students and faculty members as a measure has shown to be defective due to false negatives. Our outcome measure is thus the feedback provided by both participating students and faculty. As illustrated by Figs.  1 and ​ and2, 2 , the majority of responses provided by students and faculty are positive, which reflect the success and utility of the program.

The MRVP has faced several challenges, mainly developing, maintaining and upgrading the portal, as well as sustaining students and faculty commitment. At the early stage of the portal development, difficulties arose in managing the students’ profiles and projects opened by faculty members. Challenges that affected the follow-up process of the program included the inability to manually match students and manage the status of faculty members’ projects, the inability to insert comments to student profiles, and the difficulty in culminating results to establish a report. Nonetheless, functionalities and features were added to incrementally adapt to the program maturity and to users’ requirements. Committee members now have access to override the portal and manually match projects and manage the status of the projects. In addition, a reporting tab was added to increase the feasibility of reviewing the results of each call and developing reports.

As for sustaining the students and faculty commitment, it has been a challenge throughout all calls. To address the students’ misconception of what research work entails, a student orientation lecture is held as of the 2015 Fall semester. During the first orientation session, which was organized at the beginning of the 2015 Fall semester, an overview of the program and the application procedure was presented. The wide range of research processes were explained to present a clear idea to the interested volunteers what to expect when entering the field of research. In addition, as of the 2015 Fall semester, the Fall and Spring calls have been merged to increase student commitment to the assigned project and program and thus encourage faculty members to recruit students. The extended work period will also provide students with a better chance to publish their findings.

Other challenges included the low response rate of filling out the “Follow Up” forms by the students, which affected the committee’s ability to monitor the progress of each student after the matching process. Moreover, faculty members have reported accountability issues where students are underperforming in the program due to other priorities such as academic responsibilities. To overcome these challenges, the importance of this step is highlighted during the orientation session. In addition, a system of closer follow up with the students is being implemented. Finally, another challenge is the lack of sufficient projects and faculty members registered in the program, which results in a number of unmatched applicants in almost every call. This challenge is expected to be resolved by merging the Fall and Spring semesters in one call, as previously discussed.

To further foster student commitment and promote educational innovation, the “Ibrahim and Loulu Durr Endowed MRVP Award” was established in May 2015. The $1000 award will be granted annually as of 2016 to an AUB Biology or Chemistry student enrolled in the MRVP, as per the wish of the donors. Based on the MRVP committee evaluation, the student awardee must “demonstrate outstanding medical research capabilities particularly in the biochemistry field”.

Conclusions

The MRVP is a program that provides undergraduate students with the opportunity to learn about research firsthand as they volunteer and aid in different research projects. This program also provides faculty members with the help to conduct their research projects and opportunity to influence future generations. The progress of the MRVP has so far proved to be dynamic, and we anticipate more changes to improve the program’s features and functionalities and to overcome the challenges faced. Discovering one’s career direction at an early stage is one of the program’s main benefits for students, in addition to acquiring and honing research skills which are crucial to both researchers and clinicians. Although the program currently involves only undergraduate AUB students, we envision to expand and collaborate with other universities in Lebanon and the Middle East to promote diversity in the community and expose students to a greater variety of projects. More studies are needed to support our findings and test our undergraduate research program model.

Ethics approval and consent to participate

The work described in this manuscript does not need ethical approval as indicated by the American University of Beirut Institutional Review Board (IRB). The IRB indicated that this work describes a “program improvement rather than a research protocol”.

Participants

The participants in the MRVP were undergraduate students who were informed about the program (through orientation session and announcements via email and on social media). The participants willingly participated in the MRVP and filled up all the required forms.

Consent for publication

Not applicable.

Availability of data and materials

Acknowledgments.

The authors sincerely acknowledge the generous gift of Dr. Ibrahim Durr and Mrs. Loulu Durr to establish the “Ibrahim and Loulu Durr Endowed MRVP Award”. The authors thank Dr. Hussain Ismaeel for fruitful discussions. We would also like to thank Mrs. Mona Boji and Mr. Rami Farran, from the Department of IT Academic Core Processes & Systems, for the development of the MRVP portal. Finally, we acknowledge Mrs. Hala Kaidbey’s support in the administrative MRVP tasks.

The video of the first MRVP student orientation session is posted on YouTube at: https://youtu.be/dy8OeJJhdKs . Accessed 28 April 2016.

No funding was provided for this work.

Abbreviations

Competing interests

The authors declare that they have no competing interests.

Authors’ contributions

MMD and JAA participated in the design of the MRVP and drafted the manuscript. MKS managed the development and implementation of the MRVP portal and drafted the manuscript. SK drafted the manuscript. HT and BRK conceived the MRVP, coordinated the MRVP, designed the MRVP portal and drafted the manuscript. All authors read and approved the final manuscript.

Contributor Information

Hani Tamim, Email: bl.ude.bua@mimath .

Bilal R. Kaafarani, Email: [email protected] .

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We are conducting a research study on the lingering neuropsychiatric symptoms of COVID-19. Participants will complete bloodwork, neuropsychological testing, and an MRI scan over the course of two visits at Johns Hopkins University, School of Medicine.

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Comprehension of informed consent and voluntary participation in registration cohorts for phase IIb HIV vaccine trial in Dar Es Salaam, Tanzania: a qualitative descriptive study

• Masunga K. Iseselo 1 &
• Edith A. M. Tarimo 2  

BMC Medical Ethics volume  25 , Article number:  29 ( 2024 ) Cite this article

Metrics details

Informed consent as stipulated in regulatory human research guidelines requires volunteers to be well-informed about what will happen to them in a trial. However, researchers may be faced with the challenge of how to ensure that a volunteer agreeing to take part in a clinical trial is truly informed. This study aimed to find out volunteers’ comprehension of informed consent and voluntary participation in Human Immunodeficiency Virus (HIV) clinical trials during the registration cohort.

We conducted a qualitative study among volunteers who were enrolled in the registration cohort of HIV clinical trials in Dar es Salaam, Tanzania. A purposive sampling strategy was used to obtain twenty study participants. The data were collected between June and September 2020 using a semi-structured interview guide. In-depth interviews were used to collect the data to obtain deep insights of the individual study participants on the comprehension of informed consent and participation in the clinical trial. A thematic analysis approach was used to analyze the data. Themes and subthemes were supported by the quotes from the participants.

Volunteers described comprehension of informed consent from different perspectives. They reported that various components of the informed consent such as study procedure, confidentiality, risk and benefits were grasped during engagement meetings. Furthermore, the volunteers’ decision to participate in the registration cohort was voluntary. However, trial aspects such as health insurance, free condoms, and medical checkups could have indirectly influenced their reluctance to withdraw from the study.

Engagement meetings may increase the comprehension of informed consent among potential participants for HIV clinical trials. However, trial incentives may influence participation, and thus future research should focus on the challenges of giving incentives in the study. This will ensure comprehension and voluntary participation in the context of HIV clinical trials.

Peer Review reports

In research involving human beings, informed consent is mandatory. There are several regulatory and ethical guidelines highlighting the need for prospective trial participants to understand the information provided during the informed consent process; these guidelines include the Nuremberg Code [ 1 ], the Council for International Organization of Medical Science (CIOMS) [ 2 ], Declaration of Helsinki [ 3 ] and Belmont Report [ 4 ]. However, the reality is that many prospective participants sign consent forms without fully understanding the contents of the forms [ 5 , 6 , 7 ]. A systematic review of studies conducted in low-income countries revealed that comprehension of informed consent is poor among study participants across Africa [ 8 ]. Thus, informed consent may be seriously compromised in these instances. Various factors influence the comprehension of informed consent among prospective participants. This includes language and medical terminology used, insufficient time allocation during the consent process, cultural/traditional reasons, and low education [ 9 , 10 ].

The interest in informed consent comprehension in developing countries has been provoked by clinical trial experts questioning participants’ potential vulnerability and risk of research participation [ 11 , 12 , 13 ]. For example, participants may agree to participate in clinical trials to obtain some of the associated benefits of clinical trials without truly understanding the relevant facts and implications [ 14 ]. Furthermore, the influence of family and economic incentives may also affect comprehension and violate the principles of individual autonomy as applied in informed consent practice. Thus, educating individuals about the nature, purpose, and procedures of clinical research is ethically essential and likely related to the successful recruitment of trial participants [ 15 ]. A lack of knowledge about clinical trials has been documented in multiple communities [ 16 , 17 ] indicating the need to provide information, dispel misinformation, and build trust in communities targeted for trials.

The process of obtaining informed consent continues to be a controversial issue in clinical and public health research carried out in low-income countries [ 18 , 19 ]. For example, when assessing the willingness of volunteers to participate in Human Immunodeficiency Virus (HIV) Vaccine trials, it is also important to check the effectiveness of informed consent given to this group of people. The understanding of informed consent allows potential participants, based on their values, to decide which risks, benefits, and procedures are acceptable to them [ 20 ]. Importantly, some participants do not know what to expect and most are vulnerable to certain aspects. They are affected by information that is believed to be true in the community though this is not proven scientifically. These misperceptions include the side effects of vaccines on health in general, the presence of HIV within the vaccine, and the possibility of contracting or transmitting HIV as a consequence of participation [ 21 ]. In any HIV vaccine trial, these misperceptions need to be addressed appropriately to increase comprehension during the informed consent process.

In the HIV vaccine studies consent process, the guidelines state that informed consent must be obtained at all stages of the trials; i.e. screening, testing, administration of test product, repeat HIV testing, and any other examinations involved [ 22 , 23 ]. It has been emphasized that prospective participants should also be informed of their relatively high-risk behaviour that can lead to HIV infection, the option to receive counselling and access to means for reducing this risk [ 24 ]. It is also important to let participants know that some participants in the trial may nonetheless become infected as a result of their high-risk behaviour and that only some of the participants will receive a test product, while others will receive a placebo [ 25 ]. These are all ethical issues that the participants need to be fully informed about, understand, and make voluntary decisions to participate without coercion or undue influence. Healthy volunteers may have altruistic motivations and actively assume some societal responsibilities [ 26 , 27 , 28 ]. Even in cases of extreme altruism, the right to withdraw is not thereby redundant since volunteers may genuinely change their minds or suffer effects that are unexpected or frightening [ 29 , 30 ]. According to ethical principles, the decision to withdraw from the study for any reason provided by the participants needs to be respected [ 23 ]. These issues are important to be explored in detail among various study participants in any particular study.

Studies in different settings report poor comprehension of different components of informed consent in clinical trials [ 31 , 32 , 33 ]. However, the nature and method of presentation of information, demographic factors, and personal factors can positively or negatively affect the depth of comprehension of informed consent among research participants [ 34 ]. Modification of the provision of the informed consent process and rapid ethical assessment can improve comprehension among participants [ 35 ]. This is crucial for the effective implementation of clinical trials in low-resource settings.

In Tanzania, several HIV vaccine trials have been conducted and informed consent was provided and signed. However, anecdotal evidence shows that some participants who previously consented declined to continue with the trial, after consulting their significant others [ 36 ]. This raises questions about the quality and comprehension of informed consent provided during HIV vaccine trial preparation. In this regard, the question of to what extent the volunteers for the HIV vaccine trial comprehend the information in the informed consent remains unanswered. This study explored the understanding of informed consent and voluntary participation among participants in the registration cohort for the Phase IIb HIV Vaccine Trial in Dar es Salaam, Tanzania.

Materials and methods

A qualitative descriptive study design was conducted to explore the comprehension of different aspects of informed consent. The choice of this design was appropriate due to the dynamic nature and ethical challenges of informed consent in clinical trials [ 37 ]. For this reason, it provided straightforward descriptions of understanding the topic under investigation and the nature of participation among the study participants [ 38 ]. Also, it recognised the subjective nature of the comprehension and thus presented the findings in a way that directly reflected or closely resembled the terminology used in the initial research question [ 39 ].

Population and setting

The study was conducted among female sex workers (FSW) who were participating in the registration cohort for the HIV Pre-exposure prophylaxis and vaccine (PrEPVacc) trial in Dar es Salaam, Tanzania. PrEPVacc is a phase IIb HIV vaccine trial evaluating the efficacy of two HIV prophylactic vaccines with a second randomization to compare Descovy and Truvada as pre-exposure prophylaxis(PrEP) [ 40 ]. The cohort involved HIV-negative FSWs aged between 18 and 40 years who had consented to participate in the preparation phase of the trial. The trial site is located within the tertiary and referral health facility, Muhimbili National Hospital (MNH).

Sampling methods and sample size

A purposive sampling strategy was used to obtain the participants. The procedure for screening, enrolment and follow-up visits is described elsewhere [ 41 ]. For this particular study, the process involved selecting participants who had rich information on the comprehension of informed consent that manifests sufficient intensity to illuminate the nature of success [ 42 ]. A research assistant who was conversant with the PrEPVacc registration cohort purposively identified the participants and invited them for interviews on a convenient day for them. This is because the first author (who conducted all the interviews) was an internal quality control team of the PrEPVacc study. The sampling process continued until information saturation was reached on the 20th participant, i.e. when no new information was elicited as far as the research question was concerned [ 43 ].

Data collection

The data were collected between June and September 2020. This was one year after the participants had consented to participate in the registration cohort. A semi-structured interview guide was used during data collection. The guide was prepared in English and later translated into Kiswahili; the language commonly used by the participants. The main question focused on understanding the components of informed consent. i.e. information disclosure, comprehension, and voluntariness. The specific domains that were covered include the purpose of the research, risks, and benefits associated with participation, decision-making, and voluntariness of participation in the HIV vaccine study. These components were derived from the participant information sheet (PIS) and informed consent form that was used by the participant in the PrEPVacc registration cohort study. The PIS was adapted from the Ethics Review Committee of the World Health Organization (WHO) [ 44 ]. The interview guide was shared among experts in HIV vaccine trials for improvement of the content. The first author conducted all the interviews. All potential participants agreed to be audio-recorded. In-depth interview (IDI) was used to collect the data. We used IDI because we wanted to obtain deep insights from the individual study participants on the comprehension of informed consent in HIV vaccine trials. The interview took place at the research project site. This setting was used for the preparation of the PrEPVacc registration cohort during the scheduled visits. Thus, the participants were familiar with the environment. The interview was conducted in a well-lit room to enable the interviewer to capture the nonverbal cues from the participants during the interview. In addition, the setting was free from external voices. The interview guide which was developed by the researchers consisted of the following questions: (1) What did you consent to participate in? (2) What are the foreseen problems as a result of participation in that study? (3) In your perspective, what benefit do you expect to get as a result of participation in the study? (4) In your view, to what extent the information and samples you provide are kept confidential? 5)To what extent do you think participation in this study is voluntary? ( See Supplementary file )

Each question was followed by specific probes to get a deeper understanding of the phenomenon. Follow-up questions were used as well for more clarification of the concept. The first three participants were used to pre-test the interview guide. This was important to determine if the questions in the interview guide were clear, understandable, and could be answered by the participants. Data from the three pre-test interviews helped to refine the interview guide by adding more probes and some question items were modified to increase clarity. The three pre-test interviews were not included in the current study sample. The interviewer (first author) who was an expert in qualitative research used most of the interviewing skills [ 45 ] which increased cooperation and a sense of acceptance among the participants. The interview continued until no information was obtained by adding new participants.

Data analysis

The data analysis process started as soon as the first two interviews were completed. This helped to expand the probes according to the new information elicited from the participants. The audio-recorded data were transcribed verbatim by an experienced research assistant. The first author read each transcript to countercheck and ensure the accuracy of the information in the original audio data. Some corrections such as typing errors were made to enhance the clarity of the transcripts. Also, translations of the transcripts were made following the principles described by Chen & Boore [ 46 ]. The first author read and re-read all the transcripts carefully, line by line to be immersed in the data and get the first impression of the whole document. The second author read and re-read two transcripts and coded them manually on the margin of the paper. The first author used Nvivo 12 (computer-assisted data analysis software, CAQDAS) to organize and code all the transcripts. This increased ability to explore different possibilities of analysis and interpretation of the data [ 47 ].

Thematic analysis was used to analyze the data. We used a hybrid approach that incorporated both the deductive and inductive approaches as outlined by Crabtree and Miller [ 48 ]. Deductive codes were derived from the main concepts as depicted in the research question and study title. We then created inductive codes by iterative reading and re-reading the transcripts to identify the most significant statements from the participants. This enabled the coding of the rest of the raw data which was not deductively captured in the previous phase. However, no major differences in categories formed between the coding approaches. We refined all the codes developed through both processes to ensure that all the patterns and meanings embedded in the participants’ text were included in the codes. Both authors shared the codes developed for comparison and discrepancies were discussed. We then compared the codes that we had created, identified patterns, and generated themes ( Fig.  1 ) .

Process of Coding and Theme Formation

To ensure that the themes developed were accurate and representative of the data, we returned to the transcripts and compared the themes with the original data to confirm that we did not miss important information. We found that these themes were reflections of the textual data. In this process, some themes were split up into subthemes for explicit representation of the information. The final themes and subthemes were reported and supported with important quotes from the participants.

Ethics approval and consent to participate

Ethical approval.

was obtained from the Institution Review Board of Muhimbili University of Health and Allied Sciences with Ref. No. 282/298/01.C. Participants were well informed about the confidentiality of the information they would provide and that all the audiotapes, transcripts, and written notes containing the participants’ information would be kept confidentially after the completion of the study. Participants were informed of their right to withdraw or discontinue the study at any time they wished to. Written informed consent was obtained from all participants before the interview sessions. All methods were performed in accordance with the relevant guidelines and regulations as stated in the Declaration of Helsinki.

Socio-demographic characteristics

Twenty [ 20 ] participants provided information in this study. The mean age of participants was 27.0 years with a standard deviation ( ±  SD) of 6.3. About two-thirds (13, 65%) had attained primary education and more than half (16, 80%) had experience in sex work between 1 and 10 years. The majority (16, 80%) of participants were mothers of at least one child ( Table  1 ).

Themes and subthemes

Participants’ understanding of various aspects of the research is described under the two themes namely Embracing study knowledge through informed consent and Consequences of Compliance to informed consent. For embracing study knowledge through informed consent; understanding of trial aim and duration, procedure and expectation as well as risks and benefits of research participation are described in detail. The consequences of compliance to informed consent honoured privacy and confidentiality, the nature of voluntary participation and the effects of incentives are elaborated in detail. Also, pitfalls of the right to withdraw from the study are described under this theme ( Table  2 ) .

Theme 1: embracing study knowledge through informed consent

Understanding the trial aim and duration.

Many participants expressed the view that the study aimed to help those involved in commercial sex work, giving them protection against HIV infection. They described the study as an excellent project to reduce the high number of HIV infections among female sex workers. Also, the participants expressed interest in taking care of themselves until the vaccination became available and believed the project would eradicate HIV infection in the country. One participant stated:

“The study itself aims to reduce or completely eradicate HIV infection. That is, by providing vaccination we should not get infected; so, the infected person can continue to use the medication, and the non-infected person may not get infected at all” (P.No.08).

Other participants reported that the main goal of the research project is to develop an HIV vaccine that will help in the prevention of new HIV infections among the high-risk population. One of the participants said:

“Its main goal is to make vaccines available. Thus, once a vaccine is available it can eradicate HIV infection, if possible” (P. No.04 ) .

Some participants were not aware of the study duration. They recollected only the number of scheduled visits that were supposed to be attended. Even though some of them were not conversant with the exact number of visits that could be correlated with the study duration as stated below:

This study has taken… [hesitates], as I am here in the ninth visit. So, there are still about four visits to complete the number of scheduled visits. For me, I started last year, the month of … (she tries to think), Let’s say we are in the second year of research. So here we are at the end of the study” (P.No.08).

Regarding the trial duration, participants were aware that they were taking part in an HIV vaccine trial and were informed about the trial’s duration from the start. However, they did not consider as an important aspect to be comprehended as narrated below:

I still do not know how many years the study will take. You see, because the vaccine has not yet been found, we are still in the study and I think it will probably take maybe even… [Tried to remember but failed to get the answer]. We will participate until the vaccine becomes available” (P.No.13).

Although some participants reported the research to take two years or more, they envisioned that, once the research had started, it would be sustainable as far as the trial participants would be available to participate during the research period.

Understanding of trial procedures and expectation

Many participants expressed that the most important procedure they consented to was attending the scheduled visits and getting checked for health status. They said they were testing for HIV because the project required a person who was not infected with HIV.

“I was told I had to get tested because once infected, you cannot get into the study. Once infected, you can no longer get vaccinated. So, the vaccine does not require a person with a serious illness, such as hepatitis, syphilis, or hypertension, because of an unknown vaccine’s reaction (P .No.07).

They also asserted that every three months there were long and short visits. When they come for a long visit, they are tested for hepatitis, HIV, and pregnancy. When it comes to short-term visits they only tested for HIV. They stated that the pregnancy test was one of the important tests at that time because the project aimed to exclude pregnant women for safety purposes, particularly for the unborn baby. They also reported testing for STIs because they faced so many challenges as sex workers. One participant expressed:

“As I understand we are being tested for pregnancy because you can get pregnant any time. If enrolled in this study, at the end of the day you can get a problem such as miscarriage or a baby born with abnormalities. That is why they said, vaccination is not recommended for pregnant women , (P.No.14)

However, some participants reported that they did not understand the details of various tests as described below:

“ They did not tell me the reasons for testing. But they told me you are testing just to look after your health” (P.No.11).

Participants described that even the participation in the actual vaccine trial would be determined by those who were attending regular visits. They reasoned that they would not be included in the vaccination if they had poor attendance to the scheduled visits. They also added that regular visits to the clinic were beneficial as they were given education about research and vaccination.

Understanding the risks and benefits of trial participation

Participants verbalized that providing blood samples was not a problem. They only stated feeling some pains due to the injection or mild headache after donating the blood. These events were described as a minor side effect that human beings could tolerate and also can be found in any other health facility providing such services as stated by one participant:

“We saw the effects in the early stages of participation when coming to give the blood sample, it hurts. That is the only minor harm or injury. But for effects like feeling dizziness, nausea after donating blood sample, I don’t think it can be considered a major risk for participating in this trial, it depends on the person and how he/she takes it” (P. No. 13).

Many participants reported fear of HIV test results because of risky sexual behaviour undertaken during sex work. They said, sometimes they get clients who do not want to use condoms. Although they were counselled to use protective methods during sexual activities with their clients, they described it to be difficult to implement due to the desire to get a high amount of money when they practice sex without condoms as expressed below:

“I must be scared because I am in the sex business. Someone comes with his load [a large amount of money], he tells you I don’t want to wear [use a condom], I go [have sex] with him dry [ condomless], so I go without a condom” (P.No. 09).

Concerning the benefit of participation, a few participants expressed increased confidence in their sex work. They said the vaccine derived from participation in the study would help in the prevention of HIV infection from their customers and therefore no longer be afraid of contracting HIV. They stated that when meeting with a male customer /client who engages in sex without a condom, they would not be worried anymore like in the beginning as expressed by one of the participants:

“The first benefit is that I will be safe, I will have sex without stress, and I will not get HIV infection. Since I will have received this vaccine, I will be safe, I will have sex with confidence. If I go with him dry [without a condom] my money will increase. I will make important goals of running my family” (P. No 14).

Participants stated that getting checked on their health status was one of the benefits obtained from participation in the study because they had hardly been tested before. They expressed that, although HIV testing services were freely offered in all hospitals, testing for other STIs such as gonorrhoea and syphilis had cost implications that prevented them from checking their health status as expressed below:

“You know testing for HIV is free at the hospital. But to test for gonorrhoea, syphilis must be paid for But when I come here, I get tested for all STIs to know my health in general ” (P.No.17).

They added that participating in the study had increased their morale of knowing their health status. They said that having someone to remind and encourage was an important aspect for them that they had not experienced before joining the study as revealed below:

“If someone has not persuaded you, you cannot go straight to the test for HIV. But if somebody comes and persuades you that if we do this, there is more relief. That is why it was hard on me to check my health status at the facility ” (P.No.20).

Some participants also asserted that participation in the study was a chance to increase their social network particularly when meeting with other participants from different places in Dar es Salaam. They said that the scheduled visits would help in coming out and having fun and exchanging sex work information with others. They also expressed that the collective benefit of the effective vaccine that could have resulted from their participative efforts would free people from the risk of HIV infection.

“ In the future, the benefits that will come out of this [study] are not just for me, it will benefit the whole community. Because once you have completed the vaccine trial, the vaccine will be available for everyone” (P. No .17).

They also added that if the vaccine were available and they were lucky enough to get vaccinated, it would be a benefit to them because they would be free to do their business.

Theme 2: consequences of compliance to informed consent

Honoured privacy and confidentiality.

Many participants expressed that they were informed about the sample collection and that the information they would provide during the study period would be kept confidential. They further elaborated that, the use of numbers instead of names was a very good strategy that increased the sense of trust that their information remained non-identifiable as expressed by one of the participants below:

“What I like is that they do not call names, it is just numbers. So, I have found there is a lot of secrecy that’s why I am not worried. I think my information will be confidential” (P. No. 01).

The use of computers in data entry and preservation of participants’ information was similarly considered an essential component for maintaining privacy and confidentiality. Participants reported that electronic data handling enhanced trust among the research participants and the research team as stated below:

“They use computers. Names are not entered into the computer, they put our numbers that you see. I like it because I only know that number, but no one else knows ” (P.No.13).

A few participants also expressed that, the research team was trustworthy in that they had counselling skills that helped them to understand how their information would be handled and processed. They said, their work would be jeopardized if the information would not be kept confidential. They verbalized that the research team helped to allay participants’ anxiety as narrated by one of the participants:

“When I came here, I told them, I am a sex worker, how do you assure my privacy? These sisters [counsellors and nurses] reassured me, …until now, I observe privacy. This means no one knows what I am coming here for” (P. No. 8).

Participants were also confident that the data and information they provided could not leak because they believed those who work in health facilities, to a very large extent, have taken oaths. They commented that it was not possible to be a doctor or a nurse without taking an oath as part of their ethical practice as expressed below:

“I don’t think my information can leak because I believe those who work here have taken oaths. This is because you cannot be a doctor or a nurse without taking an oath ” (P. No. 13).

Participants praised the way laboratory results were handled. They insisted that it was the right way of giving test results without the presence of other people around. They argued that the room that they used for testing was well furnished which contributed to the high sense of privacy. This maintained confidentiality from data collection to giving results in such a way that no one else could hear or know the test results.

“We were told, for example, if you have been tested and found to be HIV positive, no one will know besides your doctor who tested you or gave your test results ” (P.No. 12).

Nature of voluntary participation

Many participants expressed that participation in the registration cohort for HIV vaccine efficacy trials was voluntary and that they did not feel pressured to participate. They verbalized that they had the freedom of choice whether to join the study or not. In addition, participants described that their decision to participate in the study was not influenced by other external forces. In this case, participants revealed the ability to make their own decisions coupled with the absence of coercion for participation; illustrating the overriding importance of free will and individual choice as described below:

From that first day, we were not told if you sign you will be given money or what. As I saw this, something will help me, even if I am not there, it will help others. Because I participated even if there were no such things, I would participate because I had free will. (P.No. 02)

Participants commented that participation in the study was voluntary to a certain extent because when they started, everyone was given a form to fill in. They said that each person had to read and understand those forms before signing. They also augmented that there were no payments for participation in the study and therefore needed to volunteer as expressed below:

“I wanted to participate through my own free will. I was not forced by anyone. I decided to take part in the study after understanding the purpose of the study. ” (P.No.19).

Some participants went further by emphasizing the importance of meeting the criteria and eligibility of the study rather than the voluntariness alone to participate in the vaccine trial. They said that even if participation was their choice, they should meet the study eligibility criteria as expressed below:

“I think meeting the criteria is the priority. You may want to participate voluntarily, but if you do not meet the criteria, you will not be a participant. Or if you meet the criteria but you are forced, you will not be a participant. So, if you are willing and you meet the criteria you can be a participant” (P.No.13).

Effect of incentives and financial compensation

Many participants pointed out that financial compensation such as transport reimbursement and refreshments that were offered to them could not influence their decision to participate in the prospective vaccine trial. They described that those who expected money as a criterion to participate were not willing and left the registration cohort. This was revealed by one of the participants as shown below:

“I am not the type of person to be given those things (money) to participate … so you get the reputation of saying ‘I am going to that place because I am given the money. Not really. First of all, the amount of money I get here is smaller than what I get from my work”. So, participation in this study is not influenced by the money” (P.No.16).

Some participants described mixed feelings on the role of incentives as a propellant of participation in the study. They verbalized that some services that they were informed to receive as part of the study might have contributed to the consent to participate in the study. They said that the financial challenges coupled with difficulties in obtaining menstrual hygiene materials could have indirectly contributed to continuing participating in the study as stated by one of the participants below:

Yes, they may have attracted me to continue being in the research, because we have things that we are missing. For example, as for the pad or tampons needs, if they give me a pad, when it comes to my menstruation, it can help to move on. In short, such things can make a person attracted even if has no intention (P. No. 02).

The participants expressed that they were given transport reimbursements because of the time they wasted during the clinic activities. Due to the many clinical procedures that each participant had to undergo, for them, it was the right thing to be given such support that could compensate particularly for transport. They stated that such an offer could not be regarded as motivation for them to participate in the study.

Pitfalls of the right to withdraw from the study

An important aspect of voluntary participation in research is the capacity to withdraw from an ongoing study. In this aspect, participants narrated that they had the right to discontinue the study at any time they felt to do so. However, they said they had to explain first the reason for the withdrawal from the study. They added that if they had clear reasons for quitting, the study team would not force the participant to stay in.

“If I want to stop participating, I have the right to report to the study team because I agreed and signed the consent form.” (P.No.07).

Concerning the consequences of withdrawing from the study, participants revealed that they did not think they would be affected in any way. They asserted that there was no penalty for the utilization of usual health services for such withdrawal except that some research incentives would be lost. They mentioned incentives such as health insurance, free condoms, and medical checkups would be lost because they were directly linked to participation in the study. They emphasized condoms were important for their daily commercial sex work.

“If I give up, some of the benefits I get will be affected. Because there will be no one to advise me anymore, I will be going as I am. There will be no one to listen to me, no one to educate me, at the end of the day I will be lost” (P.No.17).

Some participants further expressed that one can stop participating in the study if she gets pregnant or infected and this would be the right of the study team or investigators to exclude from the trial. They added that the trials had several criteria which every participant should have met to be enrolled in the study or continue to participate in the study as asserted by the participant herein:

“You can stop if you are pregnant or infected. It is the right of the project owners to exclude you from the project, and you have the right to leave the project because they do not want you to get pregnant or infected. So, you cannot be forced to stay. Just information is the key” (P.No.08).

This study aimed to explore the understanding of informed consent and voluntary participation in the registration cohort for the Phase IIb HIV Vaccine Trial. The participants described comprehension of informed consent according to their level of understanding. The understanding of the purpose, risks and benefits of participation, trial procedures and confidentiality fairly emerged in the current study. However, the nature of the participants’ occupations might have influenced their voluntary participation in the study. Since the main purpose of the vaccine trials was to develop an HIV vaccine that would help in the prevention of new HIV infections among the high-risk population, participants’ understanding of the purpose is coupled with their desire for HIV risk reduction as a consequence of commercial sex work.

In conjunction with the information disclosed by the trial staff about the study purpose during consenting, the participants have shown adequate comprehension similar to the study reported in Romania [ 49 ]. On the other hand, the duration of the trials was understood by the participants in terms of the scheduled visits and total registration period preparation. This indicates the information provided by the staff team is congruent with the requirements of the ethical guidelines [ 1 , 2 , 3 ] and as per the study protocol. Notwithstanding this understanding of the study duration, it should be borne in mind that our finding is based on the registration cohort only. The actual understanding of the trial duration might have been affected by the continued engagement meetings between the study participants and the trial staff.

The expression that every three months there were long and short visits indicates that the participants understood the planned trial procedure. This is attributed to the regular engagement meetings conducted to enhance participants’ comprehension. Engagement meetings are one of the strategies reported to improve comprehension of informed consent among the trial participants [ 50 , 51 ]. The understanding of specific tests such as HIV and pregnancy during the specified visits was the cornerstone of the registration cohort. It was also crucial for establishing the incidence among the potential trial volunteers as reported in the previous study [ 41 ]. In the current study, an engagement meeting is important because participation in the actual vaccine trial is determined by proper attendance and adherence to the stipulated procedures. The good understanding of the study procedure in our study demonstrates that participants comprehended the information provided by the trial team. This is consistent with other studies reported elsewhere [ 5 , 52 ]. Furthermore, regular visits to the clinic and sample testing are beneficial procedures. This is because the health education provided by the study team helped to know their health status. These activities motivate participants to participate in clinical trials as reported in other studies [ 53 , 54 ]. The pregnancy test as one of the procedures in the registration cohort was well understood by the participants. This is because the project aimed to exclude pregnant women for the safety of the unborn baby [ 55 , 56 ]. This prerequisite condition increased their effort to understand the study procedure and what to expect during the study.

Concerning the risks and benefits of participation in the trials implies that the comprehension of risks in the current study might be attributable to the nature of the study. The risks explained in the consent form and during the consent process were discomfort during sample collection and embarrassment during physical examination. For the pain due to injection, while taking blood samples, the participants might not have perceived these as major ‘risks’ because they might have experienced these discomforts before, sometimes with more sophisticated procedures [ 57 ]. These events are minor side effects that human beings can tolerate. Our findings are consistent with other studies reported in the United States (US) where respondents minimized the risks of research participation [ 24 , 58 ]. The reported fear of HIV test results in the current study is regarded as a risk for participating in the trials. This fear indicates that participants do not have regular HIV testing because of risky sexual behaviour undertaken during sex work. This is similar to other studies reported in China and Indonesia [ 59 , 60 ]. The inconsistent use of condoms increases the fear of HIV testing due to the increased chance of HIV infection among the study population. The high-risk behaviour is motivated by the financial gain after condomless sex as reported in South Africa [ 61 ] and India [ 62 ]. It is worthwhile to note that the risk of minor discomfort and the known safety of the vaccines are well described in this study. However, one of the major risks is the notion that trial participation is somehow protective, which may lead to riskier behaviour and subsequent HIV infection. This is consistent with systematic reviews that found an increase in risky sexual behaviour following HIV prevention trials [ 63 , 64 ].

The trust towards the research team in the confidentiality of information and data as reported in this study may be described based on ethical principles of respect for persons [ 65 , 66 ]. The use of computers in data entry and preservation of participants’ information increases trust among study participants similar to other studies reported elsewhere [ 67 , 68 , 69 ]. The ability to handle participants’ information in the current study indicates that the project recruited a research team who are competent in education, experience and training as recommended in Good Clinical Practice (GCP) for clinical trials [ 70 ]. Additionally, the research team regularly received training in research ethics that enhanced their competencies in handling participants’ information and providing informed consent.

The voluntary participation as expressed by the study participant indicates that participants have altruistic motives and consciously assume certain responsibilities to the wider society as reported in other studies [ 26 , 27 , 28 ]. The intention for voluntary participation was not affected by any other undue influences such as financial reimbursement. This is contrary to studies in the US which reported that financial reimbursement increased willingness to participate in HIV studies [ 71 , 72 ]. It is also worthwhile to note that meeting the eligibility criteria of the study is a prerequisite condition to participate in the HIV clinical trial [ 73 ] rather than the voluntariness alone as stated by the participants in our study.

The right to withdraw from participation in research is recognized in virtually all national and international guidelines for research on human subjects [ 1 , 2 , 3 ]. The concept also applies to biobank samples as reported by Helgesson and Johnsson [ 74 ]. Although the withdrawal right was described during the consenting process, participants in the current study understood this information in the light of the perceived benefit of participation including the free medical checkups. The importance of the inclusion of information about the right to withdraw in the consent form has also been emphasized and reported in other research findings [ 74 , 75 ]. The reason that only pregnancy and HIV acquisition remove the participant from participating is linked to the understanding of the eligibility criteria of the proposed trial. This indicates that the study protocol and procedures were well-grasped by the study participants and the consequences of withdrawing from the study cannot be underestimated. Although, it is stipulated that no penalty for the utilization of usual health services for participants’ withdrawal [ 76 ], this study found that volunteers may not voluntarily leave the study due to the indirect benefits obtained from the study. This can be explained by the fact that our study sample was a high-risk and marginalized population; hence, have little access to HIV prevention services in other settings as a result of self-stigma [ 77 ]. This might have decreased the tendency of volunteers to withdraw from the study once they were recruited.

Several limitations can be described in this study. First, findings may not be transferred to other Tanzanian sites due to the differences in the goals and procedures of the study they were consenting to. Second, the translation of the participant’s excerpts from Kiswahili to English represents another possible limitation. However, a process of back-translation was implemented by experts such that the final statements represent the participants’ intended meaning. Third, in our study, we did not attempt to explore participants’ prior knowledge of participation in similar HIV prevention studies. Thus, we do not know if the comprehension of informed consent and participation might be influenced by prior experience in other studies.

Our study contributes to the literature on voluntary participation and comprehension of informed consent to participation in HIV prevention studies in similar settings in Tanzania. The importance of qualitative empirical research on applications of requirements for informed consent to HIV prevention studies will increase as more people in the community, particularly the high-risk groups volunteer to participate in such studies. Nevertheless, the nature and purpose of the studies and their associated risks and benefits vary in complexity and this can influence the process of communicating information during the consent conversation.

Although the regulatory guidelines describe what the informed consent process should involve for individual participation, in practice the beliefs, values, trust and power dynamics during clinical trial implementation may influence the consent process in which the participants and the research team interact with each other and with their wider social networks. The informed consent process not only involves obtaining a signature from the participants but also continuous engagement between the research team and the volunteers throughout the clinical trial. However, trial procedures may influence participation, and thus future research should focus on the challenges of giving incentives in the study. This will ensure comprehension and voluntary participation in the context of HIV clinical trials. This will further our knowledge of comprehension and voluntary participation in the context of HIV clinical trials.

Data availability

The dataset supporting the conclusions of this article is included in the article.

Abbreviations

Council for International Organization of Medical Science

Computer-assisted data analysis software

Good Clinical Practice

Human Immunodeficiency Virus

In-depth interview

Muhimbili National Hospital

Participant information sheet

Pre-exposure Prophylaxis

Pre-exposure prophylaxis and vaccine

World Health Organization

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Acknowledgements

We are grateful to all participants for making this study possible. The following people or groups of people deserve special appreciation: Mary Ngatulowa and Ashura Rangi for assisting in the recruitment of participants. We also thank Ms. Tecla Mtomoni for her tireless work in transcribing the audio-recorded data. We appreciate the input from Asli Kulane in the preparation of the data collection tool and that provided by Eric Sandstrom for the final refinement of the manuscript. Since the participants were recruited from the PrEPVacc registration cohort, we would like to acknowledge the PrEPVacc trial team members who in one way or another assisted in the accomplishment of this study.

The Sida-MUHAS Collaboration, a partnership for training institutions between Tanzania and Sweden, provided financial support for this study.

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MKI and EAMT contributed to the design, data collection and analysis. MKI developed the first draft of the manuscript. EAMT further reviewed and provided significant additional improvement to the manuscript. Both authors read and approved the final version of the manuscript.

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Correspondence to Masunga K. Iseselo .

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Ethical approval was obtained from the Institution Review Board of the Muhimbili University of Health and Allied Sciences with Ref. No. 282/298/01.C. Participants were well informed about the confidentiality of the information they would provide and that all the audiotapes, transcripts, and written notes containing the participants’ information would be kept confidentially or destroyed after the completion of the study. Participants were informed of their right to withdraw or discontinue the study at any time they wished to. Written informed consent was obtained from all participants before the interview sessions. All methods were performed in accordance with the relevant guidelines and regulations as stated in the Declaration of Helsinki.

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Iseselo, M.K., Tarimo, E.A.M. Comprehension of informed consent and voluntary participation in registration cohorts for phase IIb HIV vaccine trial in Dar Es Salaam, Tanzania: a qualitative descriptive study. BMC Med Ethics 25 , 29 (2024). https://doi.org/10.1186/s12910-024-01033-z

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Dental Students Volunteer in the Community

UConn dental student volunteers provide screenings, education in several communities across the state

Dr. Sarita Arteaga and dental students volunteer at the Remote Area Medical two-day free clinic in Willimantic, Connecticut.

Over the last few weeks, several Connecticut communities got visits from UConn dental students offering free oral care and hygiene education.

Dental students volunteered at the Remote Area Medical (RAM) free two-day clinic in Willimantic, Connecticut. Coordinated by the Medical Club at UConn Storrs, the students helped provide medical, vision, and dental care to over 300 people, with services valued at over $185,000.

33 dental students, along with five faculty members volunteered at the free clinic.

“Through this pop-up clinic in Willimantic, the students from the School of Dental Medicine learn outside of the clinic walls by providing quality dental care through service,” said Dr. Sarita Arteaga, associate dean for students at the School of Dental Medicine. “Our goal is include teaching through outreach and leave a lasting impression for students to continue when they become professionals.  This event allowed our students to do this and it became evident how much they supported one another through this learning.”

RAM provides  free, quality health care services to underserved and uninsured individuals through pop-up clinics around the country.

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