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Executive summary, aclam public statements: medical records for animals used in research, teaching and testing 2, introduction, aclam position on medical records content and scope, components of a medical record, types of medical records, other types of records, conclusions.

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Medical Records for Animals Used in Research, Teaching, and Testing: Public Statement from the American College of Laboratory Animal Medicine

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ACLAM Medical Records Committee, Karl Field, Michele Bailey, Larry L. Foresman, Robert L. Harris, Sherri L. Motzel, Richard A. Rockar, Gaye Ruble, Mark A. Suckow, Medical Records for Animals Used in Research, Teaching, and Testing: Public Statement from the American College of Laboratory Animal Medicine, ILAR Journal , Volume 48, Issue 1, 2007, Pages 37–41, https://doi.org/10.1093/ilar.48.1.37

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Medical records are considered to be a key element of a program of adequate veterinary care for animals used in research, teaching, and testing. However, prior to the release of the public statement on medical records by the American College of Laboratory Animal Medicine (ACLAM), the guidance that was available on the form and content of medical records used for the research setting was not consistent and, in some cases, was considered to be too rigid. To address this concern, ACLAM convened an ad hoc Medical Records Committee and charged the Committee with the task of developing a medical record guideline that was based on both professional judgment and performance standards. The Committee provided ACLAM with a guidance document titled Public Statements: Medical Records for Animals Used in Research, Teaching, and Testing , which was approved by ACLAM in late 2004. The ACLAM public statement on medical records provides guidance on the definition and content of medical records, and clearly identifies the Attending Veterinarian as the individual who is charged with authority and responsibility for oversight of the institution's medical records program. The document offers latitude to institutions in the precise form and process used for medical records but identifies typical information to be included in such records. As a result, the ACLAM public statement on medical records provides practical yet flexible guidelines to assure that documentation of animal health is performed in research, teaching, and testing situations.

Diplomates of the American College of Laboratory Animal Medicine (ACLAM 1 ) have long recognized that the medical record is one of the hallmarks of a program of adequate veterinary care ( Gaertner 2003 ). Although the value of a medical record is widely recognized, a comprehensive guidance document written specifically for the use of medical records in the research, teaching, and testing environment was not readily available to the biomedical research community. A proposal was made by the Animal and Plant Health Inspection Service (APHIS 1 ) in 2003 to institute regulations relevant to medical records for animals used in teaching, testing, and research ( APHIS 2003 ). The proposed regulation was considered by ACLAM and others to be prescriptive rather than based on performance standards because it did not differentiate between spontaneous and induced medical disease and the expectations were unclear, making them difficult to apply ( Gaertner 2003 ; Hanley 2003 ). Therefore, in early 2004, ACLAM formed an ad hoc Medical Records Committee and charged it with the following task: develop guidelines for medical records applicable to the research setting that (1) allow for the use of performance standards and avoid overly rigid engineering standards; and (2) are not so prescriptive that they undermine the veterinarian's use of professional judgment.

The Medical Records Committee, under the guidance of the ACLAM Government Regulatory Affairs Committee (GRAC 1 ), produced a document titled Public Statement: Medical Records for Animals Used in Research, Teaching and Testing ( ACLAM 2004 ). The GRAC provided guidance to the Medical Records Committee so that the final document would accomplish the following:

endorse professional judgment and performance standards, both of which promote a higher level of care than strict engineering standards, without being overly burdensome;

establish clear authority over the medical record program (i.e., Attending Veterinarian and IACUC oversight);

differentiate between the medical record requirements for spontaneous medical conditions versus those that were induced (animal models); and

provide guidance on the type of record that was outside the scope of this document.

The Committee developed a draft public statement, which was reviewed by the ACLAM Board of Directors (BOD 1 ). During development of the public statement, the Committee addressed a number of complex issues. For example,

It was very challenging to write a “one size fits all” guidance document. The public statement was carefully worded to ensure that it provided nonprescriptive guidance on defining what constitutes a medical record, who decides when the record is needed, how the records are maintained, and what is included in the record.

The Attending Veterinarian must have the authority to establish and oversee a medical records program, and the institution must support that authority.

Documentation of experimentally induced disease (animal model) is a research record and is not necessarily a part of the medical record. The course of the disease development is part of an experimental protocol that is reviewed and approved by an institutional animal care and use committee (IACUC 1 ), and the details of that disease are recorded in the research notes. Although this type of information may be part of a research record, it must be readily available for review by the veterinary staff, as well as appropriate for internal (e.g., IACUC) or external (e.g., US Department of Agriculture [USDA 1 ]) oversight uses.

A breeding record is not necessarily a medical record, although it may contain useful information regarding the animal's welfare.

A reference to the research use of the animal should be included in the medical record.

Use of an electronic signature was addressed, as was the need for hand-written records that are “legible to someone other than the writer.”

After several revisions of the document, a final draft of the public statement was approved by the ACLAM BOD. This document was distributed to more than 700 ACLAM board-certified laboratory animal medicine veterinarians for comment. All comments were reviewed and addressed by the committee, a final version was presented to and approved by the BOD, and the public statement was released in October 2004.

As noted in the conclusion of the ACLAM public statement on medical records ( ACLAM 2004 ), “Medical records for animals used in research, teaching and testing are a core component of adequate veterinary care. They should document information associated with management of clinical disease, diagnostic and therapeutic procedures performed, and preventive medical procedures. The methods by which medical records are developed and maintained should be determined by the institution, with the guidance and professional judgment of the Attending Veterinarian. Application of performance standards within the medical record program allows the veterinarian to effectively employ professional judgment, ensuring that the animal receives the highest level of care available.”

The following text is a copy of the ACLAM public statement on medical records, with references added in brackets.

The guidelines summarized below were prepared by the American College of Laboratory Animal Medicine (ACLAM) to assist research facilities in their efforts to establish and maintain animal health medical records (medical records). The professional guidance of the Attending Veterinarian or his/her designee in the development and oversight of a medical records program is essential in the application of these guidelines by an institution [ FASS 1999 ]. Application of performance standards within the medical record program allows the veterinarian to effectively employ professional judgment, ensuring that the animal receives the highest level of care available. The Attending Veterinarian must receive institutional support through the IACUC, Institutional Official, or other means, to assure compliance with the development and effective application of these guidelines for the medical records program.

This document provides guidelines for maintenance of clinical data for animals used in research, teaching and testing. Because of the potential volume of data generated in these settings, there is a risk that critical information may be diluted. For this reason, the precise mechanism chosen to summarize clinical data into a medical record is not prescribed. Each institution must establish its own standards of performance [ Haskins and Eisele 1997 ]. The ACLAM recognizes that varied approaches can be used to achieve the desired outcome of providing the highest quality of care available.

Establishing and maintaining appropriate medical records is a core component of adequate veterinary care [ AVMA 2002 ; Gaertner 2003 ]. Medical records provide documentation of the care given, and communicate that information to other professionals [ APHIS 2000 ; CFR 2003 ; Osborne 1983 ]. Medical record information may be retained in a medical record and/or research record, depending on how the institution wishes to run its program.

The institution, under the guidance of the Attending Veterinarian, should determine the method(s) by which medical records are maintained. Medical records may take many forms [ Haskins and Eisele 1997 ] and have several components, such as written records, computerized records, sentinel animal reports, clinical pathology reports, quality assurance reports, cage cards, and animal disposition reports. These components can be included in the medical and/or research record, or can be linked and available. The method of record keeping should be designed to fit the specific needs of each program of veterinary care.

Oversight of the medical records must fall under the direction of the Attending Veterinarian or his/her designee and the IACUC. Individuals typically responsible for making notations in medical records include veterinary staff (veterinarians and/or veterinary technicians), animal husbandry staff (animal care staff, managers, supervisors), and research staff (e.g., principal investigators, study directors and/or research technicians).

The ACLAM recognizes that many research animals, particularly rodents, can be obtained and maintained in a state of good health, without the necessity of a medical record being created. When medical records for such animals are indicated, group records may be acceptable and may be more efficient than individual records [ FASS 1999 ]. Individual medical records should be maintained for animals that receive regular individual health evaluations, as deemed appropriate by the institution [ Suckow and Doerning 2000 ].

When a medical record is created, the information should be recorded so that the care and course of treatment for animals can be reconstructed, if necessary [ Lees 1981 ]. The medical record should also contain a sufficient amount of detail to determine the research use of the animal. However, clinical notations related to a disease that is experimentally induced in animals do not necessarily need to be maintained in the medical record. Rather, it may be appropriate for this information to be retained within research records, but the information must be readily available for review by the veterinary staff, as well as for appropriate internal (e.g., IACUC) or external (e.g., USDA) oversight uses.

When institutional representatives determine that a medical record should be created, the record typically contains the following types of information [ APHIS 2000 ; NRC 1996 ]:

Identification of the animal(s) or group(s),

Clinical information such as results of physical examination, the behavior of the animal, and notations regarding observed abnormalities, illnesses, and/or injuries,

Immunizations and other prophylactic treatments and procedures as appropriate for the species,

Documentation of diagnostic tests and interpretation,

Reference to the research intervention, where appropriate,

Treatment prescribed and provided, the clinical response, and follow up,

Surgery, anesthesia, analgesia and peri/post-operative care,

Control of pain and distress,

Documentation of euthanasia or other disposition,

Documentation of necropsy findings, if indicated.

Medical records should be written to define and reflect the current level of understanding of a health problem [ FASS 1999 ]. The record should be refined as additional information is acquired, and communicate the medical logic and case progression [ Chavis and Hutton 1998 ; Lees 1981 ].

Notations in the medical record should be made by individuals who have administered treatments, or made direct observations or evaluations of the animal(s) or their diagnostic results, or their designee. Individuals typically responsible for making notations in the record include veterinary staff (veterinarians and/or veterinary technicians), animal husbandry staff (animal care staff, managers, supervisors), and research staff (e.g., principal investigators, study directors and/or research technicians). All entries in the record should be dated, indicate the originator of the entry (e.g., initials, signature, and electronic signature) and be legible to someone other than the writer [ CareFirst 2004 ].

Facilities may wish to consider establishing a list that summarizes the animal's medical history at a glance. This may be particularly valuable for animals that undergo a major survival surgery and/or are reassigned to another project. A copy of the medical record, or a pertinent summary of that animal's medical history, should follow the animal upon reassignment [ APHIS 2000 ].

A. Individual Health Records

Individual health records should be maintained for animals that receive regular individual health evaluations, as deemed appropriate by the institution [ Haskins and Eisele 1997 ]. Examinations performed on the animal should be recorded; however, performance of routine preventive medical procedures on an entire group of animals may be recorded as a group record. Clinical records maintained on individual animals are used to document routine preventive care (e.g., physical examinations, vaccinations, dental prophylaxis), as well as spontaneous (non-induced) illnesses or injuries [ NRC 1996 ]. These records should also document peri-surgical and peri-anesthetic care.

B. Group Health Records

Group health records may be appropriate for animals that are members of a larger cohort (e.g. a colony/school/flock/herd/room), as well as for animals that undergo periodic evaluation by means of examination of several representative individuals of the group [ Haskins and Eisele 1997 ; Suckow and Doering 2000 ]. Documentation of peri-surgical and peri-anesthetic care may also be done as a group record.

C. Records of Sedation or Anesthesia and Peri-surgical/Peri-procedural Care for Survival and Terminal Procedures

Records of sedation and anesthesia (with or without surgery), and peri-surgical / peri-procedural care, document adequate veterinary care and the alleviation of pain and distress during the conduct of these procedures [ Haskins and Eisele 1997 ], whether survival or terminal. Procedures of this nature should be documented in a medical record and/or research record, or can be linked and available to the record, as deemed appropriate by the institution.

The procedural documentation may contain:

Animal or group identification and the date of the procedure,

All drugs administered, including dose, route, time, and the ability to identify the person administering the drugs,

A description of the surgical procedure and identification of the surgeon(s),

Ongoing findings during monitoring,

Notation of any variations from the normal and expected events during the anesthetic and recovery periods, including the actions taken and the time performed, the animal's response to these actions, and the ability to identify the person performing these actions,

Assessment for pain and distress,

Actions taken to alleviate pain and distress, including non-pharmacologic interventions, and the response to these actions,

A notation defining the end of the monitoring period (euthanasia or functional recovery from the sedation or anesthesia), including the time, date, and the ability to identify the person performing this observation.

Experimentally induced disease/research records, and breeding records, are not necessarily a part of the medical record, but they may provide useful adjunctive information about the animal's welfare. The information in these records may be included as part of the medical record when deemed appropriate by the Attending Veterinarian.

A. Experimentally Induced Disease/Research Record

A distinction must be made between spontaneous disease (rare in young, microbiologically-defined research animals) and experimentally induced diseases. Clinical notations for disease which is experimentally induced in animals do not necessarily need to be recorded in the medical record. Rather, it may be appropriate for this information to be retained within the research records, which must then be readily available for review by the veterinary staff. If research data in a researcher's notebook or computerized database cannot be readily retrieved, then essential clinical data should be included within the medical record.

Research records can be maintained for an individual or a group of animals, and may take on many forms and have several components, such as a laboratory notebook, cage cards, or other suitable records. Such information may include: animal identification information (may be group ID); date and type of procedure performed/compound administered/etc; routine observations defined by the protocol; adverse or unexpected complications; and date of euthanasia or termination of study.

B. Breeding Records

Records for breeding animals may be maintained to document medical information relevant to reproduction. When maintained, these records can be included within the animal's medical record, or can be linked and available to the record. These records should allow the veterinary and/or research staff to identify the pedigree of the animal, when appropriate [ NRC 1996 ]. Typically useful information includes the animal identification, genotype, sire and dam, animals with which the individual has been paired, and the outcome of each breeding attempt. Additional information which allows identification of the animal's breeding history and productivity may be included as needed [ FASS 1999 ].

Medical records for animals used in research, teaching and testing are a core component of adequate veterinary care. They should document information associated with management of clinical disease, diagnostic and therapeutic procedures performed, and preventive medical procedures. The methods by which medical records are developed and maintained should be determined by the institution, with the guidance and professional judgment of the Attending Veterinarian. Application of performance standards within the medical record program allows the veterinarian to effectively employ professional judgment, ensuring that the animal receives the highest level of care available.

ACLAM [American College of Laboratory Animal Medicine] . 2004 . Public Statements: Medical records for animals used in research, teaching and testing . Available online ( http://www.aclam.org/aclam_public.html ACLAM public statements).

APHIS [Animal and Plant Health Inspection Service], US Department of Agriculture . 2000 . Regulation of agricultural animals (Policy 3). In: Animal Care Resource Guide . Washington DC : USDA . Available online ( http://www.aphis.usda.gov/ac/polmanpdf.html ).

APHIS [Animal and Plant Health Inspection Service], US Department of Agriculture . April 11, 2003 . Docket No. 97-033-1: Animal Welfare; Medical Records. ACTION: Proposed rule. Available online ( http://www.aphis.usda.gov/ac/medicalrecords.html ).

AVMA [American Veterinary Medical Association] . 2002 . Principles of Veterinary Medical Ethics of the American Veterinary Medical Association . Section VII.A. Available online ( https://vetboard.glsuite.us/Renewal/Resources/Main/Principles%20of%20Veterinary%20Medical%20Ethics%20of%20the%20AVMA.doc ).

CareFirst [CareFirst Blue Cross Blue Shield] . 2004 . Medical Record Documentation Standards . Section 4. Available online ( http://www.carefirst.com/providers/html/MedicalRecord.html ).

CFR [Code of Federal Regulations] . 2003 , Title 9, Chapter 1, Subchapter A - Animal Welfare. US Department of Agriculture, Animal and Plant Health Inspection Service . Available online ( http://www.nal.usda.gov/awic/legislat/usdaleg1.htm ).

Chavis SA Hutton JI . 1998 . The medical record . In: McCurnin DM ed. Clinical Textbook for Veterinary Technicians . 4th ed . Philadelphia : W. B. Saunders . p 59 – 78 .

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FASS [Federation of Animal Science Societies] . 1999 . Guide for the Care and Use of Agricultural Animals Used in Agricultural Research and Teaching . 1st rev ed . Savoy IL : Federation of Animal Science Societies . p 20 – 25 .

Gaertner DJ . June 3, 2003 . Letter to APHIS on proposed medical records rule making, Docket No. 97-033-1, Animal Welfare; Medical Records . Available online ( http://www.aclam.org/aclam_public.html ). ACLAM public statements .

Hanley MF . June 9, 2003 . Letter to APHIS RE: Animal Welfare, Medical Records, Docket No. 97-033-1, Animal Welfare; Medical Records .

Haskins SC Eisele PH . 1997 . Postoperative support and intensive care . In: Kohn DF Wixson SK White WJ Benson GJ eds. Anesthesia and Analgesia in Laboratory Animals . New York : Academic Press . p 381 – 382 .

Lees GE . 1981 . Symposium on physical diagnosis. History-taking and development of the examination record . In: Bistner SI ed. The Veterinary Clinics of North America. Small Animal Practice . Vol. 11 / No. 2 . Philadelphia : W. B. Saunders Co . p 441 – 452 .

NRC [National Research Council] . 1996 . Guide for the Care and Use of Laboratory Animals . 7th ed . Washington DC : National Academy Press . p 46 – 47 .

Osborne CA . 1983 . The problem-oriented medical system . In: Furumoto HH ed. The Veterinary Clinics of North America. Small Animal Practice . Vol. 13 / No. 4 . Philadelphia : W. B. Saunders Co . p 745 – 790 .

Suckow MA Doerning BJ . 2000 . Assessment of veterinary care . In: Silverman J Suckow MA Murthy S eds. The IACUC Handbook . Boca Raton : CRC Press . p 460 .

Abbreviations used in this article: ACLAM, American College of Laboratory Animal Medicine; APHIS, Animal and Plant Health Inspection Service; BOD, Board of Directors; GRAC, Government Regulatory Affairs Committee; IACUC, institutional animal care and use committee; USDA, US Department of Agriculture.

Reprinted with permission from the American College of Laboratory Animal Medicine, State of Illinois.

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Medical records for animals used in research, teaching, and testing: public statement from the American College of Laboratory Animal Medicine

Affiliation.

  • 1 Department of Veterinary Sciences, Bristol-Myers Squibb, Mail Code G1.3701, Princeton, NJ 08543-4000, USA. [email protected]
  • PMID: 17170494
  • DOI: 10.1093/ilar.48.1.37

Medical records are considered to be a key element of a program of adequate veterinary care for animals used in research, teaching, and testing. However, prior to the release of the public statement on medical records by the American College of Laboratory Animal Medicine (ACLAM), the guidance that was available on the form and content of medical records used for the research setting was not consistent and, in some cases, was considered to be too rigid. To address this concern, ACLAM convened an ad hoc Medical Records Committee and charged the Committee with the task of developing a medical record guideline that was based on both professional judgment and performance standards. The Committee provided ACLAM with a guidance document titled Public Statements: Medical Records for Animals Used in Research, Teaching, and Testing, which was approved by ACLAM in late 2004. The ACLAM public statement on medical records provides guidance on the definition and content of medical records, and clearly identifies the Attending Veterinarian as the individual who is charged with authority and responsibility for oversight of the institution's medical records program. The document offers latitude to institutions in the precise form and process used for medical records but identifies typical information to be included in such records. As a result, the ACLAM public statement on medical records provides practical yet flexible guidelines to assure that documentation of animal health is performed in research, teaching, and testing situations.

Publication types

  • Animal Experimentation*
  • Animal Welfare
  • Animals, Laboratory*
  • Records / veterinary*
  • Veterinary Medicine / methods*
  • Veterinary Medicine / standards

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Medical records for animals used in research, teaching, and testing: Public statement from the American College of Laboratory Animal Medicine

  • Administration (AHS)

Research output : Contribution to journal › Review article › peer-review

Medical records are considered to be a key element of a program of adequate veterinary care for animals used in research, teaching, and testing. However, prior to the release of the public statement on medical records by the American College of Laboratory Animal Medicine (ACLAM), the guidance that was available on the form and content of medical records used for the research setting was not consistent and, in some cases, was considered to be too rigid. To address this concern, ACLAM convened an ad hoc Medical Records Committee and charged the Committee with the task of developing a medical record guideline that was based on both professional judgment and performance standards. The Committee provided ACLAM with a guidance document titled Public Statements: Medical Records for Animals Used in Research, Teaching, and Testing, which was approved by ACLAM in late 2004. The ACLAM public statement on medical records provides guidance on the definition and content of medical records, and clearly identifies the Attending Veterinarian as the individual who is charged with authority and responsibility for oversight of the institution's medical records program. The document offers latitude to institutions in the precise form and process used for medical records but identifies typical information to be included in such records. As a result, the ACLAM public statement on medical records provides practical yet flexible guidelines to assure that documentation of animal health is performed in research, teaching, and testing situations.

  • Adequate veterinary care
  • Attending veterinarian
  • Medical record
  • Performance standard
  • Professional judgment
  • Research animal

Publisher link

  • 10.1093/ilar.48.1.37

Other files and links

  • Link to publication in Scopus
  • Link to the citations in Scopus

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  • Higher Education Institution Social Sciences 100%
  • Teaching Research Social Sciences 100%
  • Animals Social Sciences 100%
  • Laboratory Medicine and Dentistry 100%
  • Medical Record Medicine and Dentistry 100%
  • Administrative Structure Social Sciences 42%
  • Counselling Social Sciences 42%
  • Organizations Social Sciences 28%

T1 - Medical records for animals used in research, teaching, and testing

T2 - Public statement from the American College of Laboratory Animal Medicine

AU - Field, Karl

AU - Bailey, Michele

AU - Foresman, Larry L.

AU - Harris, Robert L.

AU - Motzel, Sherri L.

AU - Rockar, Richard A.

AU - Ruble, Gaye

AU - Suckow, Mark A.

N2 - Medical records are considered to be a key element of a program of adequate veterinary care for animals used in research, teaching, and testing. However, prior to the release of the public statement on medical records by the American College of Laboratory Animal Medicine (ACLAM), the guidance that was available on the form and content of medical records used for the research setting was not consistent and, in some cases, was considered to be too rigid. To address this concern, ACLAM convened an ad hoc Medical Records Committee and charged the Committee with the task of developing a medical record guideline that was based on both professional judgment and performance standards. The Committee provided ACLAM with a guidance document titled Public Statements: Medical Records for Animals Used in Research, Teaching, and Testing, which was approved by ACLAM in late 2004. The ACLAM public statement on medical records provides guidance on the definition and content of medical records, and clearly identifies the Attending Veterinarian as the individual who is charged with authority and responsibility for oversight of the institution's medical records program. The document offers latitude to institutions in the precise form and process used for medical records but identifies typical information to be included in such records. As a result, the ACLAM public statement on medical records provides practical yet flexible guidelines to assure that documentation of animal health is performed in research, teaching, and testing situations.

AB - Medical records are considered to be a key element of a program of adequate veterinary care for animals used in research, teaching, and testing. However, prior to the release of the public statement on medical records by the American College of Laboratory Animal Medicine (ACLAM), the guidance that was available on the form and content of medical records used for the research setting was not consistent and, in some cases, was considered to be too rigid. To address this concern, ACLAM convened an ad hoc Medical Records Committee and charged the Committee with the task of developing a medical record guideline that was based on both professional judgment and performance standards. The Committee provided ACLAM with a guidance document titled Public Statements: Medical Records for Animals Used in Research, Teaching, and Testing, which was approved by ACLAM in late 2004. The ACLAM public statement on medical records provides guidance on the definition and content of medical records, and clearly identifies the Attending Veterinarian as the individual who is charged with authority and responsibility for oversight of the institution's medical records program. The document offers latitude to institutions in the precise form and process used for medical records but identifies typical information to be included in such records. As a result, the ACLAM public statement on medical records provides practical yet flexible guidelines to assure that documentation of animal health is performed in research, teaching, and testing situations.

KW - Adequate veterinary care

KW - Attending veterinarian

KW - Medical record

KW - Performance standard

KW - Professional judgment

KW - Research animal

UR - http://www.scopus.com/inward/record.url?scp=39049191876&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=39049191876&partnerID=8YFLogxK

U2 - 10.1093/ilar.48.1.37

DO - 10.1093/ilar.48.1.37

M3 - Review article

C2 - 17170494

AN - SCOPUS:39049191876

SN - 1084-2020

JO - ILAR Journal

JF - ILAR Journal

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Medical records for animals used in research, teaching, and testing: Public statement from the American College of Laboratory Animal Medicine

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Research output : Contribution to journal › Review article › peer-review

Medical records are considered to be a key element of a program of adequate veterinary care for animals used in research, teaching, and testing. However, prior to the release of the public statement on medical records by the American College of Laboratory Animal Medicine (ACLAM), the guidance that was available on the form and content of medical records used for the research setting was not consistent and, in some cases, was considered to be too rigid. To address this concern, ACLAM convened an ad hoc Medical Records Committee and charged the Committee with the task of developing a medical record guideline that was based on both professional judgment and performance standards. The Committee provided ACLAM with a guidance document titled Public Statements: Medical Records for Animals Used in Research, Teaching, and Testing, which was approved by ACLAM in late 2004. The ACLAM public statement on medical records provides guidance on the definition and content of medical records, and clearly identifies the Attending Veterinarian as the individual who is charged with authority and responsibility for oversight of the institution's medical records program. The document offers latitude to institutions in the precise form and process used for medical records but identifies typical information to be included in such records. As a result, the ACLAM public statement on medical records provides practical yet flexible guidelines to assure that documentation of animal health is performed in research, teaching, and testing situations.

  • Adequate veterinary care
  • Attending veterinarian
  • Medical record
  • Performance standard
  • Professional judgment
  • Research animal

ASJC Scopus subject areas

  • Animal Science and Zoology
  • General Biochemistry, Genetics and Molecular Biology

Access to Document

  • 10.1093/ilar.48.1.37

Other files and links

  • Link to publication in Scopus
  • Link to the citations in Scopus

Fingerprint

  • Higher Education Institution Social Sciences 100%
  • Testing Social Sciences 100%
  • Teaching Research Social Sciences 100%
  • Animals Agricultural and Biological Sciences 100%
  • Americans Agricultural and Biological Sciences 100%
  • Counselling Social Sciences 42%
  • Administrative Structure Social Sciences 42%
  • Committees Agricultural and Biological Sciences 42%

T1 - Medical records for animals used in research, teaching, and testing

T2 - Public statement from the American College of Laboratory Animal Medicine

AU - Field, Karl

AU - Bailey, Michele

AU - Foresman, Larry L.

AU - Harris, Robert L.

AU - Motzel, Sherri L.

AU - Rockar, Richard A.

AU - Ruble, Gaye

AU - Suckow, Mark A.

N2 - Medical records are considered to be a key element of a program of adequate veterinary care for animals used in research, teaching, and testing. However, prior to the release of the public statement on medical records by the American College of Laboratory Animal Medicine (ACLAM), the guidance that was available on the form and content of medical records used for the research setting was not consistent and, in some cases, was considered to be too rigid. To address this concern, ACLAM convened an ad hoc Medical Records Committee and charged the Committee with the task of developing a medical record guideline that was based on both professional judgment and performance standards. The Committee provided ACLAM with a guidance document titled Public Statements: Medical Records for Animals Used in Research, Teaching, and Testing, which was approved by ACLAM in late 2004. The ACLAM public statement on medical records provides guidance on the definition and content of medical records, and clearly identifies the Attending Veterinarian as the individual who is charged with authority and responsibility for oversight of the institution's medical records program. The document offers latitude to institutions in the precise form and process used for medical records but identifies typical information to be included in such records. As a result, the ACLAM public statement on medical records provides practical yet flexible guidelines to assure that documentation of animal health is performed in research, teaching, and testing situations.

AB - Medical records are considered to be a key element of a program of adequate veterinary care for animals used in research, teaching, and testing. However, prior to the release of the public statement on medical records by the American College of Laboratory Animal Medicine (ACLAM), the guidance that was available on the form and content of medical records used for the research setting was not consistent and, in some cases, was considered to be too rigid. To address this concern, ACLAM convened an ad hoc Medical Records Committee and charged the Committee with the task of developing a medical record guideline that was based on both professional judgment and performance standards. The Committee provided ACLAM with a guidance document titled Public Statements: Medical Records for Animals Used in Research, Teaching, and Testing, which was approved by ACLAM in late 2004. The ACLAM public statement on medical records provides guidance on the definition and content of medical records, and clearly identifies the Attending Veterinarian as the individual who is charged with authority and responsibility for oversight of the institution's medical records program. The document offers latitude to institutions in the precise form and process used for medical records but identifies typical information to be included in such records. As a result, the ACLAM public statement on medical records provides practical yet flexible guidelines to assure that documentation of animal health is performed in research, teaching, and testing situations.

KW - Adequate veterinary care

KW - Attending veterinarian

KW - Medical record

KW - Performance standard

KW - Professional judgment

KW - Research animal

UR - http://www.scopus.com/inward/record.url?scp=39049191876&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=39049191876&partnerID=8YFLogxK

U2 - 10.1093/ilar.48.1.37

DO - 10.1093/ilar.48.1.37

M3 - Review article

C2 - 17170494

AN - SCOPUS:39049191876

SN - 1084-2020

JO - ILAR Journal

JF - ILAR Journal

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Medical Records for Animals Used in Research, Teaching, and Testing: Public Statement from the American College of Laboratory Animal Medicine

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2007, ILAR Journal

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Medical Records for Animals Used in Research, Teaching, and Testing: Public Statement from the American College of Laboratory Animal Medicine

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Medical records are considered to be a key element of a program of adequate veterinary care for animals used in research, teaching, and testing. However, prior to the release of the public statement on medical records by the American College of Laboratory Animal Medicine (ACLAM), the guidance that was available on the form and content of medical records used for the research setting was not consistent and, in some cases, was considered to be too rigid. To address this concern, ACLAM convened an ad hoc Medical Records Committee and charged the Committee with the task of developing a medical record guideline that was based on both professional judgment and performance standards. The Committee provided ACLAM with a guidance document titled Public Statements: Medical Records for Animals Used in Research, Teaching, and Testing, which was approved by ACLAM in late 2004. The ACLAM public statement on medical records provides guidance on the definition and content of medical records, and clearly identifies the Attending Veterinarian as the individual who is charged with authority and responsibility for oversight of the institution's medical records program. The document offers latitude to institutions in the precise form and process used for medical records but identifies typical information to be included in such records. As a result, the ACLAM public statement on medical records provides practical yet flexible guidelines to assure that documentation of animal health is performed in research, teaching, and testing situations.

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Bulletin of the American College of Surgeons , 76 9

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Clinics in plastic surgery , 26 1

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  • ILAR Journal /
  • Volume 48 Issue 1
  • Subject Areas /
  • Agricultural and Biological Sciences

Medical records are considered to be a key element of a program of adequate veterinary care for animals used in research, teaching, and testing. However, prior to the release of the public statement on medical records by the American College of Laboratory Animal Medicine (ACLAM), the guidance that was available on the form and content of medical records used for the research setting was not consistent and, in some cases, was considered to be too rigid. To address this concern, ACLAM convened an ad hoc Medical Records Committee and charged the Committee with the task of developing a medical record guideline that was based on both professional judgment and performance standards. The Committee provided ACLAM with a guidance document titled Public Statements: Medical Records for Animals Used in Research, Teaching, and Testing, which was approved by ACLAM in late 2004. The ACLAM public statement on medical records provides guidance on the definition and content of medical records, and clearly identifies the Attending Veterinarian as the individual who is charged with authority and responsibility for oversight of the institution's medical records program. The document offers latitude to institutions in the precise form and process used for medical records but identifies typical information to be included in such records. As a result, the ACLAM public statement on medical records provides practical yet flexible guidelines to assure that documentation of animal health is performed in research, teaching, and testing situations.

ILAR Journal – Oxford University Press

Published: Jan 1, 2007

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Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific animal care and use research duties.

Guidelines on Medical Records for Investigative Personnel

To define the components of a medical record that are the responsibility of the investigative personnel, and to describe the procedures for generating, maintaining, and storing them.

Responsibility

  • Generating and maintaining all required records.
  • Maintaining the records in the appropriate location and for the appropriate amount of time as described in this document.
  • Submitting records to ULAM as described in this document.
  • Making records available within four working hours on request of the veterinary personnel or institutional or regulatory inspectors. ( IACUC , ULAM, AAALAC, etc.).
  • Other members of investigative personnel may perform some of the above duties under the direction of the animal health contact.
  • Maintaining and submitting records of disposition for dogs and cats.
  • Pulling surgical records for animals not covered by the Animal Welfare Act from drop boxes in animal rooms and submitting them to husbandry supervisors
  • Filing pulled surgical records once per month
  • Generating and maintaining all aspects of the permanent medical record that are not the responsibility of investigative personnel as outlined in  Procedures for Veterinary Medical Records  and the  Animal Care Identification and Communication Procedures .
  • Veterinary personnel are available on request for instructing and assisting investigative personnel in developing record keeping procedures that comply with the minimum standards in this document.
  • Receiving and reviewing medical record components generated by investigative personnel as described in this document.
  • Storage and disposition of medical records as outlined in  Procedures for Veterinary Medical Records .

Glossary Definitions

Types and components of records:, permanent medical record.

A file identified by an animal's clinical number that contains all health, surgical, and/or procedural records generated for an animal. This includes:

  • For some animals (rodents) the entirety of the permanent medical record is captured in the ATR.
  • Refer to the  Animal Care Identification and Communication Procedures .
  • Guidelines on the Performance of Surgery in Non-Rodent Mammals
  • Anesthesia and Sedation Monitoring Guidelines
  • Surgery report (drafted by veterinary staff for clinically-indicated surgeries)
  • Guidelines on the Performance of Surgery in Rodents
  • Diagnostic test results: e.g. CBC/chemistry, urinalysis, culture and sensitivity, serology, etc.
  • Radiographs
  • Master problem list
  • Necropsy report
  • Evaluation of Alopecia in Nonhuman Primates
  • Procedures for Canine Quarantine and Conditioning
  • Procedures for Feline Quarantine and Conditioning
  • Acquisition and disposition records (dogs/cats)

Health/Group Health Record

A record maintained  by investigative personnel  detailing the care and management (treatments, monitoring, etc.) of a health condition that is performed by the laboratory personnel  under the direction of the ULAM veterinary staff .

A single record can be used for multiple animals (a group health record) if:

  • All animals are being treated/monitored in the same way and for the same condition, and
  • The animals are housed together in one cage and share a single clinical number.
  • Identification of the animal(s)
  • Clinical observations/monitoring
  • Time/frequency given
  • Date and initial all entries

Surgical/Anesthetic/Sedation Record

A record maintained by investigative personnel  that includes:

  • The surgery or procedure performed
  • The date performed
  • Anesthetic agent administered, including route, dose, and time/frequency
  • Any other drugs given (e.g. analgesics, antibiotics, reversal agents, etc.), including route, dose, and frequency
  • Anesthetic monitoring parameters (e.g. temperature, pulse, respiration, blood pressure, etc.)

Post-Operative Record

  • The surgery or procedure and the date it was performed
  • Notation of (at least) daily monitoring for the duration of the post-operative monitoring period as defined in the ULAM rodent or non-rodent mammal surgical guidelines, or as described in the animal use protocol.
  • Any drugs given, including the route, dose, and time/frequency.
  • The presence or absence of pain MUST be noted each day for the duration of the post-operative monitoring period.
  • The surgical/anesthetic/sedation record and the post-operative record may be combined and kept on a single sheet of paper if preferred.

Food and/or Water Restriction Records

  • Daily food and/or fluid volume consumed
  • Hydration status
  • Appearance and general affect
  • Experimental performance
  • Routine body weights
  • Refer to the  Guidelines on Experimental Food or Water Restriction or Manipulation in Laboratory Animals

Experimentally Induced Disease/Research Record

A record that may be maintained by investigative personnel that may include:

  • Animal identification information
  • Date and type of procedure performed/compounds administered
  • Routine observations as defined by the protocol
  • Adverse or unexpected consequences
  • Date of euthanasia or termination of study

Breeding Record

A cage specific record that may include:

  • Correct nomenclature is strongly encouraged. Please refer to this Jackson Labs tutorial for guidance
  • Information about the breeding itself: the mate date (day the male and female/s were first co-housed)
  • Information about the resulting litters: birth dates of litters, number of pups born, number of pups noted to have died or become missing, and weaned, and weaning dates.
  • Digital records are useful to track breeding colony success over time. This can be done in excel or using an online mouse colony tracking software. A free online breeding tracking program is SoftMouse

Record of Disposition

A record of the death, euthanasia, transfer, sale, adoption, or donation of an animal.

Records from Vendor

Health information/medical history that arrives with the animal. This is incorporated into the animal's permanent medical record.

Required Records

Those records that  must be maintained by investigative personnel:

  • Health/group health records are required if the laboratory personnel are performing any part of the monitoring and care of a non-research-related clinical condition under the direction of the veterinary staff.
  • Surgical/anesthetic/sedation records are required for all animals undergoing those procedures.
  • Post-operative monitoring records are required for all animals undergoing survival surgery.
  • Tumor monitoring records must be maintained as described in the animal use protocol for all animals with experimentally induced tumors
  • Food and water restriction records are required for all animals undergoing such restriction as per the animal use protocol and the  Guidelines on Experimental Food or Water Restriction or Manipulation in Laboratory Animals .
  • Records of disposition are required for all cats and dogs.

Recommended Records

Those records that are not mandated (unless described in the protocol). However, generating and maintaining these records is highly recommended.

  • Experimentally induced disease/research records
  • Breeding records

Animal Health Contact

The person(s) listed as such on the animal use protocol and the cage card.

Clinical Number

A unique identifying number assigned by ULAM personnel used to centralize information into complete medical records in a retrievable form. Clinical numbers may be assigned to an individual animal or a group of animals depending on the circumstance.

  • Large animals receive an individual clinical number and is recorded on the cage card upon arrival.
  • ##### is a unique identifier for that animal
  • The format for all species, except fish or frogs, is CLN########.
  • 00 is the last two digits of the year the animal was received

Active Case

Those involving animals currently being treated and/or monitored for a clinical condition, or an experimental condition (e.g. tumor burden, food and water restriction, etc).

Inactive Case

Those involving animals that are no longer being treated and/or monitored. Cases become inactive when:

  • A clinical condition is resolved by the veterinary staff.
  • The animal is euthanized or un-enrolled from study.
  • The animal is transferred to another laboratory or institution.

Disposition

The sale, transfer, donation, adoption, death, or euthanasia of an animal.

1. Generating Records

  • Investigative personnel must generate physical, required records as described above.
  • For examples of how the above records should be filled out  see Appendix C.
  • Pre-printed cage card -sized templates are available from ULAM on request
  • Non-rodent Mammal Intra-Operative Monitoring Form.  See Appendix D.
  • Post-operative Medical Record Form for Non-rodent Mammals.  See Appendix E.
  • Disposition of Dogs/Cats by death, euthanasia, sale, transfer, donation or adoption.  See 3.b.III.
  • Investigative personnel may create records templates to fit their preferences and needs. Regardless of the format, records must contain the same minimum information as described above (definitions) and in the ULAM templates.

2. Maintaining Records

  • Date and initial all entries.
  • Write legibly.
  • Write drug names in full (e.g. buprenorphine, not "bup"); do not abbreviate.

3. Storing & Submitting Records

  • Records must be made available within four working hours on request of the veterinary staff or institutional or regulatory inspectors. ( IACUC , AAALAC, etc.).
  • Records must be made available within four working hours on request of the veterinary staff or institutional or regulatory inspectors. (IACUC, AAALAC, etc.).
  • Food and water restriction records : Must be maintained in close proximity to the animal (in the animal room is preferred) for the duration of restriction.
  • Once the surgical monitoring period is complete, investigative personnel clip records (or copies thereof) and place them into the drop box in the animal room. These records will be collected by husbandry personnel once per calendar month.
  • It is highly recommended to submit a  copy  of these documents.
  • Protocol number
  • Principal investigator last name
  • Animal's clinical number (if one has been assigned by ULAM personnel)
  • Outside the veterinary technicians' offices in Med Sci II, BSRB, LSI, and NCRC
  • Outside break rooms in MSRB and BSRB
  • Contact the husbandry supervisor in your area for ATR drop-box locations in other buildings
  • USDA identification number
  • Description of animal (species, breed, markings, sex, age)
  • Date and manner of disposition (euthanasia, transfer, etc.)
  • Records must be stored for 3 years as part of the animal's medical record.
  • Records must be made available within four working hours on request of the veterinary staff or institutional or regulatory inspectors. (USDA, IACUC, AAALAC, etc.).
  • Principal investigators leaving the University must forward their records to the IACUC Office for retention during the remainder of their 3-year IACUC approval period.
  • Promptly return tags from euthanized dogs and cats to the ULAM Husbandry Office.

Appendix A: Rodent Surgery and Post-Operative Record (Notebook Size)

Appendix b: rodent surgery and post-operative record by cage, appendix c: examples of rodent surgery and post-operative records, appendix d: non-rodent mammal intra-operative monitoring form, appendix e: non-rodent mammal post-operative record form, non-rodent mammal postop record.pdf.

PDF icon

Appendix F: USDA APHIS Form 7006

USDA APHIS Form 7006

  • Field K, Bailey M, Foresman LL, et al. (ACLAM Medical Records Committee). Medical records for animals used in research, teaching, and testing: public statement from the American College of Laboratory Animal Medicine. ILAR J. 2007;48(1):37-41.

Questions or concerns about the content of this document should be directed to the Unit for Laboratory Animal Medicine (ULAM) at (734) 764-0277 or [email protected] .

Related Documents

Guidelines by topic / species.

medical records for animals used in research teaching and testing

GUIDANCE & OVERSIGHT Animal Care & Use Office (ACUO) 2800 Plymouth Road Ann Arbor, MI 48109 Phone: (734) 763-8028 Email: [email protected]

HUSBANDRY & VETERINARY CARE Unit for Laboratory Animal Medicine (ULAM) 2800 Plymouth Road Ann Arbor, MI 48109 Phone: (734) 764-0277 Email: [email protected]

ACUO is a unit of the U-M Office of the Vice President for Research:

U-M Research

ULAM is a unit of the Medical School Office of Research:

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Weichbrod RH, Thompson GAH, Norton JN, editors. Management of Animal Care and Use Programs in Research, Education, and Testing. 2nd edition. Boca Raton (FL): CRC Press/Taylor & Francis; 2018. doi: 10.1201/9781315152189-36

Cover of Management of Animal Care and Use Programs in Research, Education, and Testing

Management of Animal Care and Use Programs in Research, Education, and Testing. 2nd edition.

Chapter 36 future directions and challenges.

Joseph N. Benoit , Robert H. Weichbrod , John N. Norton , and Janet C. Garber .

  • Managing the Biomedical Research Enterprise and the Global Status of Laboratory Animal Welfare

The latter part of the twentieth century and beginning of the twenty-first century represents an age of scientific discovery, knowledge application, globalization, and social awareness that are unlike any other periods in the history of the world. The last 50 years have seen a rapid and continuous growth of the global biomedical research enterprise that includes a worldwide increase in organizations conducting research, teaching, and testing using experimental animals. Bornmann and Mutz (2015) estimated the post–World War II growth rate of global scientific output to be 8%–9% per year, which equates to a doubling of published information every 9 years. This rate of discovery is far greater than the estimated 1% of the eighteenth century and 2%–3% of the period between the two World Wars. As the research enterprise has grown, along with the speed of global communications, so has the awareness of the public with respect to new knowledge of complex biological systems, health care improvements, and oversight of research. Expectations of accountability to the public in areas of biomedical research have grown out of increased access to information, social awareness of the general public, and the lessons of history. Globalization of biomedical research has also triggered a worldwide awareness of ethics, with greater influence from the citizenry and consumers ( Degeling and Johnson 2015 ), who are often shaping regulations designed for oversight of the research enterprise. With respect to laboratory animal welfare, there has been an increase in both the addition and amendment of laws, regulations, and guidelines designed to address public concern, promote the health and welfare of research animals, and ensure consistent practices in facilities engineering, husbandry, veterinary care, and program monitoring. Overall, the biomedical research enterprise is more attentive to the welfare of research animals than ever before. Yet parties on both sides of the discussion regarding the use of animals in research continue to debate whether the regulations and oversight are excessive or insufficient. In response, new regulations and guidelines have emerged, and in other instances, the scientific community has responded through self-imposed regulation ( Degeling and Johnson 2015 ). The challenge is to balance the wide range of expectations facing the research community in the future.

The purpose of this chapter is to examine some of the common challenges facing the global biomedical research community, with emphasis on emerging discussions related to regulatory burden and risk mitigation. The authors also recognize that the rule of law is implemented differently around the world, and that it would be beyond the scope of this chapter to attempt to provide a meaningful review of the myriad international differences in how law is developed and enforced in different countries, and the potential challenges of harmonization (covered in Chapters 7 and 8). As such, we have approached the topic of future directions and challenges from the perspective of institutional commitment, oversight, and the regulatory environment, with the goal of helping institutional researchers and research administrators gain an understanding of the complexity of the biomedical research environment involving animal care and use.

  • Regulatory Challenges

King et al., in Chapter 7 of this volume, describe the oversight of animal research that exists in today’s care and use environment. At the top of the list are regulations (i.e., laws, rules, and decrees), which are created by governing bodies or government agencies to address matters deemed to be reflective of the will of the citizens. Lower in the hierarchal scheme are the vast array of guidelines, best practices, industry standards, institutional policies, and accreditation standards that represent interpretations of the laws or, in some instances, implement local policies designed to extend the requirements of the law into species not covered by the law. While the benefits of government and self-regulation on animal welfare cannot be disputed, neither can the fact that administrative procedures developed to address regulations, policies, and practices are viewed as burdensome and challenging for both the scientists and the research institution. To this end, seemingly harmless administrative practices that are not required by animal welfare regulations and do little to improve animal welfare or the quality of the research become an unnecessary focus of institutional research administrators. From a researcher perspective, the collective practices, whether self-imposed or externally mandated, are viewed as a regulatory burden.

Regardless of the source, the number of regulations in the United States has grown over the past 25 years. A recent analysis of data from the U.S. Council on Government Relations (COGR) by the Federation of Societies for Experimental Biology (FASEB) has shown a dramatic increase in the cumulative number of unfunded mandates applicable to research institutions since 1991 ( FASEB 2015 ). The number of U.S. government–promulgated new or substantially changed regulations has increased from approximately 1.5 per year in the early 1990s to approximately 5.8 per year in more recent years (2002–2014). With more regulations to attend to, many institutions have chosen to implement conservative, sometimes overzealous, practices of self-imposed administrative practices that they view as necessary to minimize institutional risks and ensure compliance. In fact, risk aversion has been suggested to be a major contributor to excessive regulation and a source of regulatory burden ( Haywood and Greene 2008 ; Thulin et al. 2014 ). In addition to institutional-level policies, current data also suggests that federal agency risk aversion may be contributing to the increased regulatory burden in the United States. A recent National Academies report, Optimizing the Nation’s Investment in Academic Research ( National Academies of Sciences, Engineering, and Medicine 2016 ), indicated that the requirements of some federal agencies (e.g., the National Institutes of Health [NIH]) seem to strive for a zero-risk environment. In doing so, government agencies have instituted intensive oversight, monitoring, and compliance documentation processes that “require significant commitment by the institution and the investigator without any direct significant benefit for animals” ( Haywood and Greene 2008 ).

  • Expanding Oversight and the Compliance Environment

Perhaps the biggest challenge, if not threat, to the biomedical and animal science research community in the United States is the varied requirements for oversight and reporting imposed by the different federal agencies that fund research. While the rules and guidance documents are developed to ensure the humane treatment of animals and to assure the public that scientific investigation is conducted in accordance with the highest ethical standards, these same regulations have placed significant documenting requirements and financial burdens on research institutions, which have had to expand administrative offices to add staff and augment associated data management tools devoted exclusively to regulatory compliance. Challenges for research institutions in areas of regulatory compliance are compounded by reductions in funding for biomedical research, as well as the development of a “culture of overcompliance” in research organizations that are attempting to avoid penalties or liabilities that may result from noncompliance. Enhanced U.S. Department of Agriculture (USDA) enforcement of the Animal Welfare Act (AWA) and revision of the USDA Animal and Plant Health Inspection Service (APHIS) inspection requirements focus additional attention to risks of noncompliance at the institutional level ( American Physiological Society 2010 ). The tendency for risk aversion in many institutions eclipses that of rationale risk mitigation and often leads to unnecessary time-consuming practices that extend well beyond legal requirements ( FASEB 2015 ). Concerns of the scientific community and institutional administrators that increases in regulatory burden were detracting from the work of scientists in research and discovery recently garnered the attention of the U.S. Congress. As a result, Congress tasked the National Academies of Science, Engineering, and Medicine with the examinations of federal regulations designed to support basic and applied research. In doing so, Congress requested that the report include recommendations that would (1) “assess the effectiveness of current regulations to achieve their intended purposes and modify those that are currently ineffective,” (2) “decrease redundancies of effort due to different government agencies utilizing different formats and requirements for receipt of similar information,” and (3) “develop new mechanisms for government agencies and academia to develop joint recommendations that best achieve regulatory intent and optimize the federal investment in research” ( National Academies of Sciences, Engineering, and Medicine 2016 ). The findings of this report, while centered on U.S. government–funded research at U.S. universities and research centers, underscore a series of challenges facing the global research community in an increasingly “flat world” ( Friedman 2005 ). The committee recommendation for animal research centered on three major areas: (1) feasibility of harmonization, (2) streamlining federal and agency reporting, and (3) institutional-level streamlining of self-regulation.

Identification of a need for harmonization of regulations in the United States represents a major step forward for research programs. The National Academies report on optimization uses data from the COGR and compiled by FASEB to illustrate the reporting challenges facing researchers in the United States. The data shows an increase in the number of regulatory and guidance document changes applicable to research institutions since 1991. Self-regulation, overregulation, and risk management represent major temptations and, in some instances, legal challenges for many institutions. The temptation to overregulate at the institutional level is often the result of a philosophy of zero risk rather than one of risk mitigation. Haywood and Greene (2008) examined the sources and potential consequences of self-imposed regulatory burden on animal care programs and suggested that an overzealous regulatory environment may actually alienate scientists and create an environment where researchers may attempt to (1) circumvent regulations, (2) avoid conducting research in animals, (3) bypass funding opportunities that require animal studies to address important research topics, and (4) divert institutional funds into administrative areas concerned with compliance and away from areas directly responsible for animal care.

  • Governmental Sources of Regulation and Legal Challenges Related to Regulatory Burden

United States

Federally funded research in the United States is awarded to research universities and research organizations by as many as 13 different government agencies. All these agencies embrace the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training ( U.S. Department of Health and Human Services 2015 ) and are required to comply with the AWA and amendments ( USDA 2013 ). In addition to these regulations and dependent on the agency providing the funding, oversight of animal research programs may also have to be responsive to more than 20 other government-generated principles, statutes, agency policies, directives, and reference manuals. Depending on the agency, animal researchers may need to be accountable to as few as 2 (i.e., Environmental Protection Agency [EPA]) and as many as 10 (i.e., Centers for Disease Control and Prevention [CDC]) different government regulations, policies, and guidelines ( Figure 36.1 ) ( FASEB 2015 ). Large and complex research organizations often have research supported by multiple federal agencies, and therefore must be accountable to each agency. Complying with the rules of U.S. agencies is further complicated by the fact that interagency rules and regulations on animal welfare are inconsistent and may contradict each other. Ensuring compliance with all the aforementioned regulatory components represents one of the biggest challenges facing research administrators and researchers, as differences in federal agency regulatory requirements impose a need for extensive tracking and reporting systems. Excessive, duplicative, and specific reporting requirements place undue strain on institutional-level research administration and often result in the diversion of resources, both financial and personnel, away from conducting research to administrative support areas charged with tracking, monitoring, documenting, and reporting on compliance. Researchers are also impacted by having to devote more time to satisfying the reporting requirements and less time on the generation and dissemination of new knowledge.

Figure 36.1

( See color insert. ) Number of animal welfare regulations that different U.S. agencies require researchers to follow. NIST, National Institute of Standards and Technology; NOAA, National Oceanic and Atmospheric Administration; USAID, U.S. Agency for International (more...)

European Union

The governmental regulatory environment in other parts of the world parallels that observed in the United States. A recent report by Bert et al. (2016) explored some of the challenges that European Directive 2010/63/EU is placing on the scientific community in Europe. Issued as a directive rather than a regulation, 2010/63/EU sets out goals that all European Union (EU) countries must achieve by developing their own laws that are largely wrapped around the framework of the directive. The issuing of a directive by the EU provides considerable flexibility in that it allows member states to create regulations that conform to the culture and will of their people within a framework that promotes harmonization and high standards in animal welfare across the EU. However, critics of the directive claim that it is vague in some areas, which places the onus of interpretation on the member states. This could lead to discrepancies in how animal welfare regulations are managed within the EU. For example, an overzealous interpretation of the directive by some countries, particularly in areas of the directive’s goal of “full replacement of procedures on live animals for scientific and educational purposes as soon as it is scientifically possible,” could lead to premature halting of animal research, thereby impeding scientific research and discovery. The development and pending implementation of strict legislated limits to animal research in Italy serves as a prime example of how extreme legislation can negatively impact animal research ( Abbott 2013 ). At present, it is difficult to predict whether disparities in regulatory burden between member states will emerge under the directive or if the goals of harmonization of animal welfare standards in Europe will be impacted by withdrawal of Britain and possibly other countries from the EU. For more details on the harmonization of standards, refer to Chapter 8 in this volume.

Other Countries

King et al., in Chapter 7 of this volume, provide a comprehensive summary of the regulations in other countries of the world, including Canada, Australia, and in Asia, South America, and Africa. Of these, the most developed oversight environments are in Australia and Canada, both of which are independent of national regulations. Emerging regulations in Asia, South America, and Africa are establishing tiered systems similar to those in other parts of the world, with attention to replacement, reduction, and refinement (the 3Rs) ( Russell and Burch 1959 ) and ethical oversight committees playing key roles in the culture of compliance ( Choe and Lee, 2014 ). Bayne et al. (2015) recently reported on the status of implementation of the 3Rs advanced by Russell and Burch (1959) in the worldwide arena, with particular emphasis on Brazil, China, and India. The degree to which the 3Rs are embraced and implemented in each of these three countries varies from being embedded into the scientific culture of Brazil, to steadily increasing among the scientific community of India, to aiming to align with international practices in China.

  • Nongovernmental Sources of Regulatory Burden

Regulatory burden in today’s research environment is not only caused by government mandates and policies. It is also caused by misinterpretation or overinterpretation of rules, regulations, accreditation standards, and best practices by research institutions, ethical review boards, editorial review boards, and other members of the scientific community. Current-day ethical oversight and management of animal research is rooted in the 3Rs, as well as advances in scientific discovery, animal science, animal husbandry, facility engineering, and veterinary medicine. The benefits to animals, as well as to science, are indisputable, as pointed out by Thulin et al. (2014) . Infectious diseases that were once common in research animal colonies have largely been eliminated. Greater attention to psychosocial enrichment, to a large extent, has helped to eliminate unwanted stereotypical behaviors, reduce animal injuries related to fighting in group-housed environments ( Young 2003 ), and in some species or strains, improve breeding ( Whitaker et al. 2016 ). The scientific community has benefitted from having fewer confounding factors introduced into sophisticated experimental design. These practices have resulted in the development of performance-based standards that are generally accepted by the public as the current standard of care for laboratory animals. Furthermore, these practices are embraced by the scientific community as a standard for pursuing and achieving scientific excellence.

However, concerns within the scientific community do arise when implementation of research oversight regulations at the institutional level results in local practices that far exceed those of the laws, regulations, and guidelines. Self-imposed regulation has been identified in recent years as a major contributor to increased regulatory burden. In a recent opinion paper, Pritt et al. (2016) described how well-intentioned assumptions made by Institutional Animal Care and Use Committees (IACUCs) and animal oversight committees create “IACUC legend,” practices that become ingrained in the IACUC that go beyond the regulations and add an unnecessary administrative work burden for researchers, ethical oversight committees, and research administrative offices. Seemingly harmless administrative practices that are not required by animal welfare regulations frequently do little to improve animal welfare or the quality of the research, as they often involve only administrative office procedures. Thulin et al. (2014) suggested that programs with compliance specialists working on behalf of, but with little guidance from, the IACUC often experience a growth in self-regulation that is driven by decisions of a single person or small group of individuals that are typically not questioned by the IACUC. Over time, these procedures require an increasing effort from researchers having to respond to them, when in reality they are generally not incorporated into IACUC deliberations, institutional assurances, veterinary practices, husbandry, and facilities enhancements. Needless to say, unjustified procedural shift is rarely rewarded in the budget process, as it is difficult to justify. To this end, unauthorized implementation of self-regulation through independently acting organizationally empowered members may undermine the intent of regulations, create discord within the organization, increase financial strain on programs, and otherwise negatively impact an institution’s animal care and use research programs.

One challenge is to minimize what the IACUC does versus what it oversees . For example, many IACUCs require that all personnel that will participate in a research project be listed on the written protocol proposal and qualifications to perform various procedures be described. The IACUC subsequently maintains training records and verifies that all personnel have been adequately trained. However, at some institutions, training is the responsibility of a separate group or department. Training records are retained centrally, and regularly reviewed by the training coordinator and laboratory management. In a cross-functional organization, where a technician may be asked to participate at any time in support of any research project, the requirement of listing all personnel on a research protocol may essentially be redundant and poses an unnecessary burden on the investigator and the IACUC. Rather than including technical personnel on the written protocol, the institution could take an alternate approach. Specifically, the institution could have a clearly defined training program and responsibility for record keeping, regular audits of training records (e.g., by the quality assurance unit), assurances by investigators that all personnel assigned to work on a project have been trained, and a routine monitoring program that looks at this issue. The IACUC would take on an oversight role, ensuring that the training program was functioning properly. Semiannual review of all aspects of the training program would be a component of the committee’s semiannual program review. While this type of approach may not work for many programs (particularly in large academic institutions), it could be used in some smaller, centrally managed facilities.

  • Tracking Legislative and Rulemaking Actions in the United States

It is important for the institution to have a clear understanding of trends within the regulatory environment that can impact its program. Programmatic enhancements that are not required by laws, regulations, rules, and guidelines, or that do little to enhance animal welfare, should be avoided when possible ( Haywood and Greene 2008 ). Understanding what is required and what is not may present a challenge to research administrators that carries significant legal implications. Any legislation that would impact regulatory compliance, access to animal models, or the availability of information may have an impact on program management because of the added costs and other burdens such laws may impose. It is important that legislation affecting research represents sound public policy, is based on evidence of need, backed by scientific data, and does not incur costs that exceed the benefits in terms of animal welfare and the quality of the science. The importance of researchers, research administrators, and members of the general public in communicating with legislators and rule makers cannot be overstated, as advocacy is key to shaping legislation to represent the will of the citizens, rather than that of a select few with special interests. Frequently, the scientific community fails to engage in advocacy before it is too late. Once laws, rules, or regulations are enacted, efforts to change them become exceedingly more difficult. In the following paragraphs, we briefly describe the processes for making laws, rules, and regulations in the United States, as an understanding of these is important for research program management.

In the United States, as many as 10,000 bills may be introduced in any given 2-year congressional session, with only about 300–500 ultimately being enacted as law. Most bills are not voted on as introduced, as they may be amended or incorporated into much larger pieces of legislation, such as an omnibus appropriations package. One example of an omnibus package with animal welfare implications is the U.S. “Farm Bill,” a bundle of legislation that sets national agriculture, nutrition, conservation, and forestry policy, which is considered every 5 years ( U.S. Senate 2014 ). While the majority of the language in the Farm Bill is typically unrelated to animal research, the potential for the inclusion of such language exists primarily because the bill must move through the House and Senate Agriculture Committees, both of which have jurisdiction over the federal AWA. Inasmuch as omnibus legislation such as the Farm Bill is considered a must-pass piece of legislation, it often serves as a vehicle for smaller pieces of legislation with special interests. A single line of text changing only one or two words in current law, that is, the AWA, can be inserted into the omnibus package as a technical amendment with the hope of being undetected as the massive 1000+-page bill moves through the legislative process. Technical amendments, although short in word count, may have enormous implications for current law.

Other approaches to passing legislation may include reintroduction of a bill by different members of Congress over many different congressional sessions. Such persistence proved to work in the research community’s favor when it came to passage of the Animal Enterprise Terrorism Act (AETA) (S. 3880 [109th] 2006), which amended the federal criminal code to prohibit any person from “engaging in certain conduct for the purpose of damaging or interfering with the operations of an animal enterprise,” thereby providing the U.S. Department of Justice greater authority to prosecute animal rights activists ( 109th U.S. Congress 2006 ). Educating members of Congress over a number of years allowed the bill to gain a substantial amount of support over time. In other instances, persistence alone may not be enough to ensure that legislation is passed, as evidenced by failure of special interests to catalyze passage of legislation during the last 10 congressional sessions (nearly 20 years) that would eliminate USDA Class B licenses. It is worth noting that a lack of success on the legislative front may lead special interests to achieve their goals through other means, such as through the regulatory process covered later in this chapter.

Another element that affects the odds of successful passage of legislation is whether there are similar versions of the bill in each of the two legislative bodies: one version in the U.S. House of Representatives and one version in the U.S. Senate. When the language of each of these bills is identical, the odds of passage are increased. When the language of each bill is different, a lengthier process ensues. Further, if the legislation is “jointly referred” to multiple committees in either body, the odds of passage are decreased, as this represents addition hurdles for the bill to overcome. If the legislation is “sequentially referred” to multiple committees in each body, the odds of passage become extremely low, although not impossible. Finally, if each body ultimately approves the legislation, a conference committee comprised of conferees from each legislative body enters into negotiations to reach agreement on language in a final version of the bill that will be sent to the president for either signature or veto.

  • U.S. Rules and Regulations

In the United States, federal regulations are created by federal agencies, boards, and commissions by a process known as rulemaking. Under the Administrative Procedure Act, federal agencies are permitted to promulgate detailed regulations from laws enacted by Congress through a public rulemaking process in which the public is invited to participate. These regulations carry the weight of law and are specifically designed to address a problem or accomplish a goal of the legislation. Once enacted, rules are published in the Code of Federal Regulations ( Office of the Federal Register 2016 ). More information on the rulemaking process is available through the Office of the Federal Register (2016) . Monitoring wording of proposed legislation or rules and tracking the progress of legislation is a daunting task that individual research programs and program officers are seldom able to carry out. Researchers and institutional officers often rely on professional societies and advocacy groups, such as the National Association for Biomedical Research (NABR), to track legislation and comment on its potential impact. NABR is the only organization in the United States solely dedicated to advocating for sound public policy that recognizes the vital role that animals play in biomedical research. Staying abreast of animal welfare regulations constitutes a major challenge for animal researchers, administrators, and institutional officials. Ignorance of a law or regulation does not absolve an institution from penalty should violations occur. While there is no easy solution to navigating the animal welfare regulatory environment, there are several excellent online resources that can be consulted. These are listed in Table 36.1 .

Table 36.1. Internet Sources for Animal Regulations from Different Regions of the World.

Internet Sources for Animal Regulations from Different Regions of the World.

  • Emerging Legal Challenges Impacting Animal Care and Use Programs

Legal challenges by activist groups in areas of public disclosure, the transportation of animals, legal guardianship, and even “personhood” or legal standing for animals are developing trends that could pose a significant threat to animal research. Such tactics do not follow the traditional ethical arguments on the use of animals in research. The complexity of these issues extends far beyond the scope of this chapter, and as such, the authors have chosen to only briefly discuss them below. The reader is directed to several excellent sources that provide detailed background information on these topics ( Favre 2004 ; Rollin 2006 ; Dolan 2007 ; Article 19 2012 ; Cardon et al. 2012 ).

Public Disclosure Laws

Seeking access to institutional documents through public disclosure laws (Freedom of Information Act [FOIA], sunshine laws, etc.) in the United States is a tactic often used by special interest groups to force research organizations to release sensitive records that can and have been used to disrupt an animal research program’s operations and, in extreme cases, place animals, as well as research personnel, at risk. Originally designed to promote transparency in government, the U.S. FOIA was enacted in 1966 to instill accountability in government by granting public access to government records. In addition to U.S. federal law, every state also has a law that governs access to records in possession of the state and local governments and other public entities, such as state-supported universities. While both federal and state open records laws exempt certain categories of information from being released, there can be considerable state-to-state variability in the exemptions. For example, some state courts have held that IACUC minutes are subject to disclosure, while courts in other states have held that IACUCs are not public bodies and as such are not subject to disclosure (discussed in Cardon et al. [2012] ). In public universities, open records requests could garner other sensitive information, such as detailed building maps, including vivarium spaces. In instances where electronic information is transferred to private e-mail accounts or personal electronic devices, information on home computers, smartphones, digital tablets, and so forth, could be subject to certain types of records request. Concern for the safety of employees, students, property, and research animals is real for administrators in public research institutions in the United States, particularly when the frequent requesters of biomedical research information are national animal rights groups or individuals associated with those groups ( NABR 2015 ). In addition to the United States, laws granting access to public information are becoming more common in the global arena, as evidenced by the fact that public disclosure laws have increased from 13 countries in 1990 to nearly 100 countries in 2012 (Article 19 2012). For more information on security considerations for animal use programs, refer to Chapter 19 in this volume.

Public institutions and agencies must respond to an open records request and need to be adequately prepared to respond should a request be made. Cardon et al. (2012) provided detailed information on preparing and responding to public information requests. At the center of their discussion was the need for document retention and destruction policies at the institutional level. Research administrators should fully understand their institution’s policies, as well as any government requirements on document retention, archiving, and destruction. Active files relative to the animal care and use oversight program should be factual in content and devoid of extraneous information, and contain only essential information that is required for the oversight committee and research office to function. To this end, the research organization should be cognizant of what is included in the official files of the organization and of the potential impact to the institution that might arise if requested information is taken out of context and widely disseminated by the requester. Research administrators and staff should always consult their organization’s record retention officers and legal counsel when they receive an open records request for information in order to ensure that (1) the requested information is not exempt from request, and (2) the information released is specific to the request. The latter is particularly important, as an organization has no obligation to provide any information beyond what is specifically requested.

Transportation of Research Animals

Pressure placed on commercial airlines by animal rights activist groups has resulted in many commercial carriers choosing to no longer carry animals that will be used for research purposes. The reduced shipping options present logistical transportation challenges, limit access to important animal models, and increase the costs associated with animal research. Disruption of the use of commercial transport for moving research animals to biomedical research organizations could significantly delay, if not halt, ongoing research projects. Although a few countries have received government support that compels airlines to transport research animals, no such regulations exist in the United States. As a result, the commercial airline has full decision-making authority on whether it will (1) carry animals and (2) refuse to carry them if they are destined for research facilities. It is likely that legal challenges to the commercial air carriers will require courts to interpret common carrier obligations as they apply to shipping live animals for research purposes. While no one can predict the outcomes of these deliberations, one can be certain that differences between countries served by any given airline will complicate and extend the discussion for years to come.

Emerging Challenge of Property versus Legal Guardianship

Legal challenges to animal research programs by lawyers and activists are testing new legal postulates that stand to grant specific legal rights to animals, including those animals that are involved in research. Leaders of this legal movement advocate the establishment of new court precedents that have the potential to significantly interfere with animal research. Unlike many earlier court cases that challenged existing laws regulating animal welfare for animals owned by a research organization, these emerging cases argue that animals are not property. Instead, they argue that animals should be placed under a legal guardianship where the guardian is held legally accountable for the welfare of the animal. Favre (2004) argues in favor of transforming property law from ownership to guardianship, which he claims would allow animals to “receive the legal respect they deserve.” He further submits that the current activist approach of abolition of animal research at the level of federal laws or regulations is unrealistic, and that more achievable outcomes on the animal activist front may arise through building a foundation of change focused at the state level. Suggestions include

  • “Modifying divorce laws to require that the court decides issues relating to pets in the best interest of the animal and not on the basis of property ownership.”
  • “Adopting state anticruelty laws such that criminal prosecution could be brought against guardians who violate the laws” (e.g., researchers and research organizations).
  • “Clarifying the law regarding pet adoption from a public or private agency such that the organization retains the ability to intervene on behalf of the animal. If the new owners/guardians do not fulfill their obligations toward the animal, the agency ought to be able to step in and correct the problem.”

The position of gradually articulating the interests of animals into the legal system as a means to gain a stronger position for the animal rights activists ( Favre 2004 ) could represent a significant legal challenge for both farmers and scientists. Discussions around ethical and humane treatment of research animals would be refocused toward the investigator’s or research organization’s ability to determine what is best for the animal. These challenges have already entered into the research animal arena with changes in policy that have resulted in the discontinuation of studies in chimpanzees and subsequent transfer of these animals to sanctuaries. In other instances, laws allowing trusts to be set up for family pets move the legal interpretation closer to legal personhood for certain species. Efforts by animal rights interests seeking to have courts recognize animals as having legal standing or personhood are on the rise. In recent years, there have been at least four such cases in the state of New York asking courts to recognize chimpanzees as having legal standing under habeas corpus . Although all have failed, groups appear to be committed to filing multiple test cases in courts around the country on behalf of different species until they are successful. While many of these strategies do not appear, at first glance, to affect laboratory animals, the “sum of their parts” has the potential to have an impact on life-saving medical and scientific research.

  • Assessing, Mitigating, and Managing Risks

Management of risk in an animal research program is a difficult task that involves a comprehensive understanding of the institution’s research endeavors, the regulations governing animal welfare, and the institution’s plans for the future. Bayne and Garnett (2008) describe the delicate balance among research costs, a complex legal and regulatory environment, societal issues, and the scientists’ passion for discovery as obligatory if the biomedical research enterprise is to maintain the privilege to conduct research in animal models. To this end, institutions must constantly assess their animal research programs from different perspectives and do so in ways that account for the nature of the research being conducted, stakeholder expectations, and a constantly changing regulatory, oversight, and compliance environment. Assessment, mitigation, and management of risks are an essential, yet highly institution-specific, component of a contemporary animal care and use program. To meet this challenge, a research organization must have a clear understanding of its mission, be willing to accept certain risks, and be responsive to the regulatory environment in ways that do not impose excessive self-regulation. Developing a zero-risk or risk aversion philosophy has been identified by numerous sources ( Haywood and Greene 2008 ; FASEB 2015 ; National Academies of Sciences, Engineering, and Medicine 2016 ) as a burdensome, somewhat unrealistic, and generally cost-prohibitive approach to the management of a research program. A more realistic approach is to build a risk assessment program geared toward risk mitigation, knowing that regulatory compliance can be achieved in a performance-based environment that aligns with the institutional needs. Haywood and Green (2008) suggested a commonsense three-question approach to assessing IACUC activities for regulatory burden: (1) Why do we do this? (2) Does it help the animals? (3) Can the end be achieved in a more efficient, cost-effective manner? Implementation of a performance-based program based on sound reasoning allows an institution to fully understand and address its specific animal welfare requirements without having to implement broad-sweeping burdensome practices. As a result, the institution animal research program becomes more strategic and less reactive.

A myopic approach to regulatory risk may also lead an institution and its investigators away from risk based on scientific foundation and understanding. Recent emphasis from funding agencies on the rigor of sound and unbiased design of research to ensure reproducibility underlies the importance of selecting the appropriate biological research model, whether in terms of species, sex, age, or health conditions of the animals ( NIH 2016a , 2016b ). Evidenced by an overdependence on male animals, preclinical studies in animals commonly neglect gender-based differences in pathophysiology and response to treatment modalities, thus leading the NIH to require grant applicants to consider and report research plans that balance the use of male and female animals ( Clayton and Collins 2014 ). Selective reporting of research results and the pressure on researchers to publish have been cited as additional factors impacting reproducibility of research ( Baker 2016 ). The development of the ARRIVE guidelines and agreement by many journals to endorse principles and guidelines on the reporting of animal research are appropriate avenues to enhance the rigor and reproducibility of animal research ( Kilkenny et al. 2010 ; NIH 2016b ). A balanced approach to ensuring animal welfare while promoting innovative and sound science through public education and advocacy (see Chapter 6) is warranted and best serves the concept of streamlining and achieving regulatory demands.

An important step in building a streamlined risk-managed compliant program is for the institution to have a clear understanding of trends within the regulatory environment that can impact its program. Programmatic enhancements that are not required by laws, regulations, rules, and guidelines or that do little to enhance animal welfare should be avoided when possible ( Haywood and Greene 2008 ). Understanding what is required and what is not may present a challenge to research administrators that carries significant legal implications.

  • Summary and Recommendations for a Path Forward

The global legal arena for animal welfare is a complex and ever-changing one that can be somewhat unpredictable. As a result, animal research organizations are constantly having to respond to newly created or modified existing regulations and evolving guidelines. While all stakeholders in research animal welfare conversation understand and support the existence of laws and regulations that promote animal welfare and the pursuit of quality science, there is growing concern that many of the regulations create large amounts of work for administrative offices, but do little to protect the animals. As a result, less time is being spent on research, discovery, and knowledge creation.

It is interesting to look at some predictions of future challenges facing the laboratory animal community from 20 years ago. In 1995, J. Derrell Clark proposed four points for consideration in the future ( Clark 1995 ). First, he surmised that there was very little scientific information on, or factors in, our knowledge that promote the comfort of animals in a research setting. He suggested the need for research on behavior, psychological well-being, enrichment, and effects of numerous physical and environmental factors. Second, he recognized the infancy of the concept of performance standards and the necessity to determine the animals’ needs and evaluate performance, specifically the need for assessment criteria (which at the time was not well established). Third, laboratory animal scientists must conduct research in areas of animal care. And finally, there is more relevant information on care and husbandry in the literature than most are aware of. Much of the relevant data may be in studies focused on animal behavior, psychology, zoology, field studies, ethology, animal science, and psychoneuroimmunology. While Clark advocated for the mining of such data, he also cautioned that the use of published information may be difficult to interpret and even harder to apply to general situations, or put into general practice.

In the years ahead, research organizations and their team of organizational leaders, scientists, veterinarians, managers, and other animal research support staff need to work collectively together to refocus and streamline the animal research regulatory environment without compromising the intent of laws and regulations that already exist. The scientific community and agencies that fund research must continue, as well as expand, advocacy for animal research through education of the general public of the human and animal health advances that have resulted from animal research (see Chapter 6 of this volume). Harmonization of regulations and reporting requirements, as well as the sharing of information between research organizations, government agencies, oversight bodies, and accreditation groups, could alleviate some of the challenges. Assessment of oversight programs within institutions, with an eye on spotting redundancies and unnecessary office or committee practices, will also help to limit the expansion of self-imposed regulatory burden. Research administrators should understand the risks associated with their research programs and develop program-specific approaches that mitigate their identified risks, rather than implementing practices designed to avert all the possible scenarios that might occur. Research strategic plans should address goals for supporting animal research and be bold enough to strongly advocate for the significant advancement of knowledge, with particular emphasis on the 3Rs. Collectively, these and other similar maneuvers can allow research organizations to prosper and coexist in today’s complex and ever-present regulatory environment.

  • Acknowledgment

The authors and editors extend their sincere appreciation to

  • Tim Allen with the U.S. Department of Agriculture’s Animal Welfare Information Center for his superlative, comprehensive, and thorough literature search assistance to the writing of this chapter
  • The National Association for Biomedical Research, Washington, DC, for providing its policy expertise in the development of this chapter
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Required Health/Medical Record Keeping for Research and Teaching Animals

Regulatory guidelines and standards of adequate veterinary care impose certain requirements for health/medical records (Animal Welfare Act regulations; Guide for the Care and Use of Laboratory Animals; Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching). All research and teaching animals at NC State must have veterinary care documented according to the USDA Animal Welfare Act Policy #3, excerpts of which follow.

Documentation Requirements

“Health records are meant to convey necessary information to all people involved in an animal’s care. Every facility is expected to have a system of health records sufficiently comprehensive to demonstrate the delivery of adequate health care. For all facilities, health records must be current, legible, and include, at a minimum, the following information:

  • Identity of the animal. *
  • Descriptions of any illness, injury, distress, and/or behavioral abnormalities and the resolution of any noted problem.
  • Dates, details, and results (if appropriate) of all medically-related observations, examinations, tests, and other such procedures.
  • Dates and other details of all treatments, including the name, dose, route, frequency, and duration of treatment with drugs or other medications. ( A “check-off” system to record when treatment is given each day may be beneficial.)
  • Treatment plans should include a diagnosis and prognosis, when appropriate. They must also detail the type, frequency, and duration of any treatment and the criteria and/or schedule for re-evaluation(s) by the [unit] attending veterinarian. In addition, it must include the [unit] attending veterinarian’s recommendation concerning activity level or restrictions of the animal.

Procedure Examples

Examples of procedures which should be adequately documented in health records include, but are not limited to:

  • vaccinations
  • fecal examinations
  • radiographs

Routine husbandry and preventive medical procedures (e.g., vaccinations and dewormings) performed on a group of animals may be recorded on herd-health-type records. However, individual treatment of an animal must be on an entry specific to that animal. As long as all required information is readily available, records may be kept in any format convenient to the licensee/registrant (e.g., on cage cards for rodents).

…[I]t is the responsibility of the licensee/registrant [i.e., NC State] to ensure that all components of the records are readily available and that the record as a whole meets the requirements listed above.

Record Retention

An animal’s health records must be held for at least 1 year after its disposition or death. (Note: Some records may need to be held longer to comply with other applicable laws or policies.) When an animal is transferred to another party or location, a copy of the animal’s health record must be transferred with the animal.”

* Identity of animal interpreted to mean positive individual identification, specific location of an isolated animal, or appropriate identification of herds, flocks, etc.

Communication to Attending Veterinarian

According to the Animal Welfare Act regulations, the program of veterinary care must include “…a mechanism of direct and frequent communication…so that timely and accurate information on problems of animal health, behavior, and well-being is conveyed to the attending veterinarian.”

Each NC State animal resource unit must develop and maintain, in consultation with the attending veterinarian for that unit, a system for medical record keeping. Format for medical records is flexible, as long as required elements are documented and clear.

Updated June 2022

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Position Statements

Overview for development of aclam position papers /statements.

When timely and relevant topics arise that are deemed by the Board of Directors or College membership to be deserving of a professional review, a Position Paper (>2 pages in length) or a Position Statement (<2 pages length) may be created ad hoc to address the stated need.

Position Papers/Statements will be overseen by the ACLAM Publications Committee and the following series of events will occur from inception to publication:

  • A "Lead" for the Position Paper/Statement will volunteer or be identified from the College membership; this person will be responsible for organizing a volunteer group of writers/editors/subject matter experts to address the intended topic;
  • Following the drafting of the Position Paper/Statement, the Lead will submit the draft to the Publications Committee Chair for assessment (the Lead and contributors will be provided on the document as the authors);
  • The Publications Committee Chair will then forward the Position Paper/Statement to the Board of Directors for additional feedback (this interaction will continue until a final draft is completed and approved by the President);
  • The Position Paper/Statement will then be provided on the website to the College membership for commentary on substantive additions (suggested max of a 30-day period);
  • Following the comment period, the Position Paper/Statement will be finalized by the BOD, posted to the ACLAM website and delivered to the AALAS Journal Editors, where it may be considered for official publication;
  • If published in the AALAS Journals, the final journal publication in downloadable PDF will replace the posted document on the ACLAM website.

Existing Position Paper/Statement will be reviewed within 5 years of publication/posting to determine if the topic remains relevant, the perspectives or references need updating, or if the document should be archived from the website.

IMAGES

  1. Animals in Research, Teaching and Testing

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  2. The history behind animal testing in research

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  4. (PDF) Using animals in research, testing and teaching

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  5. Animals Used For Medical Research

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  6. Animal Testing Statistics

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COMMENTS

  1. Medical Records for Animals Used in Research, Teaching, and Testing

    Executive Summary. Diplomates of the American College of Laboratory Animal Medicine (ACLAM 1) have long recognized that the medical record is one of the hallmarks of a program of adequate veterinary care ( Gaertner 2003).Although the value of a medical record is widely recognized, a comprehensive guidance document written specifically for the use of medical records in the research, teaching ...

  2. Medical records for animals used in research, teaching, and testing

    Medical records are considered to be a key element of a program of adequate veterinary care for animals used in research, teaching, and testing. However, prior to the release of the public statement on medical records by the American College of Laboratory Animal Medicine (ACLAM), the guidance that w …

  3. Medical records for animals used in research, teaching, and testing

    T1 - Medical records for animals used in research, teaching, and testing. T2 - Public statement from the American College of Laboratory Animal Medicine. AU - Field, Karl. AU - Bailey, Michele. AU - Foresman, Larry L. AU - Harris, Robert L. AU - Motzel, Sherri L. AU - Rockar, Richard A. AU - Ruble, Gaye. AU - Suckow, Mark A. PY - 2007. Y1 - 2007

  4. (PDF) Medical Records for Animals Used in Research, Teaching, and

    According to Field et al. (2007), from the position of the American College of Laboratory Animal Medicine on the use of animal medical hospital records for research, teaching and testing, stated ...

  5. Medical records for animals used in research, teaching, and testing

    The Committee provided ACLAM with a guidance document titled Public Statements: Medical Records for Animals Used in Research, Teaching, and Testing, which was approved by ACLAM in late 2004. ... Medical records for animals used in research, teaching, and testing: Public statement from the American College of Laboratory Animal Medicine. / Field ...

  6. Medical Records for Animals Used in Research, Teaching, and Testing

    Academia.edu is a platform for academics to share research papers. Medical Records for Animals Used in Research, Teaching, and Testing: Public Statement from the American College of Laboratory Animal Medicine

  7. [PDF] Medical records for animals used in research, teaching, and

    The ACLAM public statement on medical records provides practical yet flexible guidelines to assure that documentation of animal health is performed in research, teaching, and testing situations. Medical records are considered to be a key element of a program of adequate veterinary care for animals used in research, teaching, and testing.

  8. PDF Medical Records for Animals Used in Research, Teaching, and Testing

    the use of medical records in the research, teaching, and testing environment was not readily available to the bio-medical research community. A proposal was made by the Animal and Plant Health Inspection Service (APHIS1)in 2003 to institute regulations relevant to medical records for animals used in teaching, testing, and research (APHIS 2003).

  9. PDF Guidelines for Animal Medical Record Keeping and Transfer of Records

    1. Guide for the Care and Use of Laboratory Animals, ILAR, NAS, Eighth Edition, 2011. 2. USDA Animal Welfare Act Regulations. Title 9: Code of Federal Regulations, Chapter 1, Subchapter A: Animal Welfare. 3. ACLAM Position Statements. Medical Records for Animals Used in Research, Teaching, and Testing. 9/30/2020. Approved - 05/11/2011

  10. Medical Records for Animals Used in Research, Teaching, and Testing

    Medical records are considered to be a key element of a program of adequate veterinary care for animals used in research, teaching, and testing. However, prior to the release of the public statement on medical records by the American College of Laboratory Animal Medicine (ACLAM), the guidance that was available on the form and content of medical records used for the research setting was not ...

  11. Medical records for animals used in research, teaching, and testing

    This website requires cookies, and the limited processing of your personal data in order to function. By using the site you are agreeing to this as outlined in our privacy notice and cookie policy.

  12. Program Documentation and Monitoring

    The American College of Laboratory Animal Medicine (ACLAM) has issued a public statement indicating that medical records are considered to be a key element of a program of adequate veterinary care for animals used in research, teaching, and testing (Field et al. 2007). Individual health records should be maintained for animals that receive ...

  13. Medical records for animals used in research, teaching, and testing

    Medical records are considered to is a key element on a program of adequate veterinary care for animals used in research, learning, real testing. However, prior to the release of the public statements on medical accounts by the American College of Laboratory Animal Medicine (ACLAM), the guidance that tungsten …

  14. PDF PROTOCOL REVIEW

    Animals Used in Research, Teaching, and Testing as one of the documents outlin-ing the necessity for medical records in this case. That paper states, "When medi-cal records for such animals ...

  15. PDF Policy on Clinical Health Record Requirements for Animals Used in ...

    2. Field K et al. 2007. Medical records for animals used in research, teaching, and testing: public statement from the American College of Laboratory Animal Medicine. ILAR J 48(1): 37-41. 3. National Research Council, Institute of Laboratory Animal Resources. Guide for the care and use of laboratory animals. National Academy Press, Washington ...

  16. PDF Institutional Animal Care and Use Committee (IACUC)

    Medical Records for Animals Used in Research, Teaching and Testing: Public Statement from the American College of Laboratory Animal Medicine . American College of Laboratory Animal Medicine, 2007. Brown University Institutional Animal Care and Use Committee Record Keeping Guidelines for USDA-Regulated Species Page 3 of 4

  17. Guidelines on Medical Records for Investigative Personnel

    Field K, Bailey M, Foresman LL, et al. (ACLAM Medical Records Committee). Medical records for animals used in research, teaching, and testing: public statement from the American College of Laboratory Animal Medicine. ILAR J. 2007;48(1):37-41.

  18. PDF Monitoring Policy 2018

    Monitoring and Medical Records of Animals used for Research, Teaching and Testing". Health and Welfare assessment 1. Adequate monitoring requires regular assessment of general health and welfare. For rodents, the signs assessed must be based on the "Guidelines on Monitoring and Medical Records of Animals used for Research, Teaching and ...

  19. Future Directions and Challenges

    The latter part of the twentieth century and beginning of the twenty-first century represents an age of scientific discovery, knowledge application, globalization, and social awareness that are unlike any other periods in the history of the world. The last 50 years have seen a rapid and continuous growth of the global biomedical research enterprise that includes a worldwide increase in ...

  20. Required Health/Medical Record Keeping for Research and Teaching Animals

    An animal's health records must be held for at least 1 year after its disposition or death. (Note: Some records may need to be held longer to comply with other applicable laws or policies.) When an animal is transferred to another party or location, a copy of the animal's health record must be transferred with the animal."

  21. PDF Institutional Animal Care and Use Committee (IACUC)

    An important part of Purdue University's program for the care and use of animals used in research, teaching, or testing, is the meaningful monitoring of procedures approved by IACUC and the monitoring of the health of the animals used under an approved protocol. In this regard, IACUC requires that a copy of approved protocols and amendments be

  22. PDF Record Requirements -Animals Covered by the Animal Welfare ...

    Guide for the Care and Use of Agricultural Animals in Research and Teaching, Third Edition. Federation of Animal Science Scocieties, 2010. Medical Records for Animals Used in Research, Teaching, and Testing: Public Statement from the American College of Laboratory animal medicine. ACLAM Medical records committee: K Field, M Bailey, LL Foresman ...

  23. Position Statements

    Adoption of Research Animals Reproducibility Updated 10/1/22 Medical Records for Animals Used in Research, Teaching, and Testing Updated 9/30/20 Adequate Veterinary Care Updated 6/17/22 Research with Animals Updated 5/21/19 Pain and Distress Updated 6/11/22 The 3Rs Updated 5/21/19