|Policy & Guidance|
|Compliance & Oversight|
|Research Involving Human Subjects|
|Office of Laboratory Animal Welfare (OLAW)|
|Animals in Research|
|Peer Review Policies & Practices|
|Intellectual Property Policy|
|Acknowledging NIH Funding|
|Invention Reporting (iEdison)|
|NIH Public Access|
|NIH Staff FAQs|
|On This Page:|
OLAW welcomes comments on any of its policy guidance, click here for more information.
OLAW develops and monitors, as well as exercises compliance oversight relative to the Public Health Service Policy on Humane Care and Use of Laboratory Animals (the "PHS Policy"). One of OLAW's primary functions is to advise awarding units and awardee institutions concerning the implementation of the PHS Policy. OLAW often provides this advice by responding to policy-related questions submitted by such units and institutions. The following FAQs provide guidance that represents OLAW's current thinking on these topics. This guidance is based on OLAW's experience with the subject matter and draws on best practices followed by the biomedical community regarding the use of research animals. Unless specific statutory or regulatory requirements are cited, the FAQs should be viewed as recommendations in that an institution may use an alternative approach if the approach satisfies the requirements of the PHS Policy.
The USDA Animal and Plant Health Inspection Service (APHIS), Animal Care has reviewed and concurs with the guidance provided in these FAQs where applicable.
Similar guidance applies to surgical procedures. Surgery conducted in response to a specific, custom request is covered by the PHS Policy. An organization conducting custom surgery for an awardee must have or obtain an Assurance, or be included as a component of the awardee’s Assurance. In addition, the awardee must provide verification of project-specific IACUC approval for conducting the surgery. When both organizations hold Assurances, some latitude is allowed in determining which IACUC will review the proposal. However, the awardee always retains primary responsibility for ensuring compliance with PHS Policy. [D6, A11]
See also OLAW FAQ F8: Is the mouse ascites method an acceptable method of monoclonal antibody production?
See also OLAW FAQ D8: When institutions collaborate, or when the performance site is not the awardee institution, which IACUC is responsible for review of the research activity?
Investigators are encouraged to consult relevant professional societies, available guidelines, wildlife biologists, and veterinarians, as applicable, in the design of the field studies (Guide page 32, Appendix A) . Studies with the potential to impact the health or safety of personnel (Guide page 18) or the animal’s environment may need IACUC oversight, even if described as purely observational or behavioral. When capture, handling, confinement, transportation, anesthesia, euthanasia, or invasive procedures are involved, the IACUC must ensure that proposed studies are in accord with the Guide (page 32) . The IACUC must also ensure compliance with the regulations and permit requirements of pertinent local, state, national, and international wildlife regulations. A study on free-living wild USDA-covered species that involves invasive procedures, harms or materially alters the behavior of an animal under study is covered by USDA animal welfare regulations and requires IACUC review and approval.See also OLAW FAQ E4: Is the IACUC required to inspect field study sites?
The appointed members must be qualified through experience and expertise to provide oversight for the institution's animal programs, facilities, and procedures. At a minimum the IACUC must include a veterinarian, a practicing scientist experienced in animal research, a person whose primary concerns are in a nonscientific area, and a person who is unaffiliated with the institution except as a member of the IACUC (sometimes referred to as a public member). An individual who qualifies to fill more than one of the specified categories may be appointed to do so, but the committee must still consist of at least 5 members. The unaffiliated member should have no discernible ties or ongoing affiliation with the institution, and may not be a member of the immediate family of a person who is affiliated with the institution. Immediate family includes parent, spouse, child and sibling. Appointment of an individual who is unambiguously unaffiliated is the best way to fulfill the letter and spirit of this provision. PHS Policy incorporates the Guide which specifies that public members should not be laboratory animal users (Guide page 24) . The veterinarian on the IACUC must have direct or delegated program authority and responsibility for animal-related activities and therefore is always considered to be affiliated with the institution.
If an appointed member who fulfills one of the required specified positions (i.e., scientist, nonscientist, veterinarian, or unaffiliated) leaves the committee so that that position is no longer filled, the IACUC is not properly constituted and may not conduct official business until a member who fulfills the required position is appointed by the CEO (or designee).
Guidance in the Eighth Edition of the Guide is stated in terms of standards that must be met, standards that should be met and standards that may be met.
OLAW defines must as a minimum standard required of all Assured institutions. Deviation from these standards with IACUC approval is a departure from the Guide and must be reported in the semiannual report. Deviation from a must statement without IACUC approval is a noncompliance that must be reported to OLAW through the IO.
Reporting requirements for should statements in the Guide vary. Should statements often involve performance standards. Well-established performance standards are not departures from the Guide and need not be reported in the semiannual report to the IO. Deviation from a should statement with IACUC approval is a departure from the Guide and must be reported in the semiannual report to the IO. Deviation from a should statement without IACUC approval is a noncompliance that must be reported to OLAW through the IO.
May statements in the Guide are suggestions that institutions can choose to implement if suitable for their program and deviations are not included in the semiannual report to the IO.For examples of reporting requirements in varying circumstances and additional information, see Departures from the Guide.
Full IACUC review may result in approval, a requirement for modifications (to secure approval), or withholding of approval. Full committee review must occur during a convened meeting of a quorum of the IACUC members, and with a formal vote. It is insufficient to poll each member individually in lieu of a convened quorum when using the full committee method of review. See NIH Guide for Grants and Contracts NOT-OD-06-052 regarding use of tele- or videoconferencing when a convened meeting is required.
Designated member review may be utilized only after all members have been provided the opportunity to call for full-committee review. If any member requests full committee review then that method must be used. If not, the IACUC Chairperson may appoint one or more appropriately qualified IACUC members to serve as the designated reviewer(s). Designated review may result in approval, a requirement for modifications (to secure approval), or referral to the full committee for review. Designated review may not result in withholding of approval.
If a protocol is assigned more than one designated reviewer, the reviewers must be unanimous in any decision. They must all review identical versions of the protocol and if modifications are requested by any one of the reviewers then the other reviewers must be aware of and agree to the modifications.
The specific method of review for a given protocol must be documented, along with the outcome of the review. [D1, A2, A5, A10, A11]
PHS Policy requires that all awardees and performance sites hold an approved Animal Welfare Assurance. If an institution does not have an animal care and use program, facilities to house animals, and an IACUC, the awardee institution will conduct the animal activity at an Assured institution (performance site). Assured institutions also have the option to amend their Assurance to cover performance sites that do not have an approved Assurance with OLAW, which effectively subjugates the performance site to the Assured institution and makes the Assured institution responsible for the performance site.
If both the awardee institution and the performance site institution have Domestic Assurances, they may exercise discretion in determining which IACUC reviews animal activities and under which institutional program the research will be performed. There is no requirement for dual review; IACUCs may choose which IACUC will review protocols for the animal activities being conducted. It is recommended that if an IACUC defers protocol review to another IACUC, documentation of the review should be maintained by both committees. Additionally, the IACUC conducting the review should notify the other IACUC of significant questions or issues raised during a semiannual program inspection of a facility housing a research activity for which that IACUC bears some oversight responsibility.NIH Grants Policy Statement on Written Agreements (15.2.1.) requires that awardees have a formal written agreement with consortium participants that addresses the negotiated scientific, administrative, financial, and reporting requirements of the grant. This written agreement must include incorporation of applicable public policy requirements, including agreement for meeting the PHS Policy requirement for review and approval of proposed animal activities, significant changes to animal activities, and semiannual facilities review by an IACUC (IV.B.2.).
If a protocol is reviewed and approved by DMR, the IACUC may use the date that the designated reviewer(s) approved the protocol as the date of approval. To facilitate efficient business practice, the IACUC also has the option of selecting a reasonable later approval date as described in NOT-OD-11-053. The approval date will appear in the written notification of approval to the principal investigator. If animal work is conducted before the approval date, as stated in the written notification of approval, this is to be reported to OLAW as a serious noncompliance with the PHS Policy. (PHS Policy IV.F.3)
In response to questions from the community regarding this guidance, OLAW offers the following clarifications:
To avoid temporal delays associated with the PHS Policy requirement that all members of the IACUC must be provided the opportunity to call for FCR for a proposal requiring modifications to proceed to DMR (PHS Policy IV.C.2.), OLAW formally recognized an alternative practice in NOT-OD-09-035 (Guidance to IACUCs Regarding the Use of DMR for Animal Study Proposal Review Subsequent to FCR) issued on January 8, 2009. USDA concurred with this practice.
What is “substantive information”?
“Substantive information” is the information the IACUC needs to evaluate the proposal in accordance with the requirements of the PHS Policy. IACUCs are required to evaluate proposals to ensure that they conform with the institution’s Animal Welfare Assurance and meet the requirements specified in the PHS Policy at IV.C.1., provide the information described in the PHS Policy at IV.D.1., and adhere to provisions of the Guide for the Care and Use of Laboratory Animals . Should a proposal fail to address any of these items to the IACUC’s satisfaction, the Committee may determine that the proposal lacks substantive information and require modifications to secure its approval. Typographical or arithmetic errors, misspellings, incorrect room or telephone numbers, etc., are not considered substantive. While these corrections must be made, additional IACUC review is not required.
Can a quorum of the IACUC decide to establish the DMR subsequent to FCR policy?
No. A DMR subsequent to FCR policy, along with appropriate implementing procedures, may be established only by unanimous consent of all members of the IACUC. While all members need not be physically present at the meeting where the policy is proposed, each individual must be given the opportunity to provide their input in person or via facsimile, email, or memorandum prior to its approval.
What does “in advance, in writing” mean?
“In advance” means that the IACUC-approved policy must be in place prior to the first meeting at which it is used. “In writing” means that the policy and procedures must be written down and documented in the IACUC’s permanent records as having been established by unanimous agreement of all Committee members. Members are not required to physically sign the DMR subsequent to FCR policy.
Does there have to be a written statement for every meeting?
No. The IACUC-approved DMR subsequent to FCR policy allows an appropriately constituted Committee, by unanimous consent, to implement the policy, whenever appropriate, to evaluate revised proposals using DMR. The outcomes of DMRs must then be appropriately documented in the IACUC minutes or elsewhere.
When can the IACUC start using DMR subsequent to FCR?
As soon as all members agree to the process and the IACUC-approved, written DMR subsequent to FCR policy and procedures are in place. In addition, when an IACUC establishes the new policy and procedures, OLAW must be notified in the next institutional Annual Report, and the policy must be documented in the institution’s Assurance renewal.
PHS awarding units may not make an award for an activity involving animals unless the prospective awardee institution and all other participating institutions have approved Assurances on file with OLAW, and the awardee institution has provided verification of approval by the IACUC of those components of the application or proposal related to the care and use of animals….No award shall be made until all required Assurances have been submitted by the institution(s), been approved by OLAW, and the institution(s) have provided verification of approval by the IACUC of those components of the application or proposal related to the care and use of animals. [emphasis added]
The IACUC review must be performed prior to the conduct of any PHS-supported animal activity. Approval is valid for a maximum of three years. Because the scientific enterprise is not static, the need for changes to animal protocols is anticipated and can occur at any time during the life of the protocol. If the changes are significant, PHS Policy, Section IV.B.7. requires prior IACUC approval of the proposed change(s). OLAW provides examples of the kinds of changes it considers to be significant in FAQ D9.
In rare cases, IACUC review of animal activities is conducted later in the life cycle of a grant or contract. This occurs if a delayed onset of animal activities is a component of the experimental research design described in the VAS of the grant application or contract proposal (e.g., the initial development of a drug or device with subsequent animal testing projected into the future). In these circumstances, the funding component will issue a Notice of Award with a special term and condition indicating that no funds may be drawn from the grant or contract for animal activities until a valid IACUC approval date has been provided to the funding component.
Additional OLAW Guidance regarding IACUC review of grant applications can be found at FAQ D10 and previous OLAW Commentary.
While semiannual IACUC inspections of field study sites are not required and in many circumstances are impractical, IACUCs should be apprised of the circumstances under which studies are conducted so that they can consider risks to personnel and impact on study subjects. This may be partially accomplished by written descriptions, photographs, or videos that document specified aspects of the study site. The IACUC should also ensure that appropriate permits are in place. USDA animal welfare regulations exempt areas containing free-living wild animals in their natural habitat from inspection [See 9 CFR, Part 2, Section 2.31(c)(2)].
See also OLAW FAQ A6: Does the PHS Policy apply to research that is conducted in the field?
The IACUC is responsible for evaluating the potential adverse consequences of such agents when used for research. In making its evaluation, the IACUC may consider factors including, for example:
The IACUC may use a variety of administrative methods to review and approve the use of such non-pharmaceutical-grade agents. For example, the IACUC may establish acceptable scientific criteria for use of these agents within the institution, rather than on a case-by-case basis. Investigators and IACUCs should consider relevant animal welfare and scientific issues including safety, efficacy, availability of pharmaceutical-grade compounds, and the inadvertent introduction of new variables. Cost savings alone are not an adequate justification for the use of non-pharmaceutical-grade or compounded drugs in animals.
Although the potential animal welfare consequences of complications are less evident in non-survival studies, the scientific issues remain the same. The principles and need for professional judgment outlined above apply to non-survival studies.
Procedures that may cause more than momentary or slight pain or distress to animals must be relieved by sedation, analgesia, or anesthesia using veterinary or human pharmaceutical-grade compounds, unless the use of an investigational chemical or formulation is scientifically necessary, appropriately justified, and approved by the IACUC. The use of a non-pharmaceutical-grade euthanasia agent must meet the same criteria.
On March 1, 2012, OLAW, with USDA and AAALAC, offered additional information through a webinar on the “Use of Non-Pharmaceutical-Grade Chemicals and Other Compounds in Research with Animals”. Here you will find a recording of the webinar, a transcript that includes answers to numerous questions, plus examples of situations for the use of non-pharmaceutical-grade substances.
1 A pharmaceutical grade compound is a drug, biologic, or reagent that is approved by the Food and Drug Administration (FDA) or for which a chemical purity standard has been established by the United States Pharmacopeia-National Formulary (USP-NF) , or British Pharmacopeia (BP) . According to guidance from the FDA, “pharmaceutical secondary standards” are acceptable for use in clinical animal studies if obtained from a reputable source and comply with compendia standards.
2 A listing of pharmaceutical-grade drugs and biologics is available through the FDA database. The Orange Book is the reference for FDA-approved human drugs. The Green Book is the reference for FDA-approved veterinary drugs.
3 Veterinary compounding is the customized manipulation of an approved drug by a veterinarian, or by a pharmacist upon the prescription of a veterinarian, to meet the needs of a research study. IACUCs considering the use of veterinary compounding for research purposes are advised to consult: https://www.avma.org/KB/Resources/Reference/Pages/Compounding.aspx for more information about federal regulations.4 United States Department of Justice Drug Enforcement Agency controlled substances Schedule I and II-IV drugs may be used in biomedical research according to the standards of the Code of Federal Regulations 1301.13.
Institutions that conduct PHS-supported research, testing, or training have a responsibility to ensure animal welfare and an obligation to protect the federal investments in these activities. The Guide provides recommendations regarding temperature, humidity, and ventilation for common laboratory animals and discusses parameters regarding heating, ventilating, and air conditioning (HVAC) that must be considered. It also states, “In the event of an HVAC system or component failure, systems should, at a minimum, supply facility needs at a reduced level, address the adverse effects of loss of temperature control, and, where necessary, maintain critical pressurization gradients. It is essential that life-threatening heat accumulation or loss be prevented during mechanical failure.” (Guide page 140) Monitoring HVAC equipment performance is important to ensure timely identification of local or regional power disruptions or system malfunctions. Institutions are strongly encouraged to consider using available electronic technology to measure temperature in each animal room on a continuous basis. Appropriately installed and powered sensors and electronic alarm systems can rapidly notify maintenance and animal care staff of the need to take immediate action to prevent harm to animals (Guide page 143) . Sole reliance on employees to identify changes in animal room conditions or the use of high-low thermometers to track changes in temperature may not be sufficient to allow timely intervention and prevent catastrophic loss.
Institutions are also responsible to ensure the welfare of fishes, amphibians, and other vertebrates whose environment is aquatic, with the emphasis on water temperature and quality, including oxygenation, circulation and filtration. (Guide pages 77-88)
The Guide requires that institutions develop a plan that can be instituted if a disaster occurs. (Guide pages 35, 74-75) The disaster plan must include a scheme for relocating or euthanizing animals when power cannot be restored or repairs effected promptly. HVAC, alarm malfunctions, failures in primary and emergency power sources, mechanisms for maintaining appropriate temperatures and ventilation are important issues that must be considered and included in the disaster plan. OLAW provides a Disaster Planning and Response Resources web page to assist institutions in planning and responding to natural and other disasters affecting animal facilities.See also OLAW FAQ G3: Do awardee institutions need animal facility disaster plans?
Cost savings alone are not an adequate justification for performing multiple major survival surgical procedures. (Guide page 30)
Note that under USDA regulations (AWR 2.31 (x) A-C), “No animal will be used in more than one major operative procedure from which it is allowed to recover, unless: (A) Justified for scientific reasons by the principal investigator, in writing; (B) Required as routine veterinary procedure or to protect the health or well-being of the animal as determined by the attending veterinarian; or (C) In other special circumstances as determined by the [Animal Care] Administrator on an individual basis. Written requests and supporting data should be sent to the Animal and Plant Health Inspection Service, Animal Care, 4700 River Road, Unit 84, Riverdale MD 20737-1234”.See also OLAW FAQ F13: Are laparoscopic procedures considered major surgery?
Rodent cages of the size commonly used in the United States may be appropriate for pair or trio breeding. The Guide does not add specific, additional engineering standards for breeding configurations. This empowers institutions to determine appropriate housing. The IACUC must consider relevant factors when assessing the adequacy of cage space according to performance standards. Examples of these factors may include:
Blanket, program-wide departures from the Guide for reasons of convenience, cost, or other non-animal welfare considerations are not acceptable. Cages that might be acceptable when litters are born may have insufficient space as pups grow. Whatever parameters are used to establish breeding configurations and weaning procedures, the IACUC must ensure that cage population does not negatively impact animal well-being and overcrowding does not occur.
OLAW recognizes the authority of the IACUC to determine whether specific manipulations used in research are major operative procedures. The IACUC’s determination must be based on a detailed description of the procedure and the anticipated or actual consequences, as characterized by the investigator. In some cases, the classification by the IACUC of a procedure as major or minor may be readjusted post-procedurally depending on clinical outcome. If the IACUC, after thorough review, determines that the surgical procedure only penetrates but does not expose a body cavity and that the procedure does not produce substantial impairment, the IACUC may conclude that it is not a major operative procedure. Any laparoscopic surgery that produces substantial impairment of physical or physiological function must be considered a major operative procedure. Whether the laparoscopic procedure is classified as major or minor, the IACUC must ensure that the appropriate analgesia, sterile technique, and perioperative monitoring is employed.
Multiple major survival surgical procedures on a single animal are discouraged but may be permitted if they are related components of a research project, are scientifically justified by the investigator, or if they are needed for clinical reasons. Cost savings alone is not an adequate reason for performing multiple major survival surgical procedures.See also OLAW FAQ F9: Are multiple major surgical procedures permitted on a single animal?
There is universal agreement among oversight agencies that nonhuman primates should be socially housed. (See U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training Principle VII.) The Guide endorses social housing as the default for nonhuman primates. (Guide page xviii) The USDA requires regulated facilities to address the social needs of nonhuman primates known to exist in social groups in nature [See 9 CFR 3.81(a)], with certain specified exceptions [See 9 CFR 3.81(a)(1),(2), and (3) and 3.81(e)(1) and (2)]. Single housing of social primates is considered an exception to the standards under 9 CFR and must be reported as such in a research facility’s annual report [See 9 CFR 2.36(b)(3)].
Staff performing nonhuman primate socialization should be trained and competent in the procedure and knowledgeable about the animals. Behaviorally compatible animals should be used whenever possible in socialization attempts. Group composition is critical and numerous species-specific factors should be taken into consideration when forming a group. Due to conformational differences of animals within groups, more space or height may be required to meet the animals’ physical and behavioral needs. Determination of the appropriate cage size is not based on body weight alone. Professional judgment is paramount in making such determinations. (See Guide pages 58-61.)
Exemptions to the social housing requirement must be based on strong scientific justification approved by the IACUC or for a specific veterinary or behavioral reason. Lack of appropriate caging does not constitute an acceptable justification for exemption. When necessary, single housing of social animals should be limited to the minimum period necessary. When single housing is necessary, visual, auditory, olfactory, and (depending on the species) protected tactile contact with compatible conspecifics should be provided, if possible. (Protected tactile contact is considered single housing by USDA, with rare exceptions.) In the absence of other animals, additional enrichment should be offered (as appropriate to the species or individual animal), such as safe and positive interaction with the animal care staff, periodic release into larger enclosures, supplemental enrichment items, and / or the addition of a companion animal in the room or housing area.Institutions are encouraged to consult the Animal Welfare Act and Regulations on primate housing requirements. Compliance with the USDA regulations is an absolute requirement of this [PHS] Policy. (Footnote 2, page 9) OLAW and USDA positions are further defined at the Nonhuman Primate Enrichment and Social Housing resource on the OLAW website.
Performance standards are to be applied to housing issues. Outcome-based performance standards are paramount when evaluating cage or pen space for housing animals used for research, research training, and biological testing. While the Guide's space recommendations are accepted reference points for addressing space needs (Guide pages 50-63) , performance standards allow flexibility to improve animal welfare and scientific research. (Guide pages 6-7) An institution’s animal housing practices must be species-specific, appropriate for the animals, and in compliance with all applicable federal and local regulatory requirements. Compliance with the applicable regulations (9 CFR Subchapter A) issued by the U.S. Department of Agriculture under the Animal Welfare Act are an absolute requirement of the PHS Policy (Footnote 2, page 9).
Discussion of appropriate training is found throughout the five chapters of the Guide. At a minimum, the PHS Policy and the Guide (page 15) require institutions to:
1 The U.S. Government Principles direct that, “…housing, care, and feeding…must be directed by a veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied” (VII) and that, “Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals. Adequate arrangements shall be made for their in-service training, including the proper and humane care and use of laboratory animals” (VIII).
2 The Health Research Extension Act of 1985 requires that, “scientists, animal technicians, and other personnel involved with animal care, treatment, and use…have available to them instruction or training in the humane practice of animal maintenance and experimentation…” (Sec. 495.(c) (1) (B)).
3 The PHS Policy requires that institutions seeking an Assurance provide “a synopsis of training or instruction in the humane practice of animal care and use, as well as training or instruction in research or testing methods that minimize the number or animals required to obtain valid results and minimize animal distress, offered to scientists, animal technicians, and other personnel involved in animal care, treatment or use” (IV.A.1.g.); that medical care for animals will be provided by “qualified” veterinarians (IV.C.1.e.) and that, “Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures” (IV.C.1.f.).
“A comprehensive OHSP should include a hierarchy of control and prevention strategies that begins with the identification of hazards and the assessment of risk associated with those hazards.” (Guide page 18) An effective occupational health and safety program must encompass all personnel that have contact with animals. Depending on the species of animal or the amount of animal exposure, the program may not affect all personnel equally. Minimally, the program should include:
The disaster plan “should define the actions necessary to prevent animal pain, distress, and deaths” (Guide page 35) . Institutions may find consideration of the following components useful in the development of a comprehensive, effective plan:
Institutions should periodically review and update the plan to adapt to program changes, evolving risk, and lessons learned from drills and actual disasters. Recent hurricanes and tropical storms provide lessons on the unpredictable nature and devastating effects of extreme weather events. Examples of the impact of these events include loss of animals located in basement facilities due to flooding, failure of back-up generators and loss of fuel supplies located in low-lying areas due to flooding, and loss of frozen reagents/specimens due to sustained power outages. Institutions are encouraged to continually re-assess their vulnerabilities as future climate changes are expected to cause higher sea levels and effect precipitation patterns and the severity of storms.
Disasters can happen at any time. With advance preparation, institutions may be able to lessen or eliminate the impact before a disaster occurs. Actions to consider are relocating animals from facilities located in storm surge areas or locations prone to flooding, cryopreserving valuable strains of animals, repositioning emergency power supplies, and backing up vital records in an off-site location.OLAW provides a Disaster Planning and Response Resources webpage to assist institutions in planning and responding to natural and other disasters affecting animal facilities.
Related components of institutional programs provide monitoring by a multi-disciplinary team of individuals. Examples of such components include daily observation of animals by trained animal care personnel and communication to the veterinary staff for follow-up, facility monitoring by facility maintenance personnel, post operative care by trained personnel, evaluation of outcomes of animal procedures by investigators and staff, hands-on training in animal procedures, and appropriate reporting of incidents involving occupational health and safety. All of these functions and responsibilities imply a level of monitoring. Ultimately the institution has flexibility in how it achieves compliance.
Some institutions have developed PAM programs with dedicated staff that physically monitor procedures and practices associated with animal use protocols. This is one acceptable method that institutions may elect to adopt, but it is not a federally mandated requirement. Whatever methods an institution incorporates, it is important that the authority and responsibility of the IACUC not be contravened by a PAM program, institutional compliance officials, or other mechanism established to monitor animal care and use.
The Guide for the Care and Use of Agricultural Animals in Research and Teaching (Ag Guide) primarily refers to agricultural animals used in agricultural research for which the scientific objectives are to improve understanding of the animals’ use in production agriculture. It is therefore inappropriate to substitute the Ag Guide for the Guide based on the species of animal. However, there may be circumstances where it is appropriate to follow the standards of the Ag Guide in biomedical research (e.g., transmission studies of avian influenza under poultry production conditions). Information about environmental enrichment, transport, and handling in the Ag Guide may be helpful in both agricultural and biomedical research settings. Proposals to conduct such activities should be reviewed on a case-by-case basis and any approval to depart from provisions of the Guide must be based on scientific justifications acceptable to the IACUC.
“Since the IACUC has responsibility for the welfare of animals at its facility, it shares responsibility for the security of the animals and associated personnel with other groups within the institution, including the units responsible for security, public information, and governmental relations. Institutions receiving federal funds have an obligation to protect the federal investment in research by exercising due diligence in this area. The IACUC can serve a key role in advising the IO and the institution of potential risks and vulnerabilities, and in developing a plan for responding to potential or real threats. In all cases the IACUC must consider allegations of noncompliance or animal welfare issues as concerns that must be addressed in accordance with relevant PHS Policy provisions and Animal Welfare Regulations (AWRs). There are four key elements to an institution's preparedness:
The ARENA OLAW Institutional Animal Care and Use Committee Guidebook goes on to describe in more detail the elements of a crisis management plan and how the institution should best prepare to respond to allegations in an honest and forthcoming fashion. OLAW encourages IOs and IACUCs to evaluate their institution's readiness to deal with potential threats in accordance with the Guidebook's recommendations. OLAW shares the concerns of Institutional Officials and IACUC members about the threats and intimidation their institutions may face and strongly encourages each institution, if it has not already done so, to:
Inform the program/scientific staff of the NIH funding component of threatening or potentially threatening situations, as they arise. (If activist activities result in conditions that jeopardize the health or wellbeing of animals or result in actual harm or death to animals, the conditions must be reported to OLAW in accordance with NOT-OD-05-034.)
See http://www.flu.gov for U.S. government pandemic planning information.
The following links may be helpful in developing an institutional pandemic plan:
Additional guidance will be developed and posted on the OLAW website if an emergency situation is sufficiently severe and long-lasting that OLAW determines that the above suggestions do not meet the needs of the research community and funding components. OLAW is the only entity authorized to make determinations regarding waivers to provisions of the PHS Policy.
References are to previously published guidance or commentary in Dear Colleague Letters, Lab Animal Magazine, Contemporary Topics, and ILAR News which may provide additional elaboration or commentary. The information in this document is updated and supersedes previous guidance or commentary.
OLAW will update this page with new FAQs as necessary.
OLAW welcomes comments on any of its policy guidance. Comments may be submitted to OLAW by email at: email@example.com (please insert the title of the specific guidance document in the subject field), or by mail to:
Division of Policy and Education
Office of Laboratory Animal Welfare
National Institutes of Health
RKL 1, Suite 360, MSC 7982
6705 Rockledge Drive
Bethesda, MD 20892-7982
All relevant comments will be considered in OLAW decisions on timing and content of revisions to guidance documents, or development of new guidance documents. Comments generally will not result in direct responses from OLAW.
|Comments or Questions?|