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IACUC Form, Function & Interaction
week4-2a

The establishment of IACUCs is detailed in the PHS Policy and the Animal Welfare Regulations (AWRs) of the Animal Welfare Act. Again, PHS policy applies to all institutions receiving funding from the U.S. Public Health Service (of which the National Institutes of Health is a part) that use vertebrate animals in biomedical research, research training, and testing. The AWRs, on the other hand, are applicable to all institutions in which warm-blooded animals are used (with some specific exclusions such as laboratory-bred rats and mice, birds, and agricultural animals not used in biomedical research) for teaching, research, or testing activities regardless of funding source, unless the purpose of those activities is the production of food or fiber.

The Institutional Official

The law mandates that the IACUC be appointed by an institution’s Chief Executive Officer (CEO), the highest-level operating official of the institution. He or she may delegate authority to appoint the IACUC if that delegation is in writing.

The PHS Policy and the AWRs emphasize strong leadership and support of the animal care and use program at the level of senior management and strong oversight and evaluation of the program by the IACUC. Once appointed, the IACUC reports to the Institutional Official (IO).

The IO is the individual who is authorized to legally commit on behalf of the research institution that it will meet the requirements of the AWA. PHS Policy defines the IO as the individual who signs and has the authority to sign the institution’s Animal Welfare Assurance, which commits the institution to meet the requirements of the Policy.

[N.B. – The CEO and the IO may be one and the same. This is often the case in smaller and start-up research institutions.]

Because of this responsibility, the IO must have the authority to allocate the institutional resources necessary to maintain optimal functioning of the animal care and use program based on recommendations received from the IACUC. The IO must show support for the IACUC and its duties, and in turn, the IACUC must support and work closely with veterinarians, animal care staff, and animal users (investigators and their staff).

Though the IACUC reports directly to the IO, the IO may not unduly interfere with the performance of its duties.

Specifically, the Institutional Official:

  • has the authority to sign the institution’s OLAW Assurance and commit the institution to meet the requirements of AWA;
  • commits the institution to meet the requirements of PHS Policy;
  • receives inspection reports and recommendations from the IACUC;
  • in consultation with the IACUC, determines whether deficiencies are minor or significant, determines corrective actions or suspensions and reports such actions to regulatory and funding agencies;
  • receives notification of the IACUC’s decision to approve or withhold its approval of animal activities;
  • receives and transmits annual reports to NIH/OLAW and to the USDA Animal and Plant Health Inspection Service (APHIS);
  • may subject protocols that have been approved by the IACUC to further review and approval, but may not approve an activity that has not been approved by the IACUC;
  • ensures that all personnel involved in animal care, treatment and use are qualified to perform their duties and that specific training is provided to those personnel;
  • ensures that training and instruction and the qualifications of personnel are reviewed with sufficient frequency to fulfill the research facility’s responsibilities;
  • ensures the institution has an attending veterinarian who provides adequate veterinary care to its animals in compliance with the AWA; and
  • ensures that the institution maintains the required records for the specified time periods.

[su_note note_color=”#c7c77f”]OLAW BEST PRACTICES FOR THE IO
• The institutional or attending veterinarian and the IACUC should report directly to the IO.
• The IO should clearly define and assign responsibilities and reporting channels for other essential program elements such as training, occupational health, and facility maintenance.

SOURCE
OLAW Staff. “Frequently Asked Questions about the Public Health Service Policy on Humane Care and Use of Laboratory Animals,” in ILAR News, Vol. 35(3-4):47-49, Summer/Fall, 1993 (Institutional Responsibilities, Question 4). [/su_note]

The IACUC has authority to review and approve animal research protocols, and this authority is independent of the IO, who may not overrule an IACUC decision to withhold approval of a protocol. The converse is not true, i.e., if an IACUC approves a protocol, the institution is not required or obligated to conduct the research activity. An institution may subject protocols to additional institutional review (e.g., department head, biosafety committee, etc.).

The IACUC is also mandated to perform semiannual program evaluations as a means of overseeing the animal care and use program. This responsibility puts the IACUC in an advisory role to the IO. In its semiannual reports to the IO, the IACUC advises him/her of the status of the institution’s compliance; establishes plans and schedules for correcting deficiencies necessary to either maintain or achieve compliance; and makes recommendations to the IO regarding any aspect of the institution’s animal program, facilities, or personnel training. Again, this approach of enforced self-regulation requires that the IACUC have the full support of the IO responsible for the program.

IACUC Composition

PHS Policy and the AWRs both require that members with certain backgrounds and skills serve on an IACUC. Only an IACUC that has all the required members appointed is considered to be a constituted IACUC. Only a constituted IACUC can conduct official business. Both the AWRs and PHS Policy imply that required IACUC members must be voting members.

Regarding IACUC membership, there are both differences and overlap between the AWRs and PHS Policy:

  • The AWRs, for example, require:

o   a committee consisting of at least three (3) members, a Chair and two other members;

o   at least one of these must be a Doctor of Veterinary Medicine (DVM) with training or experience in laboratory animal science and medicine; and

o   at least one must  represent general community interests in the proper care and treatment of animals and must not be affiliated in any way with the facility other than as a member of the IACUC.

  • According to PHS Policy, the IACUC:

o   must consist of at least five (5) members;

o   at least one of these must be a DVM with training or experience in laboratory animal science and medicine;

o   at least one member must be a practicing scientist experienced in animal research;

o   at least one must be a “lay” member whose primary concerns are in a nonscientific area (e.g.,  ethicist, librarian, attorney); and

o   at least one member must not be affiliated in any way with the facility other than as a member of the IACUC.

The similarities and differences between the AWRs and PHS Policy regarding IACUC membership are compiled on the following pages [ 1Institutional Animal Care & Use Committees… A Comparison of Animal Welfare Regulations (USDA) & PHS Policy (NIH) ].

In order to comply with both the AWRs and PHS Policy in constituting an IACUC, a minimum of the following members must be appointed:

  • a chairperson;
  • a veterinarian with responsibility and authority in the Animal Care and Use Program;
  • a practicing scientist experienced in research involving animals;
  • a lay member whose primary concerns and expertise are in a nonscientific area; and
  • a non-affiliated member whose only affiliation with the institution is as a member of the IACUC.

Voting or non-voting members may also be appointed from other areas of the Animal Care and Use Program or other departments outside the Program. Consultants may also be used to provide expert guidance to the IACUC, but may not approve or withhold approval of an activity or vote with the IACUC unless they are also members of the IACUC.

While there are no statutory or regulatory prohibitions against individuals filling more than one role on the IACUC, PHS recommends against the same person serving multiple roles because the responsibilities and authorities vested in each of the positions are distinct and often require different skills[1]. Appointing one individual to more than one of these roles may circumvent intended checks and balances. The perception of conflict of interest is also important and can lead to allegations of improprieties from various sources.

 

[1]  —. ARENA/OLAW Institutional Animal Care and Use Committee Guidebook, 2nd ed. Bethesda, MD: National Institutes of Health/OLAW (2002).

The first required member of the IACUC is the Chair. While there are no specific skill or credential guidelines for the IACUC Chairmentioned in PHS Policy or the AWRs, a knowledgeable and effective leader experienced with animal research and animal research regulations is essential. An IACUC Chair must have a working knowledge of parliamentary procedure to conduct IACUC business fairly and efficiently, and must have an ability to keep deliberations focused and ensure that all committee members are able to participate. A Chair should also have sufficient institutional authority in order to perform his/her duties without concern that IACUC actions may jeopardize his/her position or career.

The specific responsibilities of the IACUC chair might include:

  • ensuring compliance with IACUC-related USDA and PHS regulations, and AAALAC guidelines;
  • recommending committee membership changes to the IO;
  • maintaining a current list of principal investigators;
  • convening/chairing meetings; designating acting chair if the Chair is unable to attend meetings; canceling meetings when appropriate;
  • ensuring that a quorum is present to conduct meetings;
  • ensuring that semiannual program reviews and facility inspections are performed every six months and appropriately documented, and taking appropriate actions based on program review and facility inspection findings, and submitting reports to IO;
  • ensuring adequate documentation of IACUC activities, such as meeting agendas, meeting minutes, inspection reports, and membership changes;
  • reviewing and documenting approval of protocols, amendments, and protocol renewals/deletions/expirations;
  • acting as spokesperson on behalf of the IACUC, both internally and externally, including championing policy and practice initiatives to improve the Animal Care and Use Program;
  • representing the IACUC to USDA and FDA inspectors and AAALAC site visitors;
  • interacting regularly with the IO, attending veterinarian, IACUC staff, other institutional committees, occupational health and safety, physical plant, and human resources;
  • coordinating IACUC subcommittees;
  • investigating cases of noncompliance and complaints about the care or use of laboratory animals;
  • preparing the OLAW Assurance Statement and annual reports; and
  • preparing the USDA Annual Report for Research Facilities.

Veterinarian

The second required member of the IACUC is a veterinarian. The veterinarian who serves on the IACUC must have authority in the animal care and use program and is officially termed the Attending Veterinarian by USDA, and sometimes the Institutional Veterinarian by PHS.

The Attending Veterinarian (AV) is the only member who serves on the IACUC on the basis of position of employment. The Attending Veterinarian’s permanent position on the IACUC is described by the Latin term “ex officio”, meaning “by virtue of the office.” A common misconception is that ex officio means non-voting, but this is not correct. PHS has encouraged the best practice that the Institutional or Attending Veterinarian, like the IACUC, should report directly to the IO[1].

Other veterinarians working at an institution may also serve on the IACUC, but they cannot replace the AV on the committee.

The Attending Veterinarian must meet the following criteria:

  • They must have graduated from a veterinary school accredited by the American Veterinary Medical Association’s Council on Education, or have a certificate issued by the American Veterinary Medical Association’s Education Commission for Foreign Veterinary Graduates, or have received equivalent formal education as determined by the USDA (Chief) Administrator;
  • They must be certified by the American College of Laboratory Animal Medicine (ACLAM) or have received training and/or have experience in laboratory animal medicine and in the care and management of the species at the institution; and
  • They must have direct or delegated authority (and accordingly, responsibility) for activities involving animals at the institution.

The 1996 Report of the American College of Laboratory Animal Medicine on Adequate Veterinary Care in Research, Testing and Teaching contains more detailed information on the role of the veterinarian on the IACUC.

The Attending Veterinarian is given additional authority and responsibilities by USDA that integrate with IACUC functions:

  • The AV or a designee must approve specific details of proposals involving surgery, including pre- through post-procedural care and relief of pain and distress, and to change postoperative care as necessary to ensure the comfort of animals;
  • He/she must make recommendations regarding activity level or restrictions of animals in health records;
  • He/she must decide when necropsies (autopsies) of animals should be performed to investigate health problems in the institution;
  • He/she must provide consultations during the planning stages of proposed animal activities that involve more than momentary pain or distress;
  • When dogs must be exercised, he/she must determine the frequency, method, and duration of dog exercise in consultation with and approval by the IACUC; and
  • He/she must direct the required environmental enrichment plan for nonhuman primates.

 

[1] “Frequently Asked Questions about the Public Health Service Policy on Humane Care and Use of Laboratory Animals.” ILAR News 35(3-4):47-49, Summer/Fall, 1993, http://grants.nih.gov/grants/olaw/references/ilar93.htm.

VETERINARIAN’S OATH

• Being admitted to the profession of veterinary medicine, I solemnly swear to use my scientific knowledge and skills for the benefit of society through the protection of animal health the protection of animal health and welfare, the prevention and relief of animal suffering, the conservation of livestock resources, the promotion of public health and the advancement of medical knowledge.
• I will practice my profession conscientiously, with dignity and in keeping with the principles of veterinary medical ethics.
• I accept as a lifelong obligation the continual improvement of my professional knowledge and competence.

Other responsibilities of the attending veterinarian might include:

  • serving as designated reviewer when appropriate ( This will be discussed later in this chapter.); and
  • assisting with the training and education of IACUC members, investigators, students and others.

As in each of the preceding responsibilities of the AV, the overall veterinary care program is carried out with the approval of the IACUC. It is important, therefore, for the AV and IACUC to work together closely and well.

Scientist 

The third required member of the IACUC is a practicing scientist. The member of the IACUC that fulfills the required role of the scientist must have experience in research involving animals. Further guidance is not provided in the regulations, but institutions often consider it helpful to have a scientist with expertise and knowledge that overlaps with research being proposed to the committee.

At large institutions, the majority of IACUC members are generally animal users. So, the scientific members form the primary link between institutional administrators and investigators with respect to animal research issues at the institution. For this reason, the scientific members of the IACUC should be individuals who are well-respected both by their peers and by the administrators within their institution, and who also have a strong commitment to the improvement of the animal care program.

In addition to the required scientist, an IACUC can include other scientifically trained individuals who may or may not be animal users. Environmental health and safety specialists who are knowledgeable about biohazards can be valuable committee members because of their ability to answer questions on occupational health in animal facilities and public health issues that may arise from certain types of research. If the program includes a significant farm animal research component, a veterinarian with clinical experience in farm animal medicine may be appropriate as a committee member. Additionally, a statistician can be extremely helpful in answering questions related to the appropriateness of experimental design.

Animal care technicians also represent a group of scientifically qualified individuals who can be asked to serve on IACUCs. Since technicians are responsible for the day-to-day care of the animals and have a working familiarity with protocols and animal facilities, they may be the first people in the institution to recognize a problem in the Animal Care and Use Program. Good communication between the IACUC and the technicians is essential, and having a technician on the committee may help to achieve this goal.

Non-scientific or Lay Member

The fourth required member of the IACUC is the non-scientific, or lay, member. This member must be an individual whose primary concerns are in a non-scientific area (e.g., an ethicist or philosopher, research librarian, attorney, or member of the clergy).

Science is an attempt to understand and explain all phenomena in the natural world on a rational basis. However, it is not helpful in addressing ethical and moral questions raised about using nonhuman animals in science. For this reason, individuals from the disciplines of philosophy and religion are frequently asked to serve as the non-scientific members on IACUCs. Although these individuals generally have no formal training or professional interest in animal care issues, they can provide fresh perspectives on the complex ethical issues that confront IACUC members. In academic institutions, faculty from a variety of departments, including mathematics, English, and music, have also become informed about animal use issues and can make important contributions to animal care programs. Having a representative from the physical plant on the committee can also be helpful with regard to maintaining the structural integrity of animal facilities.

Non-affiliated Member

The fifth and final required IACUC member is the non-affiliated member. The non-affiliated member is intended to bring his/her independent perspective on issues relating to animal research being discussed during IACUC meetings as a reflection of the current values and concerns of the community outside the research institution.

The word “community” is not specifically defined in the regulations. Some institutions interpret “community” as the city or town in which they conduct business and invite non-affiliated members from within the resident population. Others interpret “community” more broadly and may seek non-affiliated members from specific professions (e.g., clergy, attorneys and retired judges, educators, etc.)  rather than their place of residence.

As discussed in Chapter 1/Week 1, the non-affiliated member has equal status to every other committee member and must be provided the opportunity to participate in all aspects of IACUC functions.

The non-affiliated member must meet the following criteria:

  • He/she must not be affiliated in any way with the institution other than serving as an IACUC member.
  • He/she must not be a member of the immediate family of a person affiliated with the institution.
  • He/she must be a person who does not utilize laboratory animals.

The specific responsibilities of the non-affiliated member might include:

  • playing an active role in all IACUC activities;
  • making inquiries about matters that are undetected by the other members of the IACUC;
  • critically reviewing protocols; and
  • participating in semiannual program review and facility inspections.

While non-affiliated members may be willing and able to serve without reimbursement, in many instances remuneration for expenses or compensation for time may allow for participation by effective individuals that would not otherwise be possible. Both USDA and PHS allow financial compensation to the non-affiliated member for nominal expenses such as travel, parking, meals, and even participation, as long as such compensation:

  • is not so substantial as to be considered an important source of income;
  • does not influence the non-affiliated member’s voting on the IACUC; and
  • does not qualify the member as an employee of the institution.

USDA Policy #15 specifically allows a veterinarian to fulfill this non-affiliated role as long as the veterinarian is not the Attending Veterinarian.

IACUC Support Staff

Depending on the size of an institution and the volume of animal research procedures conducted, an IACUC may have full- or part-time support staff with expertise in regulatory compliance, including an IACUC Coordinator. In medium- to large-size institutions, where IACUC chairs and members usually serve on a rotating basis, a support staff serves to provide stability and continuity to the animal care and use program. In some cases, smaller and start-up institutions that are unable to hire full-time IACUC staff may outsource an IACUC support function to qualified consultants.

The role of the IACUC staff is to provide administrative support to the IACUC and the IO, serving both as the gatekeeper of information (e.g., maintenance of federal documents such as the institution’s Animal Welfare Assurance) and the fulcrum of communication for the committee. Regulatory guidance advises that neither the IO nor the IACUC members wield authority over IACUC staff with a heavy hand[1].

IACUC staff responsibilities range from administrative (e.g., preparing agendas and distributing protocols to IACUC members; coordinating IACUC meetings; preparing IACUC minutes; and/or sending out protocol expiration reminders) to highly professional (providing orientation and training to new IACUC members; pre-review of protocols; drafting of IACUC policies for committee review and approval; and/or monitoring post-approval compliance), depending on the size and complexity of the animal care and use program.

IACUC Standards

Attendance

Unlike Institutional Review Boards reviewing human subjects research, which cannot conduct business unless at least one non-scientific member is present, there is no legal requirement that every IACUC member attend every meeting, nor is any specific member required to be present to conduct business.

Although there is no mention in the AWRs or PHS Policy of the use of alternate IACUC members, the USDA Animal and Plant Health Inspection Service (APHIS) and the NIH Office of Laboratory Animal Welfare (OLAW ) agree[2] that alternate members may be appointed to the IACUC as long as they are appointed by the CEO or other official with authority to appoint members, and the number of alternates does not exceed the number of regular IACUC members. An IACUC member and his/her alternate may not count toward a quorum at the same time or act in an official member capacity at the same time. Alternates must receive training similar or identical to the training provided to regular IACUC members.

Many institutions have found that appointing more than the minimum number of IACUC members who meet the respective criteria prevents problems when an unexpected vacancy occurs, and can help the committee meet the quorum requirements necessary for a properly constituted committee.

Confidentiality

IACUC protocols contain personal, confidential and proprietary information. In mandating the IACUC, the intent of the AWRs and PHS Policy is not to force institutions to disclose trade secrets or commercial or financial information of a privileged or confidential nature. The Animal Welfare Act states that it is against the law for an IACUC member to disclose confidential information such as trade secrets; operations; or the identity, confidential statistical data, amount or source of any income, profits, losses or expenditures, of a research facility.

Therefore, members of the IACUC are generally responsible for maintaining all committee proceedings and documents in strict confidence. Some institutions require member signatures on confidentiality statements to ensure compliance in this regard.

Meeting Frequency

The IACUC must meet as often as necessary to fulfill its responsibilities, but is required by law to meet at least once every 6 months  to approve the semi-annual evaluation (covered in Chapter 6/Week 6), but IACUCs at larger institutions often meet once a month, and sometimes even more often.

To help members plan to attend meetings, IACUC meetings are often scheduled far in advance, with meeting dates announced throughout the institution. This allows IACUC meetings to be scheduled to avoid holidays and attendance at professional meetings that could otherwise reduce attendance, and allows investigators to plan their protocol submissions.

Quorum Requirements

Under both the AWRs and PHS Policy, certain official IACUC actions require a quorum. Quorum is defined as a majority (>50%) of the voting members of the IACUC. Examples of such actions are full committee review of a research project and suspension of an activity. Therefore, a protocol is approved only if a quorum is present, and if more than 50% of the quorum votes in favor. In order to suspend an activity, the IACUC must review the matter at a convened meeting of a quorum of the IACUC and the suspension must be approved by a majority vote of the quorum present.

For reasons other than conflict of interest, abstentions from voting do not alter the quorum or change the number of votes required. For example, if an IACUC has 20 voting members, at least 11 members must be present at a convened meeting to constitute a quorum and approval of a protocol would require a minimum of six votes, whether or not there were abstentions[3].

A common problem area is for an IACUC to begin with a quorum and continue to conduct business after the quorum is lost. This can happen if voting members leave a meeting early or if voting members recuse themselves from deliberations due to conflicts of interest. A quorum must be present each time an issue is before the committee. If a quorum is temporarily lost, no official action on an item may be taken.

The requirements of the PHS Policy and AWRs take precedence even though they may differ from some commonly used parliamentary procedures. Institutions may develop their own meeting procedures as long as the procedures do not contradict or are not inconsistent with the requirements of the PHS Policy or the AWRs.

Conflict of Interest Disclosure

Both the AWRs and PHS Policy state that no IACUC member “may participate in the IACUC review or approval of an activity in which that member has a conflicting interest, (e.g., is personally involved in the activity) except to provide information requested by the IACUC.”

If an investigator submitting a protocol believes that an IACUC member has a potential conflict, the investigator may request that the member be excluded. When a member has a conflict of interest, the member should notify the IACUC Chair and may not participate in the IACUC review or approval except to provide information. Members who have a conflict of interest may not be counted toward a quorum and may not vote.

IACUC Function

The IACUC represents society’s concerns regarding the welfare of animals used in science and is expected to be the conscience of an institution regarding animal welfare concerns. As a decision-making body, the IACUC ensures that all animals in research are used appropriately and are treated in accordance with the highest standards of humane care.

Under the PHS policy, IACUCs are required to evaluate the institution’s Animal Care and Use Program and inspect the institution’s animal facilities semiannually, review the animal care portions of grant proposals, and provide a continuous forum for concerns related to animal use at the institution. The AWRs require the IACUC to evaluate the institution’s animal care program and inspect the institution’s animal facilities semiannually, to evaluate proposed research projects using animals, and to ensure that the living conditions of animals are appropriate for the species and that procedures likely to cause more than momentary or slight pain will be performed as specified by the regulations.

Protocol Review

While the IACUC has numerous responsibilities in terms of oversight of the Animal Care and Use Program, the duty most identified with the IACUC is protocol review. The IACUC conducts a thorough and comprehensive review of all new proposals and amendments to existing protocols.

Only two protocol review methods fulfill USDA and PHS requirements—full committee review and designated review. A recent OLAW communiqué describes these methods in detail.

The regulations do not require that all protocols be discussed at a convened IACUC meeting, although some institutions have judged it important to do so and have that formal policy. More commonly, the IACUC chair assigns a designated reviewer to conduct the review. Projects qualifying for designated review are assigned to members who then act on behalf of the full committee. A designated reviewer may approve, require modifications to secure approval, or call for full committee review. However, the regulations specify that there must be opportunity for every IACUC member to request discussion of a protocol at a convened committee meeting. Use of designated review for protocols that are routine, repetitive, and/or involve little or no animal pain or distress can conserve valuable IACUC time and resources for protocols that are unique, more complex, or may involve moderate or severe pain or distress.

Any significant change in an approved animal use activity must be reviewed and approved by the IACUC. This typically is handled through an amendment or addendum process with paperwork specific to the institution. As with initial review, there must be opportunity for every member to request discussion at a convened committee meeting. A notice from the National Institutes of Health clarifies the specific issue of whether personnel changes are “significant” to the IACUC deliberation process, and includes links to information on other significant changes.

Regulations require continuing review of all approved animal use activities. The AWRs require annual review, though the regulations do not include details, so there may be significant differences among institutions in how this is handled. The PHS Policy requires de novo review of animal use activities every three years, and this usually means submission of new paperwork.

All continuing protocols also receive annual review to ensure that no significant deviations from established and approved procedures have occurred. All principal investigators are required to complete an annual review report as part of this process.

When reviewing protocols, the IACUC ensures that:

o   all procedures involving animals will avoid or minimize pain and distress to the animal(s);

o   the principal investigator has considered alternatives to procedures that cause more than momentary pain or distress to the animals;

o   the principal investigator has provided written assurance that the protocol proposed does not unnecessarily duplicate previous experiments;

o   appropriate anesthetics and analgesics are used when necessary;

o   personnel are properly trained to perform the proposed procedures;

o   activities that involve surgery provide for appropriate pre-operative and post-operative care and that aseptic practices are followed; and

o   that methods of euthanasia are consistent with methods set forth in the AVMA Guidelines for the Euthanasia of Animals.

The IACUC is not a scientific review group, and different institutions view IACUC examination of scientific merit of protocols differently. All proposed projects receive mission-related and scientifically sound reviews prior to reaching the IACUC. However, humane treatment and scientific methodology are closely related and often inseparable concepts. Therefore, IACUCs may discuss and review science as it relates specifically to animal use.

Semiannual Inspection of Facilities, Program Review,  and Report to the IO

The IACUC is required to inspect, at least once every six months, the research institute’s animal facilities, including animal study areas, which are defined as any area in which animal work is performed. Current interpretation from federal agencies is that this schedule applies to all housing areas (animals kept more that 12 or 24 hours, depending on the regulation), but also includes places where there is survival surgery. Investigator laboratories in which animals are used also must be inspected, although frequency of inspection should depend on nature of animal use in that area. The IACUC remains responsible for all areas where animals are used.

Not only is the physical facility inspected, such as animal housing and facility maintenance, but the entire Animal Care and Use Program is reviewed. This involves reviewing animal health records, observing surgery, reviewing post-operative records, and reviewing the biosafety, chemical safety, radiation safety, and occupational health program, as well as all USDA inspections, AAALAC program reviews and assessments; deficiencies, if noted, and responses to those deficiencies in order to ensure compliance with the Animal Welfare Act, Guide for Care and Use of Laboratory Animalsand PHS Policy.

The IACUC makes a written report of its findings, which must be signed by a majority of committee members and must include any minority views, if these views are expressed during the program inspection. This report is submitted to the IO for review. The results of the IACUC inspections are communicated to facility managers, with recommendations or suggestions for improvement of corrections of noted, and time frames for response. Problem areas not satisfactorily resolved through this communication mechanism are subsequently transmitted (with recommendations) to the Institutional Official for ultimate resolution.

Review of Animal Welfare Concerns

A specific responsibility of the IACUC is to review and investigate any concerns related to animal care and use. According to the Guide[4], “Safeguarding animal welfare is the responsibility of every individual associated with the Program. The institution must develop methods for reporting and investigating animal welfare concerns, and employees should be aware of the importance of and mechanisms for reporting animal welfare concerns. In the United States, responsibility for review and investigation of these concerns rests with the IO and IACUC.” Concerns may come from public complaints, or from within the institution. This regulation has several implications for research staff. First of all, it is a mechanism to voice an animal welfare concern that they may witness, e.g., improper care or treatment of animals by animal care staff or other researchers. Second, a concern could be brought against a researcher, e.g., improper handling of one of their animals. Mechanisms for anonymous reporting should be available and all staff should be aware that so-called whistleblower protections are required by the AWRs. This means that someone who brings a concern to the IACUC may be legally protected against discrimination or reprisal. There are other mechanisms for individuals to express concerns about how animals are cared for or used, and staff are usually encouraged to use these avenues first (e.g., contacting supervisory, management or veterinary staff in the animal care unit). Research staff should be familiar with their institution’s key personnel involved with animal care, as well as the specific mechanism to bring concerns to the IACUC.

The IACUC has the authority to suspend an activity that it previously approved if it determines that the activity is not being conducted in accordance with the description provided by the investigator in his/her protocol.

Suspension of an Activity

The IACUC has the authority, at a convened meeting, to suspend an activity (protocol) it has previously approved. This, like withholding approval of a new protocol, is an uncommon event, and one that both the IACUC and research staff would prefer to avoid.

Suspension of an activity is a matter of ensuring institutional compliance. It is usually is done when the committee learns that a researcher is conducting an animal use activity without prior IACUC approval. While it may be difficult, especially in a large/busy research laboratory, to keep up with all the activities, it remains the principal investigator’s responsibility to notify the committee whenever there is a significant change in the work. This includes not only changes in direction and addition of new studies, but also reporting any unexpected results that might affect animal welfare.

Post Approval Monitoring

IACUCs are required to conduct ongoing monitoring of animal care and use after approval of a protocol. This is commonly referred to as Post Approval Monitoring (PAM) and is described in the Guide as consisting of “continuing protocol review; laboratory inspections (conducted either during regular facilities inspections or separately); veterinary or IACUC observation of selected procedures; observation of animals by animal care, veterinary, and IACUC staff and members; and external regulatory inspections and assessments.[5]”There are myriad mechanisms for institutions to meet this directive, and the details of implementing a PAM program is largely left to the discretion of the institution.

Personnel Qualifications and Training

Although there are specific requirements for IACUC consideration of personnel qualifications, the ultimate responsibility for ensuring that personnel are adequately qualified to work with animals rests with the institution. There is wide variability in how institutions accomplish this. There may be a series of seminars or workshops for research staff, and/or on-line instructional materials; attendance or completion of a course may or may not be mandatory. There is no regulatory requirement that personnel pass a test, but many institutions include an examination and/or some type of certification of course completion. The AWRs specify that training must be availablein certain areas, but probably most institutions have judged that some level of training is required for all animal users.

The following specific topics are required to be part of an institution’s training program:

  • Humane methods of animal husbandry and experimentation, including:o   the basic needs of each animal species;o   proper handling and care for each species;o   proper pre- and post-procedural animal care; ando   aseptic surgical techniques.
  • The concept, availability, and use of research or testing methods that limit the use of animals or minimize animal distress.
  • Proper use of anesthetics, analgesics, and tranquilizers for any species of animals used.
  • Methods in which deficiencies in animal care and treatment are reported, including deficiencies in animal care and treatment reported by any employee of the facility.
  • Utilization of services (e.g., the National Agricultural Library, National Library of Medicine) available to provide information in areas such as appropriate methods of animal care and use; alternatives to the use of animals; and prevention of unintended and unnecessary duplication of animal-based research.Occupational Health and Safety (required by PHS Policy, but not AWRs)

According to the Guide for the Care and Use of Laboratory Animals, institutions must provide an occupational health program for personnel who work with animals. The discussion in the Guide provides an overview of program components, but also refers to a more comprehensive document, Occupational Health and Safety in the Care and Use of Research Animals., published by the National Research Council.

Coordination and administration of the occupational health program is typically the responsibility of the institution’s health and safety office, but the IACUC is responsible for evaluating adequacy of the program as part of its required semiannual evaluation of facilities and programs. There is substantial flexibility in the regulations with respect to details of the occupational health program and, accordingly, wide variation in institutional requirements.

IACUC Interactions

From the discussion above, it should be evident that the Institutional Animal Care and Use Committee is the critical component in promotion of animal welfare within a research institution using animals. To be effective in this role requires effective interaction and open communication between the IACUC a number of institutional resources, including:

  • the Institutional Official;
  • investigators and research staff;
  • animal facility managers and animal care staff;
  • veterinarians and veterinary staff;
  • management and supervisory personnel;
  • physical plant and security staff;
  • occupational health and safety personnel; and
  • other institutional committees, such as the Institutional Biosafety Committee and the Institutional Review Board (IRB, which oversees human subjects research at the institution).

Institutional Biosafety Committees

Because of the use of recombinant DNA research and the routine use of biohazardous materials, it is commonplace for the IACUC to interact frequently with the Institutional Biosafety Committee (IBC), the Environmental Health & Safety office or department, and the Occupational Health & Safety office or department. More and more discussion is being seen, therefore, about the need for good communication and collaboration between an institution’s IACUC and these other institutional resources. Though IACUCs and IBCs are usually autonomous, some institutions are even looking at practices for integrating the two committees.

Institutional Biosafety Committees (IBCs) were established under the NIH Guidelines for Research Involving Recombinant DNA Molecules to provide local review and oversight of nearly all forms of research utilizing recombinant DNA (rDNA). If an institution receives federal funding, then it must comply with the NIH Guidelines for recombinant DNA research. Even if a project is privately sponsored, the research experiment must still be conducted in accordance with the NIH Guidelines.

rDNA is defined as either:

  • molecules constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell; or
  • DNA molecules that result from the replication of those described above.

Over time, many institutions have chosen to assign their IBCs the responsibility of reviewing a variety of experimentation that involves biological materials (e.g., infectious agents; allergens; or blood, body fluids, unfixed tissue – of humans or animals) and other potentially hazardous agents (e.g., toxins, carcinogens). This additional responsibility is assigned entirely at the discretion of the institution.

The IBC generally reviews certain types of IACUC protocols and amendments, for example, those involving transgenic rodents and those involving biohazardous and potentially biohazardous agents. It is not uncommon for an institutional IBC representative to serve on the IACUC (as a voting or nonvoting member), and vice versa. While the IACUC traditionally examines pain and suffering, euthanasia and animal husbandry issues, the IBC recommends good work practices with rDNA as described in Animal Biosafety Levels 1-3. Biosafety Levels (BSLs), as defined by the Centers for Disease Control (CDC) and the National Institutes of Health (NIH), described the increasing levels of biohazard risk associated with certain types of research. Animal Biosafety Levels (ABSLs) refer to research using animals.

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The IBC and IACUC together should ensure that:

  • biohazard areas in the animal facility are kept clean;
  • animal carcasses are properly disposed of;
  • infected animals are housed separately;
  • infected animals are transported safely; and
  • infected animals do not infect humans.

[1] —. ARENA/OLAW Institutional Animal Care and Use Committee Guidebook, 2nd ed. Bethesda, MD: National Institutes of Health/OLAW (2002).

[2] OLAW NOTICE NOT-OD-01-017, “Administrative IACUC Issues and Efforts to Reduce Regulatory Burden,” issued February 12, 2001, http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-017.html.

[3] —. ARENA/OLAW Institutional Animal Care and Use Committee Guidebook, 2nd ed. Bethesda, MD: National Institutes of Health/OLAW (2002).

[4] National Research Council/National Academy of Sciences. Guide for the Care and Use of Laboratory Animals, 8thed. Washington, DC: National Academy Press (2010).

[5] National Research Council/National Academy of Sciences. Guide for the Care and Use of Laboratory Animals, 8thed. Washington, DC: National Academy Press (2010).