After the IACUC has approved a protocol, it has a responsibility to ensure that procedures are carried out in the laboratory or classroom as described in the protocol. This section will briefly review ways that the IACUC can monitor the conduct of approved protocols.
Acquisition and Tracking Animals should be obtained only from licensed dealers or other legal sources, and it is incumbent upon an institution to establish mechanisms to monitor and document the number of animals acquired and used in ap-proved activities. This is best accomplished if animal purchases may be made only through the institution's animal resource facility or other appro-priately designated office. Once animals have been acquired, they should be included in a tracking system. Many institutions have automated sys-tems that will alert an appropriate individual when an investigator has reached a preset percentage (e.g., 80 to 90%) of the number of animals approved for a specific project, and can prevent ordering animals in excess of the number approved. Institutions with small programs using limited numbers of animals may choose to maintain a manual log of IACUC approved activities and numbers of animals acquired.
Tracking animal use becomes more complicated when investigators main-tain breeding colonies. Keeping track of animal usage may be accom-plished by requiring that investigators with breeding colonies maintain accurate records. Investigators can be required to report to the designated office, at regular intervals, the number of animals born, weaned, or used in studies. This report can be tallied against the numbers in the approved protocol.
Compliance Specialist Some IACUCs have a full or part-time compliance specialist who monitors procedures in vivaria, laboratories, and classrooms, and reports his or her observations to the IACUC. This individual should have laboratory animal training and experience, and be authorized to conduct announced or unannounced laboratory inspections on behalf of the IACUC. In addition to this role, the compliance specialist may periodically survey individual
laboratories to ensure that actual procedures used are consistent with protocols. The survey may include meeting with investigators and staff to review concerns, answer questions, and identify procedures that may deviate from those originally approved by the IACUC. In cases of deviation, the specialist should notify the IACUC.
Eyes and Ears Research, veterinary, and husbandry staff should be aware of approved procedures for use on animals when they have responsibility for those animals. This may be accomplished by informing these individuals in staff meetings or by making standard operating procedures and animal use protocols readily accessible in the laboratory or vivarium. These practices help to ensure that procedures being used are, in fact, those that were approved by the IACUC. Maintaining an open environment in which staff can discuss apparent departures from approved procedures with the investigator often facilitates compliance and the rapid correction of deviations. Staff must also be free to report perceived deviations to the IACUC, which must then consider such concerns (see Section D).
During the semiannual facility inspections, IACUC members should note the use of animals and may verify that the observed procedures are consistent with the protocol on file.
Retrospective Reporting of Adverse Events The USDA requires that the number of covered animals used in each pain/distress category be reported annually, but there are currently no explicit federal requirements for reporting of unexpected or unintentional changes in pain category, morbidity, or mortality after the event. The USDA does expect any significant deviations from the expected pain/distress category to be reported correctly. Institutions may choose to require an accounting of unexpected, unintentional, or adverse events as a means of identifying deficiencies in procedures, faults in study design, or need for additional personnel training.
Review of Publications In academic institutions and many companies, much research is eventually published. Some IACUCs choose to review some published descriptions of animal use to verify that work was done according to the approved protocol.
Although no IACUC has the staff or time to observe all animal use in an institution, the IACUC can help establish a climate of compliance. To ensure that animal use conforms to local policy and federal regulations, it is prudent for the IACUC to confirm that animals are used according to protocol.
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D. Evaluation of Animal
Care and Use Concerns
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Evaluation of Animal Care and Use Concerns To help ensure that laboratory animals receive humane care and use or treatment in accordance with the highest ethical standards, laws, regula-tions and policies governing animal research, the IACUC must review and, if warranted, address any animal-related concerns raised by the public or institutional employees. Procedures must be established to ensure that concerns are communicated to the IACUC. The Committee must review each concern in a timely and systematic manner and, when necessary, take prompt, appropriate corrective actions.
PHS Policy, Animal Welfare Act, and USDA AWR requirements The PHSPolicy requires the IACUC to “review concerns involving the care and use of animals at the institution”, and the Guide states that the IACUC is responsible for “establishment of a mechanism for receipt and review of concerns involving the care and use of animals.” The Animal Welfare Act (AWA) (7 U.S.C. 2142; Section 13) requires training of personnel who are involved in animal care or treatment, including “methods whereby defi-ciencies in animal care and treatment should be reported.” The AWRs (9 CFR Part 2, Subpart C, 2.32 (c)(4)) require each research facility to provide the methods whereby any employee of the facility can report deficiencies in animal care and treatment. In addition, the AWRs, Section 2.31(c)(4)) require the IACUC to “review and, if warranted, investigate concerns involving the care and use of animals at the facility resulting from public complaints received and from reports of noncompliance received from laboratory or research facility personnel or employees.”
In addition, the AWRs (9 CFR Part 2, Subpart C, Section 2.32[c]) state that “no facility employee, Committee member, or laboratory personnel shall be discriminated against or be subject to any reprisal for reporting violations of any regulation or standards under the [Animal Welfare] Act.”
Compliance To ensure compliance with federal law, regulations, and policies, it is strongly recommended that each IACUC develop and implement policies and procedures to ensure that all animal care and use concerns are brought to its attention for consideration. Some of the elements that
should be included in these procedures are described below (see IACUC Responses to Complaints). Institutional policy should contain provisions to protect the confidentiality of those who report concerns as well as anyone against whom allegations are directed, while allegations are under investigation. The policy should also address mechanisms for protecting complainants from reprisals.
Origins of Concerns or Complaints Some common sources include:
animal care and use personnel - these individuals should receive instruction in institutional training programs to report perceived defi-ciencies in animal care or use to the IACUC.
other personnel - these persons (e.g., secretarial, maintenance, security staff) are likely to direct concerns to a member of the research, animal care or veterinary staff, but they should be instructed to report concerns to the IACUC.
employee “hotlines” or ombudsmen - personnel responsible for these functions should be sensitive to animal-related concerns and notify the IACUC Chair of any that may arise.
the public - they are most likely to direct complaints to senior institu-tional representatives who should promptly forward them to the IACUC Chair.
anonymous - these complainants may or may not be institutional employees.
the media - stories appearing in newspapers, and on television or radio, etc. may contain or evoke concerns about animal care and use; such reports should be evaluated by the IACUC, and, when appropriate, the institution should proactively address them.
Methods for Reporting Concerns To facilitate communication, the names and phone numbers of contact persons, including IACUC members, the Attending Veterinarian, security office, and ombudsman/hotline, if one exists, should be posted in or near the entrance to animal facilities or listed on a Web site that is readily available to institutional employees. This information should also be provided during training sessions as described above.
Although written concerns are more convenient to deal with, complainants may not be willing to submit them in this manner. In such cases, the individuals who receive concerns should document them fully to ensure that the issues are clear and to prevent misunderstandings. Requests for anonymity should be honored to the extent possible.
IACUC Responses to Complaints While specific methods for evaluating concerns about animal care and use may vary from institution to institution, all methods should contain these elements:
There should be a procedure for verifying stated concerns.
Verified concerns should be related to the AWRs, the PHSPolicy or institutional policies.
There should be guidelines for effecting appropriate corrective meas-ures, when necessary.
One of the roles of the IACUC is to review all concerns about the animal care and use program, regardless of origin, and investigate them if warranted. The IACUC Chair is normally responsible for ensuring that concerns are addressed, but may delegate investigation to a subcommittee. If the Chair has, or is perceived to have, a conflict of interest, the Institutional Official (IO) should delegate the responsibility for assuring that the concern is addressed to another non-conflicted member of the IACUC.
Concerns may include situations or activities ranging from those in which animals are reported to be in immediate, actual or perceived jeopardy to those in which violations of the AWRs or institutional Animal Welfare Assurances are alleged to be occurring but animals are not in apparent danger. They may focus on allegations of past policy and procedure violations.
The course of action taken by the IACUC should be driven by the potential significance of the alleged situation. For example, conditions that report-edly jeopardize the health or well-being of animals should be evaluated immediately. To cope promptly with such situations, some institutions have policies whereby a veterinarian or other designated person is authorized to halt procedures which they believe do not comply with institutional policies until the IACUC can be convened and consider the matter formally. Similarly, situations that may involve potential criminal activity or human safety should be reported promptly to the institution's law
enforcement or occupational health and safety officials. Allegations of other ongoing policy or procedural matters may not require such same-day attention, but should not be deferred merely as a matter of convenience. Emergency meetings may be necessary in these cases to ensure prompt consideration of concerns.
IACUC procedures for handling complaints may involve reviewing them with the veterinarian. Depending on the nature of the concern, the IO, legal counsel, and the person who submitted or fielded the complaint may also be invited to participate. Based on the results of its initial evaluation, a course of action—which may include further investigation—will then be determined and implemented. The IACUC should acknowledge receipt of concerns when the complainant is known. Details concerning the complaint, complainant, persons against whom allegations may have been directed, and the investigations in progress are usually considered confidential. However, when the Committee releases the report of its findings (including corrective actions, if applicable), those reports may become accessible to the public under state “sunshine” laws, and if provided to Federal regulatory agencies, under the Freedom of Information Act.
The AWRs and the PHSPolicy authorize the IACUC to suspend an activity after review of the matter at a convened meeting of a quorum of the IACUC and with the suspension vote of a majority of the quorum present. Suspensions must also be reviewed by the IO in consultation with the Committee; appropriate corrective action taken by the IO is reported to OLAW.
Most institutions have developed self-regulatory policies and procedures, which supplement formal suspensions by the IACUC and are intended to ensure adherence to institutional and regulatory requirements. Depending on the severity of noncompliance or deviation from accepted practices, these range from counseling and mandatory remedial training to specific monitoring of animal use, temporary revocation of animal use privileges, or termination of employment.
One model for considering concerns about animal care and use is outlined on the following pages. This example may not apply to all institutions, and may be adapted, as needed, in designing guidelines that are appropriate for individual institutions.
Suggested IACUC Procedures for the Investigation
of Animal Care and Use Concerns* Initial Evaluation And Actions Upon receipt of a concern the IACUC Chair should convene a meeting of the IACUC. After initial review of the complaint the IACUC should deter-mine whether it requires further investigation and immediate action, further investigation but no immediate action, or no action. Once this decision has been made, the IACUC should determine which individuals or other institutional or noninstitutional offices may require notification at this time.
If immediate action appears warranted because animal or human welfare may be compromised, the IACUC should notify the IO and proceed accordingly. Veterinary medical intervention, suspension of a research activity, and/or notification of appropriate safety, occupational health, or other officials, are examples of actions that may be taken immediately to protect animal or human welfare. In accordance with the AWRs (9 CFR Part 2, Subpart C, Section 2.31[d]), if an activity is suspended, the IO shall report that action to APHIS and any federal agency funding that activity. If the activity is supported in any way by the PHS, the IACUC, through the IO, must promptly notify OLAW (PHS Policy, IV.F.3.) (OPRR Reports 94-02, 1/12/94).
Investigation Should the IACUC determine that further investigation is required, the Chair, or another individual or subcommittee appointed by the Chair, should conduct the investigation and report back to the IACUC. It is important to avoid actual or perceived conflicts of interest in this process.
The IACUC should charge the designated person or group with its require-ments for information gathering and impose a completion date. The assigned completion date will depend on the IACUC’s determination of whether immediate remedial action may be required.
Neither the AWRs nor the PHS Policy provide specific guidance regarding the consideration of concerns or the institutional conduct of investigations. Owing to the considerable diversity of concerns that may arise and the contexts in which they may be voiced, no one set of procedures will be suitable for investigating all potential situations that involve violations of or deviations from animal care and use practices required by the PHS Policy, AWRs, the Guide and other federal statutes and regulations regarding animals. Consequently, the following suggestions are broad, intended for general use, and not intended for application in all situations. The nature of the information required will vary depending on the circum-stances, but often involves:
interviewing complainants (if known), any persons against whom alle-gations were directed, and pertinent program officials;
observing the animals and their environment; and
reviewing any pertinent records, (e.g., animal health records, protocol, and other documents).
The designated investigator(s) should provide a report to the IACUC, which summarizes:
the results of interviews,
the condition of animals and their environment, and
the results of records and other document reviews.
The report should also contain:
any supporting documentation such as correspondence, reports, and animal records,
conclusions regarding the substance of the concerns vis-à-vis re-quirements of the AWRs, the PHS Policy, the Guide, and institutional policies and procedures, and
recommended actions, if appropriate
Outcomes And Final Actions Upon receipt and evaluation of the report, the IACUC may request further information or find that:
there was no evidence to support the concern or complaint,
the concern or complaint was not sustained, but a) related aspects of the animal care and use program require further review or b) other institutional programs may require review, or
the concern or complaint was valid.
Subsequent actions of the IACUC may include:
implementing measures to prevent recurrence (such measures often include changes in administrative, management or IACUC policies and procedures, and may include sanctions*);
notifying the IO and the AV of its actions;
notifying funding or regulatory agencies, as required; and
notifying the complainant, any persons against whom allegations were directed, and pertinent program officials (appropriate supervisory and management staff, the public affairs office, institutional attorneys, etc.).
*Note on Sanctions: Aside from empowering the IACUC to suspend a previously approved activity, the AWRs and the PHSPolicy are silent regarding IACUC or institutionally imposed sanctions
Some institutions, as part of their programs, have developed policies and procedures that authorize the IACUC to impose sanctions on behalf of the institution. In other institutions, IACUCs recommend actions to the IO for implementation, and in still others, there exists a combination of these approaches. Some of the institutional sanctions that have been devised include:
issuing letters of reprimand;
mandating specific training aimed at preventing future incidents;
monitoring by the IACUC or IACUC-appointed individuals of research, testing, or training that involving animals;
temporary revocation of privileges to provide animal care or to conduct research, testing, or training that involves animals, pending compliance with specific, IACUC-mandated conditions;
permanent revocation of privileges to provide animal care or to conduct research, testing, or training that involves animals; and
recommending to the IO that institutional (e.g., reassignment, termi-nation of employment) sanctions be imposed.
CONCERNS UNRELATED TO ANIMAL CARE AND USE The IACUC may determine, either in its initial evaluation of a concern or as a result of investigation, that violations of non-animal-related institutional policies and procedures, local, state or federal statutes, regulations, or laws may have occurred (e.g., scientific misconduct, misuse of monies, fraud, theft, etc). In such cases, those findings should be reported to appropriate institutional officials or committees for their consideration.