Review Processes by the IACUC

  • A. Process for Investigating Harm and/or Possible Non-Compliance

    The IACUC has the responsibility of overseeing the protection of animals used in research. The IACUC insures this responsibility by investigating complaints of harm due to a research process, or Principal Investigators (or co-investigators) not following their approved research protocols. Principal Investigators are required to follow the research protocols they have submitted to, and been approved by, the IACUC. PIs are also required to promptly report to the IACUC any harm experienced by animals.

    Initial reports of harm or possible non-compliance should be brought to the attention of the IACUC Chair, any IACUC member, or IO. The Chair, in consultation with the IO and any other IACUC members as might be required, conducts the initial investigation. The purpose of the initial investigation is to, as quickly as possible, determine two points. First, does the assertion of harm or non-compliance have any merit (is it worth further investigation)? Second, are animals at risk if the research study is allowed to continue?

    To answer these questions the Chair may: interview the Principal Investigator and co-investigators and others; examine research records requested from the investigators; and may personally inspect research facilities and equipment. This initial investigation should take place as quickly as possible, typically within a few days of receiving the initial information. If no harm or possible non-compliance is uncovered no further action is necessary. The IO or the IACUC will, however, temporarily suspend the animal use if this initial investigation uncovers information supportive of harm or non-compliance. Should this occur, the Chair will notify, verbally and in writing, the Principal Investigator, his/her department Chair or unit supervisor, and the IO that the research has been temporarily suspended.

    Suspension of research activities, during which no research involving animals may be conducted, may be required by the IACUC. Although rare, a suspension is sometimes necessary to temporarily withdraw the IACUC’s approval for a particular research protocol when evidence exists that harm has occurred, or is believed likely to occur, to an animal being used in a research activity. The Full IACUC, at a convened meeting, may suspend the IACUC’s approval for a protocol if it is believed that harm has occurred and/or is likely to occur (or re-occur) if the research is allowed to continue. A suspension automatically begins an investigation of the circumstances resulting in the suspension. Such an investigation will comply with IACUC and university procedures for investigating research misconduct. Within two weeks of a suspension the IACUC will meet to consider the circumstances of the suspension and the resulting investigation to determine if the suspension should be lifted or the IACUC’s approval terminated.

    Complaints of harm or possible non-compliance that the Chair has found to have merit, regardless of whether a research protocol has been temporarily suspended, will be brought by the Chair to a special meeting of the IACUC within two weeks of the Chair’s determination. At this meeting the IACUC will be presented with whatever facts have been collected thus far. The Principal Investigator, co-investigators, and any others with relevant information will be invited to present information to the committee. The IACUC will then decide if further investigation is needed or if sufficient information is available to determine whether any harm or non-compliance has occurred. The IACUC will also decide if the research protocol should be continued as originally approved, reinstated (if temporarily suspended), suspended pending a further investigation by the IACUC or revisions by Principal Investigator, or terminated (the IACUC withdraws approval for the study).

    Non-Compliance occurs when a Principal Investigator, or other researchers under the direction of the Principal Investigator, either: (a) engage in research activities other than those approved in the original (or modified) research protocol; (b) continue to engage in approved research protocol activities beyond the time period specified in the approval period, or; (c) engage in any research activities involving animals without a research protocol previously approved by the IACUC. Instances of non-compliance will follow with IACUC and university procedures for investigating research misconduct. All instances of non-compliance will be reported by the IACUC to the IO and to the Grants Officer. Some instances might require reporting to other local, state, or federal departments or agencies.

    Termination of research activities results when a prior approval from the IACUC is withdrawn due to substantiated instances of harm (or the potential for previously unrecognized harm) to animals and/or confirmed circumstances of non-compliance.

    If harm or non-compliance is determined, the IACUC will recommend sanctions for the researcher that they deem appropriate. These recommendations will be submitted in writing, along with a summary of the incident of harm or non-compliance, and IACUC’s subsequent investigation, to the Institutional Official from the IACUC. The Institutional Official, if agreed, will articulate these sanctions, to the PI in writing.

    Certain agencies, both within and outside the university, require notification whenever harm or an issue of non-compliance in research is determined. The IACUC Chair and the IACUC ensure that these notifications are made in a timely fashion to the appropriate agencies by the Institutional Official. Principal Investigators must be aware that a suspension or termination of IACUC approval can result in the freezing of internal or extramural grant accounts, the return of equipment or other resources, and further investigation by other entities (such as the Faculty Senate, department Chairs or unit supervisors, Deans, the Provost, as well as outside funding and governmental bodies).

    The sole function of the IACUC is to provide protection for the animals used in research by approving, requiring modification in, or denying approval of proposed research. When the IACUC suspends approval for a research project no further research involving animals may be undertaken. The Principal Investigator will need to submit to the IACUC modifications to the protocol sufficient to satisfy the conditions of the suspension before the research can be resumed. When the IACUC withdraws its approval for a research project the project is considered terminated and no further research involving animals may be undertaken. A new protocol will need to be submitted, reviewed, and approved.

    B. Reporting Concerns About Animal Care and Use

    The system of regulatory oversight and compliance is founded upon a trust between the
    regulatory agencies, the Institutional Official, the IACUC, and the PI and his/her research team. The IACUC and IO rely on each member of the community to act responsibly and correctly. The entire community bears a responsibility to uphold the ethical and regulatory requirements associated with animal use. In this regard, it is critically important that the institution and its community demonstrate an ability to police itself.

    Consistent with its commitment to humane animal care and use, the University encourages anyone who perceives a problem with the way in which animals are housed, handled, or used in research or teaching to report their concerns. This includes the use of animals in ways that differ from the approved protocol. Such matters may be discussed with the individual's supervisor, the consulting veterinarian of the facility, the IACUC chair, the IACUC members, department chairs, or the Institutional Official. Reports may be made anonymously. The IACUC will investigate complaints and take appropriate actions as necessary to alleviate the problem. Animal-related emergencies should be reported immediately to the IO and Chair of the IACUC.