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Guidelines

IACUC Guidelines for Reporting Serious Noncompliance to US Department of Health & Human Services/National Institutes of Health/ Office of Laboratory Animal Welfare (OLAW)

Federal Animal Welfare Mandate

The PHS Policy on Humane Care and Use of Laboratory Animals (Policy) identifies three areas that require prompt reporting to OLAW (Section IV.F, paragraph 3):

  1. Any serious or continuing noncompliance with the PHS Policy;
  2. Any serious deviation from the provisions of the Guide for the Care and Use of Laboratory Animals; and
  3. Any suspension of an activity by the IACUC.

OLAW Guidance

According to OLAW (NOT-OD-05-034, Feb. 2005), the IACUC should apply rational judgment in determining which instances of non-compliance are "serious" or "continuing" and what deviations from the Guide are "serious". OLAW has provided examples of reportable situations, but states that rational judgment must be used to determine which situations fall within the scope of the examples and meet the provisions of PHS policy IV.F.3, i.e. they are serious or continuing.

The following examples are situations that will be reported to OLAW:

  1. IACUC suspension or other institutional intervention that results in the temporary or permanent interruption of an activity due to noncompliance with the Policy, Animal Welfare Act, the Guide, or the institution's Animal Welfare Assurance.
  2. conduct of official IACUC business during a period of time that the Committee is improperly constituted;
  3. conduct of official IACUC business requiring a quorum (full Committee review of an activity in accord with IV.C.2 or suspension in accord with IV.C.6) in the absence of a quorum;

The following are examples of situations that will be evaluated by the IACUC to determine whether they will be reported to OLAW on the basis of whether they are serious or continuing noncompliance with the PHS Policy.

  1. Conduct of animal-related activities without appropriate IACUC review and approval;
  2. Failure to adhere to IACUC-approved protocols;
  3. Implementation of any significant change to IACUC-approved protocols without prior IACUC approval as required by IV.B.7.;
  4. Conduct of animal-related activities beyond the expiration date established by the IACUC (note that a complete review under IV.C is required at least once every three years);
  5. Participation in animal-related activities by individuals who have not been determined by the IACUC to be appropriately qualified and trained as required by IV.C.1.f;
  6. Failure to monitor animals post-procedurally as necessary to ensure well-being (e.g., during recovery from anesthesia or during recuperation from invasive or debilitating procedures);
  7. Failure to ensure death of animals after euthanasia procedures (e.g., failed euthanasia with CO2);
  8. Failure to correct deficiencies identified during the semiannual evaluation in a timely manner;
  9. Chronic failure to provide space for animals in accordance with recommendations of the Guide unless the IACUC has approved a protocol-specific deviation from the Guide based on written scientific justification;
  10. Failure of animal care and use personnel to carry out veterinary orders (e.g., treatments); or
  11. Failure to maintain appropriate animal-related records (e.g., identification, medical, husbandry);
  12. Conditions that jeopardize the health or well-being of animals, including natural disasters, accidents, and mechanical failures, resulting in actual harm or death to animals; 

IACUC Guidelines for Reporting Serious Noncompliance Related to Research Activities

When incidents are identified in which investigators have conducted animal-related activities without appropriate IACUC review and approval or failed to adhere to IACUC reviewed and approved institutional policies and procedures, the IACUC Office or veterinary staff should provide the committee members with factual information on the incident. This should include the type of incident (e.g., unapproved procedure, housing violations, lack of skill/training, neglect, wasted animals) and details of the specific events (e.g., species, procedures performed, adverse effects, individuals involved).

Committee members should then consider with rational judgment the following questions in determining whether to report the incident to OLAW.

  1. In what humane use category would the procedures have been?
  2. What were the adverse effects on the animals being used?
  3. Might the adverse effects have been prevented if the procedures had been reviewed by the IACUC and the veterinary staff?
  4. Was medical intervention by the veterinary staff required?
  5. Were the individuals involved aware that IACUC approval was required before performing the procedures?
  6. Has the investigator repeatedly violated IACUC policies? Were the previous violations the same or different than the current action?
  7. Was it necessary for the IACUC to intervene to temporarily or permanently interrupt the activities? (Note: If the answer to this question is yes, the incident must be reported.)

After considering the above questions, the committee members should assess the incident for the following:

  1. Have the actions jeopardized the health or well-being of the animals being used or resulted in animals being harmed or dying?
  2. Is there evidence that the investigator and/or his or her staff disregarded SUNY Downstate animal care and use policy in order to perform procedures without obtaining approval from IACUC?
  3. Is the incident a component of serious and continuing deviations?

Committee Actions

With regard to reporting requirements, the IACUC may take any of the following actions. (Note: These actions need not be taken sequentially.)

  1. Verbal warning to the investigator
  2. Written warning to the investigator without copying the investigator's departmental chair
  3. Written warning to the investigator with a copy to the investigator's departmental chair.

Although judgment must be rendered on a case-by-case basis, prior experience with reporting incidents to OLAW suggests that the following guidelines are consistent with the philosophy of institutional self-regulation.

  1. If there was intent to circumvent IACUC authority and animals were harmed in some manner or if there is a pattern of serious or continuing incidents, the committee should report the incident to OLAW.
  2. If there was no intent to circumvent IACUC authority and animals were not harmed in some manner, the committee should consider issuing a warning to the investigator, but is not required to report the incident to OLAW.
  3. If there was intent to circumvent IACUC authority, but animals were not harmed in some manner, the committee should consider issuing a warning to the investigator prior to or in addition to reporting the incident to OLAW.
  4. If there was no intent to circumvent IACUC authority, but animals were harmed in some manner, the committee should consider issuing a warning to the investigator prior to or in addition to reporting the incident to OLAW.

IACUC Guidelines for Reporting Serious Noncompliance to OLAW regarding other animal care program activities

When serious or continuing incidents are identified in which there is non-compliance with the Guide and or IACUC reviewed and approved institutional policies and procedures, the IACUC Office or veterinary staff should provide the committee members with factual information on the incident or situation. This should include the type of incident (e.g., unapproved procedure, housing violations, lack of skill/training, neglect, wasted animals, natural disaster, HVAC failure, failure to correct deficiencies identified in semi-annual evaluations) and details of the specific events (e.g., species, procedures performed, adverse effects, individuals involved). Committee members should then consider with rational judgment the following questions in determining whether to report the incident to OLAW.

  1. Has the situation, incident or failure to correct deficiencies result in any actual harm or death to animals?
  2. Is the incident or situation a component of serious and continuing deviations?

Committee Actions

With regard to reporting requirements, the IACUC may take any of the following actions.

  1. The institutional official will be informed of the problem in writing if either #1 or #2 are true and a plan for corrective action will be developed by the IACUC in consultation with the IO.
  2. OLAW will be informed of the incident if either #1 or #2 are true and informed of the actions taken to correct the problem and/or prevent occurrence of the problem.