IACUC SOP 501

Animal Concerns, Complaints and Non-Compliance

1.                        PURPOSE

1.1. The Institutional Animal Care and Use Committee (IACUC) will review and/or investigate concerns or complaints of animal misuse or mistreatment or non-compliance in research, teaching or testing at Texas A&M University or any of its components over which they have oversight responsibilities. This includes expressions of concern by the public involving the animal care and use program or allegations by employees or students of non-compliance with any animal-related regulation or standard.

1.2.  This procedure describes the review and/or investigation and response to those concerns or complaints.

 

  1. APPLICABLE REGULATIONS AND FORMS

2.1.  AWAR Section §2.32(c) (4)

2.2.  PHS Policy IV.8.4

2.3.  IACUC policy “Investigation of Alleged Noncompliance and Animal Concerns.”

2.4.  Animal Concern and Non-compliance Intake Form

 

  1. PROCESS OVERVIEW

3.1.  Concerns or complaints regarding animal care and use may be reported by contacting the following:

3.1.1.        A member of the Office of Research Compliance and Biosafety-Animal Welfare Assurance Program (RCB-AWAP) staff

3.1.2.    A member of the Institutional Animal Care and Use Committee (IACUC)

3.1.3.    Attending Veterinarian  (AV)

3.1.4.    On line through http://rcb.tamu.edu/animals

3.2.  Concerns or complaints may be submitted anonymously at http://rcb.tamu.edu/animals.

 

3.3.  Members of the IACUC or the Attending Veterinarian will forward information regarding any concern or complaint received to the RCB-AWAP, and the standard protocol for investigation, as outlined in this section, will be followed.

 

3.4.  If animal health or well-being is at risk the AV will be contacted immediately by the AWAP. The AV will investigate immediately and report findings and actions to the AWAP.

 

3.5.  Upon receipt of a complaint, an Animal Concern and Non-compliance Intake Form will be initiated in the RCB-AWAP.  The following information is to be provided for any concern:

3.5.1.     Name of complainant, if not anonymous;

3.5.2.    Contact information for the complainant if they wish to be informed of the outcome;

3.5.3.    The individual(s) or unit the complaint is against;

3.5.4.    Description of the incident or concern including the time and dates of observation of the alleged violation(s) and location of the animal(s);

3.6.  Confidentiality will be maintained to the extent possible and appropriate. All allegations of mistreatment or non-compliance are taken seriously and investigated. “No facility employee, committee member, or laboratory personnel shall be discriminated against or be subject to any reprisal for reporting violations of the regulation or standards under the act.” AWAR 9CFR, Chapter 1, Subchapter A, §2.32(c) (4).

3.7.  The Animal Concern and Non-compliance Intake Form will detail the investigation and any actions taken and will be maintained by AWAP. The file and any supporting documentation will be forwarded to the IACUC Chair or designee. The Executive Director of the Office of Research Compliance and Biosafety, the AWAP Manager, and the AV will be kept informed of concerns

or complaints and actions related to investigation and resolution.

3.8. The Chair or designee and/or the AV shall review the information provided and conduct a preliminary assessment of expressions of concern and/or allegations of noncompliance. The Chair/Designee and/or AV will notify the parties involved that an investigation is underway. The scope of the investigation shall be limited to the welfare, care and use of animals in accordance with federal and institutional regulations and policies.

3.9.  If it is determined the complaint has substance and cannot be resolved, or if the IACUC Chair determines it necessary, an IACUC subcommittee,  appointed by the Chair, will be convened. The subcommittee will discuss the allegations, investigate the complaint with those involved, determine a course of action to correct the problem, and present their findings and conclusions at the next convened IACUC meeting.  The IACUC subcommittee has the following options:

3.9.1.     Determine if there is no evidence of misuse of animals or noncompliance;

3.9.2.    Determine if the corrective response was appropriate and sufficient and that no further action is required;

3.9.3.    Determine if there has been inappropriate care or misuse of animals and/or conduct of animal activities that have not been approved by the  IACUC. This determination requires the IACUC to either:

3.9.3.1.        Require corrective measures from the Pl.

3.9.3.2.        Suspend all or part of the investigator’s animal research and require corrective actions before consideration of reinstatement of animal activities.

3.10.              Once the investigation has concluded, the IACUC will make a recommendation concerning appropriate action. The Chair or designee will notify the individual(s) involved and inform appropriate administrators of the decision.  The Executive Director of the Office of Research Compliance and Biosafety will be notified of the IACUC’s findings and recommendations. The Executive Director will inform the Vice President for Research (Institutional Official) as determined necessary by the Executive Director.  If the incident involved a significant deficiency in the use and care of animals, the University may take additional action in accordance with University policies and/or rules.

3.11.              If the IACUC suspends the research activities of an investigator, or if the concern resulted in a reportable animal event, the IACUC Chair or designee will notify the Institutional Official (10) within one working day of the suspension vote.  The 10 will notify the Pl, the USDA Animal Care Division, the Office of Laboratory Animal Welfare and AAALAC, Intl., of the suspension in accordance with federal and institutional regulations and policies.  External funding agencies will be notified as required by each agency’s policy.

3.12.             A suspension may be lifted if the IACUC determines the Pl has met the stipulations assessed by the Committee.  The Pl and the 10 will be notified of the results of this action in writing by the IACUC Chair and a summary of the final resolution will be sent to the federal agencies by the 10.

3.13.          The Chair or Designee will inform the complainant of the resolution, if requested and appropriate.

4.  REVISION HISTORY

00 – This is an original procedure.

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