NON COMPLIANCE
I. INTRODUCTION
The purpose of this policy is to provide guidance to the IACUC, faculty, staff, and students on how allegations of noncompliance with animal care and use requirements will be reviewed, what administrative bodies will perform such reviews, and justification for such authority. This policy applies to activities of faculty, staff, students and others that are involved in the care and use of animals that are reviewed by the Institutional Animal Care and Use Committee (IACUC) of Case Western Reserve University that is governed by the Office for Laboratory Animal Welfare, the United States Department of Agriculture and the Association for Assessment and Accreditation of Laboratory Animal Care.
Per regulatory requirements (Public Health Service (“PHS”) Policy.IV.B.1-8 and 9 CFR .2.31 (c) (1)-(8) and 2.31 (d) (5) (6) & (7)) the IACUC is required to review allegations of noncompliance with animal care and use within the institution. The PHS Policy 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 deficiencies in animal care and treatment should be
reported.” The Animal Welfare Regulations (“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.” To exercise this authority the IACUC is empowered to inspect laboratories, procedure areas, animal housing areas, and to sequester research or training records.
The process by which the IACUC reviews allegations of noncompliance will be determined by the seriousness of the allegations and the probability or occurrence of harm to animals.
The IACUC may receive allegations in several different ways including external complaints, internal complaints, Animal Incident Reports, random and directed site visits, and investigator self-reporting. The IACUC encourages faculty, staff and/or students to report instances of perceived noncompliance, especially when animal or human health and welfare is in question. The institution is bound to protect individuals who report noncompliance in good faith from retaliation. Corrective actions will be determined on a case-by-case basis. Documentation regarding cases of noncompliance will be kept in the IACUC Office.
Noncompliance proceedings are confidential. Federal regulations (9 CFR Part 2, Subpart C, Section 2.32(c)(4)) state that “no facility employee, IACUC 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.” This process is confidential. Breaches of confidentiality may have serious consequences for involved parties, therefore the IACUC and above personnel are required to maintain confidentiality to the best of their ability in order to ensure a fair process. Administrative actions may be taken against those who breach confidentiality.
II. DEFINITIONS
Continuing non-compliance shall mean repeated acts of non-compliance by the same individual or research group.
Institution shall mean Case Western Reserve University.
Investigation Sub-Committee shall mean an ad hoc sub-committee of between three and five IACUC members reflecting the composition of the full IACUC and shall include a non-scientific member, a scientist, and an attending veterinarian. Whenever possible, the sub-committee should possess expertise in the area of study in question.
Less than Serious Non-Compliance shall mean an act of non-compliance that does not rise to the level of Serious Non-Compliance.
Non-Compliance shall mean using animals in research or teaching in a manner that disregards or violates federal regulations governing such research or policies established by the IACUC. This can include, but is not limited to, failure to obtain IACUC approval for research involving animals, failure to follow approved protocol, failure to report changes to the protocol to the IACUC, failure to follow mandates made by the IACUC to ensure proper animal care and use, failure by the principal investigator to provide adequate supervision and to ensure safety of personnel performing animal research, and failure to perform required record keeping.
IACUC shall mean the Institutional Animal Care and Use Committee.
IACUC Chair shall mean the Chairperson of the IACUC or, in situations where the IACUC Chair cannot participate due to unavailability or perceived or actual conflict of interest, his/her designee.
Administrative Hold shall mean certain animal procedures are temporarily stopped in order to perform an initial review of the matter.
Suspension shall mean revocation of privileges to provide animal care or to conduct research, testing, or training that involves animals, pending compliance with specific, IACUC-mandated conditions.
Complainant shall mean the individual or group of individuals that submitted the allegation of non-compliance.
Respondent shall mean the principal investigator or laboratory director about whom the allegation is made. If the complaint is made against a laboratory generally, or against an employee in the laboratory, the Respondent is still the principal investigator or laboratory director, as that person is deemed responsible for all activities occurring in the laboratory.
Serious non-compliance shall mean significant non-compliance with PHS Policy; significant deviation from an approved protocol; an action that is or may be a threat to the health and safety of animals or humans, or a situation in which animals have experienced harm, such as severe pain or death.
Institutional Official shall mean the person designated to serve as the institutional official by Case Western Reserve University.
III. Roles and Responsibilities
A. IACUC Chair
The IACUC Chair will have primary responsibility for implementation of the procedures set forth in this document. The Chair will appoint the investigation sub-committee and ensure that necessary and appropriate expertise is secured to carry out a thorough and authoritative evaluation of the relevant evidence in an investigation. The Chair will attempt to ensure that confidentiality of the process is maintained. The Chair and the IACUC Office will assist the investigation sub-committee and all personnel in complying with these procedures and with applicable standards imposed by government or external funding sources. The Chair and the IACUC Office are also responsible for maintaining files of all documents and evidence and for the confidentiality and the security of the files.
B. IACUC
The IACUC is responsible for reviewing investigation reports and determining what sanctions, if any, are appropriate, and for making final recommendations to the Institutional Official regarding sanctions, if any. Upon review by the Institutional Official, the IACUC shall implement the sanctions, if any. The IACUC is also responsible for ensuring that the process is free of conflicts of interest.
C. Complainant
The complainant is responsible for making allegations in good faith, maintaining confidentiality, and cooperating with an inquiry or IACUC investigation. Anonymity cannot be guaranteed if an allegation moves to investigation, however, every effort will be made to protect anonymity. A complainant making an allegation in good faith has the right to be protected by the University from retaliation.
D. Respondent
The respondent will be informed of the allegations in writing when an investigation is opened and notified in writing of the final determinations and resulting actions. The respondent will also have the opportunity to be interviewed by and present evidence to the investigation sub-committee, to review the draft investigation report, and to bring an advisor of choice to the investigation meetings in which the respondent is interviewed. Advisors, however, may only consult with the respondent. They may not address the sub-committee, ask questions of the sub-committee, or participate in the interviews.
The respondent is responsible for maintaining confidentiality and cooperating with the conduct of an investigation.
E. Institutional Official
The Dean of the School of Medicine (or his/her designee) as the Institutional Official will receive the investigation report and the IACUC’s recommendations. The Institutional Official will determine whether to impose sanctions beyond those recommended by the IACUC, or whether to take other appropriate administrative actions. The Institutional Official will be responsible for reporting to appropriate institutional and federal government officials as required by federal regulations. Reporting to the Office of Laboratory Animal Welfare, the United States Department of Agriculture and Association for Assessment and Accreditation of Laboratory Animal Care will be in accordance with federal regulations and accreditation standards.
F. Cooperation with Investigations
Institutional employees and those working on IACUC protocols will cooperate with the IACUC, the Chair and other Institutional officials in the review of allegations and the conduct of investigations. Employees have an obligation to provide relevant evidence to the Chair or other officials on non-compliance allegations.
IV. Process for Initial Review of Allegations of Non-Compliance
All allegations should be reported to the IACUC. The IACUC may receive allegations in several different ways including external complaints, internal complaints, Animal Incident Reports, random and directed site visits, and investigator self-reporting. The IACUC encourages faculty, staff and/or students to report instances of non-compliance, especially when animal or human health and welfare is in question. The Institution is bound to protect from retaliation individuals who report non-compliance in good faith. Anonymity of individuals submitting Animal Incident Reports will be protected insofar as possible.
All allegations shall be reviewed by the IACUC Chair (or his/her designee) and the Director of the Animal Resource Center (or his/her designee). The IACUC Chair and Director of the Animal Resource Center shall each make an assessment as to whether, based on their knowledge of all surrounding facts and circumstances, including previous allegations, the allegation should be considered Continuing Non-Compliance, Serious Non-Compliance, Less Than Serious Non-Compliance, or No Non-Compliance. If either the IACUC Chair or the Director of the Animal Resource Center has a conflict of interest in reviewing an allegation, that person shall recuse him/herself and the remaining person shall appoint a second person, who shall be a member of the IACUC, to review the allegation. If both the IACUC Chair and the Director have a conflict of interest, then the IACUC shall appoint two members of the IACUC to review the allegation.
1. Allegations Classified as Continuing Non-Compliance or Serious Non-Compliance
Any allegation deemed, upon initial intake or after receipt of further information, to be Continuing Non-Compliance or Serious Non-Compliance by either (or both) the IACUC Chair and the Director of the Animal Resource Center shall be investigated pursuant to section V. below.
- Allegations Classified as Less Than Serious Non-Compliance or No Non-Compliance
The IACUC Chair and Director of the Animal Resource Center shall obtain any additional information they deem necessary to evaluate the allegation and to determine appropriate remedial actions, if necessary. A record of the allegation, additional information (if any) obtained, and remedial actions (if any) shall be maintained by the IACUC Coordinator.
All allegations classified as Less Than Serious Non-Compliance or No Non-Compliance shall be reported at the next scheduled meeting of the IACUC and documented in the minutes of that meeting. All allegations classified as Less Than Serious Non-Compliance or No Non-Compliance may be re-evaluated at any time based on additional information.
The IACUC may determine that any such allegation rises to the level of Serious Non-Compliance or Continuing Non-Compliance. If the IACUC makes such a determination, the allegation shall be investigated pursuant to section V. below.
V. Process for Investigating Allegations of Serious Non-Compliance or Continuing Non-Compliance
A. Purpose of the Investigation
The purpose of the investigation is to determine whether non-compliance has occurred, by whom, and to what extent, and determine what sanctions or remedial actions are appropriate. The investigation will also determine whether there are additional instances of possible non-compliance that would justify broadening the scope beyond the initial allegations.
B. Sequestration of the Research Records
The IACUC Chair (or his/her designee) will sequester any pertinent research records as soon as possible. This sequestration should occur before or at the time the respondent is notified that an investigation has begun. Sequestered animals will be housed under the guardianship of the IACUC until the IACUC decides what actions are necessary, provided that the animals are not in distress or otherwise in need of euthanasia or a threat or danger to the health and welfare of other animals.
C. Appointment of the Investigation Sub-Committee
The IACUC Chair, in consultation with other Institutional officials and the IACUC as appropriate, will appoint an investigation sub-committee and sub-committee chair as soon as practicable. The investigation sub-committee shall consist of between three and five IACUC members reflecting the composition of the full IACUC and shall include a non-scientific member, a scientist, and an attending veterinarian. These members must be free of real or apparent conflicts of interest in the case, must be unbiased, and in the aggregate must have the necessary expertise to evaluate the evidence and issues related to the allegations, interview the principals and key witnesses, and conduct the investigation. Other qualified persons from inside or outside the Institution may be asked to provide information and advice to the sub-committee as expert consultants, but will not be considered members of the sub-committee.
The IACUC Chair will notify the respondent in writing or by email that an investigation is planned and inform the respondent of the proposed sub-committee membership and will provide the respondent with a copy of this policy. If the respondent submits (via email or hard copy) a written objection to any appointed member of the investigation sub-committee or expert based on bias or conflict of interest within five (5) business days of receiving notice of the proposed membership, the IACUC Chair will determine whether to replace the challenged member with a qualified substitute.
D. Time Limit for Completing the Investigation Report
An investigation should ordinarily be completed and the Institutional Official should communicate the decision to the respondent within 90 days of the first meeting of the investigation sub-committee. If the investigation sub-committee will not be able to complete the investigation in 90 days, it will inform the IACUC of the need for an extension. Any extension will be noted in the file.
E. Charge to the Sub-committee and the First Meeting
1. Charge to the sub-committee
The IACUC Chair will define the subject matter of the investigation in a written charge to the sub-committee that describes the allegations and related issues, defines Serious Non-compliance and/or Continuing Non-Compliance, and identifies the name of the respondent. The charge will state that the subcommittee is to obtain information it deems necessary to determine whether non-compliance has occurred and, if so, to what extent, who was responsible, and its seriousness, and what sanctions or remedial actions are appropriate.
2. The First Meeting
The investigation sub-committee chair, in conjunction with the University’s Office of General Counsel when appropriate, will convene the first meeting of the investigation sub-committee to review the charge and the prescribed procedures and standards for the conduct of the investigation, including the necessity for confidentiality. The investigation subcommittee will be provided with a copy of this policy.
F. Investigation Process
The investigation will normally involve examination of all documentation including, but not limited to, relevant research records, computer files, proposals, manuscripts, publications, correspondence, memoranda, and notes of telephone calls. Whenever possible, the sub-committee should interview the complainant(s), the respondents(s), and other individuals who might have information regarding aspects of the allegations and observe the animals in their environment, if applicable.
During the investigation, if additional information becomes available that substantially changes the subject matter of the investigation or would suggest additional respondents, the subcommittee will notify the IACUC Chair, who will determine whether it is necessary to notify the respondent of the new subject matter or to provide notice to additional respondents.
G. The Investigation Report
1. Elements of the Final Investigation Report
The final report must: (a) describe the allegation(s); (b) describe the condition of the animals and their environment; (c) include a detailed summary of the results of interviews and reviewing records and other documents; (d) include any supporting documentation such as correspondence, reports, and animal records, conclusions regarding the substance of the allegations vis-a vis requirements of the AWRs, the PHS Policy, the Guide and Institutional policies and procedures; and (e) recommend actions, including sanctions and remedial actions, if appropriate. Recommended actions to 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. Examples of sanctions may include, but are not limited to:
· counseling;
· 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 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,
termination of employment) sanctions be imposed.
2. Development of the Report
a. Creation of Draft Report
The Subcommittee shall create a draft investigation report. The draft investigation report will be transmitted to the University’s Office of General Counsel for a review of its legal sufficiency. The Subcommittee shall incorporate comments of the Office of General Counsel into the report as appropriate.
b. Opportunity for Review and Comment by Respondent
After the draft investigation report has been reviewed by the Office of General Counsel and that office’s comments have been incorporated (as appropriate), the Subcommittee shall send the draft investigation report to the IACUC Chair. The IACUC Chair will then provide the respondent with a copy of the draft investigation report for comment and rebuttal. The respondent will be allowed 10 calendar days from the receipt of the report to review and comment on the draft report. H. Subcommittee’s Final Investigative Report
The subcommittee will consider the comments of the respondent and, draft a final investigative report. The findings of the final report may take into account the respondent's comments in addition to all the other evidence. The respondent's comments will be attached to the final report. The final investigative report shall be submitted to the Office of General Counsel for review of legal sufficiency. The Subcommittee shall incorporate comments of the Office of General Counsel into the report as appropriate.
d. Transmittal of the Subcommittee’s Final Investigation Report to the IACUC
After comments have been received and the necessary changes, if any, have been made to the report, the investigation sub-committee should transmit the final report with attachments, to the IACUC, through the Chair.
I. Review by IACUC
The IACUC will review the Subcommittee’s Final Investigation Report and the recommended actions. At a fully convened meeting by a
vote of the majority of the quorum, the IACUC shall determine whether Serious and/or Continuing non-compliance occurred and what actions, if any, should be taken with regard to animal care and use. If the IACUC is unable to reach a decision as to whether Serious and/or Continuing non-compliance occurred, the IACUC may seek further information, and may return the report to the investigation sub-committee with a request for further fact- finding or analysis. The matter will then be reviewed and voted upon at the next regularly scheduled IACUC meeting.
J. Institutional Official and Decision
The Chair shall communicate the decision of the IACUC to the Institutional Official. The Institutional Official may take additional administrative actions but may not overturn
the IACUC’s recommendations regarding animal care and use. The Institutional Official will issue the final decision and send it to the respondent and the IACUC. The decision becomes final within five (5) business days of receipt by the respondent unless the respondent files a written request for reconsideration within that time frame.
K. Reconsideration
1. Grounds for Reconsideration
A respondent may request reconsideration of the Institutional Official’s decisions under certain limited circumstances. Grounds for reconsideration are limited to: 1) availability of new information that was not reasonably available to the respondent during the investigation and which may affect the outcome of the case; 2) a material failure to follow these policies and procedures which may have affected the outcome of the case; 3) sanction exceeds the severity of the violations; 4) decision and sanctions are substantially different than as set forth in the draft investigation report. No other grounds will be considered.
2. Process
The respondent must submit a written request for reconsideration to the Institutional Official within five (5) business days of the respondent’s receipt of the final decision. The request should set forth the basis for reconsideration. The Institutional Official will review the respondent’s request and determine whether the request for reconsideration should be granted. The Institutional Official shall ordinarily reach his/her decision within ten (10) days of receipt of respondent’s request, and shall promptly communicate his/her decision to the IACUC and the Respondent. In making his/her decision, the Institutional Official may seek a response from the investigation sub-committee.
When the IACUC reconsiders its decision, it will offer the respondent the opportunity to appear personally before the IACUC. The IACUC shall then determine whether to modify or uphold the original decision. This determination will then be forwarded to
the Institutional Official for reconsideration. The Institutional Official’s decision on reconsideration is final.
Once a final decision is reached, the matter shall not be reopened unless new information becomes available that, in the opinion of the IACUC or the Institutional Official, may substantially affect the findings of the investigation. In such a situation, the IACUC shall evaluate the information and offer the respondent the opportunity to appear personally before the IACUC and to submit written comments for the IACUC’s consideration. The IACUC shall then determine whether to modify or uphold the original decision. This determination will then be forwarded to the Institutional Official for consideration. The Institutional Official’s decision is final.
L. Confidentiality
In distributing the draft or final investigative report, or portions thereof, the Chair will inform the recipient of the confidentiality under which the draft report is made available and may establish reasonable conditions to ensure such confidentiality. For example, the Chair may request the recipient to sign a confidentiality statement or to come to his or her office to review the report.
M. Disseminating Results of Investigation
When a final determination is made, the Chair will inform the respondent and appropriate Institutional and governmental officials in
writing as required under federal regulations.
VI. ADDITIONAL CONSIDERATIONS
A. Resources
The Chair, IACUC and investigation sub-committees shall have access to the necessary resources and staff to conduct a thorough and fair review of allegations. Internal and external consultants may be called to assist in the review. The Chair, IACUC and investigation sub-committees may involve the Office of General Counsel and other university offices at any time as appropriate.
B. Coordination with other Investigative Processes
Some cases require review by other institutional or external entities. The IACUC will cooperate in the review of allegations of research misconduct or financial mismanagement or FDA inspections, etc. In cases that appear to involve research misconduct, the investigation sub-committee will report allegations of such misconduct to appropriate University officials.
Where research misconduct and IACUC investigations are pending against the same researcher, the IACUC may coordinate processes to avoid inconsistent decisions, and duplication of effort to minimize competing use of resources.
C. Conflict of Interest
As with all IACUC processes, any IACUC member who has a conflict of interest relating to the matter under review will excuse himself/herself from the proceedings.
D. Confidentiality for Complainants and Witnesses
The investigation process is confidential and the sub-committee will take necessary steps to ensure confidentiality. The IACUC will attempt to protect the identities of complainants and others who provide information while at the same time affording the respondent access to the substance of the allegations and information presented against him/her. The IACUC cannot guarantee anonymity for complainants.
E. Retaliation
Retaliation against good faith complainants is illegal and will not be tolerated. The IACUC will, to the extent possible, take appropriate steps to ensure that a complainant is not subject to retaliation.
F. Reporting to Government Agencies
The Institutional Official is responsible for compliance with reporting obligations to government agencies. Reporting to the Office of Laboratory Animal Welfare, the United States Department of Agriculture and Association for Assessment and Accreditation of Laboratory Animal Care will be in accordance with federal regulations and accreditation standards. In some instances, the Institutional Official may report the status of the proceedings while they are pending and before a final decision is reached. In such instances, the Institutional Official shall also report the outcome when a final decision is reached. |
