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UofL Non-Compliance Policy

I. PURPOSE AND BACKGROUND

This policy describes the process that the IRB follows to manage allegations and findings of non-compliance.

II. POLICY

In accordance with 45 CFR 46.103, 21 CFR 56.103 and University policy, the University of Louisville Institutional Review Boards (IRBs) have the responsibility and authority to oversee the use of human subjects in research that is under their jurisdiction. The IRB, as part of their oversight responsibilities (45 CFR 46.113 and 21 CFR 56.113), must establish procedures for the evaluation of all non-compliance and the prompt reporting of any serious or continuing non-compliance with the federal regulations or institutional policies.  The IRB chair and IRB may make an immediate decision with final approval by a convened meeting of the IRB.

The objectives of this policy are to:

  1. Establish procedures for prompt reporting of any serious or continuing non-compliance with federal regulations or institutional policies;
  2. Define non-compliance, serious non-compliance, and continuing non-compliance;
  3. Explain the investigator’s responsibilities when non-compliance, serious non-compliance and continuing non-compliance with human subjects regulations occurs; and
  4. Explain the IRB’s responsibilities in handling non-compliance, serious non-compliance and continuing non-compliance with human subject regulations.

III. DEFINITIONS

  1. Allegation of non-compliance: An unproven assertion of non-compliance.
  2. Continuing non-compliance: A pattern of non-compliance that, in the judgment of the IRB Chair or convened IRB, indicates a lack of understanding of the regulations or institutional requirements that may affect the rights and welfare of participants, would have been foreseen as compromising the scientific integrity of a study such that important conclusions could no longer be reached, suggests a likelihood that non-compliance will continue without intervention, or frequent instances of minor non-compliance. Continuing non-compliance also includes failure to respond to a request to resolve an episode of non-compliance.
  3. Finding of Non-compliance: Non-compliance determined by the IRB to be true.
  4. Non-compliance: Any action or activity associated with the conduct or oversight of research involving human subjects that fails to comply with federal regulations or institutional policies governing such research. Non-compliance actions may range from minor to serious, be unintentional or willful, and may occur once or several times.  The degree of non-compliance is evaluated on a case-by-case basis and will take into account such considerations as to what degree subjects were harmed or placed at an increased risk and willfulness of the non-compliance.
    Examples include, but are not limited to:
    1.  Failure to obtain IRB approval;
    2.  Inadequate or non-existent procedures for the informed consent process;
    3.  Inadequate supervision;
    4.  Failure to follow recommendations made by the IRB;
    5.  Failure to report adverse events or protocol changes;
    6.  Failure to provide ongoing progress reports; or
    7.  Protocol deviations.
  5. Serious Non-compliance: An action or omission in the conduct or oversight of research involving human subjects that affects the rights and welfare of participants, increases risks to participants, decreases potential benefits or compromises the integrity or validity of the research. Examples of serious non-compliance include, but are not limited to:
    1.  Conducting non-exempt research without IRB approval;
    2.  Enrollment of subjects that fail to meet the inclusion or exclusion criteria of the protocol, that in the opinion of the IRB Chair or convened IRB increase the risk to the subject; or
    3.  Enrollment of research subjects while study approval has lapsed; or
    4.  Serious protocol deviations that may place subjects at risk from the research.

IV. PROCEDURE FOR POLICY

Findings and allegations of non-compliance can come from a number of different sources, including investigators, members of the research team, study sponsors, regulatory bodies (OHRP, FDA), subjects and their families, institutional personnel or committees, the media, the public, or anonymous sources. Additionally, the IRB can identify non-compliance during it review of research studies.

Findings of Non-compliance

  1. HSPP staff members who receive reports of non-compliance may obtain additional information about the action or activity, including any corrective action. The report and additional information will be documented in writing by the HSPP staff and forwarded to the IRB Chair and HSPP Director or designee.
  2. The IRB Chair, Chair designee or HSPP Director or designee may consult with other institutional units such as the Research Integrity Program. Radiation Safety Committee, Institutional Biosafety Committee, Industry Contracts, Grants Management, research offices of affiliated institutions, and the Privacy Office concerning the reported non-compliance.
  3. The IRB Chair (or designee) and HSPP Director (or designee) will review the documentation and request additional information, if needed. Based on the information provided, the IRB Chair or designee will determine if the report of non-compliance might be serious or continuing non-compliance. If the Chair or Chair’s designee determines that the non-compliance is clearly neither serious nor continuing, the IRB Chair or designee may accept the report as presented or recommend a corrective action plan. The Chair’s or designee’s decision will be reported to the IRB for approval.  
  4. If the IRB Chair or designee determines the non-compliance might be serious or continuing, the documentation is forwarded to the fully convened IRB for review as described in the policy under “IRB Responsibilities for Handling Non-compliance that might be Serious or Continuing”.
  5. If the instance of non-compliance involves research conducted without prior IRB approval, the IRB chair will order all research activities to stop.
  6. If, in the opinion of the IRB Chair, the finding of non-compliance might be serious or continuing, the IRB Chair or Chair’s designee may suspend research activities immediately (following the IRB Policy on Suspension or Termination of IRB Approval) until such time that the full IRB can convene if he/she believes subjects may be exposed to immediate harm. Enrollment may resume after resolution of the allegation. 
  7. If the IRB chair is unavailable and in the opinion of the Director, HSPP, the finding of non-compliance might be serious or continuing, the Director, HSPP may suspend research activities immediately (following the IRB Policy on Suspension or Termination of IRB Approval) until such time that the full IRB can convene if he/she believes subjects may be exposed to immediate harm. Enrollment may resume after resolution of the allegation. The Director, HSPP, will contact the IRB Chair as soon as possible to confirm this decision.

Allegations of Non-compliance

  1. HSPP staff must immediately report any allegation of non-compliance to the HSPP Director or designee. 
  2. The HSPP Director or designee will compile information and present concerns to the IRB Chair.
  3. The IRB Chair and Director (or their designees) will promptly contact the complainant, the respondent, and the PI to obtain a greater understanding of: 
    1. The facts surrounding the allegation;
    2. Whether the allegation is true.
  4. If, in the opinion of the IRB Chair and Director, the alleged non-compliance is not true, the IRB Chair (or designee) will document the outcome of all communications and discussions in writing. The IRB Chair or Director (or designees) will communicate the outcome of these discussions to the complainant, the respondent, and the PI, and copies will be placed in the IRB file and communicated with the affiliated research office(s). Information will be provided to the IRB as an informational item.
  5. If the IRB Chair determines that the alleged non-compliance is true, it will be handled according to the section on this policy on “Findings of Non-compliance”
  6. If, in the opinion of the IRB Chair, the allegation concerns non-compliance that might be serious or continuing, the IRB Chair or Chair’s designee may suspend research activities immediately until such time that the full IRB can convene if he/she believes subjects may be exposed to immediate harm. Enrollment may resume after resolution of the allegation. 
  7. If the IRB chair is unavailable and in the opinion of the Director, HSPP, the allegation concerns non-compliance that might be serious or continuing, the Director, HSPP may suspend research activities immediately until such time that the full IRB can convene if he/she believes subjects may be exposed to immediate harm. Enrollment may resume after resolution of the allegation. The Director, HSPP, will contact the IRB Chair as soon as possible to confirm this decision.

Procedure for Reporting Non-compliance

  1. When an investigator or key personnel becomes aware of or suspects serious or continuing non-compliance, the investigator or key personnel must report this to the IRB within 5 working days.
  2. The reporting party should submit documentation to the IRB (via the HSPPO, if appropriate), including any supporting information from other sources (e.g. study sponsor, regulatory body, members of the research team, research subjects), involved in or having information related to the allegation of non-compliance (e.g. who, what, when, where, and why) and what actions were taken and will be taken to ensure subjects were not or are not harmed. 
  3. If information originated from another source other the Investigator, the Investigator should provide his/her own assessment of the allegation.

IRB Responsibilities for Handling Non-compliance that Might be Serious or Continuing

  1. Reviews will take place at a convened meeting. 
  2. If the Chair or HSPP Director has suspended the research because of findings or alleged findings of serious or continuous non-compliance, the IRB will vote to confirm or reverse that decision.
  3. To assist in making this determination, all members of the IRB will receive the: 
    1. original report of the findings or alleged findings of serious or continuous non-compliance; 
    2. any additional documentation provided in the original complaint; 
    3. the HSPPO auditor’s preliminary findings (previously reviewed by the IRB chair); and 
    4. a summary of the auditor’s findings detailing the major findings. 
  4. The IRB will then: 
    1. review the information provided in c. above;  
    2. vote on the information provided as indicated in 3 and 4 following, or defer the vote and gather additional information if needed from the investigator or others involved; 
    3. vote on whether the non-compliance is serious; and 
    4. vote on whether the non-compliance is continuing;  
  5. After voting, the IRB may require: 
    1. no action; 
    2. modification of the research protocol; 
    3. modification of the information disclosed during the consent process; 
    4. additional information be provided to past participants; 
    5. notification of current participants (required when such information may relate to participants’ willingness to continue to take part in the research); 
    6. requirement that current participants re-consent to participation; 
    7. modification of the continuing review schedule; 
    8. monitoring of the research; 
    9. monitoring of the consent; 
    10. suspension of the research; 
    11. termination of the research; 
    12. obtaining more information pending a final decision, such as requiring an audit; 
    13. referral to other organizational entities (e.g., legal counsel, risk management, institutional official); or 
    14. other actions appropriate for the local context.

Request for Reconsideration

The IRB provides the investigator an opportunity to respond in writing to the preliminary audit findings and provide additional information to refute the findings before the IRB makes a final determination and votes on penalties.  Consequently, the IRB’s determinations and recommendations are final.

V. REPORT OF FINDINGS

Follow the University of Louisville IRB Report of Findings policy for reporting serious or continuing non-compliance involving human subject research. This policy may be found on the HSPPO website.

VI. APPLICABLE REGULATIONS AND GUIDELINES
 
45 CFR 46.103(b) Protection of Human Subjects
45 CFR 46.113, Suspension or Termination of IRB Approval of Research
21 CFR 56.108 IRB Functions and Operations
 

Subject: Non-Compliance Involving Human Subjects Rsearch |  Policy and Procedure | Author: Institutional Review Board  |   Original Effective Date: 6-3-2005  |   Last Revised Date: 6-8-2010 

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