Retrospective Reviews and Mitigation Plans

Overview

For covered individuals engaged in Public Health Service (PHS) or Department of Energy (DOE) sponsored research, a retrospective review of a conflicted investigator’s activities and sponsored research is conducted to determine whether any PHS or DOE sponsored research, or portion thereof, conducted prior to the identification and management of a conflict of interest (COI) was biased in the design, conduct, or reporting of the research.

This procedure may be used for non-PHS sponsored research conflicts when directed by the Vice President for Research and Innovation, at their discretion.

Requirements for a Retrospective Review

A retrospective review is not required if a COI is timely identified and managed. A COI is considered to have been timely identified and managed if the conflict management plan (CMP) is (1) implemented before the expenditure of project funds, or (2) is established within 60 days of an investigator’s timely disclosure of a significant financial interest (SFI) or business interest (BI) discovered or acquired during the course of an on-going project. Since University policy requires an Investigator to report a significant financial interest (SFI) or business interest (BI) within 30 days of discovering or acquiring (e.g. through purchase, marriage, inheritance) the interest, the COI is timely managed if a management plan is implemented, at least on an interim basis, within 90 days of its discovery or acquisition by the Investigator during the course of an on-going project.

When a Retrospective Review is required. The retrospective review must be completed within 120 days of a standing Conflict Review Panel’s (CRP) determination that a COI exists and that it was not identified or managed in a timely manner (hereafter “retrospective review criteria”). A COI could be identified or managed in an untimely manner in any of the following circumstances:

• failure by the Investigator to disclose a SFI or BI that is determined by a Conflict Review Panel to constitute an COI;
• failure by the University to review or manage a COI (e.g., not timely reported by a subrecipient or timely reviewed by the University) ; or
• failure by an Investigator to comply with a Conflict Management Plan.

Retrospective Review Procedures  

The retrospective review, bias determination, and mitigation plan will be accomplished by a standing Conflict Review Panel (CRP), with support as required from an ad hoc Retrospective Review Committee (RRC).

1. CRP Initial Bias Determination
   When a CRP determines that retrospective review criteria are met, the CRP will make the initial determination whether the sponsored research is at a stage at which bias could have occurred.
   1. No Bias Finding. If the CRP concludes that the research is in the preliminary stages such that bias could not yet have occurred, the CRP will document that determination in the CRP meeting minutes. If applicable, the CRP will determine the appropriate action to address an untimely disclosure.
   2. Possible Bias. If the CRP determines the research is at a stage at which bias could have occurred, the CRP will direct the COI Program to promptly submit a written request to the investigator’s Associate Dean for Research to appoint an ad hoc Retrospective Review Committee (RRC) to complete a retrospective review. 
2. Request for Appointment of an RRC
   1. The Chief Compliance Officer will send a written request to the cognizant Associate Dean for Research. The written request will include the following information.
      1. Project number
      2. Project title
      3. Project Director (PD)/PI or contact PD/PI if a multiple PD/PI model is used
      4. Name of the investigator with the COI
      5. Name of the entity with which the Investigator has a COI
      6. Reason(s) for the retrospective review
      7. Requirements for the RRC written report
         • Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed);
         • Findings of the review;
         • Conclusions of the review.
   2. As soon as practicable, the Associate Dean for Research will appoint an RRC comprised of an individual or individuals with rank and expertise comparable to the conflicted investigator.
3. Retrospective Review Committee (RRC)
   1. Once appointed, the RRC will promptly conduct the retrospective review. The RRC should inform the staff of the Conflict of Interest Program if it is experiencing difficulties in accomplishing a timely and complete review.
   2. The RRC may wish to use the following questions during its review:
      1. Conflicted Investigator
         • Why was the SFI/BI not reported in a timely fashion?
         • What have your contributions or involvement in the project been thus far?
         • Do you think you have made judgments in this research project that could have been influenced by your SFI/BI?
         • Did any of your research team ever ask whether you have financial or business interests related to this project?
         • Have you presented results from the project to an audience or published an abstract, poster, or article?
         • Have you made any disclosures of your interest to your research team, to an audience, or in a publication?
      2. Non-conflicted research personnel
         • Have you participated in the experimentation or other study procedures on this research project?
         • How far along is this project?
         • Were you aware that the conflicted investigator has a SFI/BI related to this research?
         • Have any project data been presented to a scientific audience or published as an abstract, poster, or article?
         • Do you recall an instance in which the conflicted investigator made a decision that could favor their SFI/BI and went beyond sound scientific judgment?
         • Were outlier data ever culled by the conflicted investigator in a way that you think was not compatible with accepted statistical practices?
         • Were data that in hindsight might be interpreted to be unfavorable to the SFI/BI ever ignored or suppressed?
   3. The RRC will submit its written report containing its methodology, findings, and conclusions, through the Chief Compliance Officer to the Conflict Review Panel. The RRC report is advisory to the CRP. The RRC member(s) shall make themselves available to discuss their review, findings, and conclusions with the CRP.
4. Conflict Review Panel (CRP) Actions 
    
   1. The CRP will review the RRC report and vote on the issue of whether bias occurred in the design, conduct, or reporting of the sponsored research. If the CRP finds there is no reasonable basis on which to conclude that bias occurred, the finding will documented in writing and the matter will be closed.
   2. If the CRP concludes there is a reasonable basis on which to conclude that bias has occurred, it will determine whether the research project is salvageable. If the CRP concludes that the research is salvageable, it will also determine whether additional CMP mechanisms are required to mitigate the bias and to effectively manage the conduct of the research going forward. The CRP also will determine the appropriate response to any untimely disclosure. If the CRP believes the research project is not salvageable, the matter will be referred to the appropriate College Dean and/or Associate Dean for Research for review and further action. In these circumstances, the CRP will request that the College Dean and/or Associate Dean provide the CRP with their assessment of the matter and proposed resolution. Once feedback from the Dean and/or Associate Dean has been received, the CRP will be updated and a decision will be made regarding the need for any further action. 
   3. If the CRP believes that the facts support an allegation of research misconduct as it is defined in Administrative Policy: Research Misconduct, it will forward the RRC report and any other facts bearing on the matter through the Chief Compliance Officer to the University’s Research Integrity Officer.
5. COI Program Actions
   1. If bias is found, the COI Program will provide the results of the retrospective review and a mitigation report to Sponsored Projects Administration (SPA) so that it can notify the research sponsor as required. If the sponsor is a PHS agency or the DOE, SPA will notify the PHS or DOE awarding component promptly and submit a mitigation report to the PHS or DOE awarding component. The mitigation report must include, at a minimum, the key elements documented in the retrospective review, a description of the impact of the bias on the research project and the University’s plan of action or actions to eliminate or mitigate the effect of the bias (e.g., impact on the research project, extent of harm, including any qualitative and quantitative data to support any actual or future harm; and an analysis of whether the research project is salvageable). 
   2. If the CMP is modified, the COI Program will notify SPA, and SPA will update the FCOI report to the PHS or DOE funding agency.
   3. The COI Program will maintain the results of a retrospective review for at least three years from the date the final expenditures report for the project is submitted to the research sponsor.