Original Effective Date 08/27/2002
Last Revised Date 08/24/2012
Introduction
The WUSTL Research Conflicts of Interest Policy states “Unresolved disagreements concerning the application of this policy shall ultimately be referred for final resolution to a committee established by the chancellor or representative appointed by the chancellor.” This procedure outlines the necessary steps individuals shall take to resolve disagreements and, if needed, seek an appeal regarding the Conflict of Interest Review Committee’s (CIRC) determination and management plan to address the financial conflicts of interest (FCOI).
Initial Process
- Once the individual receives the CIRC’s management plan, s/he must respond within the specified period of time by signing and returning the letter. If the individual has questions or concerns regarding the CIRCs management plan, s/he should contact the CIRC Chair or the COI program, within the same specified timeframe.
- a. The individual will be invited to attend the subcommittee or full committee to present his/her concerns.
b. The individual will be provided with the written conclusions of the CIRC’s decision, in the form of a management plan. S/he must respond within the specified period of time by signing and returning the letter or pursue set number 3 in that same time period.
If the CIRC’s determination does not resolve the issue, the individual should contact the vice chancellor for research (VCR). The VCR may discuss the situation with the CIRC Chair as well as the applicable dean to try to reach a resolution.
a. Dependent upon the resolution, the VCR or CIRC Chair will communicate with the individual in writing with the proposed resolution.
b. If the individual still disagrees with the decision, s/he may submit to the VCR a written request for appeal.
- Should the situation not be resolved, the VCR, in consultation with the applicable dean, will determine if there are grounds for an appeal.
a. The VCR will send a written determination to the individual, with copies to the CIRC and the relevant department chair and dean, as appropriate.
Interim Management Procedures
If the dispute cannot be resolved within 30 days from the date of the CIRC’s management plan, the VCR may implement an interim management plan as needed. The interim management plan will be determined in consultation with the CIRC chair, the applicable dean, and the Executive Chair of the Institutional Review Board, as appropriate. Interim management plans may consist of, but are not limited to:
- Modifying the role of the conflicted individual;
- Requiring independent data analysis and/or additional oversight of the research;
- Placing a temporary hold on the human studies protocol(s) or subject accrual; and/or
- Temporarily delaying dissemination of the research results.
The interim management plan will remain in effect until such time as, in the opinion of the VCR, the situation is resolved. Interim management strategies cannot be appealed.
Appeals Committee
Charge
The COI Appeals Committee is responsible for reviewing appeals from individuals who disagree with the CIRC’s determination and/or management plan for addressing an individual’s financial conflict of interest.
Organizational Structure of the Appeals Committee
The VCR will coordinate the appointment of the Committee, with the approval of the chancellor. For more information regarding the Appeals Committee, please contact the Office of Research Integrity & Ethics (ORIE).