X. RESEARCHER QUALIFICATIONS AND FINANCIAL DISCLOSURES
10.1 General Definition
IRB Board Members are responsible for disclosing any known potential or perceived conflict of interests concerning protocols reviewed by the IRB. This would include professionals classified under the following categories:
- Principal Investigator
- Co-Principal Investigator
- Investigator receiving funding from a study as listed in the study budget
- In a supervisory role over the Principal Investigator of the study, or
10.2 IRB Deliberations and Disclosure
Principal Investigators must disclose any conflict of interest that he/she or family member holds in a protocol under review. Board members with a conflict of interest are expected to leave the meeting room prior to the IRB's deliberation and vote. Notations should be made in the minutes to reflect voting activities.
10.3 Conflict of Interest and Financial Disclosure Procedures
All Investigators are to follow the Sinai Health System Conflict of Interest Policy (SHS-BI-5). In addition, investigators must complete a "Statement of Financial Disclosures by Investigator" form for each study presented to the IRB. Investigators must identify for resolution any conflict of interest associated with a study, including but not limited to their personal investment in or other financial relationship with a company that might profit from the study. If the Investigator is permitted to proceed with the study following review under that policy, the research consent form provided to subjects should include an appropriate description of any relationship that might be received as a potential conflict of interest. This information must be reflected in the consent form.
10.4 NIH Requirements
NIH requires a declaration of significant conflict of interest within 90 days at the termination of a grant.
10.5 Change in Status
If the Conflict of Interest status of an individual changes during the course of a study, the individual is required to declare this to their Department Chair, the IRB Administrator and the Business Integrity Officer as soon as possible.
10.6 Ethics and General Research Education
In order to conduct human research, all researchers and their staff must demonstrate that they are familiar with the laws and ethical standards governing the responsible conduct of research. Researchers must complete the NIH training (http://cme.nci.nih.gov).
10.7 Professional Qualifications
All investigators and their staff must be professionally qualified to conduct the proposed research. Upon request, researchers must provide the IRB with a curriculum vitae or statement of qualifications for the principal or all co-Principal Investigators and for all key staff members involved in managing the research.
