Sections 5.7 and 6.8 of SMART IRB Agreement V3.0 provide that when a federal agency is a Relying Institution, it will provide a conflict of interest assurance to the Reviewing IRB that agency personnel may participate in the Research. Information about the NIH Intramural Research Program’s conflict of interest policies and processes (with links/citations to those policies and the underlying laws/regulations) can be found in the document titled “FAQ on the Conflict of Interest Policies of the NIH Intramural Research Program for SMART IRB.” That document addresses questions about what information NIH can and cannot disclose to the Reviewing IRB.
Articles in this section
- How are conflicts of interest of Research Personnel from federal Relying Institutions addressed under the SMART IRB Agreement?
- If study team members from a non-federal Relying Institution identify potential financial conflicts of interest after the study has received IRB approval, must they disclose this information to the Reviewing IRB?
- How do study team members from a non-federal Relying Institution communicate potential conflicts of interest and applicable management plans to the Reviewing IRB?
- Whose conflict of interest policies do a non-federal Relying Institution’s Research Personnel members follow?
- How are conflicts of interest of Research Personnel from non-federal Relying Institutions addressed under the SMART IRB Agreement?
- How do the changes in the conflict of interest provisions reflected in SMART IRB Agreement v2.0 affect institutions that are not collaborating with a federal agency?
- Is the language in Sections 5.8 and 6.6 of SMART IRB Agreement v2.0 relating to assurance to the Reviewing IRB of satisfaction of investigator conflict of interest policies from the NIH compliant with AAHRPP standards?
- Single IRB requirements when the Reviewing IRB cannot rely upon the COI assurances from NIH
- Conflicts of Interest: If a Reviewing IRB concludes that it cannot rely upon the conflict of interest assurances from a Relying Institution that is a federal agency, can the Research be withdrawn from Ceded Review with respect to that agency?
- Under SMART IRB Agreement V2.0, will a Reviewing IRB be able to impose additional, more stringent prohibitions or management plans related to conflicts of interest of federal agency Research Personnel?
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