Listserv Responses: Return of Clinical Research Results [February 2023]

Thank you to Erik Lontok, PhD, Director of Research, at the Barth Syndrome Foundation for compiling the responses to his listserv post on 2/13/2023.  ADDITIONAL SHARED RESORUCES ARE WELCOME!

Original Post for which Erik compiled responses in the “Return of Clinical Research Results” document:

BSF is revising our clinical study and trials policy and we are seeking language on how foundations navigate the return of results for clinical research participants. While acknowledging that interventional arms of trials may be difficult, we do believe that observational studies and control/placebo arms should be information returned to participants. May I ask if others have experience, policy, or grant terms & conditions language on this topic you might share?

With respect to indemnification, Erik received 2 examples shown below (not included in the document.)

Example 1:  HRiA 
To the extent permitted under applicable federal, state, and local laws and regulations which govern the Recipient and Institution, the Recipient and Institution (the together, “Indemnifying Party”) shall indemnify and hold the Administrator and Funder, as well as their respective directors, officers, employees, and assigns (the “Indemnified Parties”) harmless from and against any and all costs, losses, or expenses, including reasonable attorneys’ fees, that the Indemnified Parties may incur from any third party claim arising out of or in connection with the Award to the extent caused by the Indemnifying Party’s or its directors’, officers’, or agents’ acts or omissions, or failure to comply with the terms of this Agreement.

Example 2:  JDRF (note the funder vs sponsor distinction for investigator-initiated research)
1.7 Funding Provider and not Sponsor
The Grantee Institution acknowledges that JDRF is solely a provider of certain funding for the research to be performed under an award and is not a sponsor of the research. The Grantee Institution agrees that it will not make any statement, written or oral, alleging that JDRF is a sponsor of the research under the award.


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