Speaking with sponsors directly can quickly resolve some issues
FDA's registration rule is one issue
Device sponsors and others often seek answers and input from Marti Benedict, RN, BSN, chief compliance officer for research at SUNY Upstate Medical University in Syracuse, NY. Benedict offers these ideas on how to keep sponsors informed, sometimes bypassing the middle guys:
- IRB Advisor: A device sponsor representative recently told me that her company often speaks directly with you and your IRB to resolve issues, and she feels you do a good job handling their questions. What kind of communication and processes do you have for communicating directly with sponsors?
- Benedict: There is no set process for dealing with sponsors. We try to encourage our investigators and coordinators to have correspondence with sponsors when at all possible, to work out whatever they need to.
But it's not unusual for the sponsor to send out a questionnaire to the IRB. So recently we posted a packet of information for sponsors on the public access portion of our Web site, and we included the things they usually request, like the IRB member list, FWA, IORG, and IRB registration numbers and expiration dates, statement of compliance, voting policy for IRB members, and policy for reporting protocol deviations.
Also, once in a while a sponsor has an unusual request, and can't seem to work it out with the investigator or coordinator, and so when I'm contacted by the local study team I tell them to have the sponsor call me. Sometimes, study coordinators will convey the IRB policies to sponsors where they give information, but they can't cite the regulations that apply, or they can't explain why we do it that way. Or sometimes when you have a third party involved the communication gets lost. So now and then the sponsor or clinical research organization (CRO) will call us because they can't get what they think they need. I think there's been a surge especially lately for sponsors to request more and more statements from IRBs of things that don't necessarily have a regulatory basis.
- IRB Advisor: Could you please give me an example of this type of request from sponsors?
- Benedict: Interestingly, one thing lately involves the FDA's requirement that IRBs that review studies that involve FDA-regulated products register with HHS through the Office of Human Research Protection (OHRP) or update their information if they're already registered with OHRP.
Sponsors started calling investigators before the rule was effective (7/14/09), demanding that our IRB show proof that we were compliant with the new requirements. Study coordinators then called us, and we also received letters and phone calls directly from sponsors. Sponsors wanted us to confirm that we were in compliance with the new registration requirements before the new registration Web site was up and running (i.e., before the additional questions were added to the registration).
In addition, the final rule requires IRBs to comply by Sept. 14, 2009. So weeks before we could update our registration and months before the September deadline, sponsors were hounding us to confirm compliance.
By the sixth phone call we received about this, we sent an informational email about the new rule to all our study coordinators so they could forward it directly to sponsors who asked for it.
We tried to update our registration early, but even at the end of the second week of July, the new registration questions were not posted. So sponsors were demanding information that was really ahead of the game. And study coordinators were clueless about what to do with the sponsors' requests until they called us.
Device sponsors and others often seek answers and input from Marti Benedict, RN, BSN, chief compliance officer for research at SUNY Upstate Medical University in Syracuse, NY.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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