New president and CEO: "We’re AAHRPP 2.0’"
Paperless submissions started in April
The Association for the Accreditation of Human Research Protection Programs (AAHRPP) is moving in some new directions as Elyse I. Summers, JD, president and chief executive officer, celebrates her first anniversary with the organization. Summers previously was the director of education at the Office for Human Research Protections (OHRP). IRB Advisor asked Summers to answer a couple of questions about AAHRPP changes under her watch.
IRB Advisor: What are some of the new things AAHRPP is doing?
Summers: We’re really focusing on working collaboratively with and listening to our various stakeholders so as to make the whole accreditation process as positive of an experience as possible for all concerned. For example, we have all of our AAHRPP standards that organizations do need to meet, but I’ve articulated as an operating principle that in areas where the regulating agencies — whether it’s the FDA or OHRP — have put forth regulations and guidance and clear interpretations, AAHRPP does not need to be "greater than." AAHRPP will not create greater standards than what has already been fully and well explicated by the regulatory agencies.
Alternatively, there may be areas where there are regulations but not guidance or explicit interpretations from the regulatory agencies, and in those areas we have stepped into the void to help illuminate what needs to be addressed. If there’s a gray area where the community was seeking some guidance, we have stepped in and provided further elucidation in those areas. For example, there are regulations that describe the IRB’s structure and composition, including the necessity of having experienced IRB members and a designated IRB chair, but AAHRPP standards (II.1.B) provide for periodic review and adjustment, as necessary. In other words, IRB members (and chairs) should be evaluated and given feedback in terms of their participation.
A second example (standard II.1.C) involves managing the potential for conflicts of interest between different role-players at an organization. AAHRPP standards require that an organization have and follow written policies and procedures to separate competing business interests from ethics review functions, such that, for example, the person in charge of attracting grant money cannot be the IRB chair. Those are competing interests: The IRB chair has to say whether or not the study is ethically appropriate, and the grants director needs to attract research funding. While I’m fairly confident that my former colleagues at OHRP would recommend such separation of function to maintain the IRB’s independence, on this specific issue the regulations are silent.
Returning to my earlier point, I want to be clear, though, that one of the things I’m trying to counter is the possible perception in the community that AAHRPP requires more than federal agencies in areas where the government has spoken quite cogently, robustly and appropriately; in those cases, we do not require more. For instance, in the case of continuing review, there is well-explicated harmonized guidance from OHRP and FDA, so that is a situation where there is no reason for AAHRPP to require greater than what the regulations require because the federal regulators have spoken in a clear and helpful manner.
IRB Advisor: What is AAHRPP doing differently now?
Summers: We’re trying to make strides in the functional processes of accreditation. Before I started at AAHRPP, everything had to be submitted in physical hard copy paper — hundreds of pages. Now we’re working towards a paperless process. Although we’re not fully there yet, we have begun to accept our submissions by CD or thumb drive. It’s not the same as a fully online portal yet, but we want to do that carefully. We’re on our way to implementing processes that make the whole experience a better one for our clients. We changed this just this past spring. If an organization wishes to send paper, we’ll accept that, of course, but this is huge because the submission process includes hundreds and hundreds of pages. This change saves trees and the expense of mailing and express delivering things to us. It’s worked great. The organizations like it and our staff loves it.
The main notion we’ve been trying to put out there is we’re AAHRPP 2.0 now. AAHRPP’s founding president, Marjorie Speers, did an incredible job of getting AAHRPP off the ground and developing this great organization dedicated to recognizing and accrediting high-quality human research protection programs. And now we’re moving into our second phase of existence, looking for ways to both reconnect with our founding community as well as areas where we can grow and be innovative and helpful to our community. n