Proposed changes to the federal regulations that protect those who participate in research are aimed at improving the protection of human subjects, but researchers fear the adjustments could stifle human subject research and, ultimately, progress against preventing and treating disease. Changes to the regulations known as “The Common Rule” would complicate consent requirements for the secondary use of biospecimens and data, and mandate single IRB approval for multi-site studies.
Wednesday’s town hall, hosted by Steve Dewhurst, Ph.D., Vice Dean for Research at SMD; Kelley O’Donoghue, Associate Vice President for Human Subject Protection; and the leadership team of the Clinical and Translational Science Institute; focused largely on these two issues, though the proposed changes cover a myriad of other topics as well.
“The policies will transform the way human subjects research is conducted,” said Dewhurst. “They may also have unintended negative consequences – including limiting who can contribute biospecimens for research, and making work with biospecimens far more onerous for researchers. So it is very important that our faculty understand the proposed changes and that they comment on them if they would prefer that the policies be revised before they become finalized.”
The federal government is accepting comments on the proposed changes until Jan. 6, and researchers are encouraged to submit feedback.
Secondary use of biospecimens and data
Research goes on every day in the U.S. with anonymous biospecimens. Blood, urine, tissue, and other biospecimens collected and used for clinical purposes, and would otherwise be discarded are de-identified and used for laboratory research to advance science and discover new treatment opportunities. Currently, study of these biospecimens is not considered human subject research because the tissues are anonymous. As these samples can’t be linked back to an individual, investigators aren’t required to come to their Institutional Review Board (IRB) for approval of their research, and there’s no requirement for individual consent for secondary use of those biospecimens.
The federal government’s proposed changes, if implemented, will classify secondary research on de-identified biospecimens as human subject research and requiring “broad consent” from patients. This means an individual must provide written consent to allow their biospecimens to be stored, maintained, and used for future unspecified research.
Consent must be re-obtained every 10 years for the patient’s biospecimens collected for clinical purposes to continue to be stored and used for research. This timespan applies to the pediatric population as well, who must also provide an additional consent when they reach the age of 18. Whether this re-consent will apply to specimens collected before the child turned 18, or whether it will only apply to the storage and use of specimens collected after that point is not clear.
“If this regulatory requirement is enacted, the University of Rochester will follow it. We will develop a policy and track individual decisions and maintain all of the proper forms,” said O’Donoghue. “But we’re a large academic medical center. We can come up with the resources to do this. Smaller hospitals and clinics that contribute anonymous biospecimens for secondary research will have to stop if they don’t have the means to establish what’s necessary to obtain broad consent.”
There will be consent and notification requirements for storage and secondary research use of de-identified data also, but the application is slightly less stringent than it is with biospecimens.
“The secondary use of data remains a little more unclear” said O’Donoghue. “The proposed regulations place data and the requirements for notification into a couple different buckets depending upon how it is identified, but for identifiable data broad consent is required.”
Single-IRB approval for multi-site studies
The proposed federal regulations also mandate the use of a single IRB for multi-site studies. This proposal has good intentions; rather than having each site’s IRB review and approve a study, investigators will be mandated to use a single IRB for any multi-site research conducted in the United States. (The reviewing IRB is selected by the funding agency, or defaults to the institution of the Lead Principal Investigator conducting the study.)
But in practicality, this will place a large burden on the lead PI. For example, the lead PI for a 4-site study, will be required to create a coordination center-type infrastructure with oversight plans to ensure compliance at the other 4 sites. The lead PI will be required to oversee adverse event reporting and collecting data for continuing review from the other 4 sites, so that information can be submitted to the reviewing IRB. Or alternatively, if the Lead PI doesn’t take responsibility for overseeing and managing the other 4 site, the 4 sites will be responsible for familiarizing themselves with the reviewing IRB at the alternate site. This might mean that an active Investigator collaborating with colleagues at other institutions could be responsible for submitting to 10 or 12 different IRBs.
“I’m not against this. I think there are a lot of settings and research studies where this would make sense and potentially streamline research,” said O’Donoghue. “The problem is the mandate across every single study with more than one site. For studies with three or four sites and an expedited review, it might be quicker and less burdensome to just perform a local review rather than set up the infrastructure required for a single IRB.”
O’Donoghue, Dewhurst and other university leaders will draft a series of comments regarding the proposed changes. However, an administrative objection to some of the proposed changes is only a small piece of the puzzle. Dewhurst strongly encouraged other researchers to get involved as well, saying that grassroots objections could be a major influence, and said that those with strong connections to organizations that do research with biospecimens or recruit research subjects should make sure those organizations are aware of the proposed changes.
“Sheer numbers and individual comments matter,” said Dewhurst. “Showing there’s concern in the community about this — from both researchers and potential human subjects — I think, is the most important thing.”
All feedback must include viable alternatives to the federal government’s proposed regulation changes. More information is available on the CTSI website: resources include the slide deck O’Donoghue presented at the meeting, a fact sheet on the proposed Common Rule changes, and a one-page guide to writing effective comments. Contact Kelley O’Donoghue for assistance or more information.