Should unused clinical samples be repurposed for further research?
Grand Rounds explores a unique ethical challenge
Many clinical research studies struggle to find enough participants. Meanwhile, during their regular operations, clinicians, hospitals and clinics frequently see many patients. What if patient samples and information collected during their visits was used for research purposes? This issue was the focus of a recent Ethics Grand Rounds hosted by the NIH Clinical Center.
The April Ethics Grand Rounds, "Using Leftover Clinical Samples for Research: When is it Ethical?", posed a question: can the large amount of stored clinical samples from the on-site tests of asymptomatic NIH staff for SARS-CoV-2 (the virus that causes COVID-19) be reused for research purposes? And if so, what guidance should researchers follow surrounding their research use?
The Clinical Center, which has continued operating throughout the pandemic, was concerned about the potential spread of COVID-19 in the facility, particularly as it treats so many immune-compromised patients. In May 2020, the hospital began offering voluntary testing for asymptomatic SARS-CoV-2 and since then has collected thousands of samples from NIH staff as a part of its epidemiological surveillance program.
"OMS [the office of Medical Services] offers NIH staff free asymptomatic testing…. It’s voluntary but all NIH employees are encouraged to participate in this testing program," said Dr. James K. Gilman, Clinical Center CEO, describing the program during the lecture.
This created a research opportunity – residual clinical samples remained after staff had been tested. Now researchers wondered if these samples could help trace workplace transmissions, provide other information such as the progression of viral variants or affect procedures in hospital infection control? These and similar questions could be studied by further research on the stored specimens, moving beyond the original purpose of identifying NIH staff who were exposed to the virus.
The Grand Rounds discussion was led by Dr. David Wendler of the Clinical Center Bioethics Department, and featured contributions from Gilman and I. Glenn Cohen, professor of Law at Harvard Law School and director of Harvard Law School's Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics.
In this case, the Department of Bioethics was consulted for guidance on the policy for further use of de-identified samples of the SARS-CoV-2 virus. U.S. regulations permit the research use of previously collected and de-identified (all personal identifiable information removed) samples without notification or consent from the patients.
The speakers discussed the voluntary nature of staff participation and how the insights gleaned by moving from surveillance to research could potentially affect employees through adjusted working hours, emphasis on telework versus onsite work or other related workplace epidemiological issues. The panel also discussed what manner of employee notification is advisable, ranging from no notification, various opt-in/opt-out policies to formal written consent.
Even though it is not required by federal research regulations, Cohen believed obtaining consent in this case is desirable, given the intended use of these samples – or at the very least gaining staff input to this in other ways.
"When it comes to law and regulations, things are crystal clear… but what’s interesting is whether NIH should go beyond what the regulations require," stated Cohen.
At NIH and elsewhere, bioethics calls on experts with diverse areas of specialization to advise in sometimes unanticipated research scenarios.
"Bioethics at NIH most often concerns us…doing the research on others. What’s interesting about this case is the possibility of some NIH employees ending up as the research subjects through the use of their leftover biospecimens," said Wendler.
COVID-19 affected the daily operation of the Clinical Center in many ways – and some staff might contribute to an understanding of the virus in the workplace in ways they could never have anticipated.
- Robert Burleson