With the COVID-19 global pandemic under way, many institutions have started engaging in human subjects research related to the disease, and many will be contemplating doing so soon. A recent resource created by experts from Huron aims to assist these institutions with strategically evaluating engagement in research specific to the novel coronavirus.
“When launching into a new stream of clinical trials in a therapeutic area perhaps never tackled before by an institution, it’s important to ensure it is in alignment with organizational priorities, and that finite personnel, equipment, and supplies are reasonably allocated,” says Matthew Staman, a managing director with Huron’s Research Services team. “Organizations with an existing research feasibility review process should consider supplementing the committee with subject matter experts who can evaluate SARS-CoV-2/COVID-19 research priorities or consider establishing an ad hoc committee to specifically evaluate such research.”
Organizations without an existing feasibility review process should consider establishing a committee because of its many institutional benefits. “During a global pandemic, when resources are highly constrained, a systematic review of any new research is ever more critical,” Staman notes.
Types of research to be reviewed would include studies of the SARS-CoV-2/COVID-19 patient population or a related hypothesis, including but not limited to interventional drugs, devices, diagnostics/procedural tools, and specimen collection and/or banking. On the non-interventional side, studies of data use/registries, retrospective chart review, and lifestyle management/quality of life issues are among the possibilities.
As for the specific membership of a COVID-19 research feasibility review committee, Staman recommends that “clinical leaders from emergency medicine, pulmonary medicine, and infectious diseases should be included to assist with evaluating scientific merit and alignment with organizational priorities and capabilities. Further, infection control and risk management representatives can be included to evaluate the overall impact to the institution.”
Huron envisions that research review committee members would consider how to prioritize research under current circumstances at the institution and weigh the scientific merits of proposed studies in relation to their degree of alignment with the World Health Organization’s 2019 novel coronavirus blueprint. They would also evaluate ongoing research that may compete with or be complementary to the proposed research, assess investigator experience in the field of study, and evaluate the robustness of the proposal/protocol with respect to the study objectives, patient safety, efficacy endpoints, and other factors.
According to Staman, “Such committees also review proposed measures for minimizing risk to the research team, clinical care team, and ancillary departments, and ensure appropriate processes for managing exposure. Part of this would be confirming the ability of site staff to screen, recruit, and consent patients who are infected, and, if necessary, considering the institution’s ability to recruit healthy volunteers.”
Huron’s full recommendations on “Considerations for Evaluating Participation in COVID-19 Human Subjects Research” are among the resources available at the firm’s Resources for Higher Education Leaders Navigating COVID-19 Response page.
Edited by Gary W. Cramer