Research ethics consultation services (RECS) have grown significantly since 2010, according to a group of members of the Clinical Research Ethics Consultation Collaborative.1
“We thought it would be interesting to see whether and how 10 years has changed the field of research ethics consultation,” says Jennifer B. McCormick, PhD, MPP, one of the study’s authors and an associate professor at Penn State’s Clinical and Translational Science Institute. “Anecdotally, we knew that the field has grown in terms of number of services. But we didn’t know how the services themselves have changed, if at all.”
McCormick and colleagues surveyed 49 members of RECS programs in the United States and Canada. The results revealed consult volume has increased overall. RECS receive consult requests from a wide range of stakeholders — not just principal investigators, but also IRBs or even research participants.
Notably, a subset of RECS receives a low number of consult requests. Possible reasons for this include low need at an institution, high baseline comfort with ethical problem-solving among researchers, access to other resources to help address the issue, or lack of awareness that a service exists, says Katie Porter, JD, MPH, another study author and a clinical research scientist at the Treuman Katz Center for Pediatric Bioethics at Seattle Children’s Research Institute.
In addition, the survey revealed about one-fourth of RECS actively evaluate their work. Mainly, this happens by surveying requestors on satisfaction. For quality control, it is important to learn whether the RECS is providing value and to learn what requesters are looking for (and if they are receiving it). Also, it is also important to consider evaluation measures that go beyond requestor satisfaction.
“There are active discussions within the research ethics consultation community about what that might look like and how to implement it,” Porter reports.
Overall, “the field has changed, but not in any predictable or consistent way,” Porter concludes. RECS are receiving more consult requests generally. On the other hand, RECS tend to work with fewer consultants.
“Funding is one reason,” says Porter, director of the Seattle RECS, which receives support from the Institute of Translational Health Sciences at the University of Washington. How RECs function differs depending on the institution. “There is a huge amount of variability in terms of the structure, the process, and the types of consults that happen,” Porter explains.
As for the most frequent reason for consult requests, study design was the top concern, followed by informed consent. At the Seattle RECS, many requests involve informed consent. While anyone who conducts human subjects research is familiar with the basics of informed consent, complex questions commonly arise. “It’s a bread-and-butter element of human subjects research, but it’s deceptively complicated,” Porter says.
Unanticipated questions may come up with informed consent after the study protocol is approved. Study investigators may struggle with future communication with participants regarding research findings, or how to handle participants’ changing decisional capacity in longitudinal studies.
“Investigators want to do the right thing. They come to us when they’ve hit a hurdle and want some help thinking through what the best options are,” Porter says.
The Seattle RECS serves many repeat customers. Some researchers tend to return repeatedly with questions on their studies. Other consults are requested by researchers who recently found out about the RECS and what it has to offer.
“One of my goals is to be more intentional about that. The issue of getting the word out is something I’m constantly thinking about,” Porter says.
At the same time, the RECS has to be able to handle all the requests. “It’s a balance in terms of promoting the service and having the bandwidth and hours available to support that,” Porter observes.
Most requests come up because researchers are faced with an unanticipated issue after the study protocol was submitted. “That’s just the nature of research,” Porter says.
However, recently, the Seattle RECS has received some consult requests earlier in the process — even before the study protocol is submitted. “It’s always a great experience to help them proactively,” Porter says. “Researchers can strengthen their submission from an ethics perspective early on, before they have even engaged with the IRB.”
REFERENCE
1. Taylor HA, Porter KM, Sullivan C, McCormick JB. Current landscape of research ethics consultation services: National survey results. J Clin Transl Sci 2022;6:e148.
After a decade in existence, the most frequent reason for requesting these services is questions about study design, followed by informed consent.
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