The increasing complexity of human subjects research has driven the development of research ethics consultation (REC) services, which can complement the oversight role of IRBs.

A recently published article1 on a national REC Collaborative concluded that these forums can supplement the IRB oversight role by:

• serving as a resource on prickly ethics issues for investigators, IRBs, and other research administrators;

• helping IRBs and investigators with decisions related to informed consent and risk-benefit analyses;

• collaborating on ways to overcome study challenges;

• mediating conflicts among researchers.

Ethical and Regulatory Roles Separate

Kathryn M. Porter, JD, MPH, lead author and research scientist in the Treuman Katz Center for Pediatric Bioethics at the Seattle Children’s Research Institute, explained the distinction between IRBs and RECs.

“In many institutions, they are completely separate groups, each serving a different purpose,” she says. “REC services acknowledge and respect the regulatory role that IRBs have. REC services are available to researchers before, during, and after the regulatory review process.”

Some REC services are available for outside consultation by an IRB; “however, regulatory review remains in the purview of the IRB.”

Informed Consent Is Ethical Challenge

Overall, 49% of the specific ethical concerns raised to RECs in the recent analysis were related to informed consent.

“We focused on issues that researchers faced that rose to a level that motivated them to reach out for outside ethical assistance,” Porter says. “The 49% of consults that involved informed consent issues is striking, and suggests that despite having regulations that dictate when informed consent must be obtained, there isn’t necessarily clear guidance on how that informed consent should be obtained.”

While informed consent is a key ethical issue, emerging new lines of research raise a host of questions that RECs can assist with, she says.

“Growth in the number and size of multisite trials, investment in comparative effectiveness research, and advances in genomics and biologics have introduced novel ethical issues that will remain challenging,” Porter and colleagues note in the paper.

While the IRB system remains the foundation for the ethical review of research, RECs can be a valuable service for investigators, regulators, and research participants, they conclude.

REFERENCE

1. Porter, KM, Danis M, Taylor HA, et al. The Emergence of Clinical Research Ethics Consultation: Insights From a National Collaborative. American Jrl Bioethics 2018(1):39-45.