Providing a Network For Sharing Best Practices In Clinical Research Ethics Consultation

Federal regulations are in place to protect research participants who take part in clinical research studies. At academic medical institutions, an institutional review board (IRB) reviews proposed research studies, which can move forward only with IRB approval. But in the last decade, some institutions have developed research ethics consultation services, modeled after the clinical ethics consultation services in hospitals.

These research ethics consult services can complement the IRB and can be especially useful as a flexible resource:

  • For investigators before and after the regulatory review.
  • For investigators, IRBs and other research administrators facing challenging and novel ethical issues.
  • To assist investigators and IRBs with the increasing challenges of informed consent and risk–benefit analysis.
  • To provide collaborative assistance to overcome study hurdles, mediate conflicts within a team, or even directly engage with research participants.

Pediatric pulmonologist and bioethics center faculty Benjamin Wilfond, along with bioethics center faculty Seema Shah and bioethics center staff Katie Porter provide research ethics consultation through the Institute of Translational Health Sciences (ITHS) bioethics core.

Wilfond also leads a network of 60 research ethics consultants from 45 institutions across the United States, Canada and Australia. Established in 2014, the Clinical Research Ethics Consultation Collaborative builds on the work of the Clinical Research Ethics Consultation Working Group of the Clinical and Translational Science Awards (CTSA) program, which is funded by the National Center for Advancing Translational Sciences. When the CSTA stopped supporting working groups in 2014, the ITHS assumed the responsibility of maintaining infrastructure for the Collaborative.

The Collaborative meets on a monthly basis with a webinar. These webinars include discussions of consultation practice issues, journal articles or research ethics consultation cases that had been conducted by a Collaborative member. The Collaborative also supports "collaborative consults" where members engage around in-progress consult discussions by phone.

The Collaborative publishes two cases, each with three commentaries, every six months in the American Journal of Bioethics. It also serves as the research ethics consultation affinity group for the Association of Bioethics and Humanities

“It is very gratifying to work with research teams to address ethical questions that allow researchers to achieve their research goals ethically. The questions that researchers and IRBs bring to us are often complicated and nuanced and for which the answers emerge only after deliberative discussions. Research ethics consultation is a more nascent field than clinical ethics consultation and the Collaborative activities allow each of us to be more effective by learning from each other..”

Dr. Benjamin Wilfond

Ultimate Goal

To share practices and experiences related to clinical research ethics consultation; enhance understanding of the complex ethical dilemmas that emerge with advancing translational science; and improve the quality of clinical research ethics consult advice.

Primary Collaborators

  • Mildred Cho, Stanford University School of Medicine
  • Marion Danis, National Institutes of Health Clinical Center
  • Holly Taylor, Johns Hopkins University Bloomberg School of Public Health

Funding

  • National Center for Translational Sciences

Relevant Publications

To read a case and corresponding commentaries in AJOB, see:

To learn more, visit the collaborative’s website and read Dolgin E. Human-subjects research: The ethics squad. Nature. 2014 Oct 23;514(7523):418-420.