Creating a National Forum for Professional Engagement

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 what if ethical issues arise before IRB submission, or during the study? At many institutions, ethics consultation services provide advisory guidance in these instances.

Dr. Benjamin Wilfond, director of the Treuman Katz Center for Pediatric Bioethics, leads a network of 48 research consultants from 35 institutions across the United States. 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 program, which was funded by the National Center for Advancing Translational Sciences. When that funding ended, many in the group felt it was important to continue the Working Group initiatives. The collaborative, which meets on a monthly basis, advances these ongoing initiatives:

  • Conduct quarterly case webinars where a research ethics consultation is presented retrospectively and discussed
  • Publish two cases, each with three commentaries, every 6 months in the American Journal of Bioethics based on the quarterly case presentations
  • Participate in collaborative consults where members engage around in-progress consult discussions
  • Maintain a research ethics consult repository as a resource for members

The Collaborative has written several papers about research ethics consultation practice in the journals Academic Medicine and IRB to further advance the field.

"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.


  • Mildred Cho
  • Marion Danis
  • Katie Porter
  • Holly Taylor

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.

To read a case and corresponding commentaries in AJOB, see