Points to Consider: The Research Ethics Consultation Service and the IRB‪.‬

Research ethics consultation was first mentioned in the published literature nearly 20 years ago when Singer and colleagues described a collaborative process between clinical investigators and ethicists to analyze the ethics of liver transplants using living donors. (1) Today, such consultation is increasingly recognized as a potentially valuable mechanism for addressing the depth and breadth of ethical issues that arise in research related to human health and well-being, including biomedical, clinical, translational, behavioral, and social science research. Representatives from academic institutions, including Johns Hopkins Bloomberg School of Public Health, (2) Stanford University, (3) University of Texas Medical Branch, (4) and Weill Cornell Medical College, (5) as well as government agencies such as the National Institute of Environmental Health Sciences, (6) have recently written about their research ethics consultation services. Further, the National Institutes of Health's Clinical and Translational Science Awards (CTSA) program, an initiative that aims to "transform the local, regional, and national environment for clinical and translational science," encourages applicants to develop innovative research programs "that bridge clinical research ethics with other CTSA activities." (7) This language has generally been interpreted as encouraging something like research ethics consultation, and many of the institutions receiving a CTSA have developed or will be developing such a service. (8) In addition to generating significant interest, the concept and emerging practice of research ethics consultation has generated lively debate, (9) and fundamental questions remain: What is research ethics consultation? And what value does this activity provide beyond what existing institutional entities already offer?