Designing and performing clinical research is critical to advancing modern medicine. An integral component of research design and implementation is human subjects protections. One aspect of human subjects protection is that all protocols must undergo review by an institutional review board (IRB) that seeks to ensure scientific and ethical soundness. Sometimes, researchers seek guidance before a protocol is ready for IRB review or because the IRB has questions due to the ethical complexities of the case. Research Ethics consultations are a collaboration between clinical investigators and clinical research ethicists. Together, they review the design and implementation of a research project that poses novel issues in human subject protections.
Although both research ethics consultation and the IRB aim to promote human subjects protection, these two programs differ in process, structure, and function. The structure and function of the IRB is designated by the Code of Federal Regulations, with specific requirements regarding membership, what it must review, and how it conducts reviews. Research ethics consultation is less formal and more collaborative and seek to complement and supplement the IRB process. The research ethics consultation service works directly with investigators to design and implement a research protocol. For example, when transplant surgeons were considering the first living liver donor transplant from an adult to a child, the surgeons and the research ethics consultation service worked together for two years to determine who would be the ideal participants in this first-of-its-kind procedure, and what the informed consent would entail. (In fact, the article in which the term “research ethics consultation” was first used in the literature can be found in the following paper: Singer PA. Siegler M. Whitington PF. Lantos JD. Emond JC. Thistlethwaite JR. Broelsch CE. Ethics of liver transplantation with living donors. New England Journal of Medicine. 1989; 21(9):620-2.)
Any investigator can call for a Research Ethics Consultation (REC) at any stage of the research protocol design. Also, the Institutional Review Board (IRB) can request that an investigator obtain an REC for particularly complex ethical issues.