Academic journal article
By Taylor, Holly A.; Kass, Nancy E.
IRB: Ethics & Human Research , Vol. 31, No. 2
Although many hospitals have long offered a clinical ethics consultation service to their physicians, patients, and allied health professionals, formal ethics consultation in the research setting is a relatively new development. (1) This article describes the Research Ethics Consulting Service (RECS) that was launched in March 2005 at the Johns Hopkins Bloomberg School of Public Health (JHSPH). Johns Hopkins University was one of 142 institutions that received funding in fiscal year 2002 to develop programs to "strengthen the oversight of human subject research." (2) After obtaining the capacity development grant, the authors--faculty members at the Bergman Institute of Bioethics (BI) with appointments in the school of public health--conducted a needs assessment to determine what types of continuing education in research ethics would be most useful to school faculty. The universal preference was for a consulting service that would give faculty the opportunity, in real-time, to discuss challenging ethical issues they faced at various stages of their research, with emphasis on issues particular to their work. The authors determined early in discussions with faculty and key senior administrators that the goal of such a consulting service would be to assist investigators (whether faculty, staff, or students) in navigating the ethical challenges that might arise in the design, conduct, or analysis of research projects involving human subjects.
At the end of the six-month pilot period, the JHSPH Office for Research Subjects (ORS) decided to provide salary support for the authors to manage the RECS as a regular component in the school of public health. The focus of this article is to show how the RECS is organized, how it responds to and manages requests for consultations, and what types of consultations the service has provided since its inception.
Organization and Consultation Process
It is important to note that the RECS is a component of the JHSPH ORS. Thus, the RECS is accountable to the ORS and to the investigator who requests an ethics consultation, and this relationship is described in the service's written materials. These materials also point out that the RECS is intended to supplement rather than supplant the services and expertise provided by the ORS and the chairs and members of the JHSPH institutional review board (IRB). Investigators are informed that summaries of consultations will be made a part of their JHSPH IRB file if the consultation concerns an active protocol. In addition, the program's materials clarify that the RECS was designed to provide ethics guidance, whereas regulatory questions are more appropriately addressed to the school of public health's IRB office. Thus, the service is not designed to "pre-review" submissions to the JHSPH IRB or to review or rewrite consent documents.
The authors manage the RECS and are compensated for 10% effort by the ORS for staffing the service and providing a few other tasks for it, such as organizing a series of research ethics seminars for the school of public health and helping the JHSPH IRB to develop certain new policies. The consulting service is advertised in a variety of ways: at faculty meetings; in memoranda and periodic broadcast e-mails from the ORS to faculty, research staff, and students; at presentations at JHSPH IRB-sponsored brown bag lunch seminars; and through the distribution of a promotional flyer and post-it pads. More recently, the service has initiated a monthly drop-in office hour as an additional means of providing in-person consultations.
* The Consultation Process. A Web-based interface already in use at JHSPH for "help calls" for computer assistance was adapted to provide a way to submit requests for a research ethics consultation.3 Having a Web-based service was important so that investigators located outside the United States could easily submit a consultation request, and most of the faculty, students, and staff at the JHSPH were already familiar with this interface. …