New Requirement to Conduct Human Subjects Research

May 1, 2003

Dear Colleagues,
The Johns Hopkins University School of Medicine is deeply committed to the protection of human research subjects. A consistent message that we have received from faculty over the last year is that the institution needs to provide more training in this area. To this end, I am writing to inform you of a new requirement for all faculty and postdoctoral fellows who conduct human subjects research.

• Effective July 1, 2003, all faculty and postdoctoral fellows who conduct human subjects research must complete a new Course on Research Ethics (C.O.R.E.). All faculty members of the School of Medicine are expected to attend the morning session dealing with human subject protection; fellows must attend the entire day.
  

• The requirement for attendance at the course must be fulfilled by the end of training for fellows and by June 30, 2006 for faculty.

• After June 30, 2006, certification of completion of the course or its equivalent will be required in order to submit protocols to the Johns Hopkins Medicine Institutional Review Boards or WIRB.

The course was developed by Dr. Mark Hughes of the Division of General Internal Medicine and the Berman Bioethics Institute. It consists of a half day (for faculty) or whole day (for fellows) designed to address key concepts in human subject protection and the responsible conduct of research. It combines lectures and small group sessions, in which mock protocols and vignettes serve as the basis for discussion. The morning session addresses topics encountered in protecting the rights and interests of human subjects. Specific topics covered in the small group sessions will depend on the interests of the attendees. The afternoon session, required for fellows, covers issues of scientific integrity, conflicts of interest, data acquisition and ownership, publication, and the use of animals in research.

The full day course meets the requirements for NIH training grants and supplants the Responsible Conduct of Research Seminar Series, which will no longer be offered following the Fall 2003 series. Courses required as part of the Graduate Training Program in Clinical Investigation also meet the requirement for NIH training grants.

C.O.R.E. will be offered four times per year and each offering will accommodate about 120 attendees. Registration is coordinated through the Office of Continuing Medical Education (CME) and will be accomplished on a first-come, first-served basis. We ask that faculty apply for tuition remission and receive CME credits. The next offering is June 12, 2003. Further information about the course can be obtained at the CME website: http://www.hopkinscme.org/cme/events/core.html.

Thank you for your help and support of this important endeavor.

Sincerely,
Michael J. Klag, M.D., M.P.H.
Vice Dean for Clinical Investigation

New IRB Website

The IRB website has been completely revised and redesigned to be less cluttered and easier to navigate. The new website, in “phase 1” format can be accessed here: http://irb.jhmi.edu. “Phase 2” will add functionality for PIs and their teams. If you have any comments or suggestions of items to add to the site, please email Aaron Sorensen (aaron.sorensen@jhmi.edu).

New Policy for Postdoctoral Fellows Participating in Human Subjects Research

The policy regarding postdoctoral fellows participating in human subjects research has been updated. The new policy appears on the new IRB website at: http://irb.jhmi.edu/Guidelines/postdocpolicy.html. This new policy supercedes all previous versions of the policy.

Return to top of Human Subjects Research