November 5, 2002

Dear Colleagues:

Several faculty have contacted the JHM IRBs regarding the institutional
policy governing participation of research fellows in human subjects
research. To make sure that the current policy is applied consistently, I
recently provided the following guidance to the JHM IRBs about this policy.
I am forwarding this message to you so that you are aware of how we are
applying the current policy.

"The following points should guide IRB deliberations:

Research fellows and clinical research fellows may participate in human
subjects research except for physical contact with research subjects. For
example, they may administer questionnaires, conduct interviews, obtain
consent, and analyze data. They may not have physical contact with
subjects. Thus, they cannot, for example, measure blood pressure, perform
phlebotomy, insert devices, administer medications--experimental,
prescription, or over the counter.

Only clinical fellows may have physical contact with research participants."

Dr. Levi Watkins, the Associate Dean for Post-Doctoral Programs, agrees with the above interpretation. As you may know, Dr. Watkins has convened a group to reconsider the policy concerning participation of research fellows in human subjects research. Until the current policy is revised, the above
statement will be used by the IRBs.

Thank you for your help and support.

Michael J. Klag, MD, MPH

Vice Dean for Clinical Investigation