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Participation of Post-Doctoral Fellows in Human Subjects Research

September 2005 

1. It is the Principal Investigator's responsibility to assure that post-doctoral fellows who participate in human subjects research are trained in the data collection techniques and research procedures that they will perform as part of the research protocol.   These include any technique or procedure involving incidental patient contact.  Training for these techniques and procedures is referred to as competency training and such training should be documented.

2. When submitting a protocol to the Institutional Review Board for review, the Principal Investigator must:

  • document any post-doctoral fellows who are to participate in the protocol and
  • certify the competency training in writing of each post-doctoral fellow participating in the protocol

3. Post-doctoral fellows may participate in human subjects research only under the following conditions

  • they are credentialed by a Johns Hopkins Health System entity as clinical fellows; or
  • they have a University appointment as a research fellow, and

a. they do not administer any medication or drug,
b. they do not represent themselves as a physician or other caregiver,
c. they engage only in minimal risk research activities, as determined by the Institutional Review Board, (See OHRP for expedited examples)
d. they are given the same training to perform the techniques and research procedures as set forth in the job descriptions of personnel who perform the same duties.  For example, a research fellow who is to perform phlebotomy would have to complete the same training as required for Johns Hopkins Medicine personnel performing phlebotomy and would need to be certified to do so, and
e. if they are not a U.S. citizen or permanent resident, they obtain written authorization to engage in incidental patient contact from the Johns Hopkins Office of International Services 

[Note from JHM IRB: If you are uncertain about your fellows' post-doctoral status, call the Office of Post-Doctoral Programs at 5-3191.]

Requests for exceptions to this policy should be addressed to the Associate Dean for Postdoctoral Programs (lwatkins@jhmi.edu) and the Vice Dean for Clinical Investigation (dford@jhmi.edu).


AAHRPP

 

 

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