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Human Subject Research Issues Regarding Study Team Members and Changes in Research

March 23, 2010

Dear Colleagues

I am writing to clarify issues raised recently in the review of human subjects research proposals.

The first issue concerns the role of study team members in the conduct of research.  All study team members who conduct human subjects research must be listed on the IRB application and approved by the IRB before an individual may obtain consent or conduct study procedures.  Please remember that submission of a change in research to add or delete study team members does not mean the individuals may start their research activities.  Only when the change in research is approved by the IRB may they start to participate in the research.  Study team members who have a research fellow appointment in the School of Medicine are restricted in the types of activities they may conduct.  Research fellows may not administer any medication or drug, may not represent themselves as a physician or other caregiver, and may engage only in minimal risk research activities.  Please see additional details by consulting the IRB website at http://irb.jhmi.edu/Guidelines/postdocpolicy.html  Study team members who are nurses or licensed medical care providers may conduct research procedures that involve medical interventions or administration of drugs in research protocols.  Study coordinators or other staff who are not nurses or licensed medical care providers are not permitted to administer drugs as part of research procedures.  Finally, data analysts who have access to Personal Health Information (PHI) also need to be added to the study team and complete appropriate human subjects research training.  If the PHI is removed from the data set, the data analysts or biostatistician does not need to be listed as a study team member. 

 The second issue concerns changes in IRB approved research protocols.  The DHHS and FDA regulations on human subjects research require that all changes in IRB approved research must be reviewed and approved by the IRB before changes may be implemented.  JHM policies state clearly the requirement to submit all changes in research for IRB review and approval prior to initiating a change.  The IRB approval notices contain a reminder about this requirement.  The only exception to this requirement is that an emergency change may be made without prior IRB review and approval if it is done to eliminate an apparent immediate hazard to a specific participant.  Emergency changes to eliminate a hazard to a subject must be reported promptly to the IRB for review. 

Please contact the Office of Human Subjects Research if you have any questions about the role of study team members or limitations on the activities study team members may perform. 

Sincerely,

Daniel E. Ford, M.D., M.P.H.
Vice Dean for Clinical Investigation