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109.3 Organization Policy on Complaints from Research Participants, Investigators and Research Staff, the Community, etc.

May 2005

It is the policy of the Organization that the JHM IRBs, as part of the duty to review research applications, will receive and respond to complaints or other communication from research participants, investigators or research staff, or members of the community.  These communications may present questions, complaints, or other issues of concern to the caller that the IRB must help to resolve.

The Assistant Dean for Human Research Compliance, in consultation with the General Counsels, will make the determination whether the issue raised poses risk to human subjects, what other Organization officials should be informed, and what steps should be taken to address the caller’s concerns.  The Compliance Office will work with the Vice Dean for Clinical Investigation to contact the Principal Investigator for the study and to collect all needed information.