Organization Policy on Provision of Research Samples for Clinical Testing (Policy No. 102.7)
January 2007

The proposed use of existing blood and tissue samples from research participants for clinical testing is a matter which does not constitute human subjects research.  The Vice Dean for Clinical Investigation is the institutional official who may make a decision on whether or not a PI of a human subjects project approved by one of the JHM IRBs may release a sample for clinical testing purposes.  Requests of this type which are submitted to the IRBs are to be referred to the Vice Dean for a decision on a case-by-case basis. The samples belong to JHU, and a decision about release will be based on whether the release would compromise the research project. An individual who requests a sample for this purpose (including an individual who is the legal representative for a deceased individual) must sign a release form as developed by the General Counsels.  If release of the sample involves significant cost for preparation or transport, the individual who initiated the request will be asked to cover the costs incurred.