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IDS.1 Organization Policy on Investigational Drug Services Disclosures for Participant Safety Reasons

September 2010

The JHM Investigational Drug Services (IDS) are established to support clinical research.  IDS pharmacists and technicians assist with compliance in the receipt, storage and dispensing of investigational products used in research protocols approved by either the JHM IRBs or the BSPH IRB.  The IDS pharmacists have access to all information in eIRB on the JHM IRB approved applications which use drugs, including protocol details about the inclusion/exclusion criteria for research participants.   An IDS pharmacist has access to paper and electronic (PHIRST) application information for BSPH IRB approved applications, including protocol details about the inclusion/exclusion criteria for research participants.  As part of the implementation of research protocols, IDS pharmacists may discover information that is believed to affect the treatment (including eligibility) or safety of either one participant, or several participants, enrolled in research studies.  The Organization authorizes the IDS pharmacists to bring to the attention of the Institutional Official (IO) of the SOM and the Institutional Official of the SPH (or their designees) any treatment concerns or safety issues associated with dispensing medication to research participants.  IDS staff are authorized to disclose participant information in these cases to the principal investigators of the research protocol; such disclosure would not be a violation of HIPAA requirements.   If IDS staff and the PIs of the protocols cannot agree on a course of action concerning participant safety, IDS staff should contact the IO of each school of resolve outstanding issues.




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