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109.1a Organization Policy on Responsibility for the Human Subjects Protection Program (HSPP)

November 2010

Authority to develop, implement, and monitor all human subjects protection programs has been delegated by the President of The Johns Hopkins University (JHU) to the Divisions of the University.  In turn, the Deans of the following Divisions, JHUSOM and JHUSON, have delegated this authority to an IO. The Dean of JHUSOM is also the CEO of Johns Hopkins Medicine (JHM), and in this capacity has delegated authority to the IO. The President of the KKI has delegated this authority to the IO.  For all components of the HSPP, the one designated Institutional Official (IO) is the Vice Dean for Clinical Investigation.  The IO has the authority and independence to ensure implementation and maintenance of the HSPP and JHM IRB structure and function.

The IO responsibilities include, but are not limited to, the following areas:

  • Appointment and evaluation of IRB members
  • Negotiation of budget and space allocations for the OHSR
  • Assessment of workload of the IRBs
  • Approval of policies
  • Training of faculty and staff in the ethical conduct of research
  • Liaison with the OHRP and FDA regarding human subjects research issues, including required reporting for non-compliance and IRB termination of research
  • Review of internal monitoring reports from OHSR monitoring specialists
  • Signatory official authorized to sign sponsored research and technology transfer documents
  • Liaison with IOs for JHU divisions that are not overseen by the JHM HRPP