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112.1 Organization Policy on Institutional Review of IRB Approved Research
It is the policy of the Organization that review of IRB approved research may be conducted by senior Institutional officials. Senior officials of the Institutions include:
- The Institutional Official (Vice Dean for Clinical Investigation),
- Deans of the JHU Schools at which the approved research is to be conducted,
- President of JHHS,
- President JHCP when JHCP facilities are part of the approved research,
- President of KKI when KKI facilities or investigators are part of the approved research,
- Presidents of the JHHS hospitals at which research is to be conducted, or
- General Counsels of JHU or JHHS.
Regular meetings (generally weekly) are held by the Vice Dean for Clinical Investigation, JHM IRB Counsel, Assistant Dean for Human Research Protection and the Director of Operations, at which studies of Organization interest (e.g., 45 CFR 46.406; emergency research with a waiver of consent) are presented and discussed. In addition, the Assistant Dean for Human Research Protection, IRB Regulatory Affairs Specialists, JHM IRB Counsel, and JHU Counsels, hold regular meetings (generally monthly) to discuss studies of Organization interest. If further Organization review is determined to be required, a summary of the study and IRB determinations will be forwarded to the appropriate Department, Dean and/or President, with follow-up by the Vice Dean for Clinical Investigation.
In addition, the Vice Dean for Clinical Investigation and IRB and JHU Counsels have electronic access to all studies and IRB meeting minutes.
The Senior Institutional officials have been granted the authority to disapprove IRB approved research projects. Such actions will be communicated to the PI, with an explanation of the rationale for disapproval. Communications of institutional disapproval may be provided to the PI in writing, or by e-mail communication.
An action taken by an institutional official to disapprove an IRB approved project is final and no further appeal is possible. The PI of a disapproved research project may submit a new application to a JHM IRB that includes modifications to address the reason for Institutional disapproval. Institutional officials may not approve research that has been disapproved by the IRB.