September 2020

The Organization has granted in writing to the Institutional Official (IO) the authority to develop, implement and monitor the Human Research Protection Program (HRPP). The HRPP at the Organization will be conducted in accord with federal, state and local law and regulations. The OHSR Compliance staff and Associate Dean for Human Research Protections will meet on a regular basis with the General Counsels of the JHU and the JHHS. This meeting will focus on review of policies and procedures to assure compliance with federal, state, and local laws and regulations. New guidance and alerts from the OHRP and the FDA, and other information relevant to the HRPP, will also be discussed. The meeting will provide an opportunity to address any legal issues associated with the conduct of human subject research at the Organization, and develop new or amended guidance, policies and/or procedures as needed.

The OHSR will keep the IO informed of IRB findings and actions. The IO can access all IRB approved applications and their status through the eIRB system and receives monthly notifications via email of the availability of IRB findings and actions in the eIRB system. The IO will meet with the Director of Operations, Director of Compliance and the Associate Dean for Human Research Protections on a regular basis to discuss policies, procedures, and guidance. The IO will meet as needed with the General Counsels of the Organization. The IO will meet with the chairs and co-chairs of the JHM IRBs to obtain input on proposed new policy or modifications in existing policies and procedures. Such input shall be advisory in nature. The IO has the authority to issue policy, guidance, and procedures that govern the HRPP and the associated IRB review processes. The IO may delegate authority to approve minor policy updates, OHSR guidance and operating procedures to the Associate Dean for Human Research Protections or other senior administrative staff as determined appropriate.

OHSR staff will track all changes to HRPP policies, procedures, and guidance using a date and version system.

New and revised policies and procedures are made available to all individuals at JHM through a variety of mechanisms. The IO issues “Dear Colleagues” letters through broadcast emails to describe new or revised policies and procedures. All policies and guidance are posted on the IRB website which is publically available. The website has a “What’s New” tab used to announce updates in policies and procedures. JHM issues an on-line “Research Web Notes” monthly. “Research Web Notes” provides updates on policies and procedures for all of the offices that are part of the HRPP.