September 2020

Johns Hopkins School of Medicine/Johns Hopkins Health System may agree to rely on an External IRB of Record for multi-site research in any of the following circumstances:

• JHU/JHHS is a participating site in a multi-site study subject to single IRB review requirements
• JHU/JHHS is a participating site in a multisite study where the study sponsor has required reliance on an external IRB of Record in order for JHU to be eligible to be participate as site
• JHU/JHHS is a participating site in a multisite study where reliance is not required but is determined to be acceptable by the HRPP.

When JHU/JHHS relies on a external IRB, the following requirements apply for researchers and the Human Research Protection Program when working with the reviewing IRB:

Requirements for Researchers:

1. Researchers must accept the decisions and requirements of the reviewing IRB.
2. Researchers must not initiate research or changes to research except where necessary to eliminate apparent immediate hazards to subjects, without first receiving prior approval from the reviewing IRB.
3. Research personnel must provide any information about conduct of the research at the relying institution that the reviewing IRB requires for continuing review.
4. Research personnel must maintain all research records, including informed consent documents and HIPAA authorizations, in accordance with applicable federal, state, and local regulations.

Researchers must promptly notify the reviewing IRB of any unanticipated problems that may involve risks to human subjects or others, or any subject injuries related to research participation, or any significant subject complaints.

Additional Responsibilities for Researchers may be found here:

Requirements for the Human Research Protection Program:

1. Communicate to the reviewing IRB the requirements of any applicable state or local laws, regulations, institutional policies, standards, or other local factors, including local ancillary reviews, relevant to the research (“Local Considerations”) that would affect the conduct or approval of the research at the relying institution.
2. Provide the reviewing IRB with the site-specific information requested/identified in the customizable sections of the reviewing IRB’s consent form, for review and approval by the reviewing IRB, when written informed consent is required.
3. Maintain policies regarding the disclosure and management of research personnel conflicts of interest related to research and to share those policies with the reviewing IRB, as requested.
4. Ensure that an institutional mechanism exists by which complaints about the research can be made by local research participants or others to a local contact.
5. Work with the reviewing IRB to establish whether a separate HIPAA authorization form will be used for research or whether HIPAA authorization language will be incorporated into the consent form.
6. Promptly notify the reviewing IRB of any specific local requirements and restrictions on use and disclosure of PHI that could prevent the reviewing IRB from approving a request for waiver of HIPAA authorization with respect to the relying institution.
7. Promptly notify the reviewing IRB of any potential noncompliance with applicable human subjects protection regulations or with the requirements or determinations of the reviewing IRB in connection with the research at the relying institution, and of any suspension or restriction by the relying institution or any third parties of any of its research personnel’s authority to conduct the research.
8. Cooperate, and require research personnel to cooperate, with any audit or investigation by the Reviewing IRB of any matter under this agreement.