JHM IRB Responsibilities when Serving as the Single IRB

September 2020

The JHM IRB may serve as the sIRB for multi-site research in any of the following circumstances:

  • Studies where JHU is engaged as a site including researchers from JH-SPH or the Homewood schools as designated in the JHU IRB Reciprocity Agreement
  • Studies assigned to the JHM IRB for review through the Trial Innovation Network
  • Studies that are part of a collaborative network for which the JHM IRB has been designated as the sIRB.

JHM IRB does not serve as the sIRB for international sites.

If an individual is engaged in human subjects research and is not affiliated with an organization that can provide IRB oversight, JHM IRB can provide oversight by executing an Independent Investigator Agreement [IIA]. For more information, click here.

As a single IRB, JHM IRB will:

  1. Perform the initial and continuing reviews and reviews of changes in research, unanticipated problems that may involve risks to subjects or others, potential noncompliance and other documents, requests, or information related to the approval and continuing oversight of the study;
  2. Perform the reviews of additions of relying institutions [see: Single IRB Review – Addition of Participating Site_CIR_Internal Process; Single IRB Review – Addition of Participating Site_pSite_Internal Process];
  3. Obtain required local context information from relying institutions [see: Local Context Questionnaire + Appendix_Template]
  4. Provide relying institutions with access to JHM IRB guidelines and policies [See: SMART IRB Letter of Acknowledgment [cede letter];
  5. Provide education to researchers and research staff;
  6. Provide access to relevant IRB records to relying institutions upon reasonable request [see: OHSR SOP: Responding to Requests for IRB Determinations/Documentation when JHM IRB is serving as the sIRB]
  7. Make HIPAA determinations as required by and in compliance with the HIPAA Privacy Rule for use and disclosure of PHI for the Research, including waivers of, or alternations of authorizations, determine the form of the authorization in collaboration with the relying institution if an authorization is required [See: SMART IRB Letter of Acknowledgment [cede letter];
  8. Allow relying institutions to provide limited site-specific consent form language [using the Site-Specific Consent Information Template] at the time of site onboarding and provide a final site-specific consent form to relying institution upon site approval;
  9. Obtain information [e.g., management plans] related to individual and/or institutional conflicts of interest from the relying organization via the Local Context Questionnaire + Appendix_Template, allowing the JHM IRB to review and accept the management plan to the extent possible;
  10. Notify the relying institution of JHM IRB review decisions and determinations related to the study via the designated lead/coordinating center team [see: OHSR SOP: Communication with Participating Sites when serving as the sIRB];
  11. Notify the relying institution of JHM IRB findings of serious and/or continuing noncompliance with applicable human subjects protection regulations ad results of audits [see: SOP - Single IRB - Problem Event Reports Audits and Reporting Letters];
  12. Review the congruence of any federal grant application or proposal for human subject research with the Research submitted for Ceded Review, when required by federal regulations;