Table 1.

Roles and responsibilities of the reviewing IRB and relying institutions under the SMART IRB agreement

	Reviewing IRB(s)/Reviewing IRB Institution(s) 1	Relying Institution(s) 2
IRB Registration	Maintain current IRB registration with OHRP.	Not Applicable
IRB Membership	Maintain IRB membership that satisfies requirements of federal policy and other applicable regulations/policies.	Not Applicable
Policies and Procedures	Make policies and procedures available to the Relying Institution(s), when applicable and upon request.	Not Applicable
IRB Review and Oversight	Perform initial and continuing reviews, and reviews of amendments, unanticipated problems that may involve risks to subjects or others, and potential noncompliance, in accordance with the requirements of Relying Institution’s(s’) FWA(s) and applicable regulations/policies.	Accept Reviewing IRB’s decisions and requirements and require its Research Personnel to provide information that the Reviewing IRB requires for continuing review.
Local Considerations	Consider local requirements communicated by Relying Institution(s).	Communicate to the Reviewing IRB requirements of its FWA and any applicable state or local laws, regulations, institutional policies, standards, or other local factors, including local ancillary reviews that affect the conduct or approval of the research at the Relying Institution.
Recordkeeping		Require its Research Personnel to maintain all research records, including informed consent documents and HIPAA authorizations, in accordance with applicable federal, state, and local regulations.
HIPAA (Collectively, the Health Insurance Portability and Accountability Act of 1996, the Health Information Technology for Economic and Clinical Health Act of 2009, and their implementing regulations)	Serve as Privacy Board, when a study falls under the HIPAA Privacy Rule; may make alternate arrangements (some/all Relying Institutions perform Privacy Board determinations). Ensure PHI will not be used/disclosed unless written authorization obtained from participants, waiver of alteration of authorization granted, or use of limited data set pursuant to a data use agreement. When authorization required, provide authorization language.	With Reviewing IRB, establish whether separate or combined consent/HIPAA authorization will be used. Provide institution-specific language to the Reviewing IRB Notify Reviewing IRB of specific local requirements and restrictions on use and disclosure of PHI that could prevent Reviewing IRB from approving a request for waiver of authorization for the institution.
Consent Forms	Provide Relying Institutions/Site Investigators approved informed consent templates (when required). Permit customization of limited site-specific sections. Provide final, approved consent form(s) to Relying Institutions/Site Investigators (directly or via designee, e.g., Lead Study Team).	Provide Reviewing IRB with site-specific information requested/identified in the customizable sections of the Reviewing IRB’s consent form.
COI	Consider Relying Institution’s determinations and management plans. Incorporate management plan into deliberations, as applicable. May impose additional prohibitions or requirements more stringent or restrictive than proposed by a Relying Institution. Will not modify plan/mandated disclosure to subjects without discussion with and acceptance by Relying Institution.	Maintain and share COI policies. Perform COI analysis (unless alternate arrangement agreed upon). Communicate COI determinations to Reviewing IRB. Abide by Reviewing IRB COI determinations.
IRB Decisions, Changes, Lapses in Approval	Promptly notify Overall PI, Site Investigator(s), and Relying Institution(s) of determinations; review decisions; changes; lapses in approval and applicable corrective action plans.	May not initiate any Research or change to the Research, except where necessary to eliminate apparent immediate hazards to subjects, without Reviewing IRB’s prior approval.
Unanticipated Problems, Injuries, Complaints	Promptly notify overall PI, Site Investigators, and Relying Institution(s) about findings of and actions related to: Unanticipated problems involving risks to subjects or others. Subject injuries related to research participation. Significant subject complaints.	Require Site Investigator(s) to promptly notify Reviewing IRB of unanticipated problems that may involve risks to subjects or others, or any subject injuries related to research participation, or any significant subject complaints at the Relying Institution.
Injury Coverage	Not Applicable	Ensure provisions of any applicable grant or contract that address financial coverage for research-related injuries in connection with research funded in whole or in part by a non-federal entity are consistent with the approved Research protocol and consent form or that approved protocol and consent form, if more protective of human subjects, will control.
Complaints	Not Applicable	Ensure mechanism exists by which local research participants or others may communicate complaints about the research to a local contact.
Noncompliance, Suspension/Termination of Approval, Restriction/Suspension of Authority	Promptly notify overall PI, Site Investigators, and Relying Institution(s) about findings of and actions related to: Apparent serious and/or continuing noncompliance Serious and/or continuing noncompliance, including any steps it deems necessary for remediation at the Relying Institution Suspension or termination of IRB approval.	Promptly notify Reviewing IRB of potential noncompliance with applicable regulations or with the IRB’s requirements/determinations, and of any suspension/restriction of its research personnel’s authority to conduct the research.
Audits, Investigations; Corrective Actions	May choose to: Conduct audits of the research; Request Relying Institution conduct audit/investigation and report its findings; OR Work with Relying Institution to conduct an audit/investigation. If conducting audit or investigation, promptly notify and report findings of fact to Relying Institution and inform of any corrective actions.	Cooperate with and require its Research Personnel to cooperate with any audit or investigation by the Reviewing IRB/Institution. If asked to do so, conduct own audit/investigation or work cooperatively with the Reviewing IRB/Institution to conduct audit/investigation and report back findings of fact to Reviewing IRB/Institution within a reasonable time frame. Comply with and require its Research Personnel to comply with all corrective actions required by the Reviewing IRB/Institution; may adopt more stringent additional corrective actions.
Reporting	Notify Relying Institution if report is required to a regulatory agency, sponsor, funding agency, and/or other oversight authority. Typically, draft report and provide involved Relying Institution(s) opportunity to review before sending to external recipients. Not obligated to adopt comments of a Relying Institution.	Promptly provide any comments on draft report. If requested, promptly prepare draft report and provide Reviewing IRB/Institution with opportunity to review and comment. If making own additional report, provide copy to Reviewing IRB/Institution.
Communications with Regulatory Agencies	Promptly notify Relying Institution(s) of any communications received from the FDA, OHRP, and/or other regulatory agencies regarding: Unanticipated problems Suspension or termination of IRB approval Serious and/or continuing noncompliance Other regulatory compliance concerns the Research.	Promptly notify Reviewing IRB/Institution of communications received by or between Relying Institution and FDA, OHRP, and/or other regulatory agencies regarding unanticipated problems, noncompliance, or other compliance concerns regarding the Research. Require Overall PI/Site Investigator(s) to do the same.
Congruence of Federal Grant Applications/ Contract Proposals 3	Review congruence of any federal grant application or contract proposal with the research submitted for review, when required by federal regulations or oversight agencies (unless other arrangements are made).	Not Applicable

IRB, institutional review board; SMART, Streamlined, Multisite, Accelerated Resources for Trials; OHRP, Office of Human Research Protections; FWA, Federalwide Assurance; PHI, protected health information; COI, conflict of interest; PI, Principal Investigator; FDA, Food and Drug Administration;; HIPAA, collectively, the Health Insurance Portability and Accountability Act of 1996, the Health Information Technology for Economic and Clinical Health Act of 2009, and their implementing regulations

¹ A Reviewing IRB is the “IRB of record” (including an IRB Organization) to which authority for IRB review and oversight has been ceded by another Participating Institution for an instance of Research under the Agreement. A Reviewing IRB Institution is the institution whose IRB has become the Reviewing IRB for another Participating Institution for an instance of Research under the Agreement.

² A Relying Institution is a Participating Institution that cedes IRB review to a Reviewing IRB for an instance of Research under the Agreement.

³ IRB review for congruence is no longer required by the Common Rule regulations (2019), and the SMART IRB Agreement allows for this flexibility.