By opting for IRB reliance with SMART IRB, institutions minimize duplicative IRB reviews while maintaining appropriate oversight.
Participating in SMART IRB.
Institutions can participate in SMART IRB if they meet the eligibility criteria described within the SMART IRB Agreement, as follows:
- FWA or IRB Organization: Unless it is an IRB organization, your institution must maintain a Federalwide Assurance (FWA) approved by the Office for Human Research Protections (OHRP).
- Quality Assessment: If your institution has an IRB or is an IRB organization, it must have undergone or initiated an assessment of the quality of its human research protection program (HRPP) within five years prior to joining SMART IRB (through accreditation from an external organization, participation in OHRP's Quality Assessment Program, or equivalent approach).
- Point of Contact: Your institution must establish a Point of Contact (POC) who will be responsible for, and communicate on behalf of, your institution regarding the initial and ongoing implementation of the SMART IRB Agreement.
Eligible and interested institutions may initiate the process of joining SMART IRB through the SMART IRB Joinder Platform. For more information about eligibility requirements, view the SMART IRB Agreement [PDF] or contact a SMART IRB ambassador.
Enabling Single IRB Review: How it works.
As part of SMART IRB, institutions may choose to rely on another IRB to review, approve, and oversee a research study.
The Reviewing IRB takes on IRB oversight responsibilities associated with that study throughout its duration. Relying Institutions provide key local context information about state law, study team member training and qualifications, and any applicable conflict of interests. Investigators and institutions retain their respective responsibilities for the protection of human subjects, compliance with applicable laws, regulations, ethical standards, and the terms of the institution's FWA.
Selecting the Reviewing IRB.
A Reviewing IRB serves as the IRB of record for a particular study for the study's duration, acting on behalf of those institutions (Relying Institutions) that cede authority for IRB review and oversight of the study.
The SMART IRB SOPs [PDF] describe the default prioritization scheme for identifying a proposed Reviewing IRB as follows:
- Pre-determined by study sponsor, grant, or prior arrangement (e.g. network central IRB).
- The Overall PI's Home Institution (HI) IRB.
- The IRB of another Participating Institution, when the Overall PI HI does not have an IRB, or when the Reviewing IRB(s) is selected based on type of procedures, subject population, or other criteria; more than one Reviewing IRB may be appropriate if these will significantly vary among participating sites.
Institutions will determine on a case-by-case basis whether or not they are willing to serve as the proposed Reviewing IRB for a particular study.
If an institution declines to serve as Reviewing IRB, the Overall PI and appropriate POCs will work to identify an alternative Reviewing IRB, as described in the SMART IRB SOPs [PDF].
Identifying Relying Institutions.
Once a proposed Reviewing IRB is established, the POCs at the other sites involved in the study will:
- Review materials provided by the Overall PI.
- Discuss any outstanding concerns or local context issues with the proposed Reviewing IRB.
- Decide whether they will cede IRB review to the proposed Reviewing IRB.
If an institution agrees to rely upon the proposed Reviewing IRB, the institution's POC communicates this decision to the POC for the Reviewing IRB, the Overall PI, and the Relying Institution's Site Investigator, documenting:
- The decision to cede review.
- Any outstanding concerns or requirements that must be addressed before the Reviewing IRB approves the study for that institution (as discussed with the proposed Reviewing IRB).
- Any institutional requirements that the Reviewing IRB must take into consideration (as discussed with the proposed Reviewing IRB).
If an institution chooses not to rely on the proposed Reviewing IRB, the POC for that institution communicates this decision to the proposed Reviewing IRB POC, Overall PI, and their institution's Site Investigator.
SMART IRB has outlined specific responsibilities for communication and information sharing among the:
- Overall PI and Lead Study Team
- Site Investigators and Study Teams
- Reviewing IRB
- Relying Institutions
More information about these roles and responsibilities may be found in the SMART IRB Standard Operating Procedures (SOPs) [PDF].
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