Single IRB review

Background

The National Institute of Health (NIH) mandated single IRB (sIRB) review for any multi-site study that receives NIH funds effective January 25, 2018 (commonly referred to as ceded review, reliance agreements, or deferral of IRB oversight). In addition, the Office for Human Research Protections (OHRP) mandated single IRB review effective January 19, 2020, for all other federal agencies that have adopted the human subject rules (e.g., Common Rule). Single IRB review is required for any project funded or supported by federal agencies that have adopted the Common Rule. Note: The Department of Justice and the Food and Drug Administration have not adopted the single IRB mandate.

Single IRB means that the NAU IRB either assumes (reviewing IRB) or gives up (relying IRB) its oversight of the research activity to another equally qualified IRB. sIRB is designed to reduce duplication and increases efficiency by designating a sIRB review when more than one site is involved in a research project.

For projects that are not funded or supported by federal funds, investigators may choose to have one IRB become the IRB of record over some or all participating sites but this is not required.

The Northern Arizona University has standing agreements in place with the following entities regarding sIRB review:

• Arizona State University (ASU) or University of Arizona (UA) when ASU or UA is the primary grantee agency and a co-investigator of the project is at the Northern Arizona University

The NAU may decide to allow for single IRB review outside of the standing agreements noted above and the NIH policy when:

The NAU investigator is a collaborator on Human Research primarily conducted at another organization where:

• The PI of the organization will have direct oversight of the NAU investigator;
• The organization agrees to take responsibility for the NAU investigator; and
• The other organization is AAHRPP accredited.
• For organizations that are not AAHRPP accredited, decisions are made on a per-protocol basis to ensure that the organization can maintain equivalent standards to AAHRPP accreditation.

The NAU may not consider sIRB review when:

• The project involves prisoners, Native Americans, or vulnerable populations that require special considerations. To ensure appropriate protections are in place, projects involving Native Americans requesting single IRB review must abide by the Arizona Board of Regents policy on Native American consultation (1-118).
• The proposed IRB of record does not have sufficient knowledge of local context or a robust human subject program (as required by federal guidelines and AAHRPP accreditation) to assume IRB oversight for sites that fall under NAU HRPP purview;
• A NAU study team member has a conflict of interest that requires a management plan, and the management plan prohibits or limits activities that the individual can engage in related to human subjects research; or
• A NAU study team member has a history of non-compliance with IRB policies or processes.

Requirements before the NAU will agree to sIRB review by another site

Before a project can participate in a sIRB agreement, the University must verify that all institutional approvals are in place prior to issuing the approval to allow another IRB to review the project. A request for sIRB submitted to NAU must include the following approvals, but not limited to:

• Scientific review
• Site authorizations
• Conflict of interest
•  CITI training

In addition to required local approval, the NAU HRPP will verify the protocol, consent, and other study documents comply with local and state law. This is required for all sIRB review studies, even those where the NAU has existing standing agreements.

Responsibilities of the NAU Investigator when the NAU is the reviewing IRB

The NAU Principal Investigator and the HRPP share joint responsibility for any research project where the NAU IRB is the IRB of record for other research sites. The NAU Principal Investigator must submit an IRB application to the NAU IRB for review and approval. In addition, for each site where the NAU IRB will assume oversight, a multi-site appendix and all attachments must be submitted per site (see IRBNet forms and templates library). This appendix provides the NAU HRPP with the necessary information about the individual site.

The NAU Principal Investigator is responsible for tracking and communicating with each site’s investigator any requirements of the NAU IRB; including but not limited to renewal requirements, reporting obligations, and sharing any IRB determinations. All requirements to conduct research at the NAU apply to each site where the NAU IRB will be the IRB of record. Each site will be required, via signed reliance agreements, to agree to these terms before the NAU IRB will assume oversight.

The NAU Principal Investigator is responsible for maintaining appropriate documentation of site approvals and consent forms, and must produce documentation upon request to the HRPP.

IRB reliance agreements

Agreeing to be the sIRB for a multi-site study is much like a contract negotiation. Each institution Page 3 of 5 Single IRB Review HRPPOfficeUseOnly Single IRB Review v2020-11 must sign an agreement that outlines the responsibilities and expectations of the reviewing and relying IRBs. All studies require a signed agreement, unless 1) the project is deemed exempt, or 2) NAU has a standing agreement in place with the organization(s). Please contact the HRPP to engage in the agreement process at the earliest opportunity, as it may take time to negotiate the terms.

How long it may take to finalize an agreement depends on several factors, including the responsiveness of the other IRB and its experience with reliance agreements, as well as, whether language in the agreement requires negotiation. Study teams should keep this in mind when considering sIRB review.

Occasionally a collaborator may not be affiliated with an institution at all, but will be engaged in human research activities on behalf of a NAU project. The NAU IRB may serve as the IRB of record for this individual, but it is a very case specific. The NAU IRB will require a separate signed individual authorization agreement. Please contact the HRPP to discuss.

Responsibilities of the NAU Investigator when ceding review to a relying IRB

Once the University has agreed to allow another IRB to conduct the review, the NAU investigator has a responsibility to report and update the relying IRB according to their policies and procedures. The NAU HRPP requires notification of certain study related items when another IRB has conducted the review:

Post Review Correspondence

It is the responsibility of the investigator to submit copies of renewal letters, a PI change, and study closures to the HRPP so we can keep our records up to date. If the HRPP does not receive copies of notices, the PI will be contacted asking about the status.

Reportable Items

The NAU HRPP requires that all local unanticipated problems (UP) or reportable items be submitted to the HRPP for our files. Submit this information on the ‘Reportable Event Local Information Form’ (available in the IRBNet library) along with copies of the materials submitted to the reviewing IRB. This is so the HRPP can maintain local knowledge regarding our participants and problems with the study. If the NAU IRB needs to engage in a serious event, we will do so as required to ensure ongoing compliance with local policies for any single IRB study. Please contact the HRPP with questions when an Unanticipated Problem or local reportable item arises.

Concluding the study

Investigators are responsible for concluding all Human Research activities as soon as possible after the project is completed or no longer involves human research participants. Submit a copy of the conclusion paperwork from the reviewing IRB so the University can complete their records. Note: If the NAU is the reviewing IRB, submit the appropriate HRPP Form to conclude the study.

HIPAA authorizations

Some IRBs will not or do not approve HIPAA authorization forms. If the relying IRB does not review authorization forms, the investigator must submit the authorization form to the NAU HRPP for review. Please ask the reviewing IRB what their policy is regarding HIPAA authorization forms. If necessary, submit a request for amendment to the HRPP for review.

Renewal periods

If the project is significant risk and has a renewal requirement, the renewal period is determined by the reviewing IRB. The NAU HRPP does not issue approval periods for single IRB studies.

Responsibilities of the reviewing IRB

Policies regarding accepting IRB oversight for other institutions vary widely. Study teams are expected to contact the proposed IRB of record regarding whether it is willing to serve as the single IRB before submitting a request to the HRRP. Confirmation should be obtained from the proposed IRB of record’s staff and not from other researchers at that institution.

• Maintain an OHRP-approved Assurance for human subjects research;
• Maintain compliance with state, local, or institutional requirements related to the protection of human subjects;
• Maintain records of NAU IRB ·approved research as per institution policies;
• Review and monitor individual and institutional conflicts of interest per NAU policies and procedures;
• Perform initial review of new studies, discuss any issues with the Principal Investigator, require necessary modifications to the study, and make a final decision of approval or disapproval of the study;
• Conduct continuing review of the research and review study amendments;
• Conduct review of serious, unexpected, and related adverse events; serious or continuing noncompliance and other unanticipated problems;
• Either directly, or through the appropriate NAU coordinating center or Principal Investigator, inform the Principal Investigator at Institution B in writing of NAU IRB determinations including approvals and disapproval, required modifications, determinations related to unanticipated problems and noncompliance, and any changes in the study approval status;
• Either directly, or through the appropriate NAU coordinating center or Principal Investigator, notify the Principal Investigator at relying institution of new materials that have been reviewed and any changes in the study approval status;
• Promptly notify the Principal Investigator at NAU, the Principal Investigator at relying institution, and appropriate officials at Institution B of any NAU IRB determinations that require reporting to institutional officials and/or regulatory agencies. The NAU IRB, through the NAU Human Research Protection Program (HRPP), will submit required reports to the applicable federal department (e.g. OHRP, FDA) and/or funding agency head(s). Maintain an IRB membership that satisfies the requirements of 45 CFR 46 and 21 CFR 56 and provides special expertise as needed to adequately assess all aspects of each study;
• Make available to Institution B the roster of NAU IRB membership and the NAU IRB Standard Operating Procedures (SOPs);
• Ensure that NAU IRB members receive orientation and continuing education on topics relevant to human subjects protection;
• Ensure that the NAU IRB has adequate meeting space and sufficient staff to support the NAU IRB’ review and record keeping duties;
• Notify Institution B immediately if there is a suspension or restriction of the NAU IRB’s authorization to review a study; and
• Notify Institution B of any changes in NAU IRB SOPs that might affect the institution’s reliance on NAU IRB reviews or performance of the research at the local institution.

The responsibilities of relying IRB are to:

Maintain an OHRP-approved Assurance for human subjects research;

• Promptly notify the NAU HRPP if Institution B becomes aware of events that change the ability of the site to conduct the research (e.g., suspension of the institution’s FWA);
• Maintain a human subjects protection program compliant with 45 CFR 46 and 21 CFR 50 and 56;
• Maintain compliance with state, local, or institutional requirements related to the protection of human subjects;
• Maintain records of NAU IRB ·approved research at Institution B as per institution policies;
• Review and monitor individual and institutional conflicts of interest per Institution B’s policies and procedures;
• Provide the names and addresses to the NAU HRPP of local contact persons who have the authority to correspond on behalf of Institution B (e.g., the local IRB Director);
• Ensure the safe and appropriate performance of the research at relying institution. This includes, but is not limited to, conducting the research as approved by the NAU IRB, monitoring protocol compliance (after becoming aware of protocol deviations, unanticipated problems or noncompliance through the NAU IRB), managing any major protocol violations, managing any serious adverse events occurring at the institution, ensuring qualifications and training of research staff are commensurate with the research activity and providing a mechanism by which complaints about the research can be made by local study participants or others; and
• When needed, provide a local context reviewer who has knowledge of the local research context and is able to review the informed consent form and related documents (e.g., authorizations for testing and release of medical records or donation of human specimens) to verify for the NAU IRB that these documents comply with applicable federal, state or local laws, institutional requirements, Confidentiality requirements, or IRB policies of Institution B.

Version 2020-11