SOP 010: Single IRB Reliance

Purpose

To describe the policies and procedures for ensuring the rights and welfare of research participants are protected when West Virginia University (WVU) Institutional Review Board (IRB) is sharing oversight of research with another organization.

Procedures

1. When WVU Serves as the IRB of Record

   When a WVU principal investigator (PI) requests that the WVU IRB serve as the IRB of Record for a non-WVU research site, the PI submits a WVU specific protocol for review and approval prior to or concurrent with the addition of non-WVU sites. The WVU IRB determines on a case-by-case basis whether to review the site additions as separate protocols or as amendments to the previously approved research. If a site is added via amendment, the WVU IRB decides whether to handle such an amendment using expedited review procedures or the convened IRB for review.

   Please note: WVU IRB will not initiate reliance agreements for exempt activities, activities deemed to meet WVU’s Flex criteria, or activities deemed to be not human subject research. Exceptions may be made on a case-by-case basis for expedited/minimal risk activities that are not federally funded. (See SOPs 017: Exempt, 020: Flex, and 011: Human Subject Research Determination NHSR.) Under no circumstances, without prior written approval previous to IRB submission, will WVU serve as the IRB of Record on studies where WVU is not the prime award recipient and the WVU PI is not the primary PI on the award.

   The Relying Site Provides WVU IRB with the general information (e.g., FWA, Point of Contact/Institutional Official, Association for the Accreditation of Human Research Protection Programs (AAHRPP) Accreditation information, ancillary reviews, local consent language, local laws, investigator qualifications, local resources, recruitment materials, and communication plan, (as applicable). The WVU IRB considers this information when conducting its review. The WVU IRB, with input from the relying site, determines whether an investigator/research staff conflict of interest management plan, if any, allows the research to be approved at WVU (See SOP 042: Conflicts of Interest.)

   The WVU IRB reviews the following for all relying sites, and ensures reporting of such events in accord with the requirements specified in the reliance agreement and/or supporting documentation:

   • Suspension or termination of IRB approval;
   • All unanticipated problems involving risks to participants or others;
   • Serious or continuing noncompliance; and
   • Requests of audits of research protocols.

   Note: The relying site researcher/research team should create a process for submitting the above events to the WVU IRB when WVU serves as IRB of Record. (See SOP 031: Research Related Event Reporting for more information.)

   The WVU IRB will determine on a case-by-case basis whether it will serve as the privacy review board for organizations outside of WVU’s covered entity. If WVU IRB determines it will not serve as the privacy review board for external organizations, each relying site must comply with its own institution’s HIPAA policies and procedures.

   The WVU IRB notifies the investigators (and, if applicable, the external organization) of its review decisions consistent with any reliance agreement.

   The WVU IRB makes available relevant IRB records, including minutes, approved protocols, consent documents, and other records that document the IRB’s determinations to the relying organization upon request.

   The WVU OHRP website contains relevant IRB policies available to the relying organization, human research protection program (HRPP) staff, and investigators/research staff. The WVU investigator forwards applicable updates to collaborators at relying organizations. (See SOP 003: Investigator responsibilities, qualifications, and training.)

   The WVU IRB provides contact information to investigators/research staff to use for answers to questions, to express concerns, and to convey suggestions regarding IRB review.

   The WVU OHRP assigns one of its staff (when applicable) as a consultant to guide the WVU IRB in making determinations on amendment requests submitted by the WVU investigator that may affect consent forms, HIPAA authorization language, and/or other local language that could be considered applicable to ancillary administrative review.

2. When WVU Serves as the Relying IRB

   Please note: When a WVU investigator is conducting research involving human subjects, the WVU IRB will review and oversee the conduct of the research with some exceptions.

   The WVU investigator submits a written request to cede/defer IRB review to another organization’s IRB. A member of the WVU OHRP specifies which studies are eligible for review by another organization’s IRB. The determination to defer review is made on a case-by-case basis. Determinations may be made by the WVU VPR, WVU OHRP Director, and/or a member of the WVU OHRP staff in consultation with WVU Legal Counsel and/or WVU IRB and OHRP Leadership.

   Please note: WVU IRB will not initiate reliance agreements for exempt activities, activities deemed to meet WVU’s Flex criteria, or activities deemed to be not human subject research. Exceptions may be made on a case-by-case basis for expedited/minimal risk activities that are not federally funded. (See SOPs 017: Exempt, 020: Flex, and 011: Human Subject Research Determination NHSR.)

   A member of the WVU OHRP staff provides WVU investigators with information regarding:

   • Which activities are eligible for review by another IRB;
   • The requirements to obtain approval(s) from other WVU committees regarding local context such as Institutional Biosafety (IBC), Investigational Drug Service (IDS), Radiation Safety, and other committees as applicable prior to study activation at WVU;
   • Local requirements or local research context issues relevant to the IRB of Record’s determinations prior to study activation at WVU;
   • The requirement to notify the IRB of Record when local policies that impact IRB review are updated; and
   • The stipulation that university officials cannot approve any research subject to a reliance agreement if it has not been approved by the IRB of Record

   The WVU IRB reviews HIPAA authorization and/or waiver of authorization forms for WVU and may allow external IRB to review the WVU HIPAA authorization form if a mutually agreed between WVU and the IRB of Record.

   The WVU investigator complies with the IRB of Record’s policies and procedures for initial and continuing review, record keeping, and reporting requirements, and ensures that all information requested by the IRB of Record is provided in a timely manner. (See SOP 003: Investigator and Key Personnel Responsibilities, Qualifications and Training.)

   The WVU investigator complies with the following local reporting requirements for studies where WVU cedes/defers IRB review and oversight to an external IRB:

   • Unanticipated Problem Involving Risk to Subjects or Others when the event involves WVU subjects or researchers;
   • Serious or Continuing Noncompliance determinations by the IRB of Record when the event involves WVU subjects or researchers;
   • Suspension or Termination by the IRB of Record to which WVU cedes/defers IRB review and oversight.

   The WVU IRB and/or WVU OHRP staff may:

   • Review local reports and request additional information (when applicable) for studies where WVU cedes/defers IRB review and oversight to an external IRB; and/or
   • Conduct local audits/administrative assessments of protocols for studies where WVU cedes/defers IRB review and oversight to an external IRB.

   (See SOP 041: WVU OHRP Quality Improvement Program.)

Organizational Responsibilities

The WVU IRB requires a written agreement to be completed between organizations involved in a reliance relationship. The written agreement describes which organization (reviewing and relying) is responsible for the following:

• Human subjects research education qualifications of investigators and research staff;
• Scientific review;
• Verifying concordance between any applicable grant and the IRB or Ethics Committee (EC) application;
• Review of potential noncompliance, including complaints, protocol deviations, and results of audits:
  • Identifying which organization is responsible for deciding whether each allegation of noncompliance has a basis in fact; and
  • Identifying which organization’s process is used to decide whether each incident of noncompliance is serious or continuing;
• Management plans for investigators and research staff when a conflict of interest exists;
• Management of organizational conflict of interest related to the research; and
• Continued oversight of active studies until closure or a mutually agreed upon transfer of the studies to another IRB of Record, should a reliance agreement be terminated.

Protocols Under DHHS and/or FDA Purview

The WVU IRB requires a written agreement to be completed between the organizations involved in a reliance relationship under HHS and/or FDA purview. The written agreement outlines which organization (reviewing or relying) is responsible for determining the following:

• Whether the relying organization applies its FWA to some or all research and ensures that the IRB review is consistent with the relying organization’s FWA;
• When required, which organization is responsible for obtaining approvals from the US Department of Health and Human Services (HHS) when the research involves pregnant women, fetuses, and/or neonates; children; or prisoners; and
• Which organization is responsible for reporting serious or continuing noncompliance; unanticipated problems involving risks to subjects or others; and suspensions or terminations of IRB of EC approval

The IRB Reliance Administrator (or designee) is responsible for managing all reliance and/or authorization written agreements falling under WVU IRB purview.

For any non-domestic (outside of the US) research under the purview of WVU IRB where single IRB criteria do not apply, WVU IRB will work with external IRBs and/or Ethics Committees to ensure that the research can commence in the location outside of the United States. IRB approval should be obtained from an IRB and/or Ethics Committee familiar with the location outside of the United States where the research takes place.

WVU's IRB Reliance Administrator (or designee) will work to ensure the following when single IRB review applies:

• Communicate with the awardee organization to ensure applicable authorization agreements are in place and that documentation is maintained.
• Determine on a case-by-case basis which organization will be responsible for meeting additional certification requirements, such as Certificates of Confidentiality or NIH Genomic Data Sharing Policy.
• Communicate with participating institutions to document the rationale for not relying upon a Single IRB review in accordance with NIH policy on exceptions from single IRB review (also see below, Section 5).

Protocols Under the NIH Single IRB Review Policy

The NIH requirement for single IRB (sIRB) review applies to awardees and participating research sites within the United States. For non-exempt protocols under the purview of the NIH Single IRB Policy, the WVU IRB requires a written agreement to be completed between the organizations involved in the reliance relationship. The written agreement describes the responsibility for:

• Ensuring reliance agreements are in place and documentation supporting the agreements is maintained;
• Ensuring additional certification requirements are completed, such as the NIH Genomic Data Sharing Policy; and
• Determining whether the reliance on a single IRB is appropriate versus conducting local IRB review in accordance with NIH policy on exceptions from single IRB review.

Protocols Under the Revised Common Rule Cooperative Research Provision

The Revised Common Rule’s Cooperative Research Provision (45 CFR 46.114) applies to all institutions located in the United States that are engaged in cooperative research conducted or supported by a Common Rule department or agency. These institutions must rely on approval by a single IRB for the portion of the research conducted in the United States. For Non-exempt protocols that fall under the Cooperative Research Provision, the WVU IRB requires a written agreement to be completed between the organizations involved in the reliance relationship. The written agreement describes the responsibility for:

• Ensuring reliance agreements are in place and documentation supporting the agreements is maintained;
• Ensuring additional certification requirements are completed, such as the NIH Genomic Data Sharing Policy, if applicable; and
• Determining whether the reliance on a single IRB is appropriate versus conducting local IRB review in accordance with the Revised Common Rule’s Cooperative Research Provision on exceptions from single IRB review.

Collaboration With Non-AAHRPP Accredited Institutions

WVU may agree to cede/defer responsibility for IRB review to an institution not accredited by AAHRPP for research that is not greater than minimal risk. To defer responsibility, the non-WVU IRB must have an OHRP-approved FWA and OHRP-registered IRB. Under the terms of the FWA, an institution guarantees that it complies with the federal regulations governing human subjects research and follows a statement of ethical principles for protecting the rights and welfare of human subjects in research.

Assurance of compliance with the applicable laws and regulations is further documented through the completion of a written reliance agreement. WVU investigators comply with WVU’s standard operating procedures (SOPs) as outlined above when relying on an external IRB.

WVU may request a response to the following questions from the non-WVU IRB before WVU determines whether to cede/defer IRB review to an institution not accredited by AAHRPP:

• Has the institution’s HRPP/IRB been cited in the last three years by FDA or OHRP?

• Can the institution’s HRPP/IRB leadership attest that it has completed its own quality review process, such as:
  • Use of AAHRPP’s Evaluation Instrument for Accreditation to conduct a self-assessment;
  • Completion of the US FDA’s self-evaluation checklist for IRBs or ECs; or
  • An equivalent process? (And, if so, to describe it.)

When appropriate, the non-WVU IRB is asked to submit its institution’s HRPP/IRB policies and/or procedures regarding the following* to WVU OHRP staff:

• Initial Review;
• Continuing Review;
• Adverse Event/Unanticipated Problem/Protocol Violation Review; and
• Reporting of serious/continuing noncompliance, unanticipated problems involving risks to subjects or others, and suspension or termination of research.

Please note: upon review, additional policies/procedures may be requested by WVU’s OHRP staff.

Other HRPP Requirements

Ancillary reviews such as biosafety or radiation safety review are conducted by the Relying Institution or another organization external to the IRB of Record. To ensure the IRB of Record/HRPP is appropriately informed of these reviews, WVU requires the completion of acIRB/Reliance Application. When WVU acts as the Relying institution, the WVU cIRB/Reliance Application is made available to appropriate ancillary reviewers and the result of the review is communicated to the WVU investigator. The cIRB/Reliance Application also documents circumstances when the IRB of Record must consider additional regulatory requirements such as those of the Department of Defense (DOD) and/or the Department of Justice (DOJ). (See SOP 051: Ancillary Reviews.)

WVU investigators are informed of ancillary reviews and the requirements of communicating the outcomes to the IRB of Record in the Reliance Acknowledgement after submitting a Reliance Application in WVU’s electronic IRB system. When appropriate, investigators receive education regarding the ancillary reviews and the importance of forwarding the reviews to the external IRB of Record. Reliance Applications receive a 10-year acknowledgement.

90-Day PI Site-Specific Holds
Protocols overseen by an external IRB where it is discovered the WVU PI did not submit a reliance request and/or did not register and receive acknowledgement from WVU OHRP prior to initiating research activities will be subject to a 90-day PI site-specific hold. This site-specific hold will be communicated to the external IRB of Record and will be in effect until the PI submits the reliance application to WVU and receives acknowledgement to begin human subject research at WVU. Additional requirements, such as relying site investigator training/education, may be imposed on a case-by-case basis, at the discretion of the WVU OHRP staff.

Direct-Sponsor Submissions to Central IRBs
WVU site PIs and research teams must submit protocol materials received by the Sponsor to the Central IRB. Sponsors may not submit protocol materials to Central IRBs directly, on behalf of the WVU site PI and research team.

Individual Investigator Agreements

A member of the WVU OHRP staff and/or the WVU IRB determines on a case-by-case basis whether Individual Investigator Agreements (IIAs) apply to studies where WVU serves as the IRB of Record.

References

WVU Policies:
SOP 003: Investigator and Key Personnel Responsibilities, Qualifications, and Training
SOP 011: Human Subject Research Determination (NHSR)
SOP 017: Exempt
SOP 020: Flex
SOP 042: Conflicts of Interest
SOP 051: Ancillary Reviews

Federal Regulations:
21 CFR 50
21 CFR 56
46 CFR 46.114
NIH Single IRB Policy

AAHRPP:
AAHRRP Standard I-9

Guidance:
FDA Cooperative Research Guidance
FDA Non-Local IRB Review Guidance
OHRP Engagement Memo (2008)
OHRP Terms of the Federalwide Assurance of Protection for Human Subjects