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.
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:
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.
*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:
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:
(See SOP 041: WVU OHRP Quality Improvement Program.)
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:
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:
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:
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:
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:
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:
*Please note: upon review, additional policies/procedures may be requested by WVU’s OHRP staff.
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-yearacknowledgement.
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.
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.
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