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1.4 UNMC Ceding Review to an External Central IRB

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for the UNMC IRB to cede review to an external IRB.

2.0 Policy

  • 2.1. It is the policy of the Organization that all non-exempt research under the authority of the UNMC IRB and conducted, supported, or otherwise subject to regulation by any Federal department or agency which has adopted the Common Rule will rely on upon approval by a single IRB for that portion of the research that is conducted in the United States, in accordance with 45 CFR 46.114, unless excluded from this requirement under 45 CFR 46.114(b)(2).
  • 2.2. It is the policy of the Organization that all NIH-funded research will rely on upon approval by a single IRB, in accordance with the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research (NOT-OD-16-094), unless excluded from this requirement under NIH policy (NOT-OD-18-003).
  • 2.3. It is the policy of the Organization that selected independent commercial IRBs may serve as the IRB of record as permitted by HHS regulations at 45 CFR 46.114 and FDA regulations at 21 CFR 56.114 for new Phase II, III, and IV commercially sponsored clinical trials, with the exceptions specified under Section 2.5 below.
  • 2.2.4. It is the policy of the Organization that the National Cancer Institutes (NCI) Central IRBs (CIRBs) may serve as the IRB of record for pediatric and adult research sponsored by the National Cancer Institute (NCI) National CooperativeClinical GroupsTrials Network (NCTN) as permitted by HHS regulations at 45 CFR 46.114 and FDA regulations at 21 CFR 56.114.
  • 2.3.5. It is the policy of the Organization that other external IRBs may serve as the IRB of record as permitted by HHS regulations at 45 CFR 46.114 and FDA regulations at 21 CFR 56.114 on a case-by-case basis, with the exceptions specified under Section 2.5 below, provided thatthe following conditions are met:
    • 2.5.1. For research which constitutes greater than minimal risk, the external IRB:IRB
      • 2.3.1. Isis part of an accredited HRPP (or has completed the OHRP QA Self-Assessment Tool
        • if
      • 2.5.2. theFor research which constitutes no more than minimal risk)
      • 2.3.2. The research is conducted in association with a consortium requiring use of a Central IRB, orrisk, the research is federally funded and requires the use of a Central IRB.
      • 2.3.3. The external Institution has a valid FWA, and their IRB(s) is registered with OHRP and FDA (as applicable).
    • 2.4. It is the policy of the Organization that an external IRB, including selected independent commercial IRBs, may serve as the IRB of record as permitted by HHS regulations at 45 CFR 46.114 and FDA regulations at 21 CFR 56.114 for NIH-funded research, in accordance with the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research (NOT-OD-16-094).
      • 2.4.1. The following requirements must be met for NIH funded research
        • 2.4.1.1. The requirement for single IRB review applies to awardees in the United States and participating research sites in the United States.
        • 2.4.1.2. The requirement for single IRB review does not apply to organization as outside the United States.
        • 2.4.1.3. Awardee organizations are responsible for ensuring authorization agreement are in place, and that documentation is maintained.
        • 2.4.1.4. The reviewing IRB is responsible for determining the additional requirements of the NIH Genomic Data Sharing Policy have been appropriately addressed.
      • 2.4.2. Participating sites are expected to rely on the single IRB, though they may conduct their own review in accordance with NIH policy on exceptions from single IRB review.
    • 2.5. It is the policy of the Organization that if the external IRB is not AAHRPP accredited, the Organization must be assured:
      • 2.5.1. The external IRB reviews the research appropriately, in compliance with all federal, state, and local regulations.
        • regulations,
      • and 2.5.2. Thethe review criteria utilized by the external IRB isare in compliance with the Organization’s ethical standards and with applicable laws and regulations.regulations, and with the specific approval of the IO, in consultation with the IRB Executive Chair as appropriate.
      • 2.5.3. The extentexternal ofInstitution reviewhas willa varyvalid dependingFWA, onand the levelexternal ofIRB riskis toregistered participantswith inOHRP theand research.FDA (as applicable).
    • 2.6. It is the policy of the Organization that, unless fundeduse of a single IRB subject is required by 45 CFR 46.114, or required by NIH and required to use an external IRB,policy, the use of an external IRB is not permitted for:
      • 2.6.1. Phase I clinical trials
      • 2.6.2. Clinical trials initiated by a UNMC investigator
      • 2.6.3.2. Use of a Humanitarian Use Device (HUD) subject to 21 CFR 814.124(a)
      • 2.6.4.3. Emergency research subject to FDA regulations at 21 CFR 50.24.
      • 2.6.5.4. Research that involves the use of vaccines developed or manipulated at UNMC.
      • 2.6.6.5. Research involving gene transfer.
      • 2.6.7.6. Emergency use of a test article subject to FDA regulations at 21 CFR 56.102(d) and 21 CFR 56.104(c).
      • 2.6.8.7. Research involving prisoners as subjects.
      • 2.6.9.8. Research involving fetal tissue or HESCs, or their derivatives
    • 2.7. It is the policy of the Organization that the IOIO, in consultation with the IRB Executive Chair as appropriate, has the sole authority to determine whether or not to allow the UNMC IRB to cede review of research described in 2.1, 2.2 and 2.3,5 to an external IRB.
    • 2.8. It is the policy of the Organization that the IO, in consultation with the IRB Executive Chair as appropriate, has the sole authority to allow exceptions to the exclusions under sectionin 2.56 above.
    • 2.9. It is the policy of the Organization that it will accept the review and approval of an external IRB for human subject research exempt under 45 CFR 46.104; however, the Organization will not require the execution of a Reliance Agreement.
    • 2.10. It is the policy of the Organization that there must be an executed Reliance Agreement between UNMC and the external IRB’s institution or the commercial IRB, prior to utilization of the external or commercial IRB, for all non-exempt research.
      • 2.9.1. The execution of the agreement should (but is not required to) precede submission of the application to utilize the external IRB.
      • 2.9.2. For exempt research, the Organization does not normally require execution of the Reliance Agreement.
    • 2.10.11. It is the policy of the Organization that all Organizational review requirements must be completed and the Reliance Agreement be fully executed before the research will be released to the external or commercial IRB.IRB, for all non-exempt research; however the IO and Executive Chair have the authority to allow exceptions to this policy.
    • 2.11.12. It is the policy of the Organization that the research may not commence until approval has been granted by the external IRB.
    • 2.12.13. It is the policy of the Organization that research conducted under the purview of an external IRB will be subject to all relevant policies of the external (reviewing) IRB, and investigators of the Organization must comply with those policies, except as specified in addendum 2.
    • 2.14. It is the policy of the Organization that investigators must comply with Organization policies as described in Addendum 2.
    • 2.15. It is the policy of the Organization that all research conducted under an external IRB is subject to post approval monitoring per HRPP policy 1.21 (Post-Approval Monitoring of Research).
    • 2.13. The status of studies where review is ceded to an external IRB are maintained in the Research Administration (RA) database and Research Support Services (RSS) application system.

    3.0 Definitions

    • 3.1. Cede Review:Review: The Organization has agreed to transfer IRB review and oversight authority for specified research to another IRB.institution’s IRB (reviewing or external IRB)
    • 3.2. Reliance Agreement (also known as an Authorization Agreement): An agreement between two Organizations engaged in human subject research that documents respective authorities, roles, responsibilities, and communication between an organization providingbetween the ethical reviewreviewing and a participating organization relying on a reviewing IRB.IRBs.
    • 3.3. Relying Institution:Institution: A participating Institution that cedes IRB review to the IRB of record (reviewing IRB) designated under a Reliance Agreement.
      • In
    • 3.4. Reviewing IRB (or External IRB): The IRB which is responsible for conducting IRB review and approval as described in 45 CFR 46.109 for cooperative human subject research. For the purpose of this policy, the UNMCreviewing IRB isand cedingexternal reviewIRB toare anotherthe Organization’s IRB.same.

    4.0 External IRB, UNMC IRBIRB, and PI Responsibilities

    • 4.1. It is the responsibility of the external IRB to:
      • 4.1.1. Ensure all investigators and research staff have the appropriate qualifications and expertise to conduct the research, are knowledgeable about laws, regulations, codes and guidance governing their research, and are knowledgeable about the Institutions policies and procedures.
      • 4.1.2. The external IRB is responsible for obtaining any additional approvals from DHHS when the research involves pregnant women, fetuses, and neonates; or children; or prisoners (as applicable per DHHS and FDA regulations).
      • 4.1.3. The external IRB is responsible for reporting all determinations of serious or continuing noncompliance, unanticipated problems involving risk to the subject or others, and suspensions or terminations to the Relying Institution, Institutional Officials and Federal Agencies.
      • 4.1.4. Provide a Point of Contact (POC) and contact information for UNMC researchers and research staff to obtain answers to questions, express concerns, and convey suggestions regarding the use of the external IRB.
      • 4.1.5. Report to the UNMC IRB:
        • 4.1.5.1. Any unanticipated problems involving risk to the subject or others associated with subjects enrolled at this site.
        • 4.1.5.2. Any serious or continuing noncompliance.
        • 4.1.5.3. Any serious complaints which impact the rights and welfare of research subjects.
        • 4.1.5.4. The results of any external audits conducted by FDA, OHRP, sponsors, and CROs.
        • 4.1.5.5. Any reports filed with the FDA or OHRP.
        • 4.1.5.6. Any FDA 483 or warning letter pertaining to the study or IRB review.
    • 4.2. It is the responsibility of the UNMC IRB to advise the external IRB of:
      • 4.2.1. Any applicable state or local laws governing research conducted at this Organization.
      • 4.2.2. Advise the external IRB of the results of additional reviews conducted at the Relying Institution, including but not limited to biosafety review, radiation safety review, recombinant DNA research review, human stem cell research review and conflict of interest.
        • 4.2.2.1. Educate the investigators and research personnel at the Relying site of any requirements resulting from the additional reviews.
      • 4.2.3. Advise the external IRB of any circumstances when the review must take into account additional regulatory requirements.
      • 4.2.4. The termination, suspension, or modification of any clinical privileges of the Organizations investigators.
      • 4.2.5. Any allegations of noncompliance which are received by the ORA. The external IRB, in conjunction with the ORA, will determine how best to handle the allegation in consideration of the need to maintain due process and protect the whistleblower.
      • 4.2.6. Any complaint directly from subjects or others. The Research Subject Advocate Office will assist in the resolution of the complaint as necessary.
      • 4.2.7. Any contact by the FDA, HHS, or any other persons or entities regarding the research.
    • 4.3. It is the UNMC PI’s responsibility to:
      • 4.3.1. Complete all requirements for submission of request to utilize the CIRB to the ORA.
      • 4.3.2. Complete all requirements for submission to the external IRB.
      • 4.3.3. Comply with all determinations and requirements of the external IRB.
      • 4.3.4. Comply with the external IRB’s requirements for initial and continuing review, record keeping, and reporting in a timely manner.
      • 4.3.5. Promptly report the following to the external IRB (in accordance with their policies):
        • 4.3.5.1. Any proposed changes to the research. The investigator cannot implement changes to the research (including changes in the consent form) without prior IRB approval except where necessary to eliminate apparent immediate hazard to subjects.
        • 4.3.5.2. Conflict of interest management plans (in accordance with HRPP policy #1.25: Financial Conflicts of Interest). The UNMC PI and research staff must comply with all determinations.
        • 4.3.5.3. Incidents of noncompliance. Copies of all reports to the federal government must be provided to the UNMC IRB administrator.
        • 4.3.5.4. Protocol deviations.
        • 4.3.5.5. Any complaints from subjects or others. The Research Subject Advocate Office will assist in the resolution of the complaint as necessary.
        • 4.3.5.6. Data Safety Monitoring Reports
      • 4.3.6. Promptly report to the external IRB (in accordance with their policies) and the ORA any internal adverse events and other events which qualify as an unanticipated problem involving risk to the subject.
      • 4.3.7. Notify the ORA when there are changes in study personnel so that human subject protection training and conflict of interest may be reviewed in accordance with Organizational policy.
      • 4.3.8. Ensure that all research personnel understand their responsibility in enrolling participants in the research; including obtainment, documentation, and maintenance of records of consent for each subject/LAR.
      • 4.3.9. Conducting monitoring in addition to, or in cooperation with, the external IRB.
      • 4.3.10. Notify the ORA when a study is completed. The date of completion will be entered into the IRB database and the study will be reclassified as “completed”.
    • 4.4. There may be additional external IRB, UNMC IRB, and PI, responsibilities dictated by the IRB Reliance Agreement. The fully executed IRB Reliance Agreement must be maintained as documentation verifying the responsibilities of each organization to ensure compliance with the requirements of the Common Rule.

    5.0 Procedures

    • 5.1. The PI must submit the application CIRB Review of Research through RSS. The application must be accompanied by the following documents:

      • 5.1.1. Full protocol

      • 5.1.2. Sponsor’s template consent forms and/or information sheets

      • 5.1.3. Clinical Trial Master Matrix

      • 5.1.4. Pharmacy & Therapeutic Committee Drug Registry Forms, if applicable

      • 5.1.5. Recruitment materials (such as fliers and brochures, text of radio and TV advertisements)

        Note: It is recommended that the PI contact the ORA to determine if the proposed research will qualify for external IRB review prior to submission of the application. Acceptance of the application by the ORA does not signify that review will be ceded.

    • 5.2. The IRB Administrator must determine that the request to utilize an external IRB satisfies the requirements of Sections 2.1, 2.2, 2.3 or 2.4, and not excluded by 2.5 above. The administrator, in consultation with the Executive Chair as appropriate, will then present to the IO the request to allow the UNMC IRB to cede IRB review to the external IRB.
    • 5.3. If the IO approves the request, the UNMC IRB Administrator will review the “CIRB Review of Biomedical Research” application to determine that:

      • 5.3.1. The research satisfies UNMC requirements including, but not limited to:

        • 5.3.1.1. Subject payment; per HRPP policy 3.8 (Research Subject Compensation)
        • 5.3.1.2. Contraception; per HRPP policy 3.9 (Contraception Requirements)
        • 5.3.1.3. Subject identification and recruitment; per HRPP policies 3.5 (Subject Recruitment through Advertisements) and 3.6 (Subject Recruitment Through Direct Invitation), including ethical access (HRPP policy 3.12).
        • 5.3.1.4. Investigator and research staff training; per HRPP policy 1.23: HRPP Training Requirements and Opportunities for Research Personnel)
        • 5.3.1.5. Review and approval by other components of the HRPP (including, as appropriate, Conflict of Interest Committee, Fred & Pamela Buffett Cancer Center Scientific Review Committee, Pharmacy & Therapeutics Committee, Investigational Device Review Committee, Pathology, IT Security if SSNs maintained)
        • 5.3.1.6. Contract review by Sponsored Programs Administration or UNeHealth
        • 5.3.1.7. Coverage analysis and matrix/study calendar

      • 5.3.2. Appropriate agreements are in place, including, but not limited to:

        • 5.3.2.1. Executed sponsored agreement
        • 5.3.2.2. Data Use, Data Transfer and/or Material Transfer Agreements
        • 5.3.2.3. IRB Reliance Agreement between UNMC IRB and external IRB

      • 5.3.3. The UNMC IRB Administrator will issue a conditional acceptance letter to the investigator, conditional on any required modifications based on Organizational requirements.

      • 5.3.4. The UNMC Administrator will supply to the investigator the following items, to be provided to the external IRB:

        • 5.3.4.1. UNMC CF letterhead
        • 5.3.4.2. UNMC Addendum CF containing required language as per addendum to this policy. The external IRB may, at its discretion, merge the required UNMC CF language into the main CF.
        • 5.3.4.3. Any COI management plan and the potential impact on the protocol (for example, prohibiting the PI from obtaining informed consent) or any requirements for disclosure in the informed consent form.
        • 5.3.4.4. Additional information related to local context issues, including state, local or institutional regulations or policies that may impact IRB review.
        • 5.3.4.5. Updates to all local context issues as applicable.

      • 5.3.5. When the external IRB has completed its review, the approved CF language must be placed on UNMC letterhead. The UNMC IRB Administrator will review CF to assure inclusion of required language.

      • 5.3.6. Once all Organizational requirements have been met (as specified in HRPP policy 2.2; Section 8.0: Full IRB Review and HRPP policy 2.3; Section 13.0: Expedited Review and the IRB Reliance Agreement is fully executed, the IRB Administrator will provide the PI with an acceptance letter granting acceptance of IRB oversight by external IRB.

      • 5.3.7. The study may not be initiated until the acceptance letter has been provided to the PI.
        Note: Once it has been determined that an external IRB will serve as the IRB of record for any given study, all communications from the PI and other study personnel regarding IRB review of the study or its status must be with the external IRB, except as specified in Sections 4.3.6, 4.3.7, and 4.3.8 above. UNMC IRB staff do not have the authority to respond to questions or concerns on behalf of the external IRB.

        Note: The external IRB policies and procedures for stamping (or not stamping) consent forms with the approval dates take precedence. The UNMC IRB will not review or provide an approval stamp on any consent forms or information sheets approved by an external IRB.

      • 5.3.8. The full UNMC IRB will be notified of the acceptance of the external IRB review and approval of the research as a special notification item in the IRB agenda and minutes.

      • 5.3.9. The ORA, the IRB and the IO retain the authority to suspend research conducted within the organization which has been ceded to an external IRB, if the ORA, IRB or IO believes such action is necessary to protect the rights and welfare of human subjects of the research. The suspension will be promptly reported to the external IRB.

    ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

    POLICY AMENDED:

     REVISED FEBRUARY 28, 2018

     REVISED MAY 30, 2017

    Addendum: UNMC Required Consent Form Language

    1. What will being in this research study cost you? [This section should describe the financial obligations the subject will incur as a result of participating in the study and whether any financial obligations will be increased as a result of procedures performed solely for research purposes.]

    You will be responsible for any applicable insurance deductibles and co-payments. If you wish to speak with a financial counselor about your insurance coverage and benefits, let the investigator or other study personnel know. A contact for personal assistance will be made available for you.

    [If there are no financial obligations, use only the following clause] There is no cost to you to be in this research study.

    1. Who is paying for this research study?

    [For commercially supported studies]: The sponsor of the research is [name of sponsor]. [Name of Institution; Nebraska Medicine, UNMC, CHMC and/or UNO] receives money from the sponsor to conduct this study.

    [For studies supported by research grants]: This research is being paid for by [name of granting agency]. The Institution receives money from [name of granting agency] to conduct this study.

    [For NIH funded cooperative group studies]: The Institution receives money from [name of cooperative group] to conduct this study.

    [For studies without external support, include as applicable]: This research is being paid for by [for example, the Department of Internal Medicine, Section of Oncology of the University of Nebraska Medical Center].

    [If required by the institution, the PI will be directed to add any required financial conflict of interest statement here.]

    1. What are the pregnancy risks associated with this study? Insert appropriate contraception language based on FDA Pregnancy and Lactation Labeling Rule and/or FDA Use-In-Pregnancy category, as per HRPP Policy 3.9 (Contraception Requirements)

    2. What should you do if you are injured or have a medical problem during this research study? Your welfare is the main concern of every member of the research team. If you are injured or have a medical problem as a direct result of being in this study, you should immediately contact one of the people listed at the end of this consent form. Emergency medical treatment for this injury or problem will be available at Nebraska Medicine [or Children’s Hospital Medical Center]. If there is not sufficient time, you should seek care from a local health care provider.

    The Institution has no plans to pay for any required treatment or provide other compensation. If you have insurance, your insurance company may or may not pay the costs of medical treatment. If you do not have insurance, or if your insurance company refuses to pay, you will be expected to pay for the medical treatment.

    Agreeing to this does not mean you have given up any of your legal rights.

    1. How will information about you be protected? In addition to the information given to you in the main consent form, we may share information about you with other groups: • The UNMC Institutional Review Board (IRB) • Institutional officials designated by the UNMC IRB [if the research involves patients with cancer]: • The Fred & Pamela Buffett Cancer Center Scientific Review Committee (SRC)

    2. What are your rights as a research subject? You have rights as a research subject. These rights have been explained in this consent form and in “ The Rights of Research Subjects” and “ What Do I Need to Know” handout that you have been given. If you have any questions concerning your rights or want to discuss problems, concerns, obtain information or offer input, or make a complaint about the research, you can contact any of the following:
      • The investigator or other study personnel • [insert contact information for CIRB] • UNMC Institutional Review Board o (402) 559-6463 o IRBORA@unmc.edu o UNMC Institutional Review Board, 987830 Nebraska Medical Center, Omaha, NE 68198-7830 • UNMC Research Subject Advocate o (402) 559-6941 o unmcrsa@unmc.edu

    3. What will happen if you decide to stop participating once you start? You can stop participating in this research (withdraw) at any time. Please tell the Principal Investigator or any of the research staff if you want to withdraw. The investigator may ask you to have some additional tests done. You do NOT have to agree to do these tests.

    Deciding to withdraw will otherwise not affect your care or your relationship with the investigator or this institution. You will not lose any benefits or care that you would have gotten if you weren’t in the research study.

    OR

    You can stop participating in this research (withdraw) at any time. Please tell the Principal Investigator or any of the research staff if you want to withdraw. They will advise you how to safely stop taking any study drugs or treatments. If you withdraw the investigator may ask you to have some additional tests done. You do NOT have to agree to do these tests.

    Deciding to withdraw will otherwise not affect your care or your relationship with the investigator or this institution. You will not lose any benefits or care that you would have gotten if you weren’t in the research study.

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