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1.10 Scientific and Other Committee Review of Research

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for scientific and scholarly merit review, and review by other component committees of the HRPP, of all human subject research protocols (see HRPP policy 1.9: Review of Resources Necessary to Protect Subjects).

2.0 Policy

  • 2.1. It is the policy of the Organization that all human subject research must undergo a substantive scientific and scholarly merit review prior to initiating research.
  • 2.2. It is the policy of the Organization that human subject research be reviewed by other component committees of the HRPP as appropriate.

3.0 College, Department or Division Review of Scientific Merit

  • 3.1. The Department Chairperson/designee or appointed review committee in the PI’s college, department or division is responsible for review of the research proposal prior submission to the IRB. In addition to the review of resources described in HRPP policy 1.9 (Resources Necessary to Protect Subjects), the College, Department or Division review must determine the following:
    • 3.1.1. The research has a sound scientific design:
      • 3.1.1.1. The methods are valid and practically feasible
      • 3.1.1.2. The research has a clear scientific objective
      • 3.1.1.3. The research is designed using accepted principles, methods, and reliable practices
      • 3.1.1.4. The research has sufficient power to definitively test the objective
      • 3.1.1.5. The research offers a plausible data analysis plan
    • 3.1.2. The research has an acceptable level of scientific/scholarly merit; that is the knowledge to be gained from the research is sufficiently important.
    • 3.1.3. The College, Department or Division reviewer must sign the attestation (certification) statement in the IRB application.
    • 3.1.4. The online IRB application system will not allow submission of a new protocol without this attestation.
    • 3.1.5. The IRB will also evaluate the scientific and scholarly merit of all proposed studies. If the IRB does not have the appropriate disciplinary expertise for review of the protocol, the Board will utilize a consultant.

4.0 Reviews by Other Components of the HRPP

Depending upon the nature of the research, proposals may be subject to additional review and approval by one or more of the following groups:

  • 4.1. Fred & Pamela Buffett Cancer Center Scientific Review Committee (SRC):
    • 4.1.1. The Fred & Pamela Buffett Cancer Center is a National Cancer Institute (NCI) designated cancer center. As such, a mandatory element of the cancer center is a functioning Scientific Review Committee (SRC).
    • 4.1.2. The SRC reviews the scientific aspects of industry sponsored and investigator initiated cancer-related research involving human subjects conducted by members of the UNMC faculty and students and members of the Fred & Pamela Buffett Cancer Center.
    • 4.1.3. The SRC is responsible for:
      • 4.1.3.1. Evaluating all new and amended clinical research protocols for scientific merit and to ensure that there are adequate resources available to successfully complete the proposed research.
      • 4.1.3.2. Monitoring accrual to active protocols to ensure that studies meet their accrual goals and to require a reassessment of recruitment strategies and/or accrual goals when necessary.
      • 4.1.3.3. Ensuring that there are no competing studies with overlapping eligibility criteria for a specific disease indication.
      • 4.1.3.4. Establishing each protocol’s priority based on NCI guidelines and institutional priorities.
      • 4.1.3.5. Performing annual scientific review of open cancer center protocols.
    • 4.1.4. A designated IRB Administrator attends every SRC meeting as the IRB representative.
    • 4.1.5. SRC review may precede or follow IRB review depending upon the investigator’s response to submission deadlines.
    • 4.1.6. If SRC review precedes IRB review, the assigned IRB reviewers are notified by the designated IRB Administrator of any concerns expressed by the SRC.
    • 4.1.7. If SRC review follows IRB review, the designated IRB Administrator in consultation with the IRB Executive Chair, or one of the Chairs or Vice-Chairs will be responsible for assuring that no substantive changes have been made to the protocol or the consent forms by the SRC. If substantive changes have been made, re-review by the convened IRB will be required.
    • 4.1.8. If the SRC tables a study, IRB review will be held pending resolution of the SRC concerns. A revised protocol must be provided to the IRB for review.
    • 4.1.9. The ORA will be provided a copy of all SRC review letters. The letters are uploaded to the study file in RSS. The SRC is provided a copy of all IRB review letters for inclusion in the appropriate study files.
    • 4.1.10. The IRB will not issue full approval for any cancer-related study involving human subjects without first receiving written notice of approval from the SRC, stating that all scientific requirements for the study have been met.
    • 4.1.11. The SRC may not approve human subject research to commence that has not yet been approved or has been disapproved by the IRB.
  • 4.2. Pharmacy and Therapeutics Committee (P&T Committee):
    • 4.2.1. The purpose of the Nebraska Medicine P&T Committee review is to ensure safe use, adequate monitoring, accurate dispensing and control of both investigational and marketed drugs used in research conducted at UNMC/Nebraska Medicine. In addition, upon request of the IRB, the P&T Committee will also review research involving the administration of agents such as vitamins or other chemicals not classified as drugs.
      Note: The Nebraska Medicine P&T Committee does not review research conducted at CHMC. Review of research involving investigational and marketed drugs conducted at CHMC is accomplished by a designated CHMC pharmacist who is a member of IRB-04.
    • 4.2.2. P&T Committee review may precede or follow IRB review depending upon the investigator’s response to submission deadlines.
    • 4.2.3. If the P&T Committee review precedes IRB review, the assigned IRB reviewers are notified by ORA staff of any concerns expressed by the P&T Committee.
    • 4.2.4. If the P&T Committee review follows IRB review, the ORA staff, in consultation with the designated IRB Administrator and the IRB Executive Chair, or one of the Chairs or Vice-Chairs will be responsible for assuring that no substantive changes have been requested by the P & T Committee. If substantive changes have been requested, re-review by the convened IRB will be required.
    • 4.2.5. The P&T Committee reviews are posted directly into the study file in RSS. The ORA is sent an email from RSS when the review is complete.
    • 4.2.6. The IRB is responsible for assuring all issues identified by the P&T Committee are resolved. The IRB will not issue a full approval for any study involving drugs without resolution of all identified issues.
    • 4.2.7. Investigational drugs shall be released for administration only after the P&T Committee has assurances of compliance with all state and federal statutes, and the IRB has formally approved and released the protocol to enrollment.
    • 4.2.8. If a Request for Change involves a modification in dosing or route of administration of a study drug, P&T Committee must review, and any issues identified prior to full approval by the IRB, as above.
    • 4.2.9. The P&T Committee may not approve human subject research to commence that has not yet been approved or has been disapproved by the IRB.
  • 4.3. Nebraska Medicine Investigational Device Committee
    • 4.3.1. The Investigational Device Review Committee (IDRC) is an ad hoc review committee comprised of representatives from UNMC and Nebraska Medicine ancillary department(s) that review the study requirements. The PI must provide the following information:
      • 4.3.1.1. General study overview
      • 4.3.1.2. Specific services requested
      • 4.3.1.3. Cost, if any, to the ancillary department, along with the availability of grant funding to cover those costs
      • 4.3.1.4. Logistical considerations, including inventory of device(s), confirmation of billing account number(s),
      • 4.3.1.5. Services that are considered investigational, impact on workload when adding research patients to conventional care patient workload.
    • 4.3.2. The purpose of the IDRC is to assure regulatory and operational compliance in efficient management and security of receiving, storing, dispensing, returning/destroying, and billing of investigational devices in accordance with Nebraska Medicine policy MI29 and Attachments 1-4.
    • 4.3.3. A designated IRB Administrator will attend all IDRC meetings as the IRB representative.
    • 4.3.4. The IDRC will send ORA the results of the review and final determinations. All letters will be uploaded to RSS in the study file.
  • 4.4. Clinical Trial Master Matrix and Coverage Analysis
    • 4.4.1. The Clinical Trial Master Matrix (CTMM) is an Excel spreadsheet workbook that records basic information about the clinical trial along with protocol specific scheduling of research related procedures/treatments and details how these procedures/treatments will be billed. The CTMM was designed to function as a “stand alone” document that serves as a resource for authorized personnel who do not have immediate access to the contract, budget, and/or protocol.
      Note: Nebraska Medicine is utilizing the OnCore Clinical Trial Management System (CTMS) for management of clinical research. The clinical study calendar created through CTMS may be used in place of the matrix.
    • 4.4.2. The Coverage Analysis (CA), using the CTMM, is conducted by the UNMC Center for Clinical and Translational Research (CCTR). The Coverage Analysis verifies conventional “standard” care vs. research only costs to identify what can or cannot be billed to a third party payer (either private insurance or Medicare).
      • 4.4.2.1. The process also compares the matrix, ICF, and preliminary budget to ensure that all costs are covered, thereby assuring that the study budgets reflect the true cost of research.
    • 4.4.3. A CTMM and CA is required of any study that includes clinical care activities conducted at Nebraska Medicine/UNMC regardless of the funding source.
    • 4.4.4. A CTMM and CA is not required for any study that does not include clinical care activities or has no potential to create a bill for technical fees and/or professional fees for Nebraska Medicine/UNMC
    • 4.4.5. The completed CTTM must be uploaded to RSS at the time of initial submission or at any time there are modifications associated with modifications in the protocol.
    • 4.4.6. The IRB will not review a study that includes clinical care activities conducted at Nebraska Medicine/UNMC if the matrix has not been provided.
    • 4.4.7. The results of the CA are provided to ORA and will be uploaded into RSS in the study file. The full IRB will be notified if the study poses high financial risk to subjects.
  • 4.5. UNMC Institutional Biosafety Committee (IBC):
    • 4.5.1. The purpose of the Institutional Biosafety Committee (IBC) is to review research involving recombinant DNA molecules or human testing of materials containing recombinant DNA (including gene transfer and some vaccine trials.)
    • 4.5.2. The IBC is administratively managed through the ORA. An assigned IRB/IBC Administrator attends every IBC meeting.
    • 4.5.3. IBC review may precede or follow IRB review depending upon the investigator’s response to submission deadlines. The ORA will be given a copy of the IBC review.
    • 4.5.4. If IBC review precedes IRB review, the assigned IRB reviewers are notified by ORA staff of any concerns expressed by the IBC.
    • 4.5.5. If IBC review follows IRB review, the ORA staff will refer the protocol for re-review by the full IRB if the IBC required modifications or concerns are more than minor in nature.
    • 4.5.6. The IRB will not issue a full approval for any study without first receiving written notice of approval from the IBC.
    • 4.5.7. The IBC may not approve human subject research to commence that has not yet been approved or has been disapproved by the IRB.
    • 4.5.8. A copy of the IBC review letters will be uploaded to RSS in the appropriate study file.
  • 4.6. Radioactive Drug Research Committee (RDRC): The RDRC is currently registered with the FDA as inactive. However, should a human subject protocol involve research with radioactive drugs, the RDRC would be activated and IRB approval contingent upon RDRC approval.
  • 4.7. Conflict of Interest Committee (COIC): Refer to HRPP policy 1.25 (Financial Conflicts of Interest).

5.0 Sponsored Programs Administration (SPA):

Refer to HRPP policy 1.12 (Sponsored Research).

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

POLICY AMENDED:

 REVISED FEBRUARY 12, 2018

 INITIAL MAY 6, 2016

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