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). conducted under the jurisdiction of the UNMC IRB.
2.0 Policy
2.1. It is the policy of the Organization that allAll human subject research must undergo a substantive scientific and scholarly merit review prior to
initiatingsubmission research.to the IRB.
2.2. ItHuman issubject research under the
policyjurisdiction and oversight of the
OrganizationUNMC thatIRB humanwill subject researchalso be reviewed by other component committees of the HRPP as appropriate.
3.0 Department, Division, School, College, Department or Division Review of Scientific MeritInstitute
3.1. The
Department Chairperson/designee or appointed review committee in the PI’s college, department or divisionPI is responsible for
obtaining scientific review of
theall human subject research
proposalprior priorto submission to the IRB.
InThe additionperson toor committee responsible for this review will vary depending on the
reviewtype of
resourcesresearch, described in HRPP policy 1.9 (Resources Necessary to Protect Subjects),and the
processes and requirements of the PI’s Department, Division, School, College,
Department or
DivisionInstitute. The scientific review
mustshould determinefocus theon following:assuring:
3.1.1. The research has a sound scientific
design:design; that is, 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. Thethe research is designed using accepted principles, methods, and
reliablepractices:
practices- The methods are practically feasible,
- The
3.1.1.4.research has a clear scientific objective
The research has sufficient power to definitively test the
objectiveobjective, and the
3.1.1.5. The researchResearch offers a plausible data analysis plan
3.1.2. The research has an acceptable level of scientific/scholarly
merit;merit that isand; 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.
3.1.5.2. 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:groups. None of these committees has the authority to approve human subject research to begin that has not yet been approved, or has been disapproved, by the IRB, as per HRPP policy 1.2 (Authority Granted to the IRB by the Organization):
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.protocols, as per SRC policies.
4.1.4. A designated IRB Administrator attends
everymeetings of the SRC
meeting as the IRB representative.
4.1.5. SRC review may precede or follow IRB review depending upon
theSRC investigator’spolicies response(see to submission deadlines.https://www.unmc.edu/cancercenter/clinical/prms.html)
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-additional 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
reviewreviews, letters.which Thewill letters arebe uploaded to the study file in
RSS. The SRC is provided a copy of all
relevant IRB
review letters for inclusion in the appropriate study files.reviews.
4.1.10. TheFor IRBhuman subject research subject to SRC review, the ORA will not
issueof fulla approvalprotocol foruntil anyit cancer-relatedhas study involving human subjects without first receivingreceived 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-additional review by the convened IRB will be required.
4.2.5. The
ORA will be provided a copy of all relevant P&T Committee
reviewsreviews, arewhich postedwill directlybe intouploaded to the study file in RSS. The
ORAP&T Committee is
sentprovided ana emailcopy fromof RSSall whenrelevant theIRB review is complete.reviews.
4.2.6. The
IRBORA is responsible for assuring all issues identified by the P&T Committee are resolved. The
IRBORA will not issue
final release of 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)
isreviews an ad hoc review committee compriseduse of
representativesinvestigational fromdevices 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 addingin 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. This includes receiving, storing, dispensing, returning or destroying, and billing of such investigational devices.
4.3.3.2. A designated IRB Administrator will attend all IDRC meetings as the IRB representative.
4.3.4.3. The
IDRCORA will
sendbe ORAprovided thea resultscopy of
theall reviewIDRC andreviews, final determinations. All letterswhich will be uploaded to
RSS in the study
file.file in RSS. The IDRC is provided a copy of all relevant IRB reviews.
4.3.4. For human subject research subject to IDRC review, the ORA will not issue final release of a protocol until it has received notice of approval from the IDRC.
4.4. Center for Clinical Trial& MasterTranslational MatrixResearch and Coverage Analysis(CCTR)
4.4.1. The
CCTR manages the OnCore Clinical Trial
MasterManagement MatrixSystem (
CTMM)CTMS), isand angenerates Excelthe spreadsheetClinical workbookStudy thatCalendar for clinical trials utilizing CTMS. The study calendar records
basic information about the clinical trial along with protocol protocol-specific scheduling of research related procedures/treatments and details how these procedures/treatments will be billed. The
CTMMStudy wasCalendar designedis to function as a “stand alone” document that serves as a resource for authorized personnel who do not have immediate accesssubmitted to the
contract,IRB budget,thru and/RSS for clinical trials conducted at NM, UNMC or
protocol.BMC.
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.
- 4.4.1.1. Studies conducted at CHMC submit a manually prepared billing grid for the same purposepurpose
4.4.2. TheCCTR conducts Coverage Analysis (CA),
usingof any study that includes clinical care activities conducted at Nebraska Medicine/UNMC, based on the
CTMM,CTMS isStudy conducted by the UNMC Center for Clinical and Translational Research (CCTR).Calendar. 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. AThe CTMMClinical Study Calendar and
CACA, isif requiredrequired, 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 beare uploaded to RSS
atand used by the
timeORA ofand initialthe submission or at any time there are modifications associated with modificationsIRB 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 resultsassessment 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.subjects associated with the research.
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 ofmolecules, materials containing recombinant DNA (including gene transfer and some vaccine
trials.)trials), or research involving biohazardous materials.
4.5.2. The IBC is administratively managed through the ORA. An assigned IRB/IBC Administrator attends every IBC meeting.
4.5.3. For research subject to both IRB and IBC review, IBC review may precede or follow IRB
review depending upon the investigator’s response to submission deadlines.review. 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. TheFor IRBhuman subject research subject to IBC review, the ORA will not issue
final release of a
fullprotocol approvaluntil forit anyhas study without first receiving writtenreceived notice of approval from the IBC.
4.5.7. The
IBCORA maywill notbe approveprovided human subject research to commence that has not yet been approved or has been disapproved by the IRB.
4.5.8. Aa copy of
theall relevant IBC
reviewreviews, letterswhich will be uploaded to
RSSthe study file in
theRSS. appropriateThe studyIBC file.is provided a copy of all relevant IRB reviews.
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).
and UNeHealth:
Refer to HRPP policy 1.12 (Sponsored Research).
4.9. In addition, review by other committees not listed may be required on a permanent or ad hoc basis, for any or all protocols, as dictated by the institution and/or the Institutional Official.
ADMINISTRATIVE APPROVAL:
BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS
CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL
POLICY AMENDED:
Revised May 17, 2021
Clarified responsibility for, and process of, scientific review; clarified responsibilities of the P&T Committee, and process of review; simplified description of function and activities of IDRC; clarified responsibilities of the IBC regarding human subject research; updated description of activities of CCTR; added reference to “other committees as directed by institution and/or IO”; clarified responsibilities of ORA vs IRB
REVISED FEBRUARY 12, 2018
INITIAL MAY 6, 2016
