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1.12 Sponsored Research

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for application of the human research protection program to sponsored research.

2.0 Policy

It is the policy of the Organization that in sponsored research, both the Sponsor and the Organization have obligations to protect research participants and ensure that the research is conducted in accordance with the Organization’s ethical standards, and in full compliance with all applicable HRPP policies, federal regulations for protection of human subjects, state and local laws and regulations, and University of Nebraska Board of Regents By-Laws.

3.0 Definitions

  • 3.1. Sponsor is defined as the company (pharmaceutical, device or biotechnology), other non-federal agencies, or individual donors providing financial or other support for a research study. The term sponsor also includes agents of sponsors (for example, contract research organizations).
  • 3.2. Contract is defined as a study agreement executed between the Sponsor and the Organization and signed by authorized representatives of each of the parties.

4.0 Procedures

  • 4.1. All Contracts are reviewed by UNeHealth, UNMC Sponsored Programs Administration (SPA) or UNO SPA.
  • 4.2. SPA and/or UNeHealth provides appropriate excerpts from the Contract to ORA. The IRB Administrator, in collaboration with SPA or UNeHealth Contract Specialists will review the detailed study protocol, the IRB application, consent documents and the Contractual language in order to ensure consistency and compliance with the Organization and HRPP policies.
  • 4.3. The Contract between the Sponsor and the Organization must address the following obligations:
    • 4.3.1. The Organization will comply with the detailed study protocol, HRPP policies, and all applicable federal regulations.
    • 4.3.2. The Sponsor’s responsibility for the payment of medical care for research participants who experience a research related injury is clearly defined as follows: 1) non-exculpatory limitations the sponsor has imposed on the extent of payment for medical care, and 2) the location(s) where medical care can be obtained. This statement of responsibility must be consistent with the “Compensation in Case of Injury” clause found in the ICF.
      Note: The ICF is required to contain standard UNMC IRB approved language which describes the availability of care in case of injury.
    • 4.3.3. All non-routine patient care costs which result from procedures performed solely for research purposes must be supported by the study budget and not charged to the subject and/or their third party payors.
    • 4.3.4. Indemnification language must not compromise the rights and welfare of research subjects.
    • 4.3.5. Contracts cannot include a financial bonus or financial penalty specifically linked to subject recruitment efforts (HRPP policy 3.7; Finders Fees and Recruitment Bonuses).
    • 4.3.6. Direct personal payments or other form of compensation from the Sponsor to investigators and other study personnel is not permitted.
    • 4.3.7. In accordance with requirements of FDA regulations for IND studies [21 CFR 312. 32(c), 21 CFR 312. 55(b)]; and IDE studies [21 CFR 812.40, 21 CFR 812.46(a)], the Sponsor or their agent of record (e.g., CRO) will promptly (no longer than within 30 days) report to the Organization and/or PI any findings that could affect the safety of subjects, the willingness of subjects to continue participation in the study (e.g., serious adverse events), influence the conduct of the study, noncompliance, or other information important to the IRB’s continued approval of the study.
    • 4.3.8. The PI must promptly report the above to the IRB in accordance with the requirements of FDA regulations at 21 CFR 56.108(b) and HHS regulations at 45 CFR 46.103(b)(5)(i) (or rev 45 CFR 46.104(a)(4)), and HRPP policies.
    • 4.3.9. The Sponsor, or their agent of record (e.g., CRO), will provide the Organization with data safety monitoring reports as well as other routine or urgent reports promptly as indicated in the data and safety monitoring plan approved by the IRB.
    • 4.3.10. The Sponsor, or their agent of record (e.g., CRO), will report to the Organization and/or PI any results of on-site monitoring conducted by the Sponsor or their agent of record at UNMC or other sites under the jurisdiction of the UNMC IRB. Corrective action shall be initiated in accordance with the requirements of 21 CFR 312.56(b) for IND studies and 21 CFR 812.46(a) for IDE studies.
    • 4.3.11. The PI must promptly report the above to the IRB in accordance with the requirements of FDA regulations at 21 CFR 56.108(b) and HHS regulations at 45 CFR 46.103(b)(5)(i) (or rev 45 CFR 46.104(a)(4)), and HRPP policies.
    • 4.3.12. The Sponsor, or their agent of record (e.g., CRO), will have a plan in place to notify the Organization/PI of the results upon completion of the study when the findings may directly affect the safety or medical care of subjects. The PI will, in turn, notify the subjects.
    • 4.3.13. There are no requirements which would cause the Organization to violate the HIPAA Privacy Rule. When PHI is provided to the Sponsor the Sponsor must:
      • 4.3.13.1. Refrain from using PHI to recruit subjects or advertise additional studies to subjects.
      • 4.3.13.2. Refrain from using the PHI for marketing or market research.
      • 4.3.13.3. Place the same restrictions on any third party to whom the Sponsor discloses PHI.
    • 4.3.14. There is no prohibition for retention of a copy of the data generated during the study at UNMC or other study sites under the jurisdiction of the UNMC IRB.
    • 4.3.15. There are no restrictions on publication of the results of the research which violate the University of Nebraska Board of Regents Policy.
    • 4.3.16. All commercially sponsored research is assessed an ORA/IRB review fee.
      • 4.3.16.1. The PI must complete the Charge for IRB Review of Commercially Sponsored Projects (Full Board and Expedited Review) forms.
      • 4.3.16.2. Request for waiver of the IRB review fee must be in writing and may be granted by the IRB Executive Chair.
  • 4.4. Contract Specialists and the Clinical Research Financial Compliance Specialist interact with Sponsors, investigators, legal counsel, IRB Executive Chair/designee and the IRB administrators to resolve identified issues and concerns.
  • 4.5. If the IRB has already reviewed the project and the Contract requires a major modification of the IRB application and/or ICFs, the IRB will re-review the study. “Major modification” is defined as per HRPP policy 2.4 (Review of Changes in Approved Research).
  • 4.6. The IRB will not issue a final release of commercially sponsored research until SPA has a fully executed Contract.
  • 4.7. The ORA will be notified by email (irbora@unmc.edu) when the Contract is fully executed.
  • 4.8. The ORA will notify SPA when the IRB has issued final approval and release of the research.
  • 4.9. When the grant or contract agreement includes human research activities that will be conducted by investigators who are not employees or agents of the Organization, a subcontract is executed between the Organization and the collaborating institution.
    • 4.9.1. The subcontract will include the requirement for the collaborating institution to assure compliance with federal regulations for the protection of human subjects in research and to provide documentation of current and ongoing IRB approval.
    • 4.9.2. The collaborating institution must also ensure that key personnel involved in human subject research are in compliance with the NIH policy on education in the protection of human research subjects and provide documentation of education of key personnel to the Organization.

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

POLICY AMENDED:

 REVISED FEBRUARY 8, 2018

 INITIAL MAY 6, 2016

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