Review of Contracts and Agreements

Institutional Review Board

HRPP Review of Contracts and Agreements Involving Human Subjects Research

Many human subjects research studies involve contracts, data use agreements (DUAs), reliance agreements, memoranda of understanding (MOUs), clinical trial agreements (CTAs), or other written arrangements between institutions, sponsors, collaborators, or clinical sites. These agreements often define responsibilities that directly affect the rights, welfare, and protections of research participants.

To ensure consistency between the approved research protocol and the legal obligations of the parties involved, all contracts and agreements related to human subjects research must be submitted to the Human Research Protection Program (HRPP) as part of the review process or prior to study activation.

Why Contracts and Agreements Must Be Submitted to the HRPP

Submitting these documents allows the HRPP to confirm that:

  • The agreement does not conflict with the IRB-approved protocol or consent materials
  • Participant protections described in the protocol are supported by the contractual terms
  • Institutional responsibilities related to human subjects protections are clearly defined and ETSU has sufficient resources and capacity to follow through
  • Data access, privacy, and confidentiality obligations are appropriate and compliant

Failure to submit relevant agreements may delay IRB approval, study activation, or result in noncompliance with institutional policy and accreditation standards.

Investigator Responsibilities

Investigators are responsible for:

  • Submitting all relevant contracts and agreements with their IRB application or as amendments
  • Ensuring that study conduct complies with both the IRB-approved protocol and the executed agreements
  • Not initiating human subjects research activities until all required approvals and agreements are in place
  • If you are unsure whether a document must be submitted, investigators are encouraged to consult the HRPP early to avoid delays.
  • What the HRPP Reviews in Contracts and Agreements

    The HRPP does not conduct a legal or financial review. Instead, the HRPP focuses on provisions that impact human subjects protections, including but not limited to:

    • Roles and responsibilities of the investigator, sponsor, institution, and collaborating sites
    • Data ownership, access, and sharing, including use of identifiable or coded data
    • Privacy and confidentiality protections, including compliance with HIPAA and applicable data security requirements
    • Publication and reporting obligations, including investigator independence
    • Safety oversight, reporting of unanticipated problems, and adverse event responsibilities
    • Injury compensation, indemnification, or subject reimbursement provisions (as they relate to participant protections)
    • Consistency with informed consent documents, including disclosures related to data use or future research

    When inconsistencies are identified, the HRPP will work with investigators and institutional offices (e.g., contracts, legal, sponsored programs) to resolve them prior to final IRB approval or study activation.

  • HRPP Review in the Context of AAHRPP Accreditation

    As an AAHRPP-accredited Human Research Protection Program, the institution is required to apply specific accreditation standards to ensure comprehensive and consistent protections for research participants.

    HRPP review of contracts and agreements supports compliance with the following accreditation standards, among others:

    • Standard I-1 and I-2: The organization ensures that human research is conducted in accordance with ethical principles, regulatory requirements, and institutional policies.
    • Standard I-3: The organization clearly defines and documents roles, responsibilities, and authorities related to human research protections.
    • Standard I-4: The HRPP has oversight mechanisms to ensure that agreements affecting participant protections are reviewed and appropriately managed.
    • Standard I-8: The organization ensures that agreements with external entities, including sponsors, collaborators, and relying sites, do not compromise the rights, welfare, or protections of research participants and are consistent with the organization’s HRPP policies and procedures.
    • Standard II-2: The IRB reviews research to ensure that risks to participants are minimized and reasonable in relation to anticipated benefits, including risks related to data use and confidentiality.
    • Standard III-1: Investigators are responsible for conducting research in compliance with IRB approvals and applicable agreements.

    By reviewing contracts and agreements, the HRPP helps ensure that institutional commitments, investigator responsibilities, and participant protections are aligned and enforceable.

  • Documentation of Contract Review

    To meet the AAHRPP standards, ETSU requires review of sponsored research agreements to verify necessary elements to ensure the protection of participants. For example, the contract must indicate that the sponsor will promptly report findings of study monitors that could affect the safety of participants or influence the conduct of the study (when appropriate to the type of research).

    For ETSU researchers whose contractact is negotiated through ETSU ORSPA:

    1. ORSPA will review your contract and negotiate with the sponsor to make sure the required language is included in the document. 
    2. A contract checklist will be completed by ORSPA and provided to the HRPP Office. 
    3. Final IRB approval cannot be issued until the IRB receives a contract checklist documenting that AAHRPP standards are met. The associated study can still go through the review process, but it would be held in an “approval pending” status until this checklist is received.

    For ETSU researchers whose contract is negotiated through an entity other than ORSPA (e.g., VA Foundation, Ballad Health, etc.):

    1. The appropriate representative (usually the person negotiating the contract) must complete the ETSU provided contract checklist to document that provisions included in the agreement meets ETSU standards. 
    2. Final IRB approval cannot be issued until the IRB receives a contract checklist documenting that accreditation standards are met. The associated study can still go through the review process, but it would be held in an “approval pending” status until this checklist is received. 

Questions?

For questions regarding HRPP review of contracts and agreements, please contact the HRPP Office at HRPP@etsu.edu or 423-439-6053.