Compliance Review

Review by the Office of Research Administration & Compliance focuses on two general areas:

  1. Ensuring that the Proposed Use of the Material meets all applicable regulatory requirements**
  2. Ensuring that the Terms of the Agreement itself do not conflict with any state laws, university policies, or other project-related agreements.

Review of the Proposed Use of the Material

If the material is human in origin or will be used as part of a human research subjects protocol, we will confirm that the PI has an IRB approval or exemption on record.

If the material will be used in an animal protocol, we will confirm that the PI has IACUC approval.

If the material is biohazardous, we will confirm that the PI has a Memorandum of Understanding & Agreement (MUA) on file with the Institutional Biosafety Committee.**

If the material will be received from or shipped to a foreign country, we will confirm that doing so does not violate any Export Control Laws.

** It is critical to ensure that the proposed work has all regulatory approvals in place in advance. The Office of Research Administration & Compliance cannot sign an MTA for any work that was performed without the necessary approvals.

Review of the Terms of the Agreement

The following terms are the most common “problem points” that need to be revised/negotiated with the other party:

  • Publication rights – VCU’s investigators must have the academic freedom to publish their work. Sponsors cannot require excessive pre-publication delay or impose other limitations on publication.
  • Intellectual Property rights – In accordance with the Intellectual Properties policy, VCU cannot agree to assign its rights in a VCU investigator’s invention to a third party. Ownership of the results of an investigator’s work similarly must stay with the university.
  • Confidentiality requirements – VCU policy limits the duration of a commitment to protect confidentiality and sets certain requirements for how confidential information is identified. Also, because VCU is a public institution and is subject to the Freedom of Information Act, agreements must make allowances for legally-required disclosures, including the existence and terms of an agreement.
  • Indemnification – VCU does not have the authority to execute an indemnification agreement and cannot indemnify any third party. VCU does, however, accept responsibility for its own actions.
  • Governing Law - VCU cannot agree to be bound by the laws of another state or country.