Institutional Review Board

PURPOSE

The University of Utah Institutional Review Board (IRB) ensures research participants are informed about compensation and treatment for any research-related injuries.

SCOPE

This policy applies to human subject research conducted at the University of Utah. This policy does not apply to remuneration or other compensation for research participation.

POLICY

Research contracts are reviewed and negotiated by both the University of Utah Office of Sponsored Projects (OSP) and the principal investigator to delineate the University’s and the sponsor’s responsibilities. The contractual agreement between the sponsor and the University of Utah, made through OSP, must include a statement that the contracting entity will provide research-related injury coverage.

For commercially sponsored clinical trials, the informed consent document must describe compensation or payment for immediate necessary care for injuries related to research participation consistent with the contract.

For research greater than minimal risk, the informed consent must include the University of Utah IRB’s standard research-related injury language, as found on the IRB website.

For research conducted at the Veteran Affairs Salt Lake City Health Care System (VASLCHCS), the informed consent must include the VASLCHCS’s standard language concerning immediate necessary care in the event of a research-related injury.

PROCEDURES

1. During pre-review, an IRB administrator reviews the informed consent document. If standard language is missing, they may request that it be added. For commercially sponsored clinical trials, the IRB administrator may request verification from OSP to ensure the consent language is congruent with the contract language. OSP and the IRB staff work together to ensure the accuracy of the language.
2. The IRB reviews the proposed language regarding compensation and research-related injuries in the informed consent as a part of the new study submission.
3. The IRB verifies that the standard research-related injury language is contained in the informed consent document, as applicable.
4. The IRB reviews the injury language to ensure it is readable, understandable, and non-exculpatory for the proposed target study population.