343. Informing Participants of Research Costs
Updated July 1, 2019
When additional costs to subjects may result from participation in a research project, University of Nevada, Reno and Affiliate investigators must inform each participant of those costs prior to enrollment (per 45CFR46.116 item (b)(3)).
Investigators and the IRB may use the following cost categories to assess for research costs.
Usual-care costs are costs or expenses that participants incur when diagnostic or treatment procedures are provided as standard care AND are used for the research study. These include but are not limited to clinic or doctor visits, hospital stays, clinical laboratory tests, and x-rays.
The investigator must inform participants of usual-care costs that will be billed to a third-party payer (e.g., participants' insurance companies or Medicare) or to the participants themselves. Usual-care costs paid by the sponsor or research site need not be disclosed to participants but the IRB may request information about the source of funds for these costs or a copy of the budget for funded research.
Extra-care costs are costs or expenses that result from activities/procedures implemented solely for research purposes (e.g., costs of study medications and tests/procedures).
The investigator must
- identify extra-care costs in the IRB application;
- inform participants of extra-care costs that will be billed to a third-party payer (e.g., participants' insurance companies or Medicare) or to the participants themselves; and
- when applicable, inform participants that third-party payers may not cover costs of experimental drugs, devices, or procedures.
Extra-care costs paid by the sponsor or research site need not be disclosed to participants but the IRB may request information about the source of funds for these costs or a copy of the budget for funded research.
Research-Related Injury Costs
Research-related costs are costs or expenses associated with the care provided when a participant is injured or becomes ill as a result of her/his participation in the research.
The investigator must
- specify arrangements for medical care for research-related injury in the IRB application;
- inform participants of the types of care that will be available for research-related injury;
- provide information about whom to contact to report research-related injury; and
- specify who will cover the costs of care for research-related injury.
NOTE: Information about research-related injury care and costs does not apply to all research. The investigator and IRB should evaluate the risk of injury in each research project to determine whether care for research-related injury might be needed.
Sponsored Projects (SP) is responsible for negotiating with sponsors to ensure
- the contract/funding agreement specifies who is responsible for paying for research-related injury costs, and
- information about research-related injury costs in consent documents is consistent with the language in the contract/funding agreement.