343. Informing w88 slot of Research Costs

Updated June 7, 2024

When additional costs to w88 slot 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 (c)(3)).

Investigators and the IRB may use the following cost categories to assess for research w88 slot.

Usual-Care w88 slot

Usual-care w88 slot are costs or expenses that w88 slot 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 w88 slotw88 slot inform w88 slot of usual-care costs that will be billed to a third-party payer (e.g., w88 slot' insurance companies or Medicare) or to the w88 slot themselves. Usual-care costs paid by the sponsor or research site need not be disclosed to w88 slot, 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 w88 slot

Extra-care w88 slot are w88 slot or expenses that result from activities/procedures implemented solely for research purposes (e.g., w88 slot of study medications and tests/procedures).
The investigator w88 slot:

• identify extra-care w88 slot in the IRB application;

• inform w88 slot of extra-care costs that will be billed to a third-party payer (e.g., w88 slot' insurance companies or Medicare) or to the w88 slot themselves; and
• when applicable, inform w88 slot 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 w88 slot, 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 w88 slot

Research-related w88 slot are w88 slot or expenses associated with the care provided when a participant is injured or becomes ill because of their participation in the research.

The investigator w88 slot:

• specify arrangements for medical care for w88 slot-related injury in the IRB application;
• inform w88 slot of the types of care that will be available for research-related injury;
• provide information about whom to contact to report w88 slot-related injury; and
• specify who will cover the w88 slot of care for research-related injury.

NOTE: Information about research-related injury care and w88 slot 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) w88 slot for negotiating with sponsors to ensure:

• the contract/funding agreement specifies who is responsible for paying for research-related injury w88 slot, and
• information about research-related injury w88 slot in consent documents is consistent with the language in the contract/funding agreement.