343. Informing Participants of w88 login Costs

Updated June 7, 2024

When additional costs to participants may result from participation in a research project, w88 login, 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 w88 login costs.

Usual-Care Costs

Usual-care costsare costs or expenses that participants incur when diagnostic or treatment procedures are provided as standard care AND are used for the w88 login study. These include but are not limited to clinic or doctor visits, hospital stays, clinical laboratory tests, and x-rays.

The investigatormustinform 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 w88 login 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 w88 login.

Extra-Care Costs

Extra-care costsare costs or expenses that result from activities/procedures implemented solely for w88 login 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 w88 login 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 w88 login.

w88 login-Related Injury Costs

w88 login-related costsare costs or expenses associated with the care provided when a participant is injured or becomes ill because of their participation in the w88 login.

The investigator must:

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

NOTE: Information about w88 login-related injury care and costs does not apply to all w88 login. The investigator and IRB should evaluate the risk of injury in each w88 login project to determine whether care for w88 login-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 w88 login-related injury costs, and
• information about w88 login-related injury costs in consent documents is consistent with the language in the contract/funding agreement.