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The Veterans Affairs Health Care System requires that the standard Informed Consent Document be copied onto its own form. This form is a template choice on the Consent/Assent attachments page of HawkIRB.
For VA studies, the following is included in the consent and regulations pertaining to the participation of veterans including requirements for indemnification in cases of research-related injury pertains to both veterans and non-veteran subjects enrolled in VA-approved research:
- A statement that in the event of a research-related injury the VA has to provide necessary medical treatment to a subject injured by participation.
- A statement that except in limited circumstances, the necessary care is provided in VA medical facilities. Exceptions include:
- Situations where VA facilities are not capable of furnishing economical care.
- Situations where VA facilities are not capable of furnishing the care or services required.
- Situations involving a non-veteran subject.
- An explanation of the VA’s authority to provide medical treatment to subjects injured by participation in a VA research project.
- A statement that a veteran-subject will not be required to pay for care received as a subject in a VA research project except in accordance with Title 38 United states Code (U.S.C.) 1710(f) and 1710(g) certain veterans are required to pay co-payments for medical care and services provided by the VA.
The signature and date for a witness to the subject’s or legally authorized representative’s signature and a note placed under the witness’ signature line if the sponsor or IRB requires a witness to the consenting process in addition to the witness to the subject’s signature and if the same person needs to serve both purposes. In addition, a statement indicating that a copy of the signed and dated consent document is given to the person signing the consent document.