Effective immediately (March 7, 2011), OHSU is implementing new liability language for consent forms for all federally funded studies.
The OLD language: “It is not the policy of the federal funding agencies to compensate or provide medical treatment for human subjects in federally funded studies.”
Must be REPLACED with: “This federally funded study does not have the ability to provide compensation for research-related injury. If you are injured or become ill from taking part in this study, it is important to tell your study doctor. Emergency treatment may be available but you or your insurance company will be charged for this treatment.”
New studies must use the new liability language. If your study has already been submitted and initial review is in process, the Institutional Review Board (IRB) will update the language for you.
Approved studies must update their liability language at the next continuing review. You may also update it as part of a modification before your next continuing review, but you are not required to submit a modification solely for this purpose.
Note: Subjects already enrolled in federally funded studies DO NOT need to be re-consented and sign the updated consent form.
If you have any questions about this policy, please contact the IRB.