The University IRB applies all Department of Health and Human Services (DHHS) requirements for informed consent to greater than minimal risk research: DHHS general requirements (at 45 CFR 46.116) (see ...

The goal of the informed consent process is to ensure that the research subject is treated with respect and human dignity. The process does this by safeguarding and advocating for the subject's right ...

The U.S. Food and Drug Administration (FDA) has published a final rule on “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations,” which permits ...

Exempt research does not require the informed consent to be documented (it is at the discretion of the researcher), but the Bowdoin IRB does expect that informed consent be provided to the ...

The use of deception or incomplete disclosure limits the subject's ability to make a fully informed decision of whether to participate in the research — one of the essential ethical concerns in human ...