The US Food and Drug Administration (FDA) finalized a rule allowing Institutional Review Boards (IRBs) to waive or alter elements of informed consent for certain clinical trials that pose minimal risk ...

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 ...

Failure to obtain informed consent can result in significant consequences Exceptions to informed consent apply only in limited circumstances Elements of valid informed consent include patient capacity ...

Obtaining the informed consent of a potential human subject for participation in any research (whether an experiment, survey, interview, or demonstration) is a federally mandated safeguard for ...

HHS on Monday revised and clarified requirements for informed consent for certain procedures done in the hospital, especially examinations done while the patient is under anesthesia. "It is critically ...

The Department of Health and Human Services and the Centers for Medicare and Medicaid Services have released new guidance to reiterate and provide clarity regarding hospital requirements for informed ...

FDA Issues Guidance on Informed Consent Waivers for Minimal Risk Studies The US Food and Drug Administration (FDA) on Monday issued a final guidance detailing the circumstances in which the agency ...

The guidance targets teaching hospitals and medical schools. U.S. Department of Health and Human Services said the informed consent requirement means patients must be aware of any sensitive ...

The Maternal Health, Dignity and Consent Act would require health care providers to obtain informed consent from pregnant ...

NOTE: The University IRB abides by information regarding the current position of the VHA Office of Research & Development’s (per email from Karen Jeans dated 01/03/14) related to use of Craigslist as ...