The HIPAA Privacy Rule sets forth provisions related to the waiver or alteration of authorization in relation to clinical research studies for circumstances in which it would be impractical or impossible to obtain...more
The Food and Drug Administration ("FDA") expands informed consent exceptions with a final rule permitting institutional review board ("IRB") waiver or alteration of elements for certain FDA-regulated minimal-risk clinical...more
The Food and Drug Administration (FDA) has issued a final rule, Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations, which allows an exception from the requirement to...more
On August 15, 2023, the Food and Drug Administration (FDA) issued its updated guidance on informed consent for clinical investigations. The FDA’s updated guidance is titled Informed Consent Guidance for IRBs, Clinical...more
Nearly nine years to the day the Food and Drug Administration (FDA) issued a draft “information sheet” on informed consent, the agency published a 66-page final guidance document on the topic—marking the first time since 1998...more
The Food and Drug Administration (FDA) recently issued a proposed rule that would extensively modify and modernize its current regulations governing the protection of human subjects and Institutional Review Boards (IRBs).1 If...more
Many sectors of the economy have ground to a halt in the effort to curtail the COVID-19 pandemic (the “Pandemic”), and the clinical research industry is not immune to the effects of these business shutdowns. While the...more
On November 15, 2018, the Food and Drug Administration (FDA) published a Proposed Rule to amend its regulations to allow waiver or alteration of informed consent requirements in certain FDA-regulated clinical investigations...more
Earlier this month, the U.S. Food and Drug Administration (“FDA”) issued new guidance (“Guidance”) for sponsors, investigators, and institutional review boards (“IRBs”) regarding how recent changes to the Federal Policy for...more
In recent years, the world of human subjects research has expanded not only with regard to the number of clinical research trials being conducted and the array of drugs and devices being tested, but also with respect to the...more