Christina Markus

King & Spalding

+ Follow Contact

Latest Posts › Informed Consent

Share:

FDA Issues Final Rule Permitting IRB Waiver or Alteration of Informed Consent for Certain Minimal Risk Clinical Investigations

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

1/4/2024 / Federal Food Drug and Cosmetic Act (FFDCA) , Final Rules , Food and Drug Administration (FDA) , Health Insurance Portability and Accountability Act (HIPAA) , Informed Consent , Institutional Review Board (IRB) , Investigations , PHI , Waivers

FDA (Finally!) Issues Proposed Rule to Amend FDA Regulations on the Protection of Human Subjects and Institutional Review Boards

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

11/15/2022 / 21st Century Cures Act , Food and Drug Administration (FDA) , Health Insurance Portability and Accountability Act (HIPAA) , HIPAA Privacy Rule , Informed Consent , Institutional Review Board (IRB) , New Regulations , Personally Identifiable Information , Proposed Rules , Waivers

HHS Issues Final Rule that Substantially Revises the Federal Policy for the Protection of Human Subjects

On January 19, 2017, the Department of Health and Human Services (HHS) and fifteen other Federal departments and agencies published a final rule that extensively revises and modernizes the Federal Policy for the Protection of...more

2/2/2017 / 21st Century Cures Act , Department of Health and Human Services (HHS) , Final Rules , Food and Drug Administration (FDA) , Informed Consent , Life Sciences , Research and Development , The Common Rule

3 Results

View per page

Page: of 1