AIHC

OCTOBER 11, 2021

Written By: Compliance Blogger This article addresses COVID testing and consent considerations for: healthcare organizations, nursing homes and business associates or non-healthcare workplaces. Workplace-based testing should not be conducted without the employee’s informed consent.

COVID-19 52

COVID-19 Nursing Homes Informed Consent Nurses 52

SQA

MAY 17, 2022

For Investigator Sites, the subject areas are Organizational Aspects, Informed Consent of Trial Participants, Review of Trial Participant Data, and Management of Investigational Medicinal Product(s). The Warning Letter was issued after the FDA review of a response to a Form FDA 483 (reviewed by FDA on 03 November 2021).

FDA 75

FDA Compliance Informed Consent Hospitals 75

Drug & Device Law

DECEMBER 29, 2023

Plaintiff knew about it, too, since he signed an informed consent document mentioning it. Plaintiff’s complaints about “consent” related to the vaccination. Plaintiff’s repeated attempts to raise nursing home jurisdictional cases failed because the only the scope of regular preemption was at issue. Preemption.

FDA 105

FDA US Department of Health and Human Services COVID-19 COVID-19 Vaccine 105