Entries from HEALTH LAW SECTION BLOG tagged with 'informed consent'

Vaccine design claims-Bruesewitz v. Wyeth, SCT

From the Supreme Court’s webpage: Arguments Transcripts, for Bruesewitz v. Wyeth, Inc. 09-152 argued 10/12/10 (1), the case involves a vaccine designed in the 1940s that was administered to a child in 1992, some 30 years after scientist discovered a...

The FDA Postmarketing Drug Safety Information website

From the FDA news (1):On June 15, 2010, FDA began posting summaries of Agency safety analyses of recently approved drug and biologic products. These summaries are intended to share what the FDA has learned about the safety of products 18...

NIH's new 'Challenge Grants'. Bioethics, 'Nature' on the stem cell EO

Post Edit 3/13/09 From NIH (1):'The American Recovery and Reinvestment Act of 2009 ( the Recovery Act)... [2/17/09] makes supplemental appropriations for job preservation/creation, infrastructure investment, energy efficiency and science, assistance to the unemployed, and State and local fiscal stabilization,...

1/26/09 ESSCB Ethics Committee meeting , (includes funding report update)

The ESSCB Ethics Committee met for their 11th meeting on Jan. 26, 2009 at which the ESSCB Funding Committee reported on their Nov. 6 and Dec 18 meetings. View the webcast (1). Here are a few notes: The Funding Committee...

FDA /CDERWarning Letters 2008-Bioresearch monitoring program

For purposes of thinking about trends, I found it interesting to take a look at the last 6 months of FDA/CDER Warning Letters resulting from inspections in regard to its Bioresearch Monitoring Program. The Warning Letters show recent and...

Update your CDER bearings

For more information on clinical investigators, protection of human subjects, and regulatory and compliance programs, a recent CDER news item sugggests CDER's "Information for Clinical Investigators" webpage. This webpage provides guidance for conducting clinical trials with investigational drugs and information...

Hospital Liable for Failing to Obtain Consent From One of Five Siblings in Wrongful Autopsy

RAKOW v. STATE OF NEW YORK (2007 NY Slip Op 27556) Court of Claims (December 10, 2007): [Public Health Law § 4210] gives the right of consent [to an autopsy] to the husband, wife, or next of kin being charged...

DOH Posts Proposed Consumer Consent Policies for RHIOs

The New York Health Information Security and Privacy Collaboration (NYHISPC) has produced a proposed "Standardized Consumer Consent Policies and Procedures for RHIOs in New York State" which is now posted on the DOH website. (Link here.) The purpose of this...

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