Genetics

Human Subjects Research - Major Revision Planned

The federal Food and Drug Administration (FDA) plans to make sweeping changes to federal regulations on human subjects research. In this response to the administration's request for public comments on their Advance Notice of Proposed Rulemaking, CCHF says data and DNA ownership as well as patient consent for access to and use of medical records and biospecimens collected from patients in clinics, hospitals and elsewhere is necessary.

Bearder vs. State of Minnesota/MDH - Appellants Brief Filed

Baby DNA Court Ruling Disregards Constitutional Rights

Yesterday, the Minnesota Court of Appeals ruled to affirm the lower court's dismissal of the 9-parent lawsuit against the Minnesota Department of Health (MDH). The parents had challenged the collection, retention, use, and dissemination of newborn DNA by MDH as unconstitutional and in violation of the Minnesota Genetic Privacy Act.

CCHC Opposes Baby DNA Banking in Comments on HHS Proposal

According to Recommendations from HHS, the newborn DNA of children is a valuable resource that should be banked by government and made available to researchers without parent consent. Citizens' Council on Health Care has responded in opposition by sending public comments to HHS.

CCHC Opposes HHS' Lack of Consent for State Retention of Baby DNA

CCHF responds to HHS Request for Public Comments on “Considerations and Recommendations for National Guidance Regarding the Retention and Use of Residual Dried Blood Spot Specimens after Newborn Screening,” – a Briefing Paper issued April 26, 2010 by HHS through the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children.

Newborn DNA Sent to U.S. Military for Law Enforcement Database without Parent Consent

Texas began storing newborn DNA, collected for the newborn screening program, in 2002 without parent consent. A recent lawsuit against the State was settled, forcing Texas officials to destroy the 5.3 million infant blood spots in storage.

Texas Department of Health to destroy newborn bloodspots to settle parent lawsuit

The Texas Department of Health should never have stored or analyzed the DNA and unique genetic codes of its newborn citizens. It is only right that they destroy the genetic information that they have stored and given to researchers without legal authority or the consent of parents.

CCHF Reports on Newborn Screening Nationwide

Newborn Genetic Screening - The New Eugenics?

Increasingly, the specter of eugenics has emerged over State government newborn genetic screening programs. For example, The Changing Moral Focus of Newborn Screening, the December 2008 report issued by The President’s Council on Bioethics, states: “...At what point have we crossed the line from legitimate family planning to capricious and morally dubious eugenics?"

RE: CCHF Letter Opposing MN Collection of Patient Medical Records

Unless the Administrative Law Judge chooses otherwise, the Minnesota public will be at the mercy of the Health Department's warehousing, data-mining, tracking, research and health care rationing agendas. Their private data will be warehoused in the State of Maine and placed online. They won't have had a choice—or a voice.