Genes without Patents

Harvard Gazette, November 14, 2013
by Alvin Powell, featuring I. Glenn Cohen

As Supreme Court Justice Elena Kagan questioned Myriad Genetics’ attorney about patenting genes, Chris Hansen rejoiced. The attorney said that yes, genes should be patentable. But it was only under…

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Biobanks: DNA and Research

The Hastings Center

This briefing chapter surveys key ethical challenges surrounding biospecimens, including issues of consent, risk, and privacy; disclosure of research results; intellectual property; and biobank governance.

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“The Tissue Issue”: Recent Developments in Biospecimen Research

by American Health Lawyers Association

A survey of many of the recent legal developments related to biospecimens, including research regulation, state developments, and proposed amendments to HIPAA.

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Guidance on Research Involving Coded Private Information or Biological Specimens

Office for Human Research Protections

This document seeks to explain when research involving biospecimens constitutes human subjects research for the purpose of federal regulations.

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International Compilation of Human Research Standards

by Office for Human Research Protections

This list includes international laws, regulations, and guidelines governing the use of human biological materials.

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Moore v. Regents of University of California

This seminal case held that patients generally do not own their biological materials once excised or the subsequent products of those materials, but do have consent rights.

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Greenberg v. Miami Children’s Hospital

This case addressed a variety of legal claims lodged by specimen donors after researchers sought to commercialize their findings in a manner the donors did not expect.  

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Washington University v. Catalona

Another key case regarding biospecimen ownership and disposition via consent forms.

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2011 ANPRM to the Common Rule

Department of Health and Human Services

In 2011, the US government proposed a variety of changes to the regulations applicable to human subjects research, and in particular, several changes related to consent and identifiability of biospecimens…

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Found Your DNA on the Web: Reconciling Privacy and Progress

Hastings Center Report
by Amy Gutmann and James Wagner

This essay describes some of the privacy issues associated with biospecimen research, with reference to two additional resources: a study by Gymrek et al. in which supposedly deidentified specimens were…

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The Havasupai Indian Tribe Case — Lessons for Research Involving Stored Biologic Samples

NEJM
by Michelle Mello and Leslie Wolf

This short article provides a synopsis of a key case regarding what constitutes adequate informed consent for biospecimens collected for research to be stored and used in future, possibly unrelated…

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The Immortal Life of Henrietta Lacks

by Rebecca Skloot

This book tells the story of HeLa cells, a tremendously important cell line for scientific research – but developed from cells taken without the patient’s knowledge or consent.

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State Laws Regarding the Retention and Use of Residual Newborn Screening Blood Samples

Pediatrics
by Michelle H. Lewis et al.

After newborn screening has been completed, many states retain residual newborn screening dried blood samples for various purposes, including program evaluation, quality assurance, and biomedical research. The extent to which…

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Charles Fried on Evidence as a Public Good

Friday, March 01, 2013
Lectures and Panels
2012-2013
Langdell 225 (Vorenberg Classroom), Harvard Law School
Watch Event Recordings

We hear a lot about the conflict between use of an individual's information for the public good and that individual's…

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