Final Revisions to the Common Rule

U.S. Department of Health and Human Services

On January 19, 2017, federal regulators published the Final Rule to amend and update the Federal Policy for the Protection of Human Subjects (“the Common Rule”).  Key provisions govern research with identifiable private information, identifiable biospecimens, broad consent, new exemption categories, and single IRB review of multi-site research.

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HHS Announces Proposal to Improve Rules Protecting Human Research Subjects
Changes proposed to ensure the highest standards of protections for human subjects involved in research, while enhancing effectiveness of oversight

U.S. Department of Health and Human Services

The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have announced proposed revisions to the regulations for protection of human subjects in research. A Notice of Proposed Rulemaking (NPRM) was published in the Federal Register on September 8, 2015. The NPRM seeks comment on proposals to better…

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Specimen Science: Ethics and Policy Implications

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics

Many important advances in human health depend on the effective collection, storage, use, and sharing of biological specimens and their associated data.  However, recent controversies involving specimen-based research have raised important questions about ownership, data-sharing, privacy considerations, group harms, and standards for responsible specimen stewardship.  

This November 2016 symposium addressed key…

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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


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


Office for Human Research Protections

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

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Office of Biorepositories and Biospecimen Research (OBBR)
Ethical, Legal, and Policy Best Practices

OBBR

This resource provides best practices related to biospecimen resources, covering responsible custodianship, informed consent, privacy, access, intellectual property, and conflict of interest.

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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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Obtaining Informed Consent for Procurement/Use of Human Tissues, Cells, & Fluids in Research

World Health Organization

This Guideline is intended to assist researchers in dealing with the ethical issues relating to how clinical research materials are obtained, used and eventually disposed of, and the corresponding informed consent requirements.

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One-Time General Consent for Research on Biological Samples


David Wendler, BMJ

This article reviews the available literature to conclude that although consent ought to be required for biospecimen research, one-time general consent is sufficient.

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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 for research.

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Found Your DNA on the Web: Reconciling Privacy and Progress

Hastings Center Report
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 able to be re-identified, and a report on privacy and security concerns related to whole genome sequencing by…

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

NEJM
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 studies.

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The Immortal Life of Henrietta Lacks


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
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 states possess legal authority to retain residual dried blood samples and use them for purposes unrelated to newborn screening is…

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