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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FDA - Food

U.S. Food and Drug Administration

Website for the U.S. Food and Drug Administration, one of the agencies responsible for regulating the safety of the U.S. food supply. 

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Genetically Modified Crops

Foundation of American Scientists

An introduction to genetically modified crops, including key ecological concerns. 

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Title 21: Food and Drugs

Code of Federal Regulations

In Chapter I, Subchapter B, Parts 100-190, the regulations applicable to FDA’s oversight of food.

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Food, Genetically Modified

World Health Organization

Educational page providing general and technical information on genetically modified foods. 

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FDA - Guidance and Regulation

U.S. Food and Drug Administration

Section of the FDA website containing FDA guidance and regulatory information applicable to food, including information about food safety programs, manufacturing processes, industry systems, and import/export activities. 

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Genetically Engineered Crops in the United States

United States Department of Agriculture,
February 2014

Report by the USDA Economic Research Service on recent trends in adoption of genetically engineered crops. 

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Food Code

U.S. Food and Drug Administration

The FDA’s Food Code is a model that assists food control jurisdictions at all levels of government by providing them with a technical and legal basis for regulating the retail and food service segment of the industry.

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Food from Genetically Engineered Plants

Food and Drug Administration

This FDA site includes consumer information about food from genetically engineered plants, as well as FDA regulatory guidelines on these plants. 

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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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Americans with Disabilities Act (ADA)

U.S. Department of Justice

Federal government website regarding the protections provided by, implementation of, and enforcement of the primary law prohibiting discrimination on the basis of disability.

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USDA - Food Safety

U.S. Department of Agriculture, Food Safety and Inspection Service

Website for FSIS, an agency of the USDA responsible for ensuring food safety for meat, poultry, and egg products.

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Genetically Engineered Crops: Past Experience and Future Prospects

National Academy of Science

Website announcing NAS study on the benefits and risks of GE crops. 

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Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk

Institute of Medicine,
2015

A report commissioned by NIH and other sponsors on promoting responsible access to participant level data.

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What is a biobank? Differing definitions among biobank stakeholders

Clinical Genetics,
March 2014

Shaw et al.

An article discussing areas of agreement and difference in determining what constitutes a biobank.

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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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Disability Rights Section

Department of Justice

The Disability Rights Section works to achieve equal opportunity for people with disabilities in the United States by implementing the Americans with Disabilities Act (ADA).

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Foodborne Outbreaks

Centers for Disease Control

This site outlines the CDC’s role in investigation, surveillance, and prevention of food safety outbreaks. 

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Bioengineered (Genetically Engineered) Crops and Foods

American Medical Association

AMA statement on genetically engineered crops and foods. 

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Sharing Clinical Trial Data — A Proposal from the International Committee of Medical Journal Editor

International Committee of Medical Journal Editors,
Jan. 2016

A proposal from the editors of major medical journals across the world to make publication in their journals contingent on sharing de-identified, individual-level participant data from clinical trials with other researchers under certain parameters.

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