Federal Government

American College of Medical Genetics/American Society of Human Genetics Working Group on ApoE and Alzheimer Disease

• Statement on use of Apolipoprotein E Testing for Alzheimer Disease

American Society for Microbiology (ASM)

• ASM Issues Statement on Genetically Modified Organisms

CDC

• CDC Guidelines for Hereditary Hemochromatosis
• Newborn Screening for Cystic Fibrosis: A Paradigm for Public Health Genetics Policy Development

CDC Genetics Working Group

• From Genes to Public Health: The Applications of Genetic Technology in Disease Prevention

Centers for Disease Control (CDC) and National Human Genome Research Institute (NHGRI) expert panel

• Consensus Statement: Hereditary Hemochromatosis: Gene Discovery and Its Implications for Population-Based Screening

DOE Human Genome Program's Human Genome News

• Ethical Issues in Human Gene Therapy (LeRoy Walters)
• Fear of Genetic Discrimination Drives Legislative Interest
• Genetics in the 21st Century (Eric Lander)
• Protecting Genetic Privacy: Why It is So Hard to DO (Mark Rothstein)
• The Human Genome Project: Science, Law, and Social Change in the 21st Century: Reports from the Cambridge Symposium

Department of Health and Human Services

• Statement on Genetic Discrimination by Donna Shalala, Secretary of Health and Human Services

Department of Health and Human Services and NIH

• Guidelines for Research Involving Recombinant DNA Molecules
• Recombinant DNA Research: Proposed Actions under Guidelines

FDA Center for Biologics Evaluation and Research (CBER)

• Points to Consider in Human Somatic Cell Therapy and Gene Therapy (1991)

National Cancer Institute

• Confidentiality, Data Security, and Cancer Research: Perspectives from the National Cancer Institute

National Cancer Institute and National Center for Human Genome Research Workshop

• Recommendations on Predictive Testing for Germ Line p53 Mutations Among Cancer-Prone Individuals

National Center for Human Genome Research (NCHGR) (from Brody: The Ethics of Biomedical Research)

• Policy on Availability and Patenting of Human Genomic DNA Sequence Produced by NCHGR Pilot Projects

National Human Genome Research Institute (NHGRI)

• Genetic Information and the Workforce (by NHGRI, DHHS, EEOC, and Department of Justice)
• NCHGR-DOE Guidance on Human Subjects Issues in Large-Scale DNA Sequencing
• Policy Recommendations: Insurance Discrimination, Employment Discrimination, Privacy/Confidentiality
• Preparing Health Professionals for the Genetic Revolution (statement by Francis Collins)
• Update of NHGRI Policy for the use of Human Subjects in Large-Scale Sequencing

National Human Genome Research Institute (NHGRI): Task Force and Workshop Reports

• Consensus Statement: The Clinical Introduction of Genetic Testing for Alzheimer Disease: An Ethical Perspective
• Genetic Testing for Cystic Fibrosis Consensus Development Conference Statement
• Hereditary Hemochromatosis: Gene Discovery and Policy Meeting
• Insurance Task Force Report - Executive Summary
• NCHGR/CDC Workshop on Informed Consent for Genetics Research Using Stored Tissue Samples
• NIH-DOE ELSI Working Group and National Action Plan on Breast Cancer Workshop on Genetic Discrimination and the Workplace
• NIH-DOE ELSI Working Group and National Action Plan on Breast Cancer Workshop on Genetic Discrimination and Health Insurance
• NIH Workshop Statement: Reproductive Genetic Testing: Impact on Women
• NIH Workshop Statement: Population Screening for the CF Gene
• Promoting Safe and Effective Genetic Testing in the United States: Final Report of the Task Force on Genetic Testing
• Protecting Human Research Subjects: 1993- present OPPR IRB Guidebook Chapter on Human Genetic Research
• Report of the Joint NIH/DOE Committee to Evaluate the Ethical, Legal, and Social Implications of the Human Genome Project

National Institute on Aging (Alzheimer's Association Working Group)

• Alzheimer's Association Reccommendations on the Applications of Apolipoprotein E Genotyping to Alzheimer's Disease
• Consensus Statement: Apolipoprotein E Genotyping in Alzheimer's Disease
• Genetic Testing and Alzheimer Disease: Recommendations of the Stanford Program in Genomics, Ethics, and Society

NIH-CDC Workshop

• Consensus Statement: Informed Consent for Genetic Research on Stored Tissue Samples

NIH-DOE ELSI Working Group

• The Bell Curve: Statement by the NIH-DOE Joint Working Group on the Ethical, Legal, and Social Implications of Human Genome Research

NIH-DOE ELSI Working Group: Task Force on Genetic Information and Insurance

• Genetic Information and Health Insurance: Report of the Task Force on Genetic Information and Insurance

NIH-DOE ELSI Working Group and the National Action Plan on Breast Cancer (NAPBC)

• Genetic Discrimination and Health Insurance: An Urgent Need for Reform
• Genetic Information and Health Insurance: State Legislative Approaches
• Genetic Discrimination and Health Insurance: A call for Legislative Action
• Government-Citizen Group Suggest Policies to Limit Genetic Discrimination in the Workplace
• Policy Forum: Genetic Information and the Workplace: Legislative Approaches and Policy Changes
• State Legislative Approaches to Regulating the Use of Genetic Material

NIH/DOE Joint Committee To Evaluate The Ethical, Legal, and Social Implications Program of the Human Genome Project

• Full Report of the Joint NIH/DOE Committee To Evaluate The Ethical, Legal, and Social Implications Program of the Human Genome Project

NIH-Funded Cancer Genetics Studies Consortium

• Recommendations for Follow-up Care of Individuals with an Inherited Predisposition to Cancer: I. Hereditary Nonpolyposis Colon Cancer
• Recommendations for Follow-up Care of Individuals with an Inherited Predisposition to Cancer: II. BRCA1 and BRCAII

NIH-Funded Cancer Genetics Studies Consortium: Task Force on Informed Consent

• Consensus Statement: Genetic Testing for Susceptibility to Adult-Onset Cancer: The Process and Content of Informed Consent

NIH Human Embryo Research Panel (from Brody: The Ethics of Biomedical Research)

• Report of the Human Embryo Research Panel (1994)

NIH National Center for Human Genome Research

National Advisory Council for Human Genome Research

• Statement on Use of DNA Testing for Presymptomatic Identification of Cancer Risk

The Hastings Center Project on Priorities in the Clinical Application of Human Genome Research

• Special Communication: National Policy Development for the Clinical Application of Genetic Diagnostic Technologies: Lessons from Cystic Fibrosis

NIH National Heart, Lung, and Blood Institute

• Report of the Special Emphasis Panel: Opportunities and Obstacles to Genetic Research in NHLBI Clinical Studies

NIH National Human Genome Research Institute

• A Brief Primer on Genetic Testing

NIH Office of Medical Applications of Research

• Consensus Conference: Newborn Screening for Sickle Cell Disease and Other Hemoglobinopathies

NIH Recombinant DNA Advisory Committee (RAC)

• Amendments to Appendix M, The Points to Consider in the Design and Submission of Protocols for the Transfer of
• NIH Launches Discussion of In Utero Gene Therapy...and Seeks to repair "Flaw" in Review Process
• Recombinant DNA Research: Proposed Actions Under Guidelines
• RAC Meeting Minutes: June 7-8, 1993
• RAC Meeting Minutes: March 6-7, 1995
• RAC Meeting Minutes: March 6-7, 1997
• RAC Meeting Minutes: June 18-19, 1998
• RAC Confronts In Utero Gene Therapy Proposals
• Recombinant DNA Molecules into the Genome of One or More Human Subjects
• Recombinant DNA Research: Request for Public Comment on "Points to Consider in the Design and Submission of Human Somatic-Cell Gene Therapy Protocols": January 22, 1985

NIH Technology Assessment Panel on Gaucher Disease

• Gaucher Disease: Current Issues in Diagnosis and Treatment

NIH Workshop on Population Screening for the Cystic Fibrosis Gene

• Special Report: Statement from the National Institutes of Health Workshop on Population Screening for the Cystic Fibrosis Gene

National Institute of Mental Health (NIMH)

• Genetics and Mental Disorders: Report of the NIMH Genetics Workgroup

National Performance Review (Clinton and Gore Administration)

• Reinventing the Regulation of Human Tissue (FDA)

National Research Council

• NRC Oks Long-Delayed Survey of Human Genome Diversity
• (Committee on DNA Forensic Science): The Evaluation of Forensic DNA Evidence (Excerpt from Executive Summary with recommendations)

Office for Human Research Protections (OHRP)

• Human Subject Regulations Decision Charts
• Privacy Protection for Research Subjects: "Certificates of Confidentiality" 2003

Office of Technology Assessment

• Cystic Fibrosis: Chapter 1: Summary, Policy Issues, and Options for Congressional Action
• Genetic Counseling and Cystic Fibrosis Carrier Screening: Results of a Survey
• Genetic Screening and Monitoring in the Workplace : Chapter 1: Summary, Policy Issues, and Options for Congressional Action