Medical Research and Human Experimentation Law

Also see: Medical Records, Privacy

These are new pages that will contain information for both researcher and subjects. The organization will be changed, so link to this page, not internal pages.

Articles on Scientific Misconduct and Research Fraud

Cases and Case Briefs - Human Experimentation

Cases and Case Briefs - Animal Experimentation

Reports of the National Bioethics Advisory Commission - this is a archive of the commission's work before it was disbanded. These documents include detailed reports on most of the legal issues in human subjects research. This is a good starting point for understanding the law. These public domain documents are provided for general use and to assure that they remain available if their primary WWW site is taken off line.

President's Commission on Bioethics - this is an archive of the current (2004) bioethics commission that replaced the National Bioethics Advisory Commission. These public domain documents are provided for general use and to assure that they remain available if their primary WWW site is taken off line.

Nuremburg Trials - Trial of the Major War Criminals before the International Military Tribunal

Hippocratic Oath

The Nuremberg Code

World Medical Association Declaration of Helsinki

Federal Laws and Reports

Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review Boards, March 24, 2009. pdf

OHRP - Guidance on Engagement of Institutions in Human Subjects Research - Oct 2008

CRS: "Clinical Trials Reporting and Publication," updated July 12, 2007.

Federal Research: NIH and EPA Need to Improve Conflict of Interest Reviews for Research Arrangements with Private Sector Entities.
GAO-05-191, February 25.

Beyond Therapy: Biotechnology and the Pursuit of Happiness The President's Council on Bioethics Washington, D.C., October 2003

See HIPAA for information about HIPPA and medical research.

45 CFR 46 - Protection of Human Subjects - the "Common Rule"

UNIVERSITY RESEARCH Most Federal Agencies Need to Better Protect against Financial Conflicts of Interest GAO-04-31, November 2003

CDC - Guidelines for Defining Public Health Research and Public Health Non-Research - Revised October 4, 1999 - additional information

Information on Smallpox Vaccine Trials in Children

Council of State and Territorial Epidemiologists (CSTE) report: Public Health Practice vs. Research: A Report for Public Health Practitioners Including Cases and Guidance for Making Distinctions. Original link: http://www.cste.org.

NIH - Report of the National Institutes of Health (NIH) Working Group on Research Tools

NIH - NIH Principles and Guidelines for Sharing of Biomedical Research Resources -- Final

NIH - Certificates of Confidentiality

Promoting Safe and Effective Genetic Testing in the United States - Final Report of the Task Force on Genetic Testing

FINAL REPORT of the Tuskegee Syphilis Study Ad Hoc Advisory Panel

Office for Civil Rights - HIPAA - Medical Privacy - National Standards to Protect the Privacy of Personal Health Information - OCR Guidance Explaining Significant Aspects of the Privacy Rule - December 4, 2002 - Specific Section on Research - Text of the Regs - Standards for Privacy of Individually Identifiable Health Information (Unofficial Version) (45 CFR Parts 160 and 164) Regulation Text (December 28, 2000) as amended: Part 160 (May 31, 2002) Parts 160, 164 (August 14, 2002)

Statutory Confidentiality Protection of Research Data - Subject: Statutory Confidentiality Protection of Identifiable Research Data Collected with AHRQ Support

Office of Human Research Protections (OHRP)

Reports and International Documents

State Statutes and Regulations

California

Maryland

Virginia

Washington State Law