Industry Links and Resources

This report was published in 1978 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.  The Department of Health and Human Services (HHS) later revised its regulations for the protection of human subjects 45 CFR part 46 in the late 1970’s and early 1980’s.  The Commission’s report which is entitled “Ethical Principles and Guidelines for the Protection of Human Subjects of Research” was named the Belmont Report, for the Belmont Conference Center, where the National Commission met when first drafting the report.

The Belmont Report identifies three fundamental ethical principles for all human subject research:

• Respect for persons
• Beneficence
• Justice

To access a copy of the Belmont Report, click here.

To review the Belmont Report Historical Archive, click here.   This site is an invaluable resource for all involved in clinical research.   It reviews the history of human subject protections, and provides helpful video and other educational and training resources.

• 45 CFR Part 46 – For a PDF of the Federal DHHS Policy for Protection of Human Research Subjects, 45 CFR 46, click here.

• FWA – The Federal Wide Assurance Program (FWA) requires that each institution engaged in federally supported human subject research file an “Assurance” of protection.   For detailed instructions on how to file for an FWA, see this link.

• Informed Consent – Click here to review OHRP’s informed consent FAQs which gives insight into the current agency thinking.

• Financial Relationships – Click here for a PDF of “Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Protection”.

• • 21 CFR Parts 50 and 56 – For a PDF of the FDA regulations for IRBs click here.
  • Center for Drug Evaluation in Research (CDER)
  • Center for Biologics Evaluation in Research (CBER)
  • Center for Devices and Radiological Health Devices (CDRH)
  • GCP Principles- FDA Good Clinical Practices

The HIPAA Privacy Rule provides federal protections for personal health information held by covered entities and gives patients an array of rights with respect to that information.  Visit the HIPAA homepage for more information.    The NIH information on Protecting Personal Health Information in Research:  Understanding the HIPAA Privacy Rule is a valuable resource as well, click here to view.

• Bioethics Resources on the Web

• Office of Human Subjects Research

The President’s Council on Bioethics advises the President on bioethical issues that may emerge from advances in biomedicine and related areas of science and technology.

The Hastings Center is a bipartisan research institution dedicated to bioethics.

World Medical Association: The Declaration of Helsinki was developed as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.

The Nuremberg Code – Directives for Human Experimentation resulting from the Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law.

Center for Bioethics, University of Pennsylvania http://www.bioethics.net
Indiana University Center for Bioethics http://www.bioethics.iu.edu/about.html
Johns Hopkins University Bioethics Institute http://www.hopkinsmedicine.org/bioethics/about.html
Kennedy Institute of Ethics Georgetown University http://www.georgetown.edu/research/nrcbl