Federal and other Human Research Related Links

Federal:

 

National Institute of Health (NIH) - The primary Federal agency for conducting and supporting medical research.

• NIH Home Page.

• NIH Office of Biotechnology Activities - Monitors scientific progress in human genetics research in order to anticipate future developments, including ethical, legal, and social concerns, in basic and clinical research involving Recombinant DNA, Genetic Technologies, and Xenotransplantation. 

• History of Human Research Protections.  Includes information and links to significant human research historical documents, including the Belmont Report and the Nuremberg Code.

• Certificates of Confidentiality Information. Certificates of Confidentiality are issued by the NIH to protect identifiable research information from forced disclosure.

• Policy and Guidelines. on the Inclusion of Children as Participants in Research

• UNMHSC FWA Website information

• NIH Genetic and Clinical Database (Framingham SHARe) - one of the most extensive collections of genetic and clinical data ever made freely available to researchers worldwide. 

Health and Human Services (HHS) - The U.S. government's principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.

• HHS Home Page. 

• Title 45 Part 46, Code of Federal Regulations.  Protection of Human Subjects. Subpart A is the "Common Rule" - these are accepted by all Federal Organizations.

• OHRP Home Page.  Office of Human Research Protections/HHS.  Supports, strengthens and provides leadership to the nation’s system for protecting volunteers in research that is conducted or supported by the HHS.

• ORI Home Page.  Office of Research Integrity/HHS.  Promotes integrity in biomedical and behavioral research supported by the U.S. HHS.

• AHRQ Home Page.  Agency for Health Care Research and Quality/HHS.  Supports health services research that will improve the quality of health care and promote evidence-based decision-making.

• International Compilation of Human Subject Protections 2008.   Lists 900 laws, regulations, and guidelines form 84 countries on human subject protections.  New this year is a separate listing of the standards that govern research governing research involving embryos, stem cells, and cloning. 

Federal Drug Administration

• FDA Home Page.

• Title 21, Part 50, Code of Federal Regulations. Protection of Human Subjects.

• Title 21, Part 56, Code of Federal Regulations. Institutional Review Boards.

• Title 21, Part 312, Code of Federal Regulations. Investigational New Drug Application.

• Title 21, Part 314, Code of Federal Regulations. Applications For FDA Approval To Market A New Drug.

• Title 21, Part 812, Code of Federal Regulations. Investigational Device Exemptions

Other Federal

• Veteran's Administration, Albuquerque. 

• The Presidents Council on Bioethics.

Human Research Protections Education:

• NIH Protecting Human Research Participants - on-line training (does not replace our required CITI Training)

• Public Responsibility in Medicine and Research.  Dedicated to creating, implementing, and advancing the highest ethical standards in the conduct of research

• Institutional Review Board Guidebook.  OHRP - The Guidebook is addressed to new and continuing IRB members, researchers, and institutional administrators.

• The Hastings Center.  The Hastings Center is an independent, nonpartisan, and nonprofit bioethics research institute founded in 1969 to explore fundamental and emerging questions in health care, biotechnology, and the environment.

• Clinical Research Resources.  publisher of regulatory compliance publications for the regulated pharmaceutical, biotech, and health care industries.

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