Guidance Materials

The Belmont Report, written by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1979.

The Declaration of Helsinki, World Medical Association guidelines for human subjects research.

Federal Wide Assurance (FWA): As a contractor with the federal government, Jewish Hospital holds a contract with the Department of Health and Human Services, which assures the government that all applicable regulations governing human subject protections are followed. This contract is called a Federal Wide Assurance. The Jewish Hospital Federal Wide Assurance number is FWA 00002167.

IRB Assurance Letter

The Nuremburg Code, the basis for human subjects protections around the world.

Internet Resources

Regulations that Apply to Research Involving Human Subjects

45 CFR 46 - Federal Policy for the Protection of Human Subjects. The Common Rule (DHHS)

Human Subject Regulations Decision Charts, (DHHS) (9/98)

21 CFR 50 - Protection of Human Subjects, (FDA)

21 CFR 56 - Institutional Review Boards, (FDA)

21 CFR 312 - Investigational New Drug Applications, (FDA)

21 CFR 812 - Investigational Device Exemptions, (FDA) 

Office for Human Protections (OHRP)

Humanitarian Use Device (HUD) Humanitarian Device Exemption (HDE) Questions and Guidance

Humanitarian Use Device (HUD)

Humanitarian Device Exemption (HDE) Information

Ethical Principles Involving Human Research Subjects

Certificates Of Confidentiality

Institutional Review Board (IRB) Guidebook

IRB Guidebook Prepared by Robin Levin Penslar, J.D., Research Associate, The Poynter Center for the Study of Ethics and American Institutions and Joan P. Porter, D.P.A., OPRR Program Officer, Office for Protection from Research Risks. The Guidebook provides a basic understanding of the background and purposes of the IRB review system. It should be particularly useful for new and continuing IRB members, researchers, and institutional administrators. Topics included: Institutional Administration, Regulations and Policies, Basic IRB Review, Considerations of Research Design, Biomedical and Behavioral Research: An Overview, and Special Classes of Subjects.