This is a small collection of useful materials for persons doing research projects using human subjects.An Introduction to SCRIHS (document)
The Springfield Committee for Research in Human Subjects (SCRIHS) is an Institutional Review Board (IRB) located in Springfield, Illinois. This essay describes Federal law regulating human research, describes the functions of IRBs, why they were established, and some of the issues they deal with. It is of general interest to those wanting to learn about IRBs, but is aimed specifically at investigators who wish to submit research protocols to this particular IRB.Bioethics and the Institutional Review Board (slide show)
This is a brief introduction to the ethics of human studies and the functions of IRBs. It is presented in slide show format, and requires Java to be enabled. Each slide is a java applet and Netscape 4 kills some of them before they finish, so if not all the slides load properly, then try again by pressing the "reload" button.The Nuremberg Code (document)
This is the text of the Nuremberg Code, an influential statement of principles that should guide research in human beings.The Belmont Report (link to OHRP)
This is the text of the Belmont Report, a statement of principles on which the U.S. Federal law regarding human research is based.The Declaration of Helsinki (document)
This is the 1964 text of the Declaration of Helsinki, a statement of
principles referred to by researchers in many parts of the world.
It has been amended many times. The latest version can be found here at the World Medical Association.
This is the text of the 45 CFR 46, the section of the Code of Federal Regulations governing research in human subjects. These regulations are the Federal Policy (or "Common Rule") for sixteen federal agencies involved in supporting, regulating, or performing human research. Food and Drug Administration regulations are in 21 CFR 50 and 56. Additional relevant FDA regulations are in parts 312 (Investigational New Drug Application), 812 (Investigational Device Exemptions), and 860 (Medical Device Classification Procedures).Good links
Springfield Committee for Research in Human Subjects
SIU Office of the Associate Dean for Research
Office for Human Research Protections
Code of Federal Regulations
Last revised 21 April 2005. Dead links fixed October 2012.
M. Steven Evans [ e-mail | home page ]