SNHMC IRB Standard Operating Procedures and Forms are available upon request from the IRB office. See below for brochures, training manuals, ethical principles, rules and regulations, and resource links.

SNHMC IRB Brochures

• SNHMC Research Brochure for IRB
• What You Need to Know Before Participating in a Research Project

Training Materials

• National Cancer Institute Educational Materials About Clinical Trials
• NIH Office of Extramural Research (OER) on-line Tutorial for Protecting Human Research Participants: This training is for all Board Members, PI’s, Research Coordinators, and all those involved with the protocol.

Fundamental Ethical Principles
Research must be carried out in an ethical manner.  The basic ethical principles guiding research involving human subjects are described in the following documents.
 
The Nuremberg Code.  The modern history of human subject protections begins with the discovery after World War II of numerous atrocities committed by Nazi doctors in war-related human research experiments.  The Nuremberg Military Tribunal developed ten principles as a means of judging their “research” practices known as the “The Nuremberg Code”.  The significance of the Code is that it addressed the necessity of requiring the voluntary consent of the human subject and that any individual “who initiates, directs, or engages in the experiment” must bear personal responsibility for ensuring the quality of consent.  This report is available on line at http://ohsr.od.nih.gov/guidelines/nuremberg.html

The Declaration of Helsinki.  Similar principles to The Nuremberg Code have been articulated and expanded in later codes, such as the World Medical Association Declaration of Helsinki:  Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects (1964, revised 1975, 1983, 1989, 1996, 2000), which call for prior approval and ongoing monitoring of research by independent ethical review committees.  This report is available on line at the World Medical Association web site.  http://ohsr.od.nih.gov/guidelines/helsinki.html

The Belmont Report.  Revelations in the early 1970’s about the 40 year United States Public Health Service Study of Untreated Syphilis in the Negro Male at Tuskegee and other ethically questionable research resulted in 1974 legislation calling for regulations to protect human subjects and for a National Commission to examine ethical issues related to human subject research (i.e. the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research).  The Commissions final report, The Belmont Report:  Ethical Principles and Guidelines for the Protection of Human Subjects of Research, defines the ethical principles and guidelines for the protection of human subjects. This report is available on line at http://ohsr.od.nih.gov/guidelines/belmont.html
 
Rules and Regulations

• Federal Regulations: Office for Human Research Protections (OHRP) Federal Policy for the Protection of Human Subjects (often referred to as the "Common Rule")
• Code of Federal Regulations: Title 21 (food and drug)
• Code of Federal Regulations: Title 45 (human welfare) and 46 (protection of human subjects)

Resource Links
Medicare Coverage Clinical Trial Policy
Good Clinical Practice in FDA Sponsored Clinical Trials
Clinical trial information for consumers
NIH Office of Human Subjects Research
List of Clinical Trials
The Center for Information and Study on Clinical Trial Participation
Public Responsibility in Medicine and Research (PRIM&R)
Institute for Community Research
National Library of Medicine - Ethical Issues in Research Involving Human Participants (Bibliography)
Office of Legislative Policy and Analysis - track legislation on human subjects
The Institutional Review Board - Discussion and News Forum
Thompson Center Watch - Clinical Trials Listing Service
World Health Organization - Operational Guidelines for Ethics Committees That Review Biomedical Research (.pdf file)
World Health Organization - Scientific and Ethical Review Group - Guidelines for Research