Code of Federal Regulations, Title 45, Part 46
Protection of Human Subjects
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
Department of Health & Human Services
Office for Human Research Protections – Policy Guidance
http://www.hhs.gov/ohrp/policy/index.html
Department of Health & Human Services
Office for Human Research Protections – IRB Guidebook
http://www.hhs.gov/ohrp/irb/irb_guidebook.htm
The Belmont Report
Ethical Principles and Guidelines for the Protection of Human Subjects of Research
http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
Declaration of Helsinki
http://www.fda.gov/oc/health/helsinki89.html
Institutional Review Board Guidebook
http://www.hhs.gov/ohrp/irb/irb_preface.htm
The Guidebook is also intended to be a resource that will serve as the focal point of IRB administrators' and members' human subjects work. Constructed in a loose leaf format, the Guidebook holds the regulations, relevant institutional documents (e.g., the institution's assurance and operating policies and procedures), and relevant forms. In addition to the text dealing with specific topics, the Guidebook contains a glossary of terms and a bibliography of sources.
Collaborative IRB Training Initiative
Program in the Protection of Human Research Subjects
http://www.irbtraining.org
A free, web-based course that can be completed in about an hour and consists of five modules:
1. History and Ethical Principles
2. Basic Institutional Review Board (IRB) Regulations and Review Process
3. Informed Consent
4. International Studies (Resource information/ country specific information)
5. Course Documents & Links to Research Compliance Information
