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REGULATIONS AND GUIDANCE THAT APPLY TO RESEARCH INVOLVING HUMAN SUBJECTS

ICH/GCP Regulations
ICH GCP E6(R1) Guidelines

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

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

Human Subject Regulations Decision Charts, (DHHS) (9/04)

http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm

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

http://www.fda.gov/oc/ohrt/irbs/appendixb.html

21 CFR 56 - Institutional Review Boards, (FDA)

http://www.fda.gov/oc/ohrt/irbs/appendixc.html

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

http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm

21 CFR 812 - Investigational Device Exemptions, (FDA) 

http://www.fda.gov/cdrh/devadvice/ide/application.shtml

Office for Human Research Protections (OHRP)

http://www.hhs.gov/ohrp/

Office for Human Research Protections (OHRP) - Frequently asked Questions

http://answers.hhs.gov/ohrp/

Clinical Trials and Insurance Coverage - A Resource Guide

http://cancer.gov/clinicaltrials/insurance

FDA Guidance

http://www.fda.gov/oc/ohrt/irbs/default.htm

Certificates of Confidentiality

http://grants2.nih.gov/grants/policy/coc/

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Full Association for the Accreditation of Human Research Protection Programs, Inc. Accreditation
 
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