Unsure if your research activity needs to be submitted to the IRB? Click here for OHRP's Human Subject Regualtions Decision charts
www.hhs.gov/ohrp/humansubjects/ guidance/decisioncharts.htm
Department of Health and Human Services
The Belmont Report www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm
Nuremberg Code ohsr.od.nih.gov/guidelines/nuremberg.html
Declaration of Helsinki www.fda.gov/oc/health/helsinki89.html
Title 45 Code of Federal Regulations Part 46 Protection of Human Subject www.hhs.gov/ohrp/
Statutory Basis for 45 CFR 46 www.hhs.gov/ohrp/humansubjects/guidance/statute.htm
Food and Drug Administration (FDA)
FDA Forms - Devices www.fda.gov/opacom/morechoices/fdaforms/cdrh.html
FDA Forms - Drugs www.fda.gov/opacom/morechoices/fdaforms/cder.html
21 CFR 50- Protection of Human Subjects www.access.gpo.gov/nara/cfr/waisidx_00/21cfr50_00.html
21 CFR 54- Financial Disclosure by Clinical Investigators www.access.gpo.gov/nara/cfr/waisidx_00/21cfr54_00.html
21 CFR 56 - Institutional Review Boards www.fda.gov/oc/gcp/default.htm
21 CFR 312 - Investigational New Drug (IND) Applications www.access.gpo.gov/nara/cfr/waisidx_99/21cfr312_99.html
21 CFR 812 - Investigational Device Exemptions (IDE's) www.access.gpo.gov/nara/cfr/waisidx_00/21cfr812_00.html
FDA ICH Good Clinical Practice Consolidated Guidelines www.fda.gov/cder/guidance/959fnl.pdf
ICH GCP Consolidated Guidelines,5/9/97 www.fda.gov/cder/guidance/iche6.htm
FDA Information Guidance Sheets www.fda.gov/oc/ohrt/irbs/default.htm
National Institutes of Health (NIH)
Office of Grants and Contracts grants.nih.gov/grants/oer.htm
National Human Genome Research Institute www.genome.gov/
Office for Human Subject Research Protection (OHRP)
IRB Guidebook www.hhs.gov/ohrp/irb/irb_guidebook.htm
OHRP Guidance (listed by topic) www.hhs.gov/ohrp/policy/index.html#topics
OHRP Compliance Oversight Procedures www.hhs.gov/ohrp/references/ohrpcomp.pdf
Human Subject Regulations Decision Charts www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm
Other Sites of Interest
AAMC Research www.aamc.org/research/start.htm
Public Responsibility in Medicine and Research www.primr.org/
AAMC Research Compliance Resources www.aamc.org/research/start.htm
ClinicalTrials.gov clinicaltrials.gov