Web Links

General Information
Information about federally and privately supported
clinical research involving human volunteers
http://www.clinicaltrials.gov

Clinical trial information for patients and general resources
and industry and professional resources
http://www.centerwatch.com

Belmont Report - ethical principles in the conduct of research
http://ohsr.od.nih.gov/guidelines/belmont.html

Federal agencies and other resources
US Food and Drug Administration website with clinical trial information
http://www.fda.gov/

National Cancer Institute clinical trial information includes educational resources
http://www.nci.nih.gov/clinicaltrials/resources/clinical-trials-education-series

National Institute of Health Clinical Center information for
researchers and research subjects
http://www.cc.nih.gov/

National Institute Library of Medicine website with
general to specific clinical trial information
http://www.nlm.nih.gov/medlineplus/clinicaltrials.html

National Institute of Mental Health website with information regarding
participation in mental health clinical trials
http://www.nimh.nih.gov/Publicat/clinres.cfm

Local institutions
Froedtert Hospital clinical trial information
http://www.froedtert.com/ClinicalResearch/
ClinicalTrialsBasics/ClinicalTrialsBasics.htm

Medical College of Wisconsin health information
http:// www.healthlink.mcw.edu

Information specifically for researchers
Office of Human Research Protections
http://www.hhs.gov/ohrp/

Code of Federal Regulations:

45 CFR 46 -
code of federal regulations regarding the protection of human subjects
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

21 CFR 50 -
code of federal regulations regarding enrollment into clinical trials
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/
cfCFR/CFRSearch.cfm?CFRPart=50&showFR=1

21 CFR 812 -
code of federal regulations regarding enrollment in device studies
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/
cfCFR/CFRSearch.cfm?CFRPart=812&showFR=1

IRB Guidebook
http://www.hhs.gov/ohrp/irb/irb_chapter5.htm#h1

NIH Bioethics Resource
http://www.nih.gov/sigs/bioethics/

National Cancer Institute Clinical Trials
http://www.cancer.gov/clinical_trials/

National Eye Institute Clinical Study Database
http:// www.nei.nih.gov/resources/

FDA Good Clinical Practice Information Sheets
http://www.fda.gov/oc/ohrt/irbs/default.htm

International Conference on Harmonization for Good Clinical Practices E6
http://www.fda.gov/cder/guidance/959fnl.pdf