Helpful IRB Website Links

The Belmont Report – This report is the basis for all U.S. Federal regulations pertaining to human research ethics.

http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html 

Declaration of Helsinki – An international statement with updates of principals of ethical research.

http://www.wma.net/en/30publications/10policies/b3/index.html

Decision Charts from OHRP – Eleven Charts designed to help evaluate whether the project is human research that must be approved by an IRB, whether the research may be approved by expedited review, and whether informed consent or its documentation may be waived.

http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html 

Expedited Review Categories – A listing of categories of research which may be approved by an expedited process including some examples.

http://www.hhs.gov/ohrp/policy/exprev.html

FDA Information Sheets – Guidances and frequently asked questions from the FDA.

http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm113709.htm

AND

http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/default.htm

Good Clinical Practices – An international statement of acceptable clinical practices for all phases of clinical trials.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073122.pdf

IRB Forum Links – A free online reference with IRB-related material, including search and archived materials and opportunity to post questions.  A List-Serv.

http://www.irbforum.org/links/

Informed Consent Tutorial – U of Minnesota – A step by step tutorial to writing an informed consent document.

http://www.research.umn.edu/consent/orientation.html

Medical Terms – Dictionary of Medical Terms online

http://www.medterms.com/script/main/hp.asp

OHRP IRB Guidebook – A basic guidebook on IRBs, their administration, regulations, investigator responsibilities, and reference materials.

http://www.hhs.gov/ohrp/archive/irb/irb_guidebook.htm 

NIH – Bioethics Website – An excellent and frequently updated listing and links to websites of listing to anyone involved in research.