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Helpful IRB Website Links

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

 

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

https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/

 

  • 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/expedited98.html    and

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

 

  • FDA Information Sheets – Guidance and frequently asked questions from the FDA.

https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/clinical-trials-guidance-documents

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

https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/regulations-good-clinical-practice-and-clinical-trials

 

  • 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.

https://www.hhs.gov/ohrp/regulations-and-policy/guidance/index.html

 

  • NIH—Bioethics Website—This is an excellent and frequently updated listing with links to websites for anyone involved in research.

https://www.bioethics.nih.gov/home/index.shtml

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