IRB Guidance Documents
University of Pikeville

1. IRB Policies and Procedures 2012 (UPIKE-IRB Policies and Procedures) The following websites provide information about research ethics and regulations. Office for Human Research Protections (OHRP)
  1. OHRP Home Page (http://www.hhs.gov/ohrp/)
  2. Federal Regulations for Research with Human Subjects (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html) Department of Health and Human Services, 45 CFR, Part 46 Including Subpart D, Additional DHHS Protections for Children Involved as Subjects in Research IRB Guidebook for Protecting Human Research Subjects
  3. The Belmont Report Synopsis (IRB_BelmontReportSynopsis)  
  4. The Belmont Report – All 26 Chapters (http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html)
  5. The Nuremberg Code (http://www.hhs.gov/ohrp/archive/nurcode.html)  
  6. The World Medical Association Declaration of Helsinki (http://www.wma.net/en/30publications/10policies/b3/index.html
2. U.S. Food and Drug Administration (FDA)

  1. FDA Home Page
         (http://www.fda.gov/)
  2. FDA Regulations
         (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50&showFR=1)
  3. FDA Guidance Documents
         (http://www.fda.gov/RegulatoryInformation/Guidances/ucm122046.htm)
  4. Protection of Human Subjects
         (www.gpo.gov
  5. Institutional Review Boards
         (www.gpo.gov)
  6. FDA Information Sheets
         (http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm113709.htm)

    Health Insurance Portability and Accountability Act (HIPAA)
         http://www.hhs.gov/ocr/privacy/hipaa/administrative/privacyrule/index.html

    Jesse's Intent
         http://www.circare.org/submit/jintent.pdf
3. IRB Instructions & Forms


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