IRB Guidance

IRB Guidance Documents

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 – All 26 Chapters (http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html)
4. The Nuremberg Code (http://www.hhs.gov/ohrp/archive/nurcode.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:
       (https://www.fda.gov/regulatory-information/search-fda-guidance-documents)
4. Protection of Human Subjects:
       (www.gpo.gov)
5. Institutional Review Boards:
       (www.gpo.gov)
6. Health Insurance Portability and Accountability Act (HIPAA):
   https://www.hhs.gov/hipaa/index.html
7. Jesse’s Intent:
       http://www.circare.org/submit/jintent.pdf

3. IRB Instructions & Forms