Research Compliance Office
Published on Research Compliance Office (https://researchcompliance.stanford.edu)

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Regulations

Belmont report [1]


California Law: Protection of Human Subjects in Medical Experimentation Act [2]

 

FDA: Food and Drug Administration [3]

  • Informed Consent  [4](guidance)
  • 21 CFR Part 50 [5] - Protection of Human Subjects
  • 21 CFR Part 56 [6] - Institutional Review Boards
  • 21 CFR Part 312 [7] - Investigational New Drug Applications (INDs)
  • 21 CFR Part 812 [8] - Investigational Device Exemptions (IDEs)
  • Information Sheet Guidances [9] for IRBs, Investigators and Sponsors
    • Significant Risk and Nonsignificant Risk Medical Device Studies [10]
  • IRB Frequently Asked Questions [11]
  • Clinical Trials and Human Subject Protections [12] - Guidance, resources, good clinical practices (GCPs)
  • Human Tissue Intended for Transplantation [13]
  • Human Cells, Tissues, and Cellular and Tissue-Based Products [14]
  • FDA Tissue and Tissue Product Q&A  [15]
     

OHRP: Office of Human Research Protections [16]

  • Title 45 CFR 46: Protection of Human Subjects [17]
  • Policy guidance and documents [18]
  • Decision Charts - Human Subject Regulations [19]
  • Inclusion of Children - Policy Implementation (NIH) [20]
  • Certificates of Confidentiality [21]
  • International Compilation of Human Research Protections [22] - listing laws, regulations, and guidelines on human subjects research in over 100 countries, and standards from international and regional organizations
  • International Compilation of Social-Behavioral Human Research Protections [23] – Similar to the “International Compilation of Human Research Protections” listed above, but including only standards for social-behavioral research.
  • OHRP Frequently Asked Questions [24]

 

VA: Department of Veterans Affairs [25]

  • 38 CFR Part 16 [26]
  • Office of Research & Development (ORD) Programs [27]
    • Human Research Policies and Guidance [28]
  • VHA Publications website including: [29]
    • VHA Directive 1200.05 [30] - Requirements for the Protection of Human Subjects in Research
    • VHA Handbook 1058.01 [31] - Research Compliance Reporting Requirements
    • VHA Handbook 1108.04 [32] - Investigational Drugs and Supplies
  • VA Directive 6500 - Managing Information Security Risk: VA Information Security Program [33]

 

International Research

  • International Compilation of Human Research Protections [34] (OHRP) - listing laws, regulations, and guidelines on human subjects research in over 100 countries, and standards from international and regional organizations

Source URL: https://researchcompliance.stanford.edu/panels/hs/policies/regulations

Links
[1] http://www.hhs.gov/ohrp/policy/belmont.html
[2] http://leginfo.legislature.ca.gov/faces/codes_displayText.xhtml?lawCode=HSC&division=20.&title=&part=&chapter=1.3.&article=
[3] http://www.fda.gov/
[4] http://www.fda.gov/RegulatoryInformation/Guidances/ucm126431.htm
[5] http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=50
[6] http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=56
[7] http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=312
[8] http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=812
[9] http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm113709.htm
[10] http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126418.pdf
[11] http://www.fda.gov/RegulatoryInformation/Guidances/ucm126420.htm
[12] http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm
[13] https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1270
[14] https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1271
[15] https://www.fda.gov/vaccines-blood-biologics/tissue-tissue-products/tissue-and-tissue-product-questions-and-answers
[16] http://www.hhs.gov/ohrp/
[17] http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html
[18] https://www.hhs.gov/ohrp/regulations-and-policy/index.html
[19] https://www.hhs.gov/ohrp/regulations-and-policy/decision-charts/index.html
[20] https://grants.nih.gov/grants/funding/children/children.htm
[21] http://grants2.nih.gov/grants/policy/coc/
[22] https://www.hhs.gov/ohrp/international/compilation-human-research-standards/index.html
[23] https://www.hhs.gov/ohrp/international/social-behavioral-research-standards/index.html
[24] http://answers.hhs.gov/ohrp/categories
[25] http://www.research.va.gov/
[26] http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=114946adcd2b776336899ff2a0f59458&n=38y1.0.1.1.18&r=PART&ty=HTML
[27] http://www.research.va.gov/programs/
[28] https://www.research.va.gov/resources/policies/human_research.cfm
[29] https://www.va.gov/vhapublications/publications.cfm?pub=2
[30] https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8171
[31] https://www.va.gov/ORO/Docs/Checklists/VHA_Directive_1058_01_Research_Compliance_Reporting_Requirements.pdf
[32] https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2497
[33] https://stanfordmedicine.box.com/shared/static/99adu40ktdf1eksf8oc33ctpfbd5pez2.pdf
[34] https://www.hhs.gov/ohrp/sites/default/files/2019-International-Compilation-of-Human-Research-Standards.pdf