Regulations

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

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]
Inclusion of Children - Policy Implementation (NIH) [19]
Certificates of Confidentiality [20]
International Compilation of Human Research Protections [21] - 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 [22] – Similar to the “International Compilation of Human Research Protections” listed above, but including only standards for social-behavioral research.
OHRP Frequently Asked Questions [23]

VA: Department of Veterans Affairs [24]

38 CFR Part 16 [25]
Office of Research & Development (ORD) Programs [26]
- Human Research Policies and Guidance [27]
VHA Publications website including: [28]
- VHA Directive 1200.05 [29] - Requirements for the Protection of Human Subjects in Research
- VHA Handbook 1058.01 [30] - Research Compliance Reporting Requirements
- VHA Handbook 1108.04 [31] - Investigational Drugs and Supplies
VA Directive 6500 - Managing Information Security Risk: VA Information Security Program [32]

International Research

International Compilation of Human Research Protections [33] (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://grants.nih.gov/grants/funding/children/children.htm
[20] http://grants2.nih.gov/grants/policy/coc/
[21] https://www.hhs.gov/ohrp/international/compilation-human-research-standards/index.html
[22] https://www.hhs.gov/ohrp/international/social-behavioral-research-standards/index.html
[23] http://answers.hhs.gov/ohrp/categories
[24] http://www.research.va.gov/
[25] http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=114946adcd2b776336899ff2a0f59458&n=38y1.0.1.1.18&r=PART&ty=HTML
[26] http://www.research.va.gov/programs/
[27] https://www.research.va.gov/resources/policies/human_research.cfm
[28] https://www.va.gov/vhapublications/publications.cfm?pub=2
[29] https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8171
[30] https://www.va.gov/ORO/Docs/Checklists/VHA_Handbook_1058.01_Research_Compliance_Reporting_Requirements.pdf
[31] https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2497
[32] https://stanfordmedicine.box.com/shared/static/99adu40ktdf1eksf8oc33ctpfbd5pez2.pdf
[33] https://www.hhs.gov/ohrp/sites/default/files/2019-International-Compilation-of-Human-Research-Standards.pdf