Published on Human Subjects Office (https://hso.research.uiowa.edu)


Federal & State Regulations & Guidance Materials [1]

Department of Health and Human Services (DHHS)

OHRP [2] - Office for Human Research Protections

  • 45 CFR 46 [3] - Federal Regulations for the Protection of Human Subjects

OCR [4] - Office for Civil Rights - HIPAA

  • 45 CFR 164 [5] - Health Insurance Portability and Accountability Act (HIPAA) Security and Privacy Regulations

NIH [6] - National Institutes of Health

  • Education:

    • NIH Education Requirement [7] - Frequently Asked Questions regarding the NIH Education Requirement
    • NIH Bioethics Resources [8]
  • Data and Safety Monitoring Boards:

    • NIH Policy for Data & Safety Monitoring [9]
    • Guidance on Data & Safety Monitoring for Phase I & Phase II Trials [10]
    • National Eye Institute (NEI): Data & Safety Monitoring [11]
    • National Institute on Aging (NIA) Policies for Human Intervention Studies [12]
  • Special Topics:

    • Certificates of Confidentiality [13]
    • Data Sharing [14]
    • Guidelines for the Administration of Drugs to Human Subjects [15]
    • Guidelines for Research Involving Recombinant DNA Molecules [16]
    • Inclusion of Children in Research [17]
    • Inclusion of Women & Minorities in Research [18]
    • Letters or Notices from the FDA to NIH Grantees [19]
    • New Review Criteria for Research Project Applications Involving Clinical Trials [20]
    • Research Involving Human Pluripotent Stem Cells [21]
    • Research on Human Specimens [22]
    • Use of a Single Institutional Review Board for Multi-Site Research [23]

FDA [24] - Food and Drug Administration

  • 21 CFR 50 [25] - FDA regulations for  Protection of Human Subjects
  • 21 CFR 56 [26] - FDA regulations for Institutional Review Boards
  • FDA Information Sheets [27] - guidance for IRBs and clinical investigators on interpreting 21 CFR 50 and 56
  • Good Clinical Practice in FDA-Regulated Clinical Trials [28] - FDA web site for investigators conducting clinical trials
  • Good Clinical Practice:  Consolidated Guidance [27] - ICH guidance for investigators, sponsors, and IRBs
  • Data and Safety Monitoring Boards [29] - guidance for sponsors on establishing and operating a clinical trial data safety monitoring committee
  • Payment and Reimbursement to Research Subjects [30] - guidance on compensating subjects

CDER [31] - Center for Drug Evaluation and Research (Investigational New Drugs)

  • 21 CFR 312 [25] - FDA regulations for Investigational New Drugs
  • Information for Clinical Investigators [32] - guidance for clinical investigators involved in clinical trials of investigational drugs
  • International Conference on Harmonisation [33] (ICH) - guidance from regulatory authorities from Europe, Japan, and US regarding drug development (click on "Guidelines")

CDRH [34] - Center for Devices and Radiological Health (Investigational Medical Devices)

  • 21 CFR 812 [35] - FDA regulations for Investigational Device Exemptions
  • 21 CFR 814.100 [36] - 126 - FDA regulations for Humanitarian Use Devices
  • Humanitarian Device Exemption (HDE) [37] - questions and answers from the FDA

VHA [38] - Veterans Health Administration 

  • ORO [39] (Office of Research Oversight)

NSF [40] - National Science Foundation 

  • Human Subjects [41] - basic policy information
  • Behavioral and Social Science Research [42] - NSF interpretation of applying IRB regulations to behavioral/social science research

General

  • The Belmont Report [43]
  • The Nuremberg Code [44]
  • Declaration of Helsinki [45]
  • The Common Rule - Federal Policy for the Protections of Human Subjects [46]
  • Guidelines for Assessing the Decision-Making Capacities of Potential Research Subjects with Cognitive Impairment [47], Sourced from Am J Psychiatry 155:11, November 1998 

Source URL: https://hso.research.uiowa.edu/federal-state-regulations-guidance-materials

Links:
[1] https://hso.research.uiowa.edu/federal-state-regulations-guidance-materials
[2] http://www.dhhs.gov/ohrp/index.html
[3] http://www.dhhs.gov/ohrp/humansubjects/guidance/45cfr46.html
[4] http://www.hhs.gov/ocr/privacy/
[5] http://www.gpo.gov/fdsys/search/pagedetails.action?collectionCode=CFR&searchPath=Title+45%2FSubtitle+A%2FSubchapter+C%2FPart+164&granuleId=&packageId=CFR-2007-title45-vol1&oldPath=Title+45%2FSubtitle+A%2FSubchapter+C%2FPart+164&fromPageDetails=true&collapse=false&ycord=83
[6] http://www.nih.gov/
[7] http://grants.nih.gov/grants/policy/hs_educ_faq.htm
[8] http://bioethics.od.nih.gov/
[9] http://grants.nih.gov/grants/guide/notice-files/not98-084.html
[10] http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html
[11] http://grants.nih.gov/grants/guide/notice-files/not-ey-01-002.html
[12] http://www.nia.nih.gov/
[13] http://grants.nih.gov/grants/policy/coc/index.htm
[14] http://grants.nih.gov/grants/policy/data_sharing/
[15] http://www.drugabuse.gov/funding/clinical-research/nacda-guidelines-administration-drugs-to-human-subjects
[16] http://www.ors.od.nih.gov/sr/dohs/BioSafety/rDNA/Pages/guide.aspx
[17] http://grants.nih.gov/grants/funding/children/children.htm
[18] http://grants.nih.gov/grants/funding/women_min/women_min.htm
[19] http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-053.html
[20] https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-118.html
[21] http://stemcells.nih.gov/index.asp
[22] http://grants.nih.gov/grants/policy/hs/specimens.htm
[23] https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html
[24] http://www.fda.gov/
[25] http://www.gpo.gov/fdsys/pkg/CFR-2003-title21-vol1/content-detail.html
[26] http://www.gpo.gov/fdsys/pkg/CFR-2012-title21-vol1/pdf/CFR-2012-title21-vol1-sec56-102.pdf
[27] http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm113709.htm
[28] http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm
[29] http://www.fda.gov/RegulatoryInformation/Guidances/ucm127069.htm
[30] https://www.fda.gov/RegulatoryInformation/Guidances/ucm126429.htm?utm_campaign=Payment%20for%20Research%20Subjects%20Information%20Sheet&utm_medium=email&utm_source=Eloqua
[31] http://www.fda.gov/Drugs/default.htm
[32] http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM164819.pdf
[33] http://www.ich.org/
[34] http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/default.htm
[35] http://www.gpo.gov/fdsys/search/searchresults.action;jsessionid=RT6HQhrJGLpPvJqldB5p8SNL1TYRCVyvQCLwLDgpxz9Ypc2H7vpZ!292616404!1255788395?st=21+cfr+812
[36] http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=814.100
[37] http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/HumanitarianDeviceExemption/default.htm
[38] http://www.va.gov/
[39] http://www.va.gov/oro/
[40] http://www.nsf.gov
[41] http://www.nsf.gov/bfa/dias/policy/human.jsp
[42] http://www.nsf.gov/bfa/dias/policy/hsfaqs.jsp
[43] http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
[44] http://history.nih.gov/research/downloads/nuremberg.pdf
[45] http://www.cirp.org/library/ethics/helsinki/
[46] http://www.hhs.gov/ohrp/humansubjects/commonrule/
[47] https://hso.research.uiowa.edu/sites/hso.research.uiowa.edu/files/cogimpair.doc