Related Resources
Other HHS human-subject protection regulation sites
FDA (Food and Drug Administration)
ORI (Office of Research Integrity)
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Common Rule Agencies/Departments
Human subject research conducted or supported by each federal department/agency listed below is governed by the regulations of that department/agency. The head of that department/agency retains final judgment as to whether a particular activity it conducts or supports is covered by the Common Rule. If an institution seeks guidance on implementation of the Common Rule and other applicable federal regulations, the institution should contact the department/agency conducting or supporting the research.
The federal department/agency that conducts or supports research retains final authority for determining whether an institution has complied with its regulations for the protection of human subjects. If HHS receives an allegation or indication of noncompliance related to human subject research that is conducted or supported solely by a Common Rule department/agency other than HHS, HHS will refer the matter to that department/agency for review and action as appropriate.
Department of Agriculture
Department of Energy
National Aeronautics and Space Administration
Department of Commerce
Consumer Product Safety Commission
Agency for International Development (USAID)
Department of Housing and Urban Development
Department of Justice
Department of Defense
Department of Education
Department of Veterans Affairs
Environmental Protection Agency
National Science Foundation
Department of Transportation
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Historical Documents/Information
Statutory Basis for 45 CFR Part 46
Nuremberg Code
Declaration of Helsinki
Belmont Report Historical Archive
Protection of Human Subjects (1994 Presidential Memorandum)
Henry Beecher 1966 New England Journal of Medicine article "Ethics and Clinical Research" [PDF]
Ethical Issues in Research Involving Human Participants, Bibliography
Ethical and Legal Aspects of Human Subjects Research in Cyberspace; a report from the AAAS Program on Scientific Freedom, Responsibility and Law, in collaboration with NIH/OPRR (http://www.aaas.org/spp/sfrl/projects/intres/report.pdf)
Evaluation of NIH Implementation of Section 491 of the PHS Act, Mandating a Program of Protection for Research Subjects - "Bell Report"
National Bioethics Advisory Commission (http://www.georgetown.edu/research/nrcbl/nbac/)
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Human Subjects Protection Federal Register Notices
2009
2008
2007
2006
2005
2004
2003
2002
2001
2000
1999
1998
1997
1996
1995
1994
1993
1992
1991
1990
1989
1988
1987
1986
1985
1984
1983
1982
1981
1980
1979
1978
1977
1976
1975
1974
1973
1972
1971
1970
1969
1968
1967
1966
1965
Before 1965
2009
January 15, 2009 -- Final Rule, OPHS, Institutional Review Boards: Registration Requirements [PDF - 160KB]
January 15, 2009 -- Final Rule, FDA, Institutional Review Boards: Registration Requirements [PDF - 239KB]
2008
October 23, 2008 -- Notice, HHS, Final Guidance on Engagement of Institutions in Human Subjects
Research [PDF - 54KB]
August 27, 2008 -- Notice, HHS, Agency Information Collection Request; 60-Day Public Comment Request for Former Optional Form 310 [PDF - 51KB]
July 1, 2008 -- Notice, HHS, Request for Information Regarding OHRP Education Program [PDF - 66KB]
June 23, 2008 -- Notice, HHS, July 15-16 SACHRP Meeting [PDF]
March 11, 2008 -- Notice, HHS, Meeting of Secretary's Advisory Committee on Human Research Protections [PDF]
January 29, 2008 -- Notice, HHS, Agency Information Collection Request; 30-Day Public Comment Request for Federalwide Assurance (FWA) [PDF]
January 29, 2008 -- Notice, HHS, Agency Information Collection Request; 30-Day Public Comment Request for IRB/IEC Registration [PDF]
January 2, 2008 -- Notice, HHS, Extension of Comment Period of Request for Information and Comments on Research That Involves Adult Individuals With Impaired Decision-Making Capacity [PDF]
2007
November 14, 2007 -- Notice, HHS, Agency Information Collection Request; 60-Day Public Comment Request for Federalwide Assurance (FWA) [PDF]
November 14, 2007 -- Notice, HHS, Agency Information Collection Request; 60-Day Public Comment Request for IRB/IEC Registration [PDF]
November 7, 2007 -- Notice, HHS, Solicitation of Nominations for Membership on the Secretary's Advisory Committee on Human Research Protections [PDF]
October 26, 2007 -- Notice, HHS, Expedited Review List Request for Comments [PDF]
September 24, 2007 -- Notice, HHS, October 29-309 SACHRP Meeting [PDF]
September 5, 2007 -- Notice, HHS, Request for Information and Comments on Research That Involves Adult Individuals With Impaired Decision-making Capacity [PDF]
June 25, 2007 -- Notice, HHS, July 30-31 SACHRP Meeting [PDF]
March 6, 2007 -- Notice, HHS, March 29-30 SACHRP Meeting [PDF]
2006
December 8, 2006 -- Notice, HHS, Request for Public Comment on OHRP Draft Guidance Document on Engagement of Institutions in Human Subjects Research [PDF]
October 31, 2006 -- Notice, HHS, Proposed Information Collection for Evaluation of OHRP Education Program [PDF]
October 24, 2006 -- Notice, HHS, November 2 SACHRP Meeting [PDF]
July 13, 2006 -- Notice, HHS, July 31 SACHRP Meeting [PDF]
July 7, 2006 -- Notice, HHS, Protection of Human Subjects: Interpretation of Assurance Requirements [PDF]
June 7, 2006 -- Interim Final Rule, HHS, FDA, Medical Device Consent Exception [PDF]
April 27, 2006 -- Notice, HHS, Solicitation for SACHRP Nominations [PDF]
February 23, 2006 -- Notice, HHS, March 13 SACHRP Meeting [PDF]
January 17, 2006 -- ANPRM Withdrawal, HHS, FDA, Inform IRBs of Prior IRB Review [PDF]
2005
December 13, 2005 -- Notice, HHS, Proposed Information Collection for Evaluation of OHRP Education Program [PDF]
October 14, 2005 -- Notice, HHS, SACHRP Meeting November 1, 2005 [PDF]
October 7, 2005 -- Notice, HHS, Secretarial Review of Pediatric Gonadotropin-Releasing Hormone Agonist Study [PDF]
August 22, 2005 -- Notice, HHS, Solicitation for SACHRP Nominations [PDF]
July 5, 2005 -- Notice, HHS, August 1 SACHRP Meeting [PDF]
June 23, 2005 -- Final Rule, HHS, Technical Amendments to the Federal Policy for the Protection of Human Subjects [PDF]
May 25, 2005 -- Notice, HHS, Secretarial Review of Pediatric Surfactant Study [PDF]
April 15, 2005 -- Notice, HHS, Proposed Information Collection for the OHRP Fellowship Program [PDF]
March 28, 2005 -- Notice, HHS, April 28, 2005, SACHRP Meeting [PDF]
March 25, 2005 -- Notice, HHS, Availability of Equivalent Protections Working Group Report [PDF]
February 8, 2005 -- Notice, EPA, Human Testing; Proposed Plan and Description of Review Process [PDF]
February 2, 2005 - Notice, FDA, Anthrax Vaccine Emergency Use [PDF]
2004
October 25, 2004 -- Notice, HHS, SACHRP Member Solicitation [PDF]
August 4, 2004 -- Notice, OPHS and FDA, Secretarial Review of Pediatric Study of Dextroamphetamine [PDF]
July 6, 2004 -- NPRM, HHS, IRB Registration Requirements [PDF]
July 6, 2004 -- NPRM FDA, IRB Registration Requirements [PDF]
June 10, 2004 -- NPRM, FDA, Foreign Studies Requirement [PDF]
May 12, 2004 -- Notice, HHS, Final Financial Relationships Guidance [PDF]
February 19, 2004 -- Notice, HHS, SACHRP Nominations [PDF]
2003
November 24, 2003 -- Notice, HHS, SACHRP Meeting December 11-12, 2003. [PDF]
October 22, 2003 -- Notice, HHS, Statement of OHRP Functions [PDF]
July 16, 2003 -- Notice, HHS, Secretarial Review of Pediatric Study of HIV Replication and Thymopoiesis [PDF]
July 3, 2003 -- Notice, HHS, SACHRP Meeting July 22, 2003 [PDF]
June 20, 2003 -- Notice, HHS, Final Action on Epidemiological Waiver [PDF]
June 13, 2003 -- Notice, HHS, Secretarial Review of Pediatric Study of Sleep Metabolism [PDF]
June 13, 2003 -- Notice, HHS, Secretarial Review of Pediatric Study of Cystic Fibrosis Bronchoalveolar Lavage [PDF]
April 14, 2003 - Notice, HHS, Secretarial Review of Pediatric Study of Alcohol, Sleep, and Circadian Rhythms [PDF]
March 31, 2003 -- Notice, HHS, Draft Financial Interest Guidance [PDF]
2002
December 18, 2002 -- Notice, HHS, Secretarial Review of Pediatric Study of Precursors to Diabetes in Japanese-American Youth [PDF]
October 31, 2002 -- Notice, HHS, Secretarial Review of Pediatric Study of Dryvax
[PDF]
October 7, 2002 -- Notice, HHS, Proposed Waiver for Epidemiological Studies in Prisoners [PDF]
August 7, 2002 -- Notice, HHS, Secretarial Review of Pediatric Study of Precursors to Diabetes in Japanese-American Youth [PDF]
May 8, 2002 -- Notice, HHS, Quality Improvement Instrument Notice [PDF]
April 19, 2002 -- Notice, HHS, Federal-Wide Assurance Notice [PDF]
March 13, 2002 -- Notice, HHS, NHRPAC Meeting April 29-30, 2002 [PDF]
March 6, 2002 -- Notice, HHS, Statement of OHRP Functions [PDF]
January 9, 2002 -- Notice, HHS, NHRPAC Meeting January 28-29, 2002 [PDF]
2001
November 13, 2001 -- Notice, HHS, Subpart B Final Rule [PDF]
October 3, 2001 -- Notice, HHS, NHRPAC Meeting October 30-31, 2001 [PDF]
July 9, 2001 -- Notice, HHS, NHRPAC Meeting July 30-31, 2001 [PDF]
July 6, 2001 -- NPRM, HHS, Subpart B [PDF]
May 18, 2001 -- Notice, HHS, Subpart B Effective Date Delay [PDF]
March 26, 2001 -- Notice, HHS, NHRPAC Meeting [PDF]
March 19, 2001 -- Notice, HHS, Subpart B Effective Date Delay [PDF]
January 17, 2001 -- Final Rule, HHS, Subpart B [PDF]
2000
July 3, 2000 -- Notice, HHS, Financial Relationships Conference [PDF]
June 19, 2000 -- Notice, HHS, NHRPAC Establishment [PDF]
June 13, 2000 - Notice, HHS, OHRP Establishment [PDF]
1998
November 9, 1998 -- Notice, HHS, FDA, Expedited review List Categories [PDF]
November 9, 1998 -- Final Rule, HHS, Expedited Review Categories [PDF]
May 20, 1998 -- NPRM, HHS, Subpart B [PDF]
1997
December 18, 1997 -- Notice, HHS, Assurance Paperwork Reduction Act [PDF]
November 10, 1997 -- Notice, HHS, FDA, Expedited Review List Revision Proposal [PDF]
November 10, 1997 -- Notice, HHS, Expedited Review List Revision Proposal [PDF]
August 22, 1997 -- Notice, HHS, Assurance Paperwork Reduction Act [PDF]
1996
October 2, 1996 -- Final Rule, FDA, Informed Consent Emergency Research Waiver [PDF]
October 2, 1996 -- Notice, HHS, Informed Consent Exemption for Emergency Research [PDF]
July 8, 1996 -- Notice, HHS, Intent to Propose Revisions in Recombinant DNA Policy [PDF]
1995
September 21, 1995 -- NPRM, HHS, FDA, Emergency Research Consent Exception [PDF]
July 26, 1995 -- Notice, HHS, Action Regarding Emergency Research [PDF]
1994
August 12, 1994 -- Notice, OSTP, request for Comment on NBAC Charter [pdf]
June 1, 1994 -- Final Rule, HHS, Delete Ethics Advisory Board [pdf]
January 20, 1994 -- Notice, President, Advisory Commission on Human Radiation Experiments [pdf]
1991
June 18, 1991 -- Final Rule, HHS, FDA, Revisions Conforming to Federal Policy [pdf]
June 18, 1991 -- Final Rule, OSTP, Federal Policy for Protection of Human Subjects [pdf]
1990
December 21, 1990 -- Interim Final Rule, HHS, FDA, Combat Informed Consent Waiver for Drugs and Biologics [pdf]
1988
November 10, 1988 -- NPRM, OSTP, Proposed Model Federal Policy [pdf]
1986
June 3, 1986 -- NPRM, OSTP, Proposed Model Federal Policy [pdf]
1983
July 28, 1983 -- Notice, HHS, President's Commission Availability of Reports [pdf]
March 8, 1983 -- Final Rule, HHS, Research Involving Children [pdf]
March 4, 1983 -- Final Rule, HHS, Additional Exemption for HCFA [pdf]
1982
November 23, 1982 -- Notice, HHS, President's Commission Report Compensating for Research Injuries [pdf]
March 29, 1982 -- Notice, HHS, President's Commission Report Protection of Human Subjects [pdf]
March 22, 1982 -- NPRM, HHS, Additional Exemption for HCFA [pdf]
1981
December 18, 1981 -- NPRM, HHS, FDA, Reproposal Prisoners [pdf]
September 11, 1981 -- Notice, HHS, FDA, request for Comment on Drug Approval Process [pdf]
July 7, 1981 -- Final Rule, HHS, FDA, Change of Effective Date Prisoners [pdf]
March 27, 1981 -- Final Rule, HHS, FDA, Delay of Effective Date Prisoners [pdf]
January 27, 1981 -- Final Rule, HHS, FDA, Informed Consent, Standards for Institutional Review Boards [pdf]
January 26, 1981 -- Final Rule, HHS, Amendment to Basic Protections for Human Subjects [pdf]
1980
May 30, 1980 -- Final Rule, HEW, FDA, Prisoners [pdf]
1979
August 14, 1979 -- Notice, HEW, Ethical Advisory Board Report - Fetoscopy [pdf]
August 14, 1979 -- NPRM, HEW, Amendment to Basic Protections for Human Subjects [pdf]
May 25, 1979 -- Notice, HEW, National Commission Report Protections of Human Subjects, ELSI [pdf]
April 24, 1979 -- NPRM, HEW, FDA, Children [pdf]
April 18, 1979 -- Notice, HEW, National Commission Belmont Report [pdf]
April 4, 1979 -- Final Rule, HEW, Protection of Identity of research Subjects [pdf]
1978
November 30, 1978 -- Notice, HEW, National Commission Report Institutional Review Boards [pdf]
November 17, 1978 -- NPRM, HEW, Additional Protections for Those Institutionalized as Mentally Disabled [pdf]
November 16, 1978 -- Final Rule, HEW, Additional Protections for Prisoners [pdf]
November 15, 1978 -- Notice, HEW, Determination of Secretary Regarding Psychosurgery [pdf]
November 3, 1978 -- Interim Final Rule, HEW, Amendment to Informed Consent Definition [pdf]
August 8, 1978 -- NPRM, HEW, FDA, Obligations of Clinical Investigators [pdf]
August 8, 1978 -- NPRM, HEW, FDA, Standards for Institutional Review Boards [pdf]
July 21, 1978 -- NPRM, HEW, Research Involving Children [pdf]
May 5, 1978 -- NPRM, HEW, FDA Research Involving Prisoners [pdf]
March 17, 1978 -- Notice, HEW, National Commission Report Research Involving Those Institutionalized as Mentally Infirm [pdf]
January 11, 1978 -- Final Rule, HEW, Additional Protections for Fetuses, Pregnant Women [pdf]
January 5, 1978 -- NPRM, HEW, Proposed Regulations on Research Involving Prisoners [pdf]
1977
May 23, 1977 -- Notice, HEW, National Commission report on Psychosurgery [PDF]
January 14, 1977 -- Notice, HEW, National Commission Report on Research Involving Prisoners [PDF]
January 13, 1977 -- NPRM, HEW, Amendments Concerning Fetuses, Pregnant Women and In-Vitro Fertilization [PDF]
1976
1975
August 8, 1975 -- Final Rule, HEW, Protection of Human Subjects - Fetuses, Pregnant Women, and In Vitro Fertilization [PDF]
July 1, 1975 -- Final Rule, HEW, Confidentiality of Alcohol and Drug Abuse Patient Records [PDF]
March 13, 1975 -- Final Rule, HEW, Technical Amendments to 45 CFR part 46 [PDF]
1974
August 23, 1974 -- NPRM, HEW, Protection of Human Subjects, Proposed Policy [PDF]
May 30, 1974 -- Final Rule, HEW, Protection of Human Subjects [PDF]
1973
November 16, 1973 -- Notice, HEW, NIH, Protection of Human Subjects, Policies and Procedures [PDF]
October 9, 1973 -- NPRM, HEW, Protection of Human Subjects, Proposed Policy [PDF]
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International Documents
Nuremberg Code
Declaration of Helsinki
International Conference on Harmonization - Guideline for Good Clinical Practice
CIOMS International Ethical Guidelines
Canadian Tri-Council Policy Statement
Indian Council of Medical Research
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