2012 2011 2010 2009 2008 2007 2006 2005 2004 2003 2002 2001 2000 1999 1998
2012
Notice, FDA - Draft Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE Is Needed; Availability (PDF - 177.5 KB)
November 20, 2012
Notice, HHS - Renewal of Charters for Certain Federal Advisory Committees (PDF - 195.2 KB)
October 26, 2012
Notice, HHS - Meeting of the Secretary's Advisory Committee on Human Research Protections (PDF - 170 KB)
September 20, 2012
Notice, HHS - Solicitation of Nominations for Membership on the Secretary's Advisory Committee on Human Research Protections (PDF - 193.8 KB)
September 7, 2012
Notice, HHS - Meeting of Secretary's Advisory Committee on Human Research Protections (PDF - 170.3 KB)
June 21, 2012
Notice, HHS - Agency Information Collection Request; 30-Day Public Comment Request (PDF - 173.2 KB)
June 20, 2012
Notice, HHS - Draft Guidance on Considerations in Transferring a Previously-Approved Research Project to a New IRB or Research Institution (PDF - 195.7 KB)
June 12, 2012
Notice, FDA - Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Considerations When Transferring Clinical Investigation Oversight to Another Institutional Review Board; Availability (PDF - 194.3 KB)
June 12, 2012
Notice, HHS - Agency Information Collection Request; 60-Day Public Comment Request (PDF - 173.3 KB)
April 18, 2012
Notice, FDA - Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Institutional Review Board Continuing Review After Clinical Investigation Approval; Availability (PDF - 149 KB)
February 27, 2012
Notice, HHS - Solicitation of Nominations for Membership on the Secretary's Advisory Committee on Human Research Protections (PDF - 142.5 KB)
February 16, 2012
Notice, HHS - Meeting of the Secretary's Advisory Committee on Human Research Protections (PDF - 144.9 KB)
February 9, 2012
2011
Notice, HHS - Solicitation of Nominations for Membership on the Secretary's Advisory Committee on Human Research Protections (PDF - 148.2 KB)
December 19, 2011
Notice, HHS - Meeting of the Secretary's Advisory Committee on Human Research Protections (PDF - 145.8 KB)
September 19, 2011
Notice, HHS - Guidance on Exculpatory Language in Informed Consent, Draft (PDF - 151.1 KB)
September 7, 2011
Notice, HHS - Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators; Extension of Comment Period (PDF - 140.6 KB)
September 1, 2011
Notice, HHS - Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators (PDF - 249.4 KB)
July 26, 2011
Notice, HHS - Meeting of the Secretary's Advisory Committee on Human Research Protections (PDF - 145.3 KB)
June 27, 2011
Notice, FDA - Medical Devices; Exception From General Requirements for Informed Consent (PDF - 158.9 KB)
June 24, 2011
Notice, HHS - Agency Information Collection Request; 30-Day Public Comment Request (PDF - 148.2 KB)
April 14, 2011
Notice, HHS - Secretary's Advisory Committee on Human Research Protections; Notice of Meeting (PDF - 138.9 KB)
March 1, 2011
Notice, FDA - Informed Consent Elements (PDF - 233.9 KB)
January 4, 2011
2010
Notice, HHS - Guidance on Institutional Review Board Approval of Research With Conditions (PDF - 144.2 KB)
December 1, 2010
Notice, HHS - Guidance on Institutional Review Board Continuing Review of Research (PDF - 151.1 KB)
December 1, 2010
Notice, HHS - Renewal of Charter for the Secretary’s Advisory Committee on Human Research Protections (PDF - 145.4 KB)
November 23, 2010
Notice, HHS - Meeting of Secretary’s Advisory Committee on Human Research Protections (PDF - 143.2 KB)
September 27, 2010
Notice, HHS - Draft Revision of the Federalwide Assurance (PDF - 145 KB)
September 23, 2010
Notice, HHS - Guidance on Withdrawal of Subjects From Research: Data Retention and Other Related Issues (PDF - 147.5 KB)
September 21, 2010
Notice, HHS - Meeting of the Secretary’s Advisory Committee on Human Research Protections (PDF - 140 KB)
June 30, 2010
Notice, HHS - Solicitation of Nominations for Membership on the Secretary's Advisory Committee on Human Research Protections (PDF - 137.5 KB)
May 26, 2010
Notice, HHS - Meeting of the Secretary's Advisory Committee on Human Research Protections (PDF - 133.7 KB)
February 19, 2010
Notice, FDA - Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Continuing Review After Clinical Investigation Approval (PDF - 138.3 KB)
January 13, 2010
2009
Notice, HHS, Draft Guidance on Institutional Review Board Continuing Review of Research (PDF - 60 KB)
November 6, 2009
Notice, HHS, Draft Guidance on Institutional Review Board Approval of Research With Conditions (PDF - 52 KB)
November 6, 2009
Notice, HHS, October 28-29 Meeting of Secretary's Advisory Committee on Human Research Protections (PDF - 46 KB)
October 13, 2009
Notice, FDA, Guidance for Institutional Review Boards, Frequently Asked Questions--Institutional Review Board Registration; Availability (PDF - 44 KB)
July 14, 2009
Notice, HHS, July 21-22 Meeting of Secretary's Advisory Committee on Human Research Protections (PDF - 44 KB)
July 6, 2009
Notice, HHS, NIH, Draft National Institutes of Health Guidelines for Human Stem Cell Research (PDF - 53 KB)
April 23, 2009
Notice, HHS, Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review Boards (PDF - 51 KB)
April 7, 2009
Notice, HHS, Agency Information Request; 30-Day Public Comment Request, IRB Registration Form (PDF - 47 KB)
March 24, 2009
ANPRM, HHS, Institutional Review Boards Accountability, Request for Comments (PDF - 60 KB)
March 5, 2009
Notice, HHS, March 3-4 Meeting of the Secretary's Advisory Committee on Human Research Protections (PDF - 43 KB)
February 12, 2009
Final Rule, OPHS, Institutional Review Boards: Registration Requirements (PDF - 160 KB)
January 15, 2009
Final Rule, FDA, Institutional Review Boards: Registration Requirements (PDF - 239 KB)
January 15, 2009
2008
Notice, HHS, Final Guidance on Engagement of Institutions in Human Subjects Research (PDF - 54 KB)
October 23, 2008
Notice, HHS, Agency Information Collection Request; 60-Day Public Comment Request for Former Optional Form 310 (PDF - 51 KB)
August 27, 2008
Notice, HHS, Request for Information Regarding OHRP Education Program (PDF - 66 KB)
July 1, 2008
Notice, HHS, July 15-16 SACHRP Meeting (PDF)
June 23, 2008
Notice, HHS, Meeting of Secretary's Advisory Committee on Human Research Protections (PDF)
March 11, 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 29, 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)
January 2, 2008
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 14, 2007
Notice, HHS, Solicitation of Nominations for Membership on the Secretary's Advisory Committee on Human Research Protections (PDF)
November 7, 2007
Notice, HHS, Expedited Review List Request for Comments (PDF)
October 26, 2007
Notice, HHS, October 29-309 SACHRP Meeting (PDF)
September 24, 2007
Notice, HHS, Request for Information and Comments on Research That Involves Adult Individuals With Impaired Decision-making Capacity (PDF)
September 5, 2007
Notice, HHS, July 30-31 SACHRP Meeting (PDF)
June 25, 2007
Notice, HHS, March 29-30 SACHRP Meeting (PDF)
March 6, 2007
2006
Notice, HHS, Request for Public Comment on OHRP Draft Guidance Document on Engagement of Institutions in Human Subjects Research (PDF)
December 8, 2006
Notice, HHS, Proposed Information Collection for Evaluation of OHRP Education Program (PDF)
October 31, 2006
Notice, HHS, November 2 SACHRP Meeting (PDF)
October 24, 2006
Notice, HHS, July 31 SACHRP Meeting (PDF)
July 13, 2006
Notice, HHS, Protection of Human Subjects: Interpretation of Assurance Requirements (PDF)
July 7, 2006
Interim Final Rule, HHS, FDA, Medical Device Consent Exception (PDF)
June 7, 2006
Notice, HHS, NIH, NCI, First-Generation Guidelines for NCI-Supported Biorepositories (PDF)
April 28, 2006
Notice, HHS, Solicitation for SACHRP Nominations (PDF)
April 27, 2006
Notice, HHS, March 13 SACHRP Meeting (PDF)
February 23, 2006
ANPRM Withdrawal, HHS, FDA, Inform IRBs of Prior IRB Review (PDF)
February 6, 2006
ANPRM Withdrawal, HHS, FDA, Inform IRBs of Prior IRB Review (PDF)
January 17, 2006
2005
Notice, HHS, Proposed Information Collection for Evaluation of OHRP Education Program (PDF)
December 13, 2005
Notice, HHS, SACHRP Meeting November 1, 2005 (PDF)
October 14, 2005
Notice, HHS, Secretarial Review of Pediatric Gonadotropin-Releasing Hormone Agonist Study (PDF)
October 7, 2005
NPRM, EPA, Intentional Dosing Human Testing for Pesticides (PDF)
September 12, 2005
Notice, HHS, Solicitation for SACHRP Nominations (PDF)
August 22, 2005
Notice, HHS, Proposed Extension of Information Collection for Common Rule (PDF)
August 18, 2005
Notice, HHS, August 1 SACHRP Meeting (PDF)
July 5, 2005
Final Rule, HHS, Technical Amendments to the Federal Policy for the Protection of Human Subjects (PDF)
June 23, 2005
Notice, HHS, Secretarial Review of Pediatric Surfactant Study (PDF)
May 25, 2005
Notice, HHS, Proposed Extension of Information Collection - Assurance Identification/Institutional Review Board (IRB) Certification/Declaration of Exemption (PDF)
May 19, 2005
Notice, HHS, Proposed Extension of Information Collection for Common Rule (PDF)
April 15, 2005
Notice, HHS, Proposed Information Collection for the OHRP Fellowship Program (PDF)
April 15, 2005
Notice, HHS, April 28, 2005, SACHRP Meeting (PDF)
March 28, 2005
Notice, HHS, Availability of Equivalent Protections Working Group Report (PDF)
March 25, 2005
Notice, EPA, Human Testing; Proposed Plan and Description of Review Process (PDF)
February 8, 2005
Notice, FDA, Anthrax Vaccine Emergency Use (PDF)
February 2, 2005
Notice, HHS, Anthrax Vaccine Emergency Use (PDF)
February 2, 2005
Notice, HHS, Proposed Information Collection for the OHRP Fellowship Program (PDF)
February 2, 2005
2004
Notice, HHS, January 31, 2005 SACHRP Meeting (PDF)
December 16, 2004
Notice, HHS, SACHRP Member Solicitation (PDF)
October 25, 2004
Notice, OPHS and FDA, Secretarial Review of Pediatric Study of Dextroamphetamine (PDF)
August 4, 2004
NPRM, HHS, IRB Registration Requirements (PDF)
July 6, 2004
NPRM FDA, IRB Registration Requirements (PDF)
July 6, 2004
Notice, HHS, Proposed Extension of Information Collection for Federalwide Assurance (FWA) (PDF)
June 25, 2004
Notice, HHS, July 26, 2004 Meeting of SACHRP (PDF)
June 24, 2004
NPRM, FDA, Foreign Studies Requirement (PDF)
June 10, 2004
Notice, HHS, Final Financial Relationships Guidance (PDF)
May 12, 2004
Notice, HHS, SACHRP Nominations (PDF)
February 19, 2004
Notice, HHS, March 29, 2004 Meeting of SACHRP (PDF)
February 19, 2004
2003
Notice, HHS, SACHRP Meeting December 11-12, 2003 (PDF)
November 24, 2003
Notice, HHS, Statement of OHRP Functions (PDF)
October 22, 2003
Notice, HHS, Secretarial Review of Pediatric Study of HIV Replication and Thymopoiesis (PDF)
July 16, 2003
Notice, HHS, SACHRP Meeting July 22, 2003 (PDF)
July 3, 2003
Notice, HHS, Final Action on Epidemiological Waiver (PDF)
June 20, 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)
June 13, 2003
ANPRM, EPA, Human Research Issues in EPA's Pesticide Program (PDF)
May 7, 2003
Notice, HHS, Secretarial Review of Pediatric Study of Alcohol, Sleep, and Circadian Rhythms (PDF)
April 14, 2003
Notice, HHS, Draft Financial Interest Guidance (PDF)
March 31, 2003
2002
Notice, HHS, Secretarial Review of Pediatric Study of Precursors to Diabetes in Japanese-American Youth (PDF)
December 18, 2002
Notice, HHS, Secretarial Review of Pediatric Study of Dryvax (PDF)
October 31, 2002
Notice, HHS, Proposed Waiver for Epidemiological Studies in Prisoners (PDF)
October 7, 2002
Notice, HHS, Secretarial Review of Pediatric Study of Precursors to Diabetes in Japanese-American Youth (PDF)
August 7, 2002
Notice, HHS, July 30 NHRPAC Meeting (PDF)
June 13, 2002
Notice, HHS, Quality Improvement Instrument Notice (PDF)
May 8, 2002
Notice, HHS, Federal-Wide Assurance Notice (PDF)
April 19, 2002
Notice, HHS, NHRPAC Meeting April 29-30, 2002 (PDF)
March 13, 2002
Notice, HHS, Statement of OHRP Functions (PDF)
March 6, 2002
Notice, HHS, NHRPAC Meeting January 28-29, 2002 (PDF)
January 9, 2002
2001
Notice, HHS, Subpart B Final Rule (PDF)
November 13, 2001
Notice, HHS, NHRPAC Meeting October 30-31, 2001 (PDF)
October 3, 2001
Notice, HHS, NHRPAC Meeting July 30-31, 2001 (PDF)
July 9, 2001
NPRM, HHS, Subpart B (PDF)
July 6, 2001
Notice, HHS, Subpart B Effective Date Delay (PDF)
May 18, 2001
Notice, HHS, NHRPAC Meeting (PDF)
March 26, 2001
Notice, HHS, Subpart B Effective Date Delay (PDF)
March 19, 2001
Final Rule, HHS, Subpart B (PDF)
January 17, 2001
2000
Notice, HHS, Financial Relationships Conference (PDF)
July 3, 2000
Notice, HHS, NHRPAC Establishment (PDF)
June 19, 2000
Notice, HHS, OHRP Establishment (PDF)
June 13, 2000
1998
Notice, HHS, FDA, Expedited review List Categories (PDF)
November 9, 1998
Final Rule, HHS, Expedited Review Categories (PDF)
November 9, 1998
NPRM, HHS, Subpart B (PDF)
May 20, 1998
