Older Human Subjects Protection Federal Register Notices

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Notice, FDA - Draft Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the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Notice, HHS - Draft Guidance on Considerations in Transferring a Previously-Approved Research Project to a New IRB or Research Institution (PDF - 195.7 KB)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Notice, FDA - Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Considerations When Transferring Clinical Investigation Oversight to Another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

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