| Title | Comments |
|---|---|
| 8/2/2012 National Institutes of Health (NIH) Prior NIH Approval of Human Subjects Research in Active Awards Initially Submitted without Definitive Plans for Human Subjects Involvement (Delayed Onset Awards): Notice Number: NOT-OD-12-130 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-130.html |
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| 8/2/2012 National Institutes of Health (NIH) Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval NOT-OD-12-129 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-129.html |
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| 5/30/2012 Food and Drug Administration (FDA) Final Rule on Disqualification of a Clinical Investigator http://www.gpo.gov/fdsys/pkg/FR-2012-04-30/pdf/2012-10292.pdf?source=govdelivery |
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| February 1, 2012 Food and Drug Administration (FDA) IRB Continuing Review after Clinical Investigation Approval http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294558.pdf?source=govdelivery |
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| February 9, 2012 Food and Drug Administration (FDA) Questions and Answers on Informed Consent Elements http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM291085.pdf |
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| 8/14/2012 (comments due within 60 days of publication) Food and Drug Administration (FDA) Guidance for Industry: Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm315156.htm |
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| June 12, 2012 (comments due August 13, 2012) Food and Drug Administration (FDA) Guidance for IRBs, Clinical Investigators, and Sponsors, Considerations When Transferring Clinical Investigation Oversight to Another IRB http://www.gpo.gov/fdsys/pkg/FR-2012-06-12/pdf/2012-14295.pdf |
|
| June 12, 2012 (comments due August 13, 2012) Office for Human Research Protections (OHRP) Considerations in Transferring a Previously-Approved Research Project to a New IRB or Research Institution http://www.gpo.gov/fdsys/pkg/FR-2012-06-12/html/2012-14287.htm |
|
| February 14, 2012 Food and Drug Administration (FDA) Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291573.pdf |
|
| November 8, 2011 Department of Defense (DoD) Instruction 3216.02 Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research http://www.dtic.mil/whs/directives/corres/pdf/321602p.pdf |
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| September 22, 2011 Office for Human Research Protection (OHRP) Correspondence on "Non-engaged" Scenarios http://www.hhs.gov/ohrp/policy/Correspondence/index.html |
|
| August 23, 2011 Department of Health and Human Services (HHS) Conflict of Interest (COI) http://grants.nih.gov/grants/policy/coi/ |
|
| July 1, 2011 Office for Human Research Protection (OHRP) Updated Guidance on Written IRB Procedures http://www.hhs.gov/ohrp/policy/irbgd107.html |
|
| June 21, 2011 Office for Human Research Protection (OHRP) Federalwide Assurance Process FAQs http://answers.hhs.gov/ohrp/categories/1563 |
|
| June 20, 2011 Office for Human Research Protection (OHRP) Guidance on Reporting Incidents to OHRP http://www.hhs.gov/ohrp/compliance/reports/index.html |
|
| June 15, 2011 Food and Drug Administration (FDA) Medical Devices; Exception from General Requirements for Informed Consent Final Rule http://www.gpo.gov/fdsys/pkg/FR-2011-06-24/pdf/2011-15816.pdf |
|
| March 31, 2011 Food and Drug Administration (FDA) Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors on Exception from Informed Consent Requirements for Emergency Research http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM249673.pdf |
|
| March 29, 2011 National Institutes of Health (NIH) Change in policy on the Submission of Plans for Instruction in the Responsible Conduct of Research for Individual and Institutional Career Development (K) Award http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-059.html |
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| January 4, 2011 Food and Drug Administration (FDA) Final Rule: Including Trial Registration as required basic element for informed consent for applicable trials http://edocket.access.gpo.gov/2011/2010-33193.htm |
|
| December 19, 2011 Food and Drug Administration (FDA) Draft Guidance for Industry and FDA Staff - Evaluation of Sex Differences in Medical Device Clinical Studies http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm283453.htm |
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| November 10, 2011 Food and Drug Administration (FDA) Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff - FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm277669.htm?utm_source=Customer+List&utm_campaign=355fe3b709-Draft_Guidance_Exculpatory_language9_20_2011&utm_medium=email |
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| November 10, 2011 Food and Drug Administration (FDA) Draft Guidance for Industry and Food and Drug Administration Staff - Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm277670.htm#2 |
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| September 7, 2011 (comments due November 4, 2011) Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) joint draft document - Guidance on Exculpatory Language in Informed Consent http://www.hhs.gov/ohrp/newsroom/rfc/ |
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| August 24, 2011 (comments due November 28, 2011) Food and Drug Administration (FDA) Draft Guidance: Oversight of Clinical Investigations- A Risk-Based Approach to Monitoring http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM269919.pdf |
|
| July 26, 2011 (comments due October 26, 2011) Office for Human Research Protection (OHRP) Advanced Notice of Proposed Rulemaking (ANPRM) for Revisions to the Common Rule http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html |
|
| May 24,2011 (comments due July 24, 2011) Food and Drug Administration (FDA) Guidance for Clinical Investigators, Industry, and FDA Staff Financial Disclosure by Clinical Investigators http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM256525.pdf |
|
| April 27, 2011 (comments due by June 27, 2011) Food and Drug Administration (FDA) Periodic Review of Existing Regulations; Retrospective Review http://www.regulations.gov/#!documentDetail;D=FDA-2011-N-0259-0001 |
|
| April 11, 2011 (comments due by July 12, 2011) Food and Drug Administration (FDA) Proposed rule on Disqualification of Clinical Investigators http://www.gpo.gov/fdsys/pkg/FR-2011-04-13/pdf/2011-8786.pdf |
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| November 10, 2010 Office for Human Research Protections (OHRP) Guidance on IRB Approval of Research with Conditions http://www.hhs.gov/ohrp/policy/conditionalapproval2010.html |
|
| November 10, 2010 Office for Human Research Protections (OHRP) Guidance on IRB Continuing Review of Research http://www.hhs.gov/ohrp/policy/continuingreview2010.html |
|
| September 29, 2010 Food and Drug Administration (FDA) Final Rule: Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm226358.htm |
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| September 21, 2010 Office for Human Research Protections (OHRP) Guidance on Withdraw of Subjects from Research http://www.hhs.gov/ohrp/policy/subjectwithdrawal.html |
|
| August 2, 2010 Food and Drug Administration (FDA) Guidance for Industry and Researchers, The Radioactive Drug Research Committee: Human Research Without an Investigational New Drug Application http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM163892.pdf |
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| July 8, 2010 Food and Drug Administration (FDA) Humanitarian Device Exemption (HDE) Regulation: FAQ http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm110194.htm |
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| June 21, 2010 Food and Drug Administration (FDA) FDA Inspections of Clinical Investigators http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126553.pdf |
|
| June 25, 2010 Food and Drug Administration (FDA) In Vitro Diagnostic (IVD) Device Studies FAQ http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM071230.pdf |
|
| May 1, 2010 Food and Drug Administration (FDA) Clinical Investigator Administrative Actions http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM214008.pdf |
|
| May-2010 Food and Drug Administration (FDA) Information Sheet Guidance for Sponsors, Clinical Investigators, and IRB Frequently Asked Questions - Statement of Investigator (Form FDA 1572) http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM214282.pdf |
|
| April 30, 2010 Office for Human Research Protection (OHRP) correspondence regarding use of a central http://www.hhs.gov/ohrp/policy/Correspondence/cirb20100430.html |
|
| March 30, 2010 Office for Human Research Protection (OHRP) revised set of Frequently Asked Questions and Answers (FAQs) on Institutional Review Board (IRB) Registration http://answers.hhs.gov/ohrp/categories/1565 |
|
| January 8, 2010 Office for Human Research Protection (OHRP) correspondence regarding student subject pools and use of penalties for students who fail to show up for scheduled research appointments http://www.hhs.gov/ohrp/policy/Correspondence/ohrp20100108.html |
|
| December 1, 2010 Food and Drug Administration (FDA) Electronic Source Documentation in Clinical Investigations http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM239052.pdf |
|
| October 14, 2010 (comments due by January 11, 2011) Food and Drug Administration (FDA) Investigational New Drug Applications (INDs)-Determining Whether Human Research Studies Can Be Conducted Without an IND http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM229175.pdf |
|
| September 28, 2010 (comments due by December 28, 2010) Food and Drug Administration (FDA) Guidance for Industry and Investigators Safety Reporting Requirements for INDs and Bioavailability and Bioequivalence Studies http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM227351.pdf |
|
| July 14, 2010 (comments due by Sept13, 2010) Office of Civil Rights (OCR) and Office for Human Research Protection proposed modification to HIPAA Privacy, Security, and Enforcement Rules under the Health Information Technology for Economic and Clinical Health (HITECH) Act http://edocket.access.gpo.gov/2010/2010-16718.htm |
|
| May 21, 2010 (comments due by July 20, 2010) HHS and Public Health Service (PHS) proposal to amend regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which PHS funding is sought and Responsible Prospective Contractors http://edocket.access.gpo.gov/2010/pdf/2010-11885.pdf |
|
| May 3, 2010 (comments due by May 18, 2010) HHS Request for Information - HIPAA Privacy Rule Accounting of Disclosures Under the Health Information Technology for Economic and Clinical Health (HITECH) Act. http://edocket.access.gpo.gov/2010/pdf/2010-10054.pdf |
|
| February 19, 2010 (comments due by May 20, 2010) FDA Proposed Rule on Reporting Information Regarding Falsification of Data http://edocket.access.gpo.gov/2010/pdf/2010-3123.pdf |
|
| January 13, 2010 FDA Guidance for IRBs, Clinical Investigators, and Sponsors IRB Continuing Review after Clinical Investigation Approval http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM197347.pdf |
|
| November 24, 2009 National Institutes of Health (NIH) Update on the Requirement for Instruction in the Responsible Conduct of Research http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-019.html |
|
| October 29, 2009 Food & Drug Administration (FDA) Guidance on Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM187772.pdf |
|
| October 19, 2009 NIH Notice on Development of Data Sharing Policy for Sequence and Related Genomic Data http://grants.nih.gov/grants/guide/notice-files/NOT-HG-10-006.html |
|
| October 15, 2009 Office for Human Research Protection (OHRP) FAQs regarding Exempt Research Determinations http://answers.hhs.gov/ohrp/categories/1564 |
|
| October 14, 2009 OHRP’s Compliance Oversight Procedures for Evaluating Institutions http://www.hhs.gov/ohrp/compliance/evaluation/ |
|
| August 20, 2009 National Science Foundation (NSF) Implementation of Section 7009 of the America COMPETES Act http://edocket.access.gpo.gov/2009/E9-19930.htm |
|
| August 13, 2009 FDA Expanded Access to Investigational Drugs for Treatment Use http://edocket.access.gpo.gov/2009/pdf/E9-19005.pdf |
|
| August 13, 2009 FDA Charging for Investigational Drugs Under an Investigational New Drug Application http://edocket.access.gpo.gov/2009/pdf/E9-19004.pdf |
|
| July 17, 2009 OHRP Updated Web-based Electronic Submission System for Submitting FWAs and IRB Registrations http://ohrp.cit.nih.gov/efile |
|
| July 14, 2009 FDA IRB Registration FAQ http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM171256.pdf |
|
| July 9, 2009 OHRP Guidance Registration of IRBs http://www.hhs.gov/ohrp/assurances/index.html#registernew |
|
| March 24, 2009 OHRP Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review Boards http://www.hhs.gov/ohrp/policy/gina.html |
|
| February 4, 2009 OHRP Compliance Oversight Activities: Determinations of Noncompliance http://www.hhs.gov/ohrp/compliance/findings/ |
|
| January 15, 2009 FDA IRB Registration Requirements - outlines registration requirements for IRBs reviewing FDA regulated research http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-682.pdf |
|
| January 14, 2009 FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs - Improving Human Subject Protection http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126572.pdf |
|
| January 13, 2009 OHRP Correspondence regarding determining when institutions are engaged in research http://www.hhs.gov/ohrp/policy/Correspondence/ohrp20090113.html |
|
| January 1, 2009 OIG Report -THE FDA Oversight of Clinical Investigators' Financial Information http://oig.hhs.gov/oei/reports/oei-05-07-00730.pdf |
|
| December 29, 2009 (comments due by March 1, 2010) 21 CFR Part 50 Informed Consent Elements FDA Proposed rule open for public comment http://edocket.access.gpo.gov/2009/E9-30751.htm |
|
| May 8, 2009 (comments due by July 7, 2009) NIH proposed rule regarding Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding is Sought and Responsible Prospective Contractors http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-099.html |
|
| March 5, 2009 (comments due by June 3, 2009) OHRP advanced notice of proposed rulemaking; request for comments regarding holding IRBs & the institutions operating the IRBs accountable for adherence to 45 CFR 46. http://edocket.access.gpo.gov/2009/E9-4628.htm |
|
| February 20, 2009 (comments due by March 31, 2009) [FINAL RULE listed in Final Regulation/Guidance section- 8-20-09] NSF request for comment on requirement for students and postdoctoral researchers involved in NSF proposals to be educated in the responsible and ethical conduct of research (RCR) https://www.federalregister.gov/articles/2009/02/26/E9-4100/responsible-conduct-of-research |
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| December 30, 2008 OHRP FAQ regarding Quality Assurance Research http://answers.hhs.gov/ohrp/categories/1569 |
|
| December 1, 2008 Guidance for Sponsors, Clinical Investigators, and IRBs- Data Retention when Subjects Withdraw from FDA-Regulated Clinical Trials http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126489.pdf |
|
| October 16, 2008 OHRP Guidance on Engagement of Institutions in Human Subject Research http://www.hhs.gov/ohrp/policy/engage08.html |
|
| October 16, 2008 OHRP Guidance on Research Involving Coded Private Information or Biological Specimens. This guidance has been updated to be consistent with OHRP’S OCTOBER 16, 2008 GUIDANCE ON ENGAGEMENT OF INSTITUTIONS IN HUMAN SUBJECTS RESEARCH ( Replaces OHRP’S AUGUST 10, 2004 guidance) http://www.hhs.gov/ohrp/policy/cdebiol.html |
|
| September 1, 2008 Food & Drug Administration Amendments Act (FDAAA) summarizes first year accomplishments of act. Impacts FDA (responsibilities & authorities) and sponsors/investigators (registration of clinical trials).http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/ucm083161.htm |
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| September 29, 2008 OHRP correspondence Memo to National Cancer Institute re: Protocol Review and Consent Changes for NCI/CTEP sponsored trials [original memorandum March 2008 CTEP] http://www.hhs.gov/ohrp/policy/Correspondence/nci200870929.html |
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| February 15, 2008 OHRP Statement regarding Quality Assurance Research http://www.hhs.gov/ohrp/policy/Correspondence/pronovost20080730.html |
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| January 25, 2008 NIH Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS) http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html |
|
| September 5, 2007 SACHRP Request for Information and Comments on Research That Involves Adult Individuals With Impaired Decision-making Capacity (Extended comment period to January 14, 2008) http://www.hhs.gov/ohrp/archive/requests/com090507.html |
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| July 2, 2008 OHRP Request for Information and Comments on the Implementation of Human Subjects Protection Training and Education Programs (comments due September 29, 2008) http://www.hhs.gov/ohrp/newsroom/rfc/com070208.html |
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| July 2008 Draft guidance - FAQ regarding Form FDA 1572 - impacts investigators and sponsors http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0406-gdl.pdf |
|
| June 5, 2008 ICH Draft Development Safety Update Report (DSUR) impacts sponsors http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM129284.pdf |
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| May 10, 2007 FDA Draft Guidance for Industry: Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigators http://www.fda.gov/RegulatoryInformation/Guidances/ucm127697.htm |
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| April 17, 2007 FDA Draft Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting - Improving Human Subject Protection http://www.fda.gov/OHRMS/DOCKETS/98fr/07d-0106-gdl0001.pdf |
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| January 1, 2006 FDA Frequently Asked Questions About IRB Review of Medical Devices http://www.fda.gov/oc/ohrt/irbs/irbreview.pdf |
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| January 1, 2006 FDA Significant Risk and Nonsignificant Risk Medical Device Studies http://www.fda.gov/oc/ohrt/irbs/devrisk.pdf |
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| January 1, 2006 FDA Institutional Review Board Inspections http://www.fda.gov/oc/ohrt/irbs/reviewboard.pdf |
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| January 1, 2006 FDA Inspections of Clinical Investigators http://www.fda.gov/oc/ohrt/irbs/investigator.pdf |
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| January 15, 2007 OHRP Guidance on Continuing Review http://www.hhs.gov/ohrp/policy/continuingreview2010.html |
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| January 15, 2007 OHRP Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events http://www.hhs.gov/ohrp/policy/advevntguid.html |
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| January 15, 2007 OHRP Guidance on Written Procedures http://www.hhs.gov/ohrp/policy/irbgd107.html |
|
| August 9, 2007 America COMPETES Act http://www.nist.gov/public_affairs/releases/competes-081607.cfm |
|
| September 27, 2007 Food & Drug Administration Amendments Act (FDAAA) impacts investigators and sponsors; requires registration of clinical trials. http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/default.htm |
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| Regulations.gov www.regulations.gov |
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| FDA News http://www.fda.gov/NewsEvents/default.htm |
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| FDA Guidance http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm |
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| Comprehensive list of FDA guidance http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079645.pdf |
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| FDA Guidance Search http://www.fda.gov/RegulatoryInformation/Guidances/default.htm |
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| Newly added FDA Guidance - Drugs http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm121568.htm |
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| Newly added FDA Guidance - Devices http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm162707.htm |
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| Proposed Regulations and Draft Guidance http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances/default.htm |
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| CDER Guidance & Recent Guidance http://www.fda.gov/cder/guidance/ |
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| FDA Information Sheets http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm113709.htm |
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| FDA Guidance Medical Devices http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfggp/search.cfm |
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| FDA GCP http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm |
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| OHRP NEWS http://www.hhs.gov/ohrp/newsroom/index.html |
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| OHRP Correspondence Website http://www.hhs.gov/ohrp/policy/Correspondence/index.html |
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| DHHS NIH HIPAA Guidance Website http://privacyruleandresearch.nih.gov/ |
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| DHHS HIPAA FAQ http://www.hhs.gov/hipaafaq/ |
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| Office of Inspector General - what's new website https://oig.hhs.gov/newsroom/whats-new/ |
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| Federal Register https://www.federalregister.gov/ |
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| Department of Defense (DoD) Issuances http://www.dtic.mil/whs/directives/whats_new.html |