Key Dates & Policy Notices
Clinical Research Policies & Effective Dates
| Policy & Guide Notice | Effective Date |
|---|
| Revised Clinical Trial Definition | Effective for competing grant applications and contract proposals that are submitted to NIH for due dates on or after January 25, 2015 |
| Inclusion of Children in Clinical Research: Change in Age Definition | Effective for applications and proposals submitted for due dates on or after January 25, 2016 |
| Certificates of Confidentiality (CoC) Policy Update | Effective for any NIH-funded project that was ongoing on or after December 13, 2016 |
| Good Clinical Practice (GCP) Training Requirement for NIH Awardees | Effective January 1, 2017 for all staff and investigators involved in the design, conduct, oversight, or management of clinical trials |
| Dissemination of NIH-Funded Clinical Trial Information (ClinicalTrials.gov Registration & Reporting Policy) | Effective for applications requesting support for a clinical trial that will be initiated on or after January 18, 2017 |
| Clinical Trial-Specific Funding Opportunity Announcement (FOA) Requirements | Effective for applications with due dates on or after January 25, 2018 |
| Single IRB for Multi-Site Trials | Effective for applications with due dates on or after January 25, 2018 and for contract solicitations published on or after January 25, 2018 |
| Inclusion Across the Lifespan (revision to the Inclusion of Children Policy) | Effective for all competing grant applications for due dates on or after January 25, 2019 |
Guide Notices
Flexibilities for Prospective Basic Experimental Studies with Human Participants
| NOT-OD-24-118 Continued Extension of Certain Flexibilities for Prospective Basic Experimental Studies With Human Participants | May 6, 2024 |
| NOT-OD-22-205 Continued Extension of Certain Flexibilities for Prospective Basic Experimental Studies With Human Participants | August 30, 2022 |
| NOT-OD-21-088 Continued Extension of Certain Flexibilities for Prospective Basic Experimental Studies With Human Participants | March 23, 2021 |
| NOT-OD-19-126 Extension of Certain Flexibilities for Prospective Basic Experimental Studies With Human Participants | July 24, 2019 |
| NOT-OD-19-024 Notice of Intent to Publish Parent Funding Opportunity Announcements for Basic Experimental Studies with Humans. | October 26, 2018 |
| NOT-OD-18-212 Delayed Enforcement and Short-Term Flexibilities for Some Requirements Affecting Prospective Basic Science Studies Involving Human Participants. | July 20, 2018 |
Clinical Trial Definition
| NOT-OD-15-015 Notice of Revised NIH Definition of "Clinical Trial" | October 23, 2014 |
Clinical Trial Funding Opportunity Announcements
| NOT-OD-18-106 Reminder: Policy on Funding Opportunity Announcements (FOA) for Clinical Trials Takes Effect January 25, 2018 | November 30, 2017 |
| NOT-OD-18-010 NIH Plans for Clinical Trial Specific Parent R01 and Parent R21 Funding Opportunity Announcements | October 25, 2017 |
| NOT-OD-17-043 Update on Clinical Trial Funding Opportunity Announcement Policy | February 17, 2017 |
Clinical Trial Review Criteria
| NOT-OD-18-109 Revision: The NIH Announces New Review Criteria for Career Development Award Applications Involving Clinical Trials | December 1, 2017 |
| NOT-OD-17-123 The NIH Announces New Review Criteria for Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grants Involving Research Experiences in Clinical Trials | October 6, 2017 |
| NOT-OD-17-122 The NIH Announces New Review Criteria for Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellowship Applications Involving Research Experiences in Clinical Trials | October 6, 2017 |
| NOT-OD-17-118 The NIH Announces New Review Criteria for Research Project Applications Involving Clinical Trials | September 21, 2017 |
Human Subjects and Clinical Trials Information form
| NOT-OD-18-128 Grant Application Instruction Correction for Training Grants with Human Subjects Involvement | September 25, 2017 |
| NOT-OD-17-062 New NIH "FORMS-E" Grant Application Forms and Instructions | April 27, 2017 |
Appendix Policy for Clinical Trial-related Materials
| NOT-OD-18-126 Reminder: Updated Appendix Policy Eliminates Clinical Trial-Related Materials for NIH/AHRQ/NIOSH Applications Submitted to Due Dates on or After January 25, 2018. | January 12, 2018 |
| NOT-OD-17-098 Updated Appendix Policy Eliminates Clinical Trial-Related Materials for NIH/AHRQ/NIOSH Applications Submitted to Due Dates on or After January 25, 2018. | August 2, 2017 |
Protocol Template
| NOT-OD-19-092 NIH Releases Protocol Template for Behavioral and Social Sciences Research Involving Humans | March 26, 2019 |
| NOT-OD-17-064 NIH and FDA Release Protocol Template for Phase 2 and 3 IND/IDE Clinical Trials | May 2, 2017 |
Good Clinical Practice
| NOT-OD-16-148Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials | September 16, 2016 |
Single IRB Policy
| NOT-OD-20-058 Additional Guidance on the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research | January 22, 2020 |
| NOT-OD-18-004 Guidance on Implementation of the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research | October 11, 2017 |
| NOT-OD-18-003 Guidance on Exceptions to the NIH Single IRB Policy | October 11, 2017 |
| NOT-OD-17-076 Revision: Notice of Extension of Effective Date for Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research | June 16, 2017 |
| NOT-OD-16-109 Scenarios to Illustrate the Use of Direct and Indirect Costs for Single IRB Review under the NIH Policy on the Use of a Single IRB for Multi-site Research | June 21, 2016 |
| NOT-OD-16-094 Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research | June 21, 2016 |
Registration & Reporting
| NOT-OD-16-149 NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information | September 16, 2016 |
Human Subjects System (HSS)
| NOT-OD-18-179 Transition from Inclusion Management System to New Human Subjects System (HSS) as of June 9, 2018 | May 11, 2018 |
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