Key Dates & Policy Notices

Current Clinical Research/Trial 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
FORMS-E Application Instructions 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
 

Upcoming Human Subjects Policy Changes & Effective Dates

 

Guide Notices


Flexibilities for Prospective Basic Science Studies Involving Human Participants

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-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-16-148​ Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials September 16, 2016
 

Single IRB Policy

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