Reminder: Policy on Funding Opportunity Announcements (FOA) for Clinical Trials Takes Effect January 25, 2018

Notice Number: NOT-OD-18-106

Key Dates
Release Date:   November 30, 2017

Related Announcements
NOT-OD-18-010
NOT-OD-18-001
NOT-OD-17-043
NOT-OD-16-147

Issued by
National Institutes of Health (NIH)

Purpose

This notice reminds the community that, effective for due dates on or after January 25, 2018, NIH will require all applications involving one or more clinical trials be submitted through a Funding Opportunity Announcement (FOA) specifically designed and designated for clinical trials. This policy improves our ability to identify proposed clinical trials, ensure that key pieces of trial-specific information are submitted with each application, and uniformly apply trial-specific review criteria.

Implementation Update

 

  • Included a clinical trial allowability indicator in Section II. Award Information? of all FOAs
  • Specified the allowability of clinical trials in the title and included clinical trial specific review criteria in clinical trial FOAs
  • Provided guidance on special considerations for Career Development, Fellowship, Training, and Research Education Programs in NOT-OD-18-001.

Parent Announcements

 

All current (FORMS-D) Parent Announcements will be reissued with updated application forms (FORMS-E). Many activity codes will have two Parent Announcements - one designated as "Clinical Trial Not Allowed" and another as "Clinical Trial Required".

This table indicates our target posting/reissue date for parent announcements and identifies the activity codes which will have a "Clinical Trial Required" parent announcement option.

 

Activity Code

Clinical Trial
Not Allowed Parent

Clinical Trial
Required Parent

F30

February 8, 2018

N/A - NOT-OD-18-001

F31

February 8, 2018

N/A - NOT-OD-18-001

F32

February 8, 2018

N/A - NOT-OD-18-001

F33

February 8, 2018

N/A - NOT-OD-18-001

K01

PA-18-369

PA-18-363

K02

PA-18-371

PA-18-370

K08

PA-18-373

PA-18-372

K23

PA-18-375

PA-18-374

K24

PA-18-394

PA-18-393

K25

PA-18-396

PA-18-395

K99/R00

December 12, 2017

December 12, 2017

R01

December 5, 2017

Available - PA-18-345

R03

December 16, 2017

N/A

R13

February 12, 2018

N/A

R15

December 22, 2017

N/A

R21

December 16, 2017

Available - PA-18-344

R41/R42

January 19, 2018

January 19, 2018

R43/R44

January 19, 2018

January 19, 2018

T32

PA-18-403

N/A - NOT-OD-18-001

T35

PA-18-404

N/A - NOT-OD-18-001


Important notes for "Clinical Trial Required" parent FOAs

  • The participating organizations may vary between the "Clinical Trial Not Allowed" Parent FOA and the "Clinical Trial Required" Parent FOA for the same activity code. Read the details of each FOA carefully.
  • Some institutes that participate on a "Clinical Trial Required" parent may limit their participation to mechanistic studies. Check the Related Notices section of the FOA for any restrictions.

Inquiries

Please direct all inquiries to:

NIH Grants Information
grantsinfo@od.nih.gov (preferred method of contact)
Telephone: 301-945-7573