Clarification of NIDDK Policy Regarding Ancillary Studies to Multi-Center Clinical Studies

Notice Number: NOT-DK-20-014

Key Dates
Release Date: March 3, 2020

Related Announcements

NOT-DK-14-025: Clarification of NIDDK Policy Regarding Ancillary Studies to Multi-Center Clinical Studies

PAR-18-423: NIDDK Multi-Center Clinical Study Implementation Planning Cooperative Agreements (U34 Clinical Trial Optional)

PA-19-056: NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)

Issued by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Purpose

This Notice is intended to clarify NIDDK policies regarding ancillary studies to existing multi-center cooperative agreements, initially described in the second paragraph of the Purpose section of NOT-DK-14-025Clarification of NIDDK Policy: Investigator-Initiated Multi-Center Clinical Studies and in Part 2. Full Text of Announcement, Section I. Funding Opportunity Description of PAR-18-423NIDDK Multi-Center Clinical Study Implementation Planning Cooperative Agreements (U34 Clinical Trial Optional):


Current language: “NIDDK will not accept applications for multi-center clinical studies involving three or more clinical centers that are submitted as R01s, with the exception of ancillary studies to existing cooperative agreements, which can be submitted as R01s to PAR-16-034: Ancillary Studies to Major Ongoing Clinical Research Studies to Advance Areas of Scientific Interest within the Mission of the NIDDK (R01) or to other FOAs that specifically allow multi-center clinical studies. This policy does not apply to pilot studies. Investigators who are interested in obtaining support for pilot studies may use the R21 activity code, through the appropriate funding opportunity announcements (see https://www.niddk.nih.gov/research-funding/current-opportunities).”

Revised language: “NIDDK will accept ancillary studies to multi-center studies that are not in themselves clinical trials under PA-19-056, Research Project Grant (Parent R01 Clinical Trial Not Allowed). If a proposed ancillary study is a clinical trial (i.e., adds a new intervention), the usual NIDDK process for funding of clinical trials involving three or more sites must be followed (see NOT-DK-14-025, as well as more detailed information on the NIDDK website (https://www.niddk.nih.gov/research-funding/human-subjects-research).

All other aspects of these Funding Opportunity announcements remain unchanged.

Inquiries

Please direct all inquiries to:

Tracy Rankin, Ph.D., M.P.H.
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-4748
Email: rankint@mail.nih.gov

Barbara Linder, M.D., Ph.D.
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-0021
Email: linderb@mail.nih.gov

Aynur Unalp-Arida, MD, PhD
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
Telephone: 301-594-8879
Email: aynur.unalp-arida@nih.gov