NIH RFI – Registration and Results Reporting Standards for Prospective Basic Science Studies Involving Human Participants

NIH Request For Information (RFI) NOT-OD-18-217

Registration and Results Reporting Standards for Prospective Basic Science Studies Involving Human Participants

As a follow-up to the July 20, 2018 NIH Notice (NOT-OD-18-212), NIH is requesting for input from stakeholders throughout the scientific research community regarding how best to implement the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information for prospective basic science studies involving human participants.

§NIH is considering prospective basic science studies involving human participants to be those that overlap with both the definition of fundamental research and the definition of a clinical trial.  

NIH wants to learn more about studies that meet the NIH definition of a clinical trial but are not defined as applicable clinical trials, and also meet the definition of fundamental research. 

Specifically, NIH is requesting comments in the following areas:

§examples of prospective basic science studies involving human participants that pose the greatest challenges in meeting the registration and results information submission requirements at ClinicalTrials.gov

§strengths and weaknesses of potential alternative platforms that might function as conduits for timely registration and reporting of prospective basic science studies involving human participants

§additional data elements or modification to existing data elements that could be applied to ClinicalTrials.gov to better meet the needs of the public and of researchers in assuring timely registration and results information submission of prospective basic science studies involving human participants

§other existing reporting standards for prospective basic science studies involving human participants and how such standards would fulfill the aims described in the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information

The deadline for submission of comments is November 12, 2018.  Comments must be submitted electronically at:  https://grants.nih.gov/grants/rfi/rfi.cfm?ID=80

For additional details, please review the August 10, 2018 NIH Notice NOT-OD-18-217.

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