A Researcher Calls You Stating That He Plans To Submit A Proposal To The NIH For A Human Subjects Research Study

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Question: A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit coi disclosures to comply with the PHS regulation.

Quick answer: No later than the time of proposal submission.

This question is a part of CITI Conflicts Of Interest & Basics Of Info Security Answers.

Broad Description

According to the U.S. Public Health Service (PHS) regulation, which includes the National Institutes of Health (NIH), researchers and their study team members involved in human subjects research must submit conflict of interest (COI) disclosures to comply with the requirements. These disclosures must be submitted no later than the time of proposal submission.

These COI disclosures aim to identify and manage potential conflicts of interest that may affect the research study’s integrity or the protection of human subjects. By submitting COI disclosures at the proposal stage, the institution can review and address potential conflicts before initiating the research project.

Resource: NIH Financial Conflict of Interest Regulations

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