Key Dates

Related Announcements

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Issued by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Purpose

The purpose of this Guide Notice is to notify the extramural community of NICHD's guidance for Adverse Event (AE) and Unanticipated Problems (UP) reporting for all research activities and contracts funded in whole or in part by the NICHD.

NICHD expects all clinical research to be conducted with a high standard of quality that assures the research question is answered in a reliable, valid, and unbiased manner, and that the rights and welfare of human subjects are protected. Starting with competing applications or newly started protocols for January FY21, the NICHD expects investigators to utilize the newly released NICHD Serious Adverse Events and Unanticipated Problems Guidance.

AEs and UPs that need to be reported promptly to NICHD are termed “serious adverse events.” Serious events are defined as those AEs and UPs that are serious, related, and unexpected.

The NICHD does not adjudicate serious adverse events. NICHD recognizes the authority of relevant regulatory bodies (e.g., IRB, DSMBs, and/or FDA) to determine the seriousness and unexpectedness of reportable events and make determinations on study continuance.

NICHD is responsible for the oversight of reportable events, which entails receipt of appropriate documentation of occurrence(s) and follow-up decision(s) made by regulatory bodies. NICHD requires the documentation of the reportable event(s) and regulatory decision(s) to be following the principal investigator’s (PI’s) written institutional procedures. The timeframe for submission of documentation to NICHD must also follow the PI’s written institutional procedures.

The purpose of these enhancements to monitoring and oversight of clinical research is to ensure that studies funded by the NICHD are successful in achieving their objectives and that the NICHD remains responsible stewards of public funds. For more information on NICHD and NIH policies and procedures related to clinical trials, please visit our webpage: https://www.nichd.nih.gov/grants-contracts/process-strategies/policies/clinical-research.

Inquiries

Please direct all inquiries to:

NICHD Clinical Trials
Email: NICHDTrials@mail.nih.gov