NICHD issues specific guidance on different aspects of clinical research and follows NIH- and HHS-wide guidance as well.
Please note: NIH recently launched a series of initiatives to enhance the accountability and transparency of clinical research. We outline some NICHD-specific changes here; for additional information on the changes that will affect applicants and funded investigators, visit the Clinical Trial Requirements for Grants and Contracts section of the NIH Office of Extramural Research (OER) website. If you are conducting research with human subjects, we strongly recommend you review the updates and changes on the OER website, including the information on Basic Experimental Studies Involving Humans, to determine if they apply to your work. Many proposed studies that previously would not have been classified as clinical trials may now meet the revised NIH definition of a clinical trial.
Clinical Trials Policy Changes
- NOT-HD-18-020, NICHD Policy on Monitoring and Oversight of Clinical Trials
- See the full policy document (PDF 468 KB)
- NOT-HD-17-018: NICHD will accept exploratory/developmental research grant applications for clinical trials to “NICHD Exploratory/Development Research Grant (R21)” PA-17-259
- NOT-HD-17-019: NICHD Policy on Receipt of Investigator-Initiated Clinical Trials
- Questions about clinical trials policy changes at NICHD? Contact your Program Officer or email NICHDTrials@mail.nih.gov
Data Safety & Monitoring
These policies refer to ensuring the safety of research participants and their data.
NICHD Policies on Data and Safety Monitoring
NICHD Adverse Event, Unanticipated Problem, and Serious Adverse Event Reporting Policy (PDF 125 KB)
NICHD Data and Safety Monitoring (DSM) Policies for Extramural Clinical Trials and Clinical Research (PDF 428 KB)
NIH Data and Safety Monitoring
These NIH policies aim to ensure the safety and inclusion of certain groups of research participants.
Protection of Human Subjects
These policies aim to ensure the safety of human research participants and their data.