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The Center for Global Mental Health Research Webinar Series 2023: Human Subjects Protection, Data and Safety Monitoring, and Operational Considerations in NIMH-Funded Clinical Research


July 26, 2023




This webinar reviewed key factors for grant applicants to consider when developing plans related to protecting human subjects, as well as data safety and monitoring in clinical research studies funded by the National Institute of Mental Health (NIMH). The webinar also reviewed regulatory and operational considerations for clinical research studies, which may be especially important as applicants develop their research strategy. The webinar included examples of some of the difficulties applicants experience as they develop these plans. At the end of the presentation, there was a discussion and future grant applicants will have the opportunity to ask questions related to these topics.


Read the transcript.

About the speakers

Anna E. Ordóñez, M.D., M.A.S., is the Office of Clinical Research (OCR) director at NIMH. OCR staff provide oversight for NIMH-funded clinical research studies and strategic guidance and recommendations about clinical research initiatives. As director, Dr. Ordóñez is the principal clinical research advisor to the NIMH Director and NIMH leadership on human subject research protections, data, and safety monitoring, and clinical trial operations. In addition to her current work at NIMH, Dr. Ordóñez is a co-chair of one of the NIH UNITE  committees, which was established to identify and address structural racism in science. 

Ashley Kennedy, Ph.D., MSCR, is a clinical trial program coordinator in NIMH’s OCR Clinical Trials Operations Branch (CTOB). Dr. Kennedy supports extramural clinical research and provides clinical trials operations expertise to NIMH-funded trials, ensuring quality oversight to ensure successful implementation of clinical trial start-up, conduct, and close-out per Good Clinical Practice, regulatory systems, and data integrity systems. She currently serves as CTOB operations staff for domestic and global clinical research studies. 

Sabiha Ethridge, MPH, is a health policy analyst in NIMH’s OCR. In her role, she is a subject matter expert on Human Subjects Protection and advises the director of OCR at NIMH and NIMH program officers on policy matters related to Human Subject Protection, as well as providing guidance on regulatory and ethical inquiries.

About the Center for Global Mental Health Research Webinar Series

The Center for Global Mental Health Research, part of the National Institute of Mental Health (NIMH), is hosting a series of webinars focused on applying for and managing global mental health research grants from the National Institutes of Health (NIH). We encourage students, post-docs, and new investigators interested in global mental health research to attend. The webinar series aims to increase knowledge about NIH structure and grant processes and enhance capacity in global mental health research.

Sponsored by

The Center for Global Mental Health Research