Human Subjects Protection, Data, and Safety Monitoring and Operational Considerations in NIMH funded clinical research

July 26th,  2023


This webinar will review key factors to consider as NIMH grant applicants develop plans related to the protections of human subjects, as well as data safety and monitoring in clinical research studies. It will also review important regulatory and operational considerations for clinical research studies, which may be especially salient as applicants develop their research strategy. The webinar will include examples of some of the difficulties applicants experience as they develop these plans and will allow for discussion at the end of the presentation to help answer questions that future applicants may have related to these topics.


Sabiha Ethridge, M.P.H.
Head Policy Analyst
Office of Clinical Research, NIMH

Sabiha Ethridge is a Health Policy Analyst in NIMH’s Office of Clinical Research. She has been with NIMH since 2013. Ms. Ethridge has a host of responsibilities but primarily acts as a subject matter expert on Human Subjects Protection for the NIMH advising the NIMH Director of the Office of Clinical Research and NIMH Program Officials on policy matters related to human subject protection, as well as providing guidance on regulatory and ethical inquiries. She received her bachelor’s degree in Psychology from Duke University and a Master of Public Health degree from Boston University.


Ashley Kennedy, Ph.D.
Clinical Trial Program Coordinator
Office of Clinical Research, NIMH

Dr. Ashley Kennedy is a Clinical Trial Program Coordinator for the National Institute of Mental Health’s Office of Clinical Research in the Clinical Trials Operations Branch (CTOB).  In this position, she 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 GCP/Regulatory systems and data integrity systems.  She currently serves as CTOB operations staff to domestic and global clinical research studies.


Anna E. Ordóñez, M.D., M.A.S.
Office of Clinical Research, NIMH

Dr. Anna E. Ordóñez is the Director of the Office of Clinical Research at the National Institute of Mental Health. Prior to returning to NIMH, she held a faculty position at UCSF, where among other duties, she was the Medical Director of the Division of Infant, Child and Adolescent Psychiatry. She has also engaged in research studies of typical and atypical brain development and of evidence based psychosocial interventions to enhance psychological resilience in the United States, Costa Rica, and Colombia. In addition to her current work at NIMH, Dr. Ordóñez is co-chair of the NIH UNITE E committee that is charged with evaluating and changing NIH policies, cultures, and structures to promote diversity in research.

She received her M.D. from the Pontificia Universidad Javeriana, in Bogotá, Colombia and her Adult Psychiatry and Child and Adolescent Psychiatry training at the University of California, San Francisco (UCSF). She is board certified both in adult and child & adolescent psychiatry. She has also completed postdoctoral research fellowships both at the NIMH and UCSF, and a master’s degree in Advanced Sciences in Clinical Research (M.A.S.) at UCSFs.