Human Subjects Protection, Data and Safety Monitoring, and Operational Considerations in NIMH-Funded Clinical Research

Overview

This webinar reviewed key components for grant candidates to think about when growing plans associated to defending human topics, in addition to information security and monitoring in scientific analysis research funded by the Nationwide Institute of Psychological Well being (NIMH). The webinar additionally reviewed regulatory and operational concerns for scientific analysis research, which can be particularly necessary as candidates develop their analysis technique. The webinar included examples of a few of the difficulties candidates expertise as they develop these plans. On the finish of the presentation, there was a dialogue and future grant candidates can have the chance to ask questions associated to those subjects.

Recording

Learn the transcript.

In regards to the audio system

Anna E. Ordóñez, M.D., M.A.S., is the Workplace of Medical Analysis (OCR) director at NIMH. OCR workers present oversight for NIMH-funded scientific analysis research and strategic steerage and suggestions about scientific analysis initiatives. As director, Dr. Ordóñez is the principal scientific analysis advisor to the NIMH Director and NIMH management on human topic analysis protections, information, and security monitoring, and scientific trial operations. Along with her present work at NIMH, Dr. Ordóñez is a co-chair of one of many NIH UNITE  committees, which was established to establish and deal with structural racism in science. 

Ashley Kennedy, Ph.D., MSCR, is a scientific trial program coordinator in NIMH’s OCR Medical Trials Operations Department (CTOB). Dr. Kennedy helps extramural scientific analysis and offers scientific trials operations experience to NIMH-funded trials, making certain high quality oversight to make sure profitable implementation of scientific trial start-up, conduct, and close-out per Good Medical Apply, regulatory techniques, and information integrity techniques. She at present serves as CTOB operations workers for home and world scientific analysis research. 

Sabiha Ethridge, MPH, is a well being coverage analyst in NIMH’s OCR. In her function, she is an issue skilled on Human Topics Safety and advises the director of OCR at NIMH and NIMH program officers on coverage issues associated to Human Topic Safety, in addition to offering steerage on regulatory and moral inquiries.

In regards to the Heart for World Psychological Well being Analysis Webinar Collection

The Heart for World Psychological Well being Analysis, a part of the Nationwide Institute of Psychological Well being (NIMH), is internet hosting a collection of webinars centered on making use of for and managing world psychological well being analysis grants from the Nationwide Institutes of Well being (NIH). We encourage college students, post-docs, and new investigators involved in world psychological well being analysis to attend. The webinar collection goals to extend data about NIH construction and grant processes and improve capability in world psychological well being analysis.

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The Heart for World Psychological Well being Analysis

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