Office of Regulatory Oversight
In 2017 the NIMH Office of the Clinical Director established the Office of Regulatory Oversight (ORO) to provide research support services to our investigators. The office provides assistance with protocol submissions, and ongoing monitoring of studies for research compliance.
Protocol Navigation Services
NIMH protocol navigators provide support to NIMH investigators for all aspects of research protocol submission, from preparation for initial science review to the submission of protocol amendments. The navigators work closely with the IRB and have access to all the needed documents and templates to facilitate protocol actions. It is highly recommended that NIMH clinical researchers utilize navigators prior to IRB submissions. This office also tracks all required trainings to ensure investigators comply with regulatory requirements.
Protocol Monitoring Services
The NIH Office of the Clinical Director recognizes the importance of defining and establishing infrastructure for clinical research in order to ensure participant safety and data integrity. Therefore, the NIMH OCD provides protocol monitors who are responsible for performing QA functions and communicating findings related to the resolution and evaluation of monitoring/QA issues at the clinical site to the PI and the NIMH OCD ORO. The monitors develop individualized monitoring plans for every clinical protocol. They also work with investigators on the development of regulatory binders and case report forms at the time of new protocol initiation.
The Standards for Clinical Research within the NIH Intramural Research Program, implemented in January 2000 by the Clinical Center Medical Executive Committee, establish minimum requirements for the conduct of clinical research. A major component of the Standards for Clinical Research is the establishment and maintenance of clinical research integrity and quality assurance program, including subject safety and monitoring for protocol compliance. The Standards for Clinical Research endorse the International Conference on Harmonization guidelines and Good Clinical Practices regarding the responsibilities of the clinical research sponsors. The National Institute of Mental Health Extramural Research Program has developed policies for the conduct of clinical research studies sponsored by the program.
NIMH Intramural Principal Investigators (PIs) are responsible for following the NIH policies and procedures. Per NIH SOP 19 - Investigator Responsibilities, The PI is responsible for ensuring the cooperation of all research personnel with the IC QA/QI plan and NIH (or other) monitoring and audit activities. This includes, but is not limited to, preparing for interim monitoring or other required audits and being available as needed (see SOP 23 - Quality Management System for the OHSRP).
Jeanne Radcliffe, R.N., MPH