An NINDS PSMB may monitor more than one trial. Once established, a PSMB will continue until completion of the research project or until human subjects in a research project are no longer exposed to significant risk from participation in the research.
The PSMB will be established prior to the initiation of the project. The number and expertise of the PSMB members will depend on the nature and complexity of the research project. The members of the PSMB will be selected so that as a group they have appropriate clinical expertise and knowledge about the design, monitoring, and analysis of clinical research projects necessary to conduct an ethical and scientifically rigorous study. The PSMB will deliberate, reach decisions, and make recommendations independently from the research project investigators. Each member of the PSMB is responsible for notifying the PSMB chair if any potential conflicts of interest develop after the initiation of the study.
If a non-NINDS PSMB is also involved in oversight of the trial, an NINDS-appointed PSMB will continue to provide general oversight for the research and will receive reports of the activities and recommendations of the non-NINDS PSMB.
The PSMB advises the NINDS. Advice from the PSMB does not substitute for approval and evaluation by other organizations within the Department of Health and Human Services including the Office for Protection from Research Risks, the NIH, and the NINDS. The advice of the PSMB to the NINDS is also independent of any local rules or regulatory bodies such as Institutional Review Boards at participating institutions.
Policy for Phase I-II Clinical Trials:
For phase I and II clinical trials, the investigators must submit a description of the data and safety monitoring plan as part of the research application. A detailed monitoring plan is a necessary part of the protocol and must be approved by the NINDS before the study begins. The overall elements of the monitoring plan may vary depending on the potential risk, complexity, and nature of the study. They may range from independent PSMB's to continuous, close monitoring by the study investigator or an independent individual. The NINDS is responsible for overseeing the monitoring of these trials to ensure the safety of participants and the validity and integrity of the data. An NINDS PSMB may be appropriate for phase I or II clinical trials, for example if studies are blinded (masked), or involve particularly high risk interventions or vulnerable populations.
For additional information on Performance and Safety Monitoring please go to the following sites:
Last Modified February 6, 2007