All NIH-funded clinical trials must include appropriate plans for data safety and monitoring that describes research oversight to ensure the safety of research participants and the validity and integrity of the data. The level of monitoring should be commensurate with the risks, size, and complexity of the clinical study. If applicable, the detailed data safety and monitoring (DSM) plan must be approved by both the institutional review board (IRB) that is overseeing the trial and by the funding agency.  An observational study, or a study that does not test an intervention, is not a clinical trial and does not require a DSM plan. In addition to the overall NIH policy for clinical trials monitoring, many of the NIH Institutes and Centers (ICs) have additional IC-specific clinical trials policies.

A common misconception is that an independent board known as a data safety and monitoring board (DSMB) always manages DSM. In fact, monitoring can take many forms. For example, a clinical trial that is low risk and involves only a small number of human subjects might require only close monitoring by the study investigator, whereas a multisite or large clinical trial might necessitate reporting to a central entity, such as the DSMB or an independent safety monitor. For more details, see NIH’s Further Guidance on a Data and Safety Monitoring Plan for Phase I and Phase II trials. A Phase III clinical trial requires a DSMB. The National Institute of Arthritis and Musculoskeletal and Skin Diseases offers examples of appropriate levels of monitoring for different phases and presents details about the composition of a DSMB.

One example of the role of a DSMB involves the clinical trial of a long-acting injectable drug that prevents HIV acquisition in cisgender women. Based on an interim review of clinical trial data, the DSMB recommended that NIH stop the blinded phase of the trial and share the results because of the superior efficacy of the injectable drug compared to the daily oral pill. NIH agreed with the recommendations and released the results in the interest of public health. Read more about this incident in a press release from 2020.
 

Data Management and Sharing Policy

To promote the sharing of scientific data, the NIH issued a Data Management and Sharing (DMS) Policy, effective January 25, 2023. The DMS policy requires investigators to prospectively plan for the managing and sharing of scientific data, submit a DMS plan and comply with the approved plan. An overview of the Data Management & Sharing Policy, including resources on planning and budgeting for data management and sharing, is available here. 

Responsible scientific data sharing practices promote both effective data stewardship and protection of human research participant privacy. Learn about how to protect the privacy of human research participants when sharing data under NIH policies here.