Section 21: Data and Safety Monitoring in Research
For research involving human subjects, federal regulations require that, when appropriate, research plans make adequate provisions for monitoring data to ensure the safety of research participants. The regulations do not specify when or how this monitoring should be accomplished. For each study, researchers and the IRB must determine the type and level of monitoring required to assure subject safety and well-being.
21.2 Requirement for a Data and Safety Monitoring Plan
Minimal Risk Studies - Much of the research conducted at the University pertains to social and behavioral sciences and is generally considered to be not greater than minimal risk. Thus, many research studies may not be required to establish a Data and Safety Monitoring Plan (DSMP). However, sponsors or the IRB may require DSMPs regardless of risk. In all research, regardless of whether a formal data and safety monitoring plan is required, investigators are responsible for providing ongoing oversight to protect the safety and welfare of study participants.
Greater Than Minimal Risk- All human subjects research involving the use of drugs, biologics, or devices require a DSMP. For other types of interventional human subjects research involving greater than minimal risk, a DMSP should be strongly considered and may be required by the IRB.
21.3 Types of Data and Safety Monitoring Plans
The methods and amount of monitoring required are somewhat dictated by the type and magnitude of risk involved, the population to be studied, and the complexity of the research, and can range from monitoring by the researcher or a group of researchers to the establishment of a Data and Safety Monitoring Board (DSMB).
Monitoring by an individual investigator –for studies that involve small numbers of research participants at a single site and interventions unlikely to lead to major changes in risks and benefits. Close, continuous monitoring by the researcher and prompt reporting of unanticipated problems to the IRB and sponsor are generally considered to be adequate.
Monitoring by a group of investigators– for studies where assessments may require additional expertise or objectivity from individual(s) who may or may not be directly involved with the design and/or conduct of the study. Studies overseen by a monitoring group of this type are generally short-term in nature, study endpoints do not include serious events, and risks to participants can be assessed through simple comparisons.
Data and Safety Monitoring Board (or Committee) –for studies involving large numbers of research participants, particularly vulnerable populations, multiple performance sites, blinded study groups, particularly high-risk interventions or when sophisticated data monitoring/statistical analysis is required. FDA regulated studies generally require establishment of a DSMB.
21.4 Components of DSMPs
Investigators are encouraged to utilize the DSMP Template, and should assure that the following issues are addressed in the plan:
- The type of data or events that are to be captured under the monitoring provisions.
- The frequency of assessments of data or events captured by the monitoring provisions (e.g., at certain points in time or after enrollment of a certain number of subjects).
- The entity or person(s) responsible for monitoring the data collected, including data related to unanticipated problems and adverse events and their respective roles in the research activities (i.e., PIs, research coordinators, statisticians, independent medical monitor, etc.).
- Procedures for monitoring study progress including specifics of how monitoring the data and safety of subjects will occur.
- Procedures for minimizing research-related risk.
- Procedures for analysis and interpretation of the data.
- The procedures and time frames for reporting adverse events and unanticipated problems to the monitoring entity.
- The definition of specific triggers or stopping rules that will dictate when some action is required and what the range of possible actions will be.
- Reporting mechanisms/procedures for the data monitor and others who will communicate the outcome of the reviews of the monitoring entity with the IRBs, the study sponsor (if applicable), the PIs and other appropriate officials.
- How data accuracy and protocol compliance will be assured.
21.5 IRB Review of DSMP
Initial Review – For clinical research trials including drugs, biologics, or interventions of any kind, the IRB will review the submitted DSMP to assure adequacy for protection of subjects from risks to the extent possible.
In order to approve research in which the IRB considers whether the provisions for monitoring data to ensure the safety of research participants are appropriate, the IRB must determine that the research plan makes adequate provisions for monitoring the data. In the review, the IRB might consider provisions such as:
- For studies that do not have or are not required to have a data monitoring committee (DMC) and are blinded, have multiple sites, enroll vulnerable populations or employ high-risk interventions, the IRB will carefully review the DSMP and determine whether a DMC is needed.
- If not using a DMC and, if applicable, whether there are statistical tests for analyzing data to determine whether harm to participants may be occurring.
- Provisions for the oversight of safety data, such as requiring a DMC.
Continuing Review – Researchers with DSMPs should submit information indicating that monitoring occurred as described in the research protocols. If a DSMP was not initially required, researchers should submit a summary of unanticipated problems along with any new information or literature that may be relevant to the research.