The Independent Study Monitoring and Oversight Committee (iSMOC) will monitor National Children’s Study data and the safety of Study participants. Formerly referred to as the Data and Safety Monitoring Board, the name of this committee was changed to more accurately reflect its charge. The iSMOC will be formed by a planning group within the Study Program Office.
The committee will report to the Study Director and will alert the Steering Committee if data become available that might require participants to be informed about the finding. An Ethics Advisory Committee (subcommittee of the Federal Advisory Committee to the Study) will be established to review relevant situations at the request of the Study Director or the Study’s Steering Committee.
Responsibilities
The responsibilities of the iSMOC are to:
- Monitor human subject safety through review and evaluation of accumulated Study data
- Review Study conduct and progress
- Make recommendations concerning continuation or modification of the Study.
The iSMOC considers Study-specific data as well as relevant non-Study background information.
The iSMOC will review the Study protocol and identify any major monitoring concerns prior to implementation or as soon thereafter as possible. During the Study, the iSMOC will review data regarding procedure-related adverse events; unanticipated problems involving risks to subjects or others; adherence to the protocol; factors that might affect Study outcome or compromise Study data (for example, protocol violations, losses to follow-up, breach of subject confidentiality); and barriers to Study progress or completion (such as slow enrollment, new data or findings, other milestones, change in resources, rate of endpoint accumulation). The iSMOC will recommend appropriateness of notification and referral of individual participants for significant abnormal findings on testing of stored samples. Confidentiality shall be maintained during all phases of iSMOC review and deliberations.
Membership
The committee will consist of 5 to 10 individuals not associated with the Study. Committee membership will reflect the disciplines and clinical specialties necessary to interpret Study data and to evaluate subject safety. Members collectively will reflect expertise in clinical aspects of the outcomes and the population under study and expertise in current clinical research conduct and methodology. The iSMOC will have expertise in biostatistics, community representation, epidemiology, environmental toxicology, ethics, genetics, obstetrics, pediatrics, psychology, social determinants of health, and other disciplines as appropriate.
Requirements for iSMOC membership include:
- Relevant expertise
- Experience conducting clinical, observational, epidemiological, or environmental studies and statistical knowledge
- Independence from contemporaneous direct involvement in the Study
- The absence of any conflict of interest.
A chair will be appointed by the NICHD Director and will be responsible for overseeing the meetings. The chair is the contact person for the iSMOC. Committee members will be selected by the NICHD Director.