<< Previous Section | < Previous Page | Next Page > | Next Section >> Monitoring Research (page 2 of 2) Monitoring should be commensurate with size and complexity. Monitoring may be conducted in various ways or by various individuals or groups, depending on the size and scope of the research effort. These exist on a continuum from monitoring by the principal investigator or NIH program staff in a small phase I study to the establishment of an independent data and safety monitoring board for a large phase III clinical trial. Double blinded randomized trials need intermediate assessment of both efficacy and safety as they progress. DSMBs are now constituted to carry out that function for both commercially sponsored and Federally sponsored clinical research. They are required for therapeutic studies. We expect that DSMB members be expert in the various aspects of a trial and include the capacity for sophisticated statistical analysis. DSMB members should be independent of the research and have no conflicts of interest in relation to the research. DSMB deliberations contain open and closed portions. In the closed portions, the blinding is removed to determine whether one experimental group is experiencing significantly greater efficacy or adverse events than others. DSMB members sign non-disclosure agreements and must maintain the highest degree of confidentiality in regard to their deliberations. DSMBs have been known to stop trials early either because of established efficacy to the tested agent or increased risks associated with one arm of the trial. Such actions must be taken cautiously and with great care, considering the huge investment made by participants, investigators and sponsors alike. However, the DSMB is hopefully expert and objective in its deliberations. DSMBs have stopped the Women's Health Initiative, the NIDDM diabetes study, and the study of XXXX for breast cancer among others. They constitute a strong force for maintaining the ethical conduct of clinical research and are increasingly utilized. However, DSMBs have no direct contact with research subjects. Research Subject Advocacy: In 2001 the National Center for Research Resources established research subject advocates (RSAs) in all General Clinical Research Centers (GCRCs) funded by the NIH. These individuals were charged to develop a program of monitoring research carried out on the GCRCs, advocating for the subjects, and educating the research team as to their performance and ethical responsibilities. The RSA has access to the research participants, the protocols, DSM reports and the research team. The RSA ensures proper reporting and documentation of adverse events and protocol violations. Considerable information has been generated indicating that research errors are common and that the basis is often ignorance of standards, definitions and rules. The other main source of nonadherence is logistical problems in actually carrying out the research. These unanticipated problems can lead to protocol violations in order to get the research done. Cancer center review: Cancer Centers are provided funds for staff to monitor all the research that is under their auspices. They provided auditing functions as well as scientific and data and safety monitoring review. Gene Therapy: Gene therapy protocols undergo periodic audits and must be approved by the RAC in addition to all standard reviews. Stem cell research: Stem cell research is being monitored both by IRBs and by specially constituted ESCRO (embryonic stem cell research oversight) committees. The research will be carefully monitored and the use of the stem cells audited in detail, to some extent due to societal sensitivity to the abuse of the research material. << Previous Section | < Previous Page | Next Page > | Next Section >> Chapter 5 Quick Links Monitor Research Cases Bibliography Chapter 5 Download (PDF)