Review of Coordinating Center Activities
If you are the coordinating center for a multi-centered study, there are specific requirements related to your role as the coordinating center that must be met. Please provide the IRB with information regarding the following:
- The management, data analysis, and data safety and monitoring plan are adequate for the research provided. Please explain the plan for reporting of adverse events, in which all events will be reported to the data safety monitoring board. The DSMB will be convened under the regulations of the NIH, and will compile statistics relative to the adverse events, analyze them for trends, and report on a regular basis. In addition, specify that all adverse events will be appropriately forwarded to the FDA and promptly reported to individual enrollment sites for their submission to their designated IRB's;
- As the DCC, the PI is responsible for the development of a sample protocol and consent document and for ensuring that adequate provisions are in place for their distribution to each collaborating institution.
- The PI must submit evidence that they will assure that each collaborating institution holds an applicable OHRP-approved Assurance, and will maintain documentation of such;
- The PI must submit evidence that the coordinating center will assure that the protocol will be reviewed and approved by the IRBs at the collaborating institutions prior to the enrollment of subjects at each site;
- The PI must detail what mechanisms are in place to determine if substantive modifications by the collaborating institutions of the sample consent information are appropriately justified and documented, as well as communicated to the DSMB, particularly with regard to risks or alternative procedures; and
- The PI must demonstrate that there are appropriate procedures in place to assure that informed consent is obtained from each subject in compliance with HHS regulations.
If MSSM is also serving as a site or the PI is the lead PI on the study or the PI is the Sponsor-Investigator of an IND or IDE, sufficient information must be presented to the IRB to allow the appropriate determinations to be made for each set of regulatory considerations and requirements that apply.
Program for the Protection of Human Subjects
For submissions and general inquiries send e-mail to: IRB@mssm.edu
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