Section
3 |
Research activities that involve human subjects, as described in the categories mentioned in Section 2 , must be filed with CORIHS Office, and must be approved by CORIHS prior to commencement of the activity. SBU uses the web-based program IRBNet for the electronic submission of studies and the overall administration and management of IRB processes. Full detail concerning use of the system is available here: http://www.stonybrook.edu/research/irbnet/ Involvement of the General Clinical Research Center and/or Brookhaven National Laboratory in the research activity requires additional documents and review by those entities. Involvement of University Hospital facilities and/or patients requires additional review and documents as well, although this process is provided for in the IRBNet architecture. Note that review by these entities can result in disapproval of a study that has been approved by CORIHS. However, these entities cannot approve a study that has been disapproved by CORIHS. Pharmacy will not dispense any drug to investigators unless CORIHS approval is verified, and the most current protocol has been shared with them via IRBNet for confirmation of proper administration schedule. Materials that must be uploaded into the IRBNet Study Designer, and subsequently electronically submitted to CORIHS, include: A. Completed Application for Exemption Review or Application for Expedited and Full Committee Review (available in the Forms and Document Library in IRBNet) B. Other forms, as applicable (available in the Forms and Document Library in IRBNet), including but not limited to forms addressing UH, HIPAA, and Industry Sponsor Fee Recovery C. Full protocol (including references, statistics, history, endpoints, etc.) D. For studies involving more than minimal risk to the subject: provide an inclusion/exclusion criteria checklist to be completed and kept on file for each subject who has consented to be in the study. The checklist should include enough information for each criterion (e.g., a range of acceptable values etc.) to allow an auditor to confirm the subject’s eligibility (or ineligibility, as applicable). E. All interviews, surveys, questionnaires, etc. F. Grant proposal and/or sponsor agreement, where funding is being sought or has been obtained from an internal (e.g., Targeted Research Opportunity grant etc) or external agency (e.g., NIH, NSF, pharmaceutical company, etc.), G. Consent/Permission/Assent form(s) submitted as word documents and standardized to conform to CORIHS-required format (per Sections 12, 13, 14 and 15, which provide detailed information about the informed consent process, obtaining consent from non-English speaking subjects, and guidance on writing consent forms). H. Investigator Brochure(s) for each experimental, non-FDA approved drug. (For Full Committee Review / Expedited Review studies only) I. Package Insert(s) for each FDA-approved drug being used off-label or for any FDA-approved drug specifically being investigated in the study protocol. (For Full Committee Review / Expedited Review studies only) J. All recruitment/advertisement materials: A study’s recruitment plan and all study recruitment materials must be reviewed and approved by CORIHS prior to use. The recruitment plan submitted to CORIHS should be detailed with respect to media to be used (e.g. flyer, newspaper, video, radio etc.), location (e.g., specific sites named, on or off campus) and process (i.e., under what conditions will subjects be approached? etc). When drafting the plan, the investigator must be aware of special approvals that may be required at sites she/he wishes to include in the recruitment plan. These approvals should be submitted for the CORIHS file. As an example, you should be aware that if you wish to recruit (e.g., post flyers etc) at the Northport Veterans Administration Hospital, approval must first be obtained from that site. K. Other materials as applicable |
Return to Human Subjects Research at SBU Last Updated: 2008-01-07 |