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Rutgers, The State University of New Jersey Institutional Review Board for the Protection of Human Subjects in Research (IRB)
Human Subjects Procedural Guidance Documentation
These procedural guidance documents are provided to the University's human subjects researchers in order to offer guidance about the IRB's protocol submission and review procedures, informed consent procedures, privacy and confidentiality measures, inclusion of vulnerable populations, and other issues related to ensuring the welfare of human subjects in social-behavioral and biomedical research. The IRB hopes that these guidance documents will offer valuable information relating to issues commonly found in conducting qualitative and quantitative research and enable researchers to design research projects which include the required ethical and regulatory elements. Researchers can ensure a smoother review process by designing research that includes the relevant information found in the guidance documents. Additionally, researchers are encouraged to utilize these guidance documents in responding to the protocol review concerns expressed by the IRB. The guidance documents reference the University's internal policies and procedures, as well as DHHS regulations promulgated at 45 CFR 46 and the Belmont Report. Funds for the development of these procedural guidance documents have been provided by NIH grant #0D02003, Human Subjects Compliance Certification Program. These procedural guidance documents will be periodically updated and additional documents added as subsequent guidance is developed. Please check back periodically to ensure that you are using the current version. Summary information about the IRB review process (e.g., protocol submission deadlines, IRB mailing address, etc.) may be found at the Frequently Asked Questions web page at: http://orsp.rutgers.edu/Humans/FAQ_General.php. All guidance documents are download-able as a PDF document by clicking on the colored text below. You will need Adobe Reader to download the PDF procedural guidance documents. You can download Adobe at: http://www.adobe.com/products/acrobat/readstep2.html.
To be posted.
1) Financing, structure and composition of IRB. To be posted. 2) Evaluation of proposed research; containing information on the following issues: Informed consent process, Expedited initial or continuing review, Initial review, Continuing reviews, Proposed amendments, Independent verification, Limitations on expedited review of conditional approvals, Rutgers Student Research Policy, Determining which projects require review more often than annually, and Determining which projects require verification from sources other than the PI that no material changes have occurred since the previous IRB review 3) IRB documentation; containing information on the following: Complete protocol file, Records retention, and Documentation of discussion and decision 4) Risks and benefits; containing information on the following: Criteria for continuing review, Sources of risk and measures to minimize risk, Data and safety monitoring, Risks to vulnerable populations, and Suspension or termination of previously approved research 5) Participant recruitment and selection; containing information on the following: Equitable selection of participants, Permissible recruitment practices, and Review of recruitment methods, advertising and payment arrangements 6) Protection of privacy and confidentiality; containing information on the following: Privacy of research participants, and Confidentiality of identifiable data 7) Informed consent process; containing information on the following: Evaluation of compliance, Protection of vulnerable participants, Participant understanding and voluntary decision-making, Documentation of informed consent process, Waiver or alteration of consent process, Exceptions in emergency situations, and Monitoring consent process in ongoing research 8) Multiple-site research; containing information on the following: Communication among IRBs, and Management of information and reporting
1) Investigator responsibilities and University support; containing information on the following: PI and research staff conflicts of interest, Study design, reporting and monitoring, Risk alternatives and plans for detecting and mitigating harm, Fair and equitable recruiting of participants, Adequate resources and facilities, Informed consent process and documentation, and Response to participants’ complaints / information needs. 2) Qualifications and regulatory compliance; containing information on the following: Qualification, Assessment and reporting of unanticipated problems, PI Oversight and delegation, and Data and safety monitoring.
To be posted.
1) Response to participant concerns; containing information on the following: Participant questions, concerns and complaints to PI, and Confidential channel for participant concerns independent of protocol 2) Participant education; containing information on the following: RU/ORSP outreach, and Evaluation and improvement of outreach
For information regarding the procedural guidance noted above, please contact our office via email at: humansubjects@orsp.rutgers.edu. Copyright 2005, Rutgers, The State University of New Jersey |