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 > Research > Human Subjects Research > NYUCD Human Subjects Protocol >  III. Protocol Design

III. Protocol Design

  • Purpose
    Any prospective or retrospective investigation requires a comprehensive description of the protocol (see below). A scientific/biological rationale for the study is indispensable and required by the IRB. A comprehensive protocol will ultimately guide the investigators in conducting a study that will yield potentially useful information that can be published and that will impact scientific knowledge. After approval from the NYUCD IRB and Research Proposal Oversight Committee, the research protocol will be submitted to the appropriate IRB. No study can be initiated at NYUCD before written approval of the protocol from the NYUSM IRB or the OSP IRB.

  • Process
    All consent forms must contain, at a minimum, the following:

    • Introduction/Abstract
    • Objectives/Rationale
    • Methods and Procedures
    • Inclusion and Exclusion Criteria
    • Potential Benefits to Subjects
    • Potential Risks to Subjects
    • Subject Recruitment Strategies and Compensation
    • Study Management and Personnel
    • Confidentiality Statement
    • Data Analysis Strategy
    • Bibliography
    • Appendices

    OSP IRB Applications
    Application for Review by the University Committee on Activities Involving Human Subjects (Appendix 3). Retrieve form: www.nyu.edu/ucaihs/

    NYUSM IRB Applications
    NYU Langone IRB Forms & Templates Library: http://irb.med.nyu.edu/researchers/library/guidance

    Application for New Protocol (Appendix 5). Retrieve from: http://irb.med.nyu.edu/sites/default/files/irb2/app.new_.full_.or_.expedited.2012.03.07.docx