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 > Research > Human Subjects Research > NYUCD Human Subjects Protocol >  IV. Consent Forms

IV. Consent Forms

  1. Purpose
    This is a federally-mandated process whereby the research subject is informed about the risks and benefits of the study and gives non-coerced written consent to participate in the study. The written consent form accompanies the protocol in the IRB submitted materials. It MUST be written in 10th grade verbiage. If a significant number of potential study subjects do not use English as their primary language, then the consent form must be translated into the primary language and submitted to the IRB. No study can be initiated at NYUCD before written approval of the consent form from the NYUSM IRB or the OSP IRB.

  2. Process
    All consent forms must contain the following:

    • Statement that the study is a research study
    • Purpose
    • Procedures involved including time involvement of the subject
    • Risks or discomforts
    • Benefits
    • Treatment alternatives
    • Costs of participation including compensation
    • Confidentiality
    • Voluntary participation
    • Right to withdraw
    • Termination of participation
    • Compensation for subject injury
    • Significance of new findings
    • Conflict of interest
    • To whom questions may addressed

    Special considerations in the informed consent process include vulnerable populations:

    • Pregnant women and fetuses
    • Children 0-12 years
    • Adolescents 13-18 years
    • Students and employees of NYU
    • Prisoners
    • Institutionalized/cognitively impaired persons
    • Adults with legal guardians

    Studies involved the following items also require special mention in the written consent form:

    • Videotaping
    • Collection and storage of biological samples for genetic analysis
    • HIV testing

OSP IRB Applications
Sample Language Consent Forms (Appendix 6). Retrieve form by clicking on download forms from

NYUSM IRB Applications
NYU Langone IRB Forms & Templates Library: Applications / Forms