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> Research > Human Subjects Research > NYUCD Human Subjects Protocol >
IV. Consent Forms
IV. Consent Forms
- 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.
- 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 www.nyu.edu/ucaihs/.
NYUSM IRB Applications
NYU Langone IRB Forms & Templates Library: Applications / Forms
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