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V. Investigator's Responsibility List

  1. Purpose
    Based upon Federal regulations from the Office of Protection from Research Risks, IRB Committees are now requiring that investigators demonstrate knowledge and familiarity with Good Clinical Practice and Clinical Research Guidelines. The first step in this process is for all individuals affiliated with a proposed project to take the Good Clinical Practice Tutorial and pass the examination (see #I above). This process starts before the development of a research project. The second step occurs when the Principal Investigator is preparing the IRB documents. The Principal Investigator must complete a "responsibilities list" acknowledging that he/she understands the responsibilities of protecting the rights and welfare of human research subjects and for complying with all Federal regulations underlying clinical research.

  2. Process
    For all research studies, the Principal Investigator must complete a Researcher Responsibilities List, and submit one copy to the NYUCD Office of Research.
Researcher Responsibility List Retrieve form: http://irb.med.nyu.edu/sites/default/files/irb2/guidance.how_.to_.investigator.responsibilities.2010.11.8.docx. Submit one copy to the NYUCD Office of Research and one copy to the NYUSM IRB office with all of the other IRB-related materials.