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V. Investigator's Responsibility List
V. Investigator's Responsibility List
- 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.
- 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.
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