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> Research > Human Subjects Research
> NYUCD Human Subjects Protocol
> I. Tutorial and Examination on Good Clinical Practice (GCP) Guidlines
I. Tutorial and Examination on Good Clinical Practice (GCP) Guidlines
Purpose
Federal guidelines require that all individuals involved in
human subjects research must be knowledgeable about the ethical
principles of research involving human subjects. The NYU Office
of Sponsored Programs (OSP) has designed a web-based tutorial
and examination that covers that major principles of human subjects
research and good clinical practice guidelines. A review of
the ethical principles underlying these federal guidelines may
be found at:
Process
It is NYUCD policy that all full and part-time faculties take
the OSP GCP tutorial and pass the exam. For new full
and part-time faculty, the individual must take the tutorial
and pass the exam within 30 days of official appointment to
the NYUCD faculty. The tutorial and examination also applies
to any student, resident, fellow, graduate student, staff, and
agent of NYUCD involved in clinical research. All of these individuals
must take the tutorial and pass the exam before the initiation
of a clinical research investigation.
The Human Subject Tutorial is located at: tools.med.nyu.edu/tutorials.
Involvement in research by principal investigators, co-investigators,
investigators, students, and research staff applies to the following
conditions:
- Data collection
- Data analysis
- Subject recruitment
- Evaluation of subjects
- Subject/patient treatment or interview
- Evaluation of patients' charts
- Evaluation of x-rays, study casts, and other patient-related
information
- Collection and evaluation of subjects' biological samples,
including blood, urine, feces, sweat, skin, tears, saliva, oral
mucosa, gingival crevicular fluid, gingival tissue, and teeth.
A permanent record of the date of passing the tutorial will be
kept with the NYUCD Office of Human Resources and the NYUCD Office
of Quality Assurance. This confidential information will be combined
with CPR certification, clinical licensure, DEA registration (if
applicable) and other pertinent records to document the faculty/staff/student's
research and clinical qualifications. It can be used prospectively
to help recruit future research projects at the NYUCD.
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