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Helsinki Committee

The Committee acts according to the Public Health Regulations (Clinical Trials on Human Subjects) 1980, including all subsequent additions and amendments thereto until 1999 and applies the principles stated in the Helsinki and ICH-GCP Guidelines.

The Committee deliberates on proposals for clinical trials on human subjects. It also deliberates on research proposals in the sphere of the social sciences (psychology, social medicine, and requests that include questionnaires). The Committee operates under the auspices of the Ministry of Health and the State Comptroller. The Committee is comprised of at least five (five to 11) members who have attained senior status in their professions and in academia.

The Committee comes together periodically for a plenary meeting to deliberate on requests to conduct clinical trials. The Committee may approve or reject requests, or may return a request to the researchers with suggestions for changes and/or additions and resubmission.

Responsibilities of the Committee
• Check and approve the updates and the amendments of all documents submitted during research.
• Check the reports on side effects or serious health-related adverse events or reactions observed in research participants.
• Extend the validity of research approvals.
• Direct the expansion of approved research projects.
• Report periodically to the Ministry of Health.
• Provide researchers consultation and guidance on how to proceed with research-related submissions, updates, changes, and reports.

Forms for Downloading

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Committee Chairs

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Committee Members

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Submitting Research for Approval Instructions(Forms to be submitted to the Committee)

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Registering Research with the NIH

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