Institutional Review Board and the Protection Of Human Subjects: Downstate Medical Center is guided by the ethical principles regarding all research involving humans as subjects, as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Ethical Principles and Guidelines for the Protection of Human Subjects of Research, regardless of whether the research is subject to Federal regulation or with whom conducted or source of sponsor support.
The fundamental responsibility of the Institutional Review Board is to assure that all ethical issues have been fully addressed in the protection of human subjects who volunteer to participate in research studies. The IRB reviews all protocols for research using human subjects, weighing the ethical issues raised, assessing potential benefits against risks, and assuring that the appropriate recruitment and consent procedures are used. Through this review and approval process, compliance with both the spirit and letter of federal, state and campus policies is achieved.
The use of human subjects in research will not be permitted until the IRB has reviewed and approved the research protocol and informed consent has been obtained from the subject or the subject's legal representative.
Mandatory Reading: The Belmont Report
Do you think your study is EXEMPT from IRB approval? Let the IRB staff make this decision and eliminate the risk of making an improper guess.