Research Involving Human Subjects Review of Risk and Protection from Harm.
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Presentation on theme: "Research Involving Human Subjects Review of Risk and Protection from Harm."— Presentation transcript:
http://www.brockport.edu/irb/ Research Involving Human Subjects Review of Risk and Protection from Harm
http://www.brockport.edu/irb/ What is human participants’ research? Systematic investigation Collection of new data Use of existing data Use of data Contributing to knowledge About live human beings
http://www.brockport.edu/irb/ Mission of IRB Facilitate ethical research Review of proposals in assisting the research to ethically proceed Collegial and supportive interactions with investigators Evaluation of the benefits of research with no or minimal risk to participants.
http://www.brockport.edu/irb/ The IRB Committee is composed of members who are: Faculty from varying disciplines across the campus. One faculty member who serves as IRB chair. Representatives from the community. A compliance officer (non-voting). An IRB administrator (non-voting).
http://www.brockport.edu/irb/ Why Must IRB Review? FFederal and state laws require the review. RReviewers must monitor the risk for human participants according to federal guidelines. CCollege policy requires rights and welfare of participants is adequately protected.
http://www.brockport.edu/irb/ Collaborative Process IRB is charged to review risk to participants. Investigators develop research procedures that protect participants’ rights, while meeting research objectives. Reviewers strive for flexibility and individuality in the review of each research project.
http://www.brockport.edu/irb/ How is the proposal reviewed? Risk vs. benefits Equitable selection of participants Equitable recruitment of participants Soundness of research design vs. risk to participants Informed consent process Privacy and confidentiality Special populations Consistency throughout all aspects of the proposal
http://www.brockport.edu/irb/ Project Categories Category #1 Exempt – presents no possible risk to participants. Category #2 Expedited – presents minimal risk to participants. Category #3 Full Review – presents potential for harm to participants, violates rights, or requires special protections.