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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:

1 http://www.brockport.edu/irb/ Research Involving Human Subjects Review of Risk and Protection from Harm

2 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

3 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.

4 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).

5 http://www.brockport.edu/irb/ Why Must IRB Review? FFederal and state laws require the review. RReviewers must monitor the risk for human participants according to federal guidelines. CCollege policy requires rights and welfare of participants is adequately protected.

6 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.

7 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

8 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.

9 http://www.brockport.edu/irb/ Resources  http://www.brockport.edu/irb/ http://www.brockport.edu/irb/  http://www.brockport.edu/forms/gra nt/guidelines.html http://www.brockport.edu/forms/gra nt/guidelines.html  Email: irboffic@brockport.eduirboffic@brockport.edu  Phone (585) 395-2524  Fax (585) 395-2006


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