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Research Involving Human Subjects

Research Involving Human Subjects. Review of Risk and Protection from Harm. 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. Mission of IRB.

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Research Involving Human Subjects

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

  2. 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/

  3. 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/

  4. 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/

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

  6. 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/

  7. 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 How is the proposal reviewed? http://www.brockport.edu/irb/

  8. 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. http://www.brockport.edu/irb/

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

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