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Page 1: Http:// Research Involving Human Subjects Review of Risk and Protection from Harm

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

Research Involving Human Subjects

Review of Risk and Protection from Harm

Page 2: Http:// 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

Page 3: Http:// Research Involving Human Subjects Review of Risk and Protection from Harm

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.

Page 4: Http:// Research Involving Human Subjects Review of Risk and Protection from Harm

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).

Page 5: Http:// Research Involving Human Subjects Review of Risk and Protection from Harm

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

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.

Page 6: Http:// Research Involving Human Subjects Review of Risk and Protection from Harm

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.

Page 7: Http:// Research Involving Human Subjects Review of Risk and Protection from Harm

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

Page 8: Http:// Research Involving Human Subjects Review of Risk and Protection from Harm

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.

Page 9: Http:// Research Involving Human Subjects Review of Risk and Protection from Harm

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

Resources

http://www.brockport.edu/irb/ http://www.brockport.edu/forms/grant

/guidelines.html Email: [email protected] Phone (585) 395-2524 Fax (585) 395-2006


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