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CSBS Faculty Workshop: The IRB – Institutional Review Board for the Protection of Human Subjects PRESENTED BY: FRANCES SOLANO WITH SPECIAL GUEST: DR. DANIEL RASTEIN MARCH 1, 2016 1
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Agenda Introductions What is the IRB? History and Purpose Organization Protocol review process IRB Assistance Possible Consequences Discussion Upcoming Workshops 2
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What is the IRB? Brief History Response to ethical concerns surrounding such events as Nazi experiments on humans in WWII Nuremburg Code Tuskegee syphilis study of 1940s Treatment purposely withheld from persons suffering from disease The Belmont Report Addresses not only protection of physical well-being, but also mental/emotional and social well-being of individual 3
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What is the IRB? The Belmont Report Respect for Persons Informed Consent, for each individual To assure fully informed and understood To protect the rights and welfare, especially of vulnerable populations (children, pregnant women, prisoners, mentally disabled, economically or educationally disadvantaged) Beneficence Assure sound research procedures, with no unnecessary exposure Risk is reasonable to anticipated benefit Data collection is monitored for safety Justice Selection of subjects is equitable for the purpose of the research and setting. 4
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What is the IRB? Mandated by federal legislation (Code of Federal Regulations), and registered with the federal government (DHHS/OHRP) An ethics committee – not meant to evaluate the research itself, except as design affects human subjects. Organization Composition of Board includes CSUN faculty Community members Managed by CSUN Compliance Officer, Dr. Daniel Rastein 5
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What is the IRB? Current IRB Members David Boyns, Chair (Sociology) Linda Chassiakos, Vice Chair (Student Health Center) Edwin Aimufua, Community Member Kenya Covington, Urban Studies and Planning Nathan Durdella, Educational Leadership & Policy Studies Salvador Esparza, Health Sciences Jonathan Kelber, Biology Neil Smith, Community Member Shane Stecyk, Kinesiology Kat Sohn (alternate), Prisoner Advocate Abraham Rutchick (alternate), Psychology 6
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The Process Obtain your IRB Training Certification: CSUN > Academics > Research & Graduate Studies Research & Sponsored Projects > Regulatory Compliance Responsible Conduct of Research (RCR) Training http://www.csun.edu/research-graduate-studies/responsible-conduct-research http://www.csun.edu/research-graduate-studies/responsible-conduct-research 7
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The Process Types of activities to be reviewed – Systematic investigations : Designed to develop or contribute to generalizable knowledge—to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program (e.g., publications or presentations.) Examples include: surveys and questionnaires interviews and focus groups analyses of existing data or biological specimens epidemiological studies evaluations of social or educational programs cognitive and perceptual experiments medical chart review studies 8
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The Process Prepare and Submit your Protocol Usually done after grant proposal is submitted, but must be approved before activities with human subjects commence. http://www.csun.edu/research-graduate-studies/protocol-submission-process http://www.csun.edu/research-graduate-studies/protocol-submission-process Protocol Approval Form (either for Faculty or Student) AND Project Information Form Additional Forms, depending on study needs. Electronic submission through Cayuse, expected March 2016. 9
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The Process 10 Protocol DeadlineMeeting Date April 5, 2016April 26, 2016 May 3, 2016May 24, 2016
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IRB Assistance Consult with IRB Manager for assistance. Determination of exempt status for minimal risk studies. Advice on study design to minimize risk, reduce exposure. 11
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Possible Consequences If research has not received IRB approval, may not publish. Possible cancellation of current or future funding. Exposure to legal action (both individual and university). Possible adverse effects on human subjects. 12
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Discussion… QUESTIONS? COMMENTS? SUGGESTIONS? 13
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Future CSBS Workshops – Spring 2016 Tuesday, April 5, 3:30 – 4:30 pm Wednesday, May 4, 3:30 – 4:30 pm Location: Sierra Hall, 4 th Floor Whitsett Room 14
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