1 / 14

IRB: Institutional Review Board for Human Subject Protection

This workshop provides an overview of the IRB, its history, purpose, review process, and potential consequences. Attendees will learn how to submit protocols and receive assistance. Presented by Frances Solano with special guest Dr. Daniel Rastein.

puig
Download Presentation

IRB: Institutional Review Board for Human Subject Protection

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. 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

  2. Agenda • Introductions • What is the IRB? • History and Purpose • Organization • Protocol review process • IRB Assistance • Possible Consequences • Discussion • Upcoming Workshops

  3. 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

  4. 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.

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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 • 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.

  10. The Process

  11. 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.

  12. 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.

  13. Discussion… • QUESTIONS? • COMMENTS? • SUGGESTIONS?

  14. Future CSBS Workshops – Spring 2016 • Tuesday, April 5, 3:30 – 4:30 pm • Wednesday, May 4, 3:30 – 4:30 pm Location: Sierra Hall, 4th Floor Whitsett Room

More Related