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For the Protection of Human Participants in Research

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  1. How to Successfully Apply to the IRBRichard Gordin, IRB ChairTrue Rubal, Administrator / Director For the Protection of Human Participants in Research

  2. IRB Reviews Research Conducted with Human Participants • Purpose: to determine if the rights and welfare of human participants are adequately protected. • Documents must be provided that contain enough information to allow valid judgments about the science and ethics of research

  3. How do you know if you’re doing research? A systematic investigation designed to develop or contribute to generalizable knowledge or to contribute to the general body of knowledge.

  4. How do you know if you are using human participants? • Living individuals about whom an investigator…conducting research obtains: • Data through intervention or interaction with the individual, or B. Identifiable private information

  5. What does the IRB look for in a research project? • Risks minimized (coercion?) • Risk vs. Benefits ratio • Equitable participant selection • Informed Consent process appropriate • Privacy, confidentiality, safety - maximized • Safeguards for vulnerable subjects • Research design - scientifically sound

  6. What Guides the Inclusion of Human Participants? • Respect for Persons • Informed consent • Beneficence • Do no harm • Must be some benefit to society • Justice • Equitable and fair

  7. Who submits application to the IRB? • Responsibility of principal investigator (PI), prior to implementation (includes pilot studies) • previously collected data must be submitted to the IRB

  8. What are the deadlines? • Full-board review meetings held 1st Tuesday of the month • Submit two weeks before for review at that month’s meeting • Exempt and expedited proposals reviewed as received – generally takes 2 / 3 weeks respectively Meeting dates listed at: Http://irb.usu.edu/htm/deadlines

  9. What do I need to submit? • Online application: Protis.usu.edu • Scientific Validity Form • Copy of proposed informed consent, assent, Letter of Information or cover letter • Proposal that includes the research design • Copies of instruments, surveys, questionnaires • Advertising used for recruitment

  10. What happens after that? Contacted by e-mail • Final approval for 1 year; when all info is received / reviewed • Continuing Review: yearly status update

  11. What else do I need to know? You must contact the IRB whenever there are any changes in: • methods/objectives • population used • Unanticipated problem - adverse event

  12. Training Required • PIs and any research personnel who will be in contact with HS must receive IRB training • CITI training modules (www.citiprogram.org) • Many agencies require all researchers working with people to be formally trained. • USU has a Federal Wide Assurance (FWA) with OHRP

  13. Common Mistakes by Applicants Talk to the IRB: • Does your study qualify as research? • Which application do I complete? • What’s the deadline submission? • How long for a response from the IRB? • What other requirements are needed?

  14. Common Mistakes… • Not enough information • Answer every question fully • Follow directions, please • No handwritten documents • Upload supporting documentation • Complete CITI online training modules

  15. Common Mistakes… Create informed consent (and assent) document • Write in language understandable to the subject (6th grade level) • Follow template on web page!! PLEASE • Include timeline for procedures – duration of each visit and total duration. • Use proper grammar, spell check, local phone number

  16. Common Mistakes… • Information in the Informed Consent must match the application and proposal • IRB web page: irb.usu.edu/htm/consent-forms • Address HIPAA authorization agreements if applicable, in the IC or separately

  17. Common Mistakes… • Submit materials to the IRB on time • Response to reviewer comments within 48 hrs assures your place in the queue. • Respond promptly to IRB requests for info • Don’t start the study until you have IRB approval letter in hand

  18. Common Mistakes… After IRB approval: • Implement the study according to the approved protocol and IRB conditions • Get prior approval for changes (amendments) • PIs must complete the Continuing Review Status Report form on the IRB website • Tell the IRB when the study is completed • Retain records according to federal/state reg’s

  19. Online Resources… Checklists: • http://irb.usu.edu/htm/guidelines • IRB Handbook & SOPs • Office of HS Protections http://www.hhs.gov/ohrp • Office of Research Integrity http://ori.dhhs.gov

  20. Institutional Review Board Contact: Richard Gordin (Rich.Gordin@usu.edu) or True Rubal at 7-0597 (True.Rubal@usu.edu)