1. How to Successfully Apply to the IRB Richard Gordin, IRB Chair True 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: A. 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? o Responsibility of principal investigator (PI), prior to implementation (includes pilot studies) o 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 (6 th 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 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)Rich.Gordin@usu.edu