Submitting a Successful IRB Application Karen Adams Regulatory Specialist, UW Institute of Translational Health Sciences September 26, 2013
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Submitting a Successful IRB Application Karen Adams Regulatory Specialist, UW Institute of Translational Health Sciences September 26, 2013 Goals for today • Introduction to the process • General tips • Q&A Introduction to the process Email Karen Adams for a consultation Include a 1-2 paragraph overview of the proposed study (purpose, study design, study setting, procedures, subject population) Attached relevant information (protocol, grant proposal, etc.) Set up a time to meet Review follow-up guidance Provide 1st draft of IRB application by email Be available for follow-up and proof reading Karen Adams Regulatory Specialist [email protected] 206-819-5339 General tips • Plan ahead • Know which institution has jurisdiction • Ascertain level of IRB review • Know the rules that apply to the study • Use current forms and templates • Write with clear, simple language • Distinguish standard of care vs. research • Assess risks and benefits accurately • Be complete • Proofread carefully • Market your IRB application #1. Plan ahead #2. Know which institution has jurisdiction UW Human Subjects Division: http://www.washington.edu/research/hsd/docs/1642 Engagement worksheet: http://www.washington.edu/research/hsd/docs/1652 Seattle Children’s Human Subjects Protection Program: http://www.seattlechildrens.org/research/supportservices/institutional-review-board/about/ #3. Ascertain level of IRB review • Is the activity regulated research? • Does the research involve human subjects? • Is the human subjects research activity exempt from IRB approval? • Does the non-exempt human subjects research activity qualify for expedited “minimal risk” review? • Does the non-exempt human subjects research activity require full committee review? UW Human Subjects Division: http://www.washington.edu/research/hsd/docs/1253 http://www.washington.edu/research/hsd/docs/1654 #4. Know the rules that apply to the study • Institutional requirements • Flexibility in the regulations #5. Use current forms and templates • Download documents from the IRB website • Sign up for updates http://uwfoundation.org/convio/subscription_management.asp Office of Research --Grants eNewsletter --Human Subjects Research UW Human Subjects Division: http://www.washington.edu/research/hsd/ Seattle Children’s Human Subjects Protection Program: http://www.seattlechildrens.org/research/supportservices/institutional-review-board/ #6. Write with clear, simple language • Write from scratch • Use lay language • Define clinical terminology • Use the active voice #7. Distinguish standard care vs. research • What will the patient experience if they are not in a research study? • How does enrollment in a study change that experience? • Clearly list research procedures and not the clinical care procedures • Describe risks only related to research—no clinical risks • Describe benefits only related to research—no clinical benefits #8. Assess risks and benefits accurately • Identify and provide a balanced overview of risks related to the research: • Physical harms • Psychological harms. • Social and economic harms • Explain how you will minimize risks • Assess the anticipated benefits for the study: • Benefits to society • Benefits to the individual HHS Risk/benefit analysis: http://www.hhs.gov/ohrp/archive/irb/irb_chapter3.htm #9. Be complete • Answer every question • Provide enough detail • Include a study protocol if available #10. Proofread carefully #11. Market your IRB application • Presentation is essential • Talk with the IRB Administrators/Analysts • Be available • Curb frustrations • The power of “Thank you” Additional resources Code of Federal Regulations (45 CFR 46): http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.h tml#46.102 UW Department of Anesthesiology and Pain Medicine http://depts.washington.edu/anesth/research/irb/index.shtml Other contacts: UW Human Subjects Division: 206-543-0098 Seattle Children’s Human Subjects Protection Program: 206-987-7804