How to Prepare an IRB Application Timothy J. Williamson, MPH, CHES, CPH for The Writing Center, Claremont Graduate University • 6/19/2013 Some images from Google Images; Some material adapted from http://www.cgu.edu/pages/1837.asp and http://www.pitzer.edu/irb Hello, nice to meet you!!! § A little bit about me… § Background in Psychology § Recently graduated with a Master of Public Health from the School of Community & Global Health § Headed towards a PhD in Clinical Health Psychology next year at UCLA § Emphasis will be on how to write an IRB application rather than specific content Why prepare an IRB application? § The IRB stands for the Institutional Review Board and is comprised of a diverse panel of members § “If your research involves the use of human participants (either directly or through records), your research requires human participant review. Focused on a specific topic of interest, sometimes leading to a research question” § Class projects vs. independent research § Not sure? Contact IRB office in Harper Hall § WWW.CGU.EDU/IRB Step by Step on the Form: Beginning Stages § Name of Study (concise) § Information about Principal Investigator § Vulnerable or special populations (minors, clinical, prisoners, impaired, etc.) § Nature of Information § CONFIDENTIAL vs. ANONYMOUS § Project summary (200 characters) § Must be concise! (shorter than an abstract) Research Summary § Brief description of the research (500 words or less) specifically written for IRB review § Extract from proposal, but do not use verbatim § Role of human subjects (why are you incorporating human participants?) § What will participants be told about the project? (is there any deception used?) § Do not use scientific language § No jargon Participants and Recruitment The WHO § What is the population being studied? Who do you expect to have in your study? (Be specific about expected sample sizes) § What is the recruitment procedure? Will there be any incentives or compensation offered? (ALL recruitment materials must be prepared and included upon submission) § Reasonable compensation vs. undue influence Informed Consent § Attach your consent form (sample consent form can be found at CGU IRB website) § Outline benefits and risks (we’ll go over these later in the presentation) § Will temporary deception be used? Justification MUST be provided. § Consent vs. Assent Procedures and Methods The WHAT and HOW § What materials will be used to collect data? (attach all questionnaires, materials, forms, etc. if possible). § Interview scripts/protocol, media to be shown, pictures of equipment, etc. § Re-visit confidentiality (vs. anonymity) especially when recordings, photographs, or voice recordings are used § Debriefing form (particularly when temporary deception is used) Potential Risks and Benefits The WHY (and how come?) § Risks to the participant § No risk vs. Minimal risk § What is minimal risk? What procedures are in place to minimize adverse effects that may arise? § Benefits to the participant § Potential benefits to a group or institution (beyond) § Scientific benefits (justify risks) § Compensation is NOT a benefit Tips of the Trade § Familiarize yourself with the application § Use resources available at the Writing Center and the IRB Office § NIH Human Subjects Training § Be clear and concise! Use linear logic. Thank you! Questions?