Presentation on theme: "7 Tips for Quicker IRB Approval And one unavoidable truth."— Presentation transcript:
7 Tips for Quicker IRB Approval And one unavoidable truth
1. Focus on human subjects. The IRB committee is concerned only with risks to participants. Our focus is protection measures. Be brief about project objectives – we don’t need theories, citations, and statistical procedures to be used in analysis. The main risk in CCI research is the loss of anonymity. Clearly show how you will protect it. – Show how you will disassociate names and data.
2. Show precautions you will take to protect anonymity. Transcribe tapes as soon as possible. Destroy tapes that have identifying information. Tell how you will store and protect them in the meantime. Get signed confidentiality statement from transcribers. Storage of informed consent forms is more important than storage of data that does not have identifiers. – Data with no identifiers can be kept indefinitely. Consent forms must be kept in a clearly identified, secure location on campus for 3 years. State who will have access.
You don’t need a signed consent form for an anonymous survey. – Requiring a signature makes it not anonymous. “By continuing to the next page I am indicating that I have read the consent form and am voluntarily agreeing to participate….” Focus groups need extra protection. – On the informed consent form, ask participants to agree that they will not discuss what was said in the focus group.
3. Recruitment methods must be clear. Be clear that subjects are not being coerced. Clearly state incentives (or lack thereof). If students are earning credit for participation, they should be given other options for credit so they are not being “forced” to participate. Include recruitment statement as an appendix.
4. Word carefully. Use the “lawyer- approved” language on the instruction guide. To write, “There are minimal risks…” implies risks. It is better to write, “There are no anticipated risks….” I.e., Your participation in this study is voluntary; you may decline to participate without penalty. If you decide to participate, you may withdraw from the study at anytime without penalty and without loss of benefits to which you are otherwise entitled. If you withdraw from the study before data collection is completed, your data will be returned to you or destroyed.
5. Match the wording on the IRB Form and Informed Consent form. Redundancy and consistency are necessary. Eventually, the consent form will live in a file cabinet in your office and the IRB form will live in a file cabinet in the Office of Research. Consistent information needs to be in both places.
6. If the research is not about children, subjects must be at least 18 years of age. State this explicitly on Form A or B and on the informed consent statement. – …even if they are retired librarians with advanced degrees or parents of teenagers.
7. Clean up your form. Delete all instructions and superfluous information Faculty Advisor: Complete name and address including telephone number and address
Be prepared to make further changes. Every research project is different. Brenda Lawson, the UT Office of Research Compliance Officer, makes judgment calls based on her experience. (Changes requested by Brenda can be sent directly to her. They do not have to go through CCI review.)