How to Smoothly and Successfully Complete the Process for IRB ...

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Consent IRB Presentation • Consent is a continual PROCESS in which the investigator shares all relevant information and potential subject has opportunity to ask questions: key aspect of any study • The consent form is a permanent record of conveyed information and subject’s willingness to participate (can be withdrawn). DEFAULT: Written consent w/ signature AND copy given • Includes ads/flyers and re-consent at all stages of a study Dept. of Communication 18
IRB Presentation Requirements of Basic Consent Elements: 46.116(a) • 8 basic consent elements (from Regulations) • 1. Description (research, purpose, duration, procedures) • 2. Foreseeable risks/discomforts • 3. Potential Benefits • 4. Alternatives to participating (if any) • 5. Confidentiality (data collection, storage, & removal/destruction) • 6. Compensation/inducements (including partial) • 7. Contact Information (Investigator and IRB) • 8. Voluntary Participation Dept. of Communication 19
Page 1 and 2: How to Smoothly and Successfully Co
Page 3 and 4: IRB Presentation Why IRB Tuskegee,
Page 5 and 6: IRB Presentation Belmont Report: Th
Page 7 and 8: IRB Presentation What’s different
Page 9 and 10: What makes something “Generalizab
Page 11 and 12: IRB Presentation When to Submit •
Page 13 and 14: IRB Presentation Procedure • Each
Page 15 and 16: IRB Presentation 3 categories of Su
Page 17: IRB Presentation Level of Risk Mini
Page 21 and 22: IRB Presentation Consent: Details
Page 23 and 24: IRB Presentation Anonymity • Anon
Page 25 and 26: When Does IRB Review “end” for
Page 27 and 28: IRB Presentation What about Student
Page 29 and 30: IRB Presentation Applications that
Page 31 and 32: IRB Presentation Use Current Form &
Page 33: IRB Presentation Questions • What

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