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Investigator Meeting Meeting The EFIC Regulations CC & PD Update - The ProTECTIII Trial November, 2012 Deneil Harney MPH, MSW Human Subjects Protection Coordinator University of Michigan. CC Summary. CC Closed-ended Results. CC Open-ended Results. Concerns reported
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Investigator Meeting Meeting The EFIC Regulations CC & PD Update- The ProTECTIII Trial November, 2012 Deneil Harney MPH, MSWHuman Subjects Protection CoordinatorUniversity of Michigan
CC Open-ended Results Concerns reported • Lack of consent /deception • Being blinded to the study treatment received • Randomization – “a shot of hope” • Study treatment unproven/ Lack of FDA approval • Suspicious of research & researchers motives • Risk of getting a blood clot Participants reported they needed to know more about • Side effects • All of them • Short term/long term • The chances of one occurring • Progesterone • Dosage • How it works • How it’s made • More about other progesterone studies, # of them, safety issues, findings, etc.
CC Open-ended Results Reasons to wear an opt-out bracelet • Do not want to be in the study • “to protect my rights” • Allergic to eggs Reasons not to wear an opt-out bracelet • Would want to be in the study • Length of time too long/unrealistic • Unattractive “It doesn’t look cool” • Shouldn’t have to • Would forget • Would have to explain it • Do not anticipate having a TBI • It might get caught on something (work hazard) • People who want to be in the study should have to wear it.
