Conventional consent with opting in versus simplified consent with opting out: An exploratory trial for studies that do not increase patient risk☆,☆☆,★
Section snippets
Description of PCT
The PCT was a large randomized clinical trial to assess whether primary follow-up care is a cost-effective method to reduce life-threatening illness resulting in death or admission to a pediatric intensive care unit among indigent infants at high risk between nursery discharge and 1 year adjusted age (1 year after term). Infants born at Parkland Memorial Hospital who were either <1001 gm birth weight or treated with a ventilator and 1001 to 1500 gm birth weight were randomized to receive either
Results
A total of 57 eligible mothers were randomized to receive modified (n = 25) or conventional (n = 32) consent; 13 mothers (7 modified, 6 conventional) were not interviewed. Of these 13, consent was not sought from 3 (all modified): one was heavily medicated and obtunded at the time of multiple visits, one refused to be approached for consent, and one was randomized when the investigator responsible for seeking consent was unavailable. Ten mothers (four modified, six conventional) who received
Discussion
Conventional consent procedures have undoubted benefits, particularly for studies that increase risk to participants. The modification that we assessed is designed to augment these benefits for studies judged by the responsible IRB to reduce or have no discernible effect on patient risk. Such studies would include clinical trials that improve supportive care or monitoring or assess unproven but widely used therapies and impose no procedures that increase risk above that associated with clinical
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Cited by (0)
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From the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Texas.
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Reprint requests: Jon E. Tyson, MD, MPH, UT Southwestern, 5323 Harry Hines Blvd., Dallas, TX 75235.
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9/21/86653