Conventional consent with opting in versus simplified consent with opting out: An exploratory trial for studies that do not increase patient risk,☆☆,

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Abstract

Objective: The objective of this study was to assess a modified consent procedure allowed under federal regulations and developed for studies, particularly clinical trials, that are judged by the Institutional Review Board to reduce or have no effect on patient risk. Study design: This was a randomized trial of a conventional consent procedure that required parental signature to give consent (opting in) after a comprehensive disclosure of the rights of participants in research versus a modified consent procedure that required parental signature to refuse consent (opting out) after specific disclosures appropriate when risk is not increased. Consent was sought for a trial of primary follow-up care for disadvantaged infants at high risk, a trial judged by our Institutional Review Board to increase access to care for both groups. A blinded assessor interviewed mothers within 24 hours of the consent decision. Results: Among the 44 mothers interviewed, the modified consent group scored higher than the conventional consent group in recall and understanding of study purpose and methods (47% vs 30%; p < 0.02). Other comparisons provided no evidence that the modified consent procedure was less desirable. Virtually all mothers reported satisfaction. Conclusions: The modified approach may improve communication and facilitate studies judged by the Institutional Review Board to be risk-neutral or risk-reducing. Further evaluation of a modified consent procedure for such studies is warranted. (J Pediatr 1998;132:606-11)

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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    From the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Texas.

    ☆☆

    Reprint requests: Jon E. Tyson, MD, MPH, UT Southwestern, 5323 Harry Hines Blvd., Dallas, TX 75235.

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