Traditional informed consent (TIC) is highly regulated but poorly studied. As we previously reported, TIC may result in poor comprehension and cause unwarranted parental concerns, particularly in stressful circumstances, e.g. the perinatal period. In seeking consent for a trial of primary follow-up care(PC) for infants ≤ 1500g birth weight at a county hospital, we have assessed whether a modified informed consent (MIC) process reduces undue consent-associated concerns; communicates study purpose, benefits, and risks more accurately; and increases maternal satisfaction. We randomly assigned the mothers of eligible infants to receive TIC (requiring parental signature for participation [opting-in] after detailed disclosure of research risks and patient rights) or MIC (requiring parental signature solely for refusal to participate [opting-out] and including only disclosures applicable to the study). Opting-out was approved by our Institutional Review Board and allowed under federal regulations because PC involved no more than minimal risk and included no experimental procedures; moreover, PC reduced maternal inconvenience and increased access to care. To augment reliability, a standard script was developed for each consent group and the two approaches were thoroughly rehearsed. Mothers were interviewed by a blinded assessor within 24 hours of their consent decision.
To date, we have studied 32 English-speaking mothers (18 TIC, 14 MIC). At present, there is no significant difference between TIC and MIC groups in undue consent-associated concerns (28% vs. 14%, respectively; p=0.20). Both groups scored poorly on recall and understanding of study purpose and design, though MIC mothers scored higher than TIC mothers (44% vs. 30%; p<0.05). Maternal responses to our questions about risk and benefit indicated difficulty in understanding questions and in comprehending the effects of the study on their infant's care. However, the great majority--94% of TIC and 96% of MIC mothers--reported satisfaction with the consent process, the study, and their infant's care. In conclusion, both groups expressed satisfaction but had poor understanding, despite our efforts to communicate clearly. Study of more mothers is needed to verify benefits of MIC. The process and value of obtaining “informed” consent deserve critical re-evaluation. Without better methods of informing parents in difficult clinical situations, meaningful consent may not be feasible.
