A Culbert1, D J Davis. 1. Center for Clinical Education, Teilum, Afsnit 5404, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen O, Denmark.
Abstract
OBJECTIVE: Obtaining informed consent for resuscitation research, especially in the newborn, is problematic. This study aimed to evaluate parental preferences for hypothetical consent procedures in neonatal resuscitation research. DESIGN: Mail-out survey questionnaire. SETTING/ PARTICIPANTS: Randomly selected parents who had received obstetrical or neonatal care at a tertiary perinatal centre. MAIN OUTCOME MEASURES: Parental levels of comfort (Likert-type scale 1-6) regarding different methods of obtaining consent in hypothetical resuscitation research scenarios. RESULTS: The response rate was 34%. The respondents were a group of highly educated women with a higher family income than would be expected in the general population. In terms of results, parents valued the impact the research would have on their baby and the importance of a positive interaction with the physicians conducting the research study. Parents felt most comfortable with prospective consent in the setting of prenatal classes or prenatal visits with a physician, but they were somewhat uncomfortable with prospective consent upon admission to hospital after labour had begun. Parents were uncomfortable with waived consent, deferred consent, and opting out, no matter when during the pregnancy consent was requested. CONCLUSION: This pilot study reports parental preferences for prenatal information and consent for such research trials of neonatal resuscitation. A low response rate and potentially skewed demographics of the respondents prevent generalisability of this result. Interview studies should be performed to better determine parental preferences for informed consent in a more representative population.
OBJECTIVE: Obtaining informed consent for resuscitation research, especially in the newborn, is problematic. This study aimed to evaluate parental preferences for hypothetical consent procedures in neonatal resuscitation research. DESIGN: Mail-out survey questionnaire. SETTING/ PARTICIPANTS: Randomly selected parents who had received obstetrical or neonatal care at a tertiary perinatal centre. MAIN OUTCOME MEASURES: Parental levels of comfort (Likert-type scale 1-6) regarding different methods of obtaining consent in hypothetical resuscitation research scenarios. RESULTS: The response rate was 34%. The respondents were a group of highly educated women with a higher family income than would be expected in the general population. In terms of results, parents valued the impact the research would have on their baby and the importance of a positive interaction with the physicians conducting the research study. Parents felt most comfortable with prospective consent in the setting of prenatal classes or prenatal visits with a physician, but they were somewhat uncomfortable with prospective consent upon admission to hospital after labour had begun. Parents were uncomfortable with waived consent, deferred consent, and opting out, no matter when during the pregnancy consent was requested. CONCLUSION: This pilot study reports parental preferences for prenatal information and consent for such research trials of neonatal resuscitation. A low response rate and potentially skewed demographics of the respondents prevent generalisability of this result. Interview studies should be performed to better determine parental preferences for informed consent in a more representative population.
Entities:
Keywords:
Biomedical and Behavioral Research; Empirical Approach
Authors: Carrol Gamble; Simon Nadel; Dee Snape; Andrew McKay; Helen Hickey; Paula Williamson; Linda Glennie; Claire Snowdon; Bridget Young Journal: PLoS One Date: 2012-05-07 Impact factor: 3.240