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Journal of Medical Ethics logoLink to Journal of Medical Ethics
. 2005 Dec;31(12):721–726. doi: 10.1136/jme.2004.011247

Parental preferences for neonatal resuscitation research consent: a pilot study

A Culbert 1, D Davis 1
PMCID: PMC1734075  PMID: 16319238

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.

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Selected References

These references are in PubMed. This may not be the complete list of references from this article.

  1. Abramson N. S., Safar P. Deferred consent: use in clinical resuscitation research. Brain Resuscitation Clinical Trial II Study Group. Ann Emerg Med. 1990 Jul;19(7):781–784. doi: 10.1016/s0196-0644(05)81703-2. [DOI] [PubMed] [Google Scholar]
  2. Allmark P. Should Zelen pre-randomised consent designs be used in some neonatal trials? J Med Ethics. 1999 Aug;25(4):325–329. doi: 10.1136/jme.25.4.325. [DOI] [PMC free article] [PubMed] [Google Scholar]
  3. Biros M. H., Lewis R. J., Olson C. M., Runge J. W., Cummins R. O., Fost N. Informed consent in emergency research. Consensus statement from the Coalition Conference of Acute Resuscitation and Critical Care Researchers. JAMA. 1995 Apr 26;273(16):1283–1287. doi: 10.1001/jama.273.16.1283. [DOI] [PubMed] [Google Scholar]
  4. Burgess E., Singhal N., Amin H., McMillan D. D., Devrome H. Consent for clinical research in the neonatal intensive care unit: a retrospective survey and a prospective study. Arch Dis Child Fetal Neonatal Ed. 2003 Jul;88(4):F280–F286. doi: 10.1136/fn.88.4.F280. [DOI] [PMC free article] [PubMed] [Google Scholar]
  5. Etchells E., Sharpe G., Walsh P., Williams J. R., Singer P. A. Bioethics for clinicians: 1. Consent. CMAJ. 1996 Jul 15;155(2):177–180. [PMC free article] [PubMed] [Google Scholar]
  6. Low James A. Determining the contribution of asphyxia to brain damage in the neonate. J Obstet Gynaecol Res. 2004 Aug;30(4):276–286. doi: 10.1111/j.1447-0756.2004.00194.x. [DOI] [PubMed] [Google Scholar]
  7. Manning D. J. Presumed consent in emergency neonatal research. J Med Ethics. 2000 Aug;26(4):249–253. doi: 10.1136/jme.26.4.249. [DOI] [PMC free article] [PubMed] [Google Scholar]
  8. Mason S. A., Allmark P. J. Obtaining informed consent to neonatal randomised controlled trials: interviews with parents and clinicians in the Euricon study. Lancet. 2000 Dec 16;356(9247):2045–2051. doi: 10.1016/s0140-6736(00)03401-2. [DOI] [PubMed] [Google Scholar]
  9. Mason S. Obtaining informed consent for neonatal randomised controlled trials--an "elaborate ritual"? Arch Dis Child Fetal Neonatal Ed. 1997 May;76(3):F143–F145. doi: 10.1136/fn.76.3.f143. [DOI] [PMC free article] [PubMed] [Google Scholar]
  10. Mutch L., King R. Obtaining parental consent--opting in or opting out? Arch Dis Child. 1985 Oct;60(10):979–980. doi: 10.1136/adc.60.10.979. [DOI] [PMC free article] [PubMed] [Google Scholar]
  11. Rogers C. G., Tyson J. E., Kennedy K. A., Broyles R. S., Hickman J. F. Conventional consent with opting in versus simplified consent with opting out: an exploratory trial for studies that do not increase patient risk. J Pediatr. 1998 Apr;132(4):606–611. doi: 10.1016/s0022-3476(98)70347-6. [DOI] [PubMed] [Google Scholar]
  12. Spivey W. H., Abramson N. S., Iserson K. V., MacKay C. R., Cohen M. P. Informed consent for biomedical research in acute care medicine. Ann Emerg Med. 1991 Nov;20(11):1251–1265. doi: 10.1016/s0196-0644(05)81484-2. [DOI] [PubMed] [Google Scholar]
  13. Zelen M. Randomized consent designs for clinical trials: an update. Stat Med. 1990 Jun;9(6):645–656. doi: 10.1002/sim.4780090611. [DOI] [PubMed] [Google Scholar]

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