Abstract
Background: Although parents of neonates with congenital heart disease are often asked permission for their neonates to participate in research studies, little is known about the factors parents consider when making these decisions.
Objective: To determine the reasons for parents' decisions about participation in research studies.
Methods: Qualitative analysis of the unsolicited comments of 34 parents regarding reasons for agreeing or declining to participate in research studies. Parents' comments were offered spontaneously during interviews about clinical care decisions for neonates with congenital heart disease.
Results: Parents cited five types of reason for or against permitting their newborn to participate in research studies: societal benefit (n = 18), individual benefit for their infant (n = 16), risk of study participation (n = 10), perception that participation posed no harm (n = 9), and anti-experimentation views (n = 4).
Conclusion: Addressing parental decision making in the light of these reasons could enhance the parental permission process for parents of critically ill neonates.
Full Text
The Full Text of this article is available as a PDF (51.1 KB).
Selected References
These references are in PubMed. This may not be the complete list of references from this article.
- Elbourne D., Snowdon C., Garcia J., Field D. Trial experience and problems of parental recollection of consent. BMJ. 2001 Jan 6;322(7277):49–50. doi: 10.1136/bmj.322.7277.49. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Gaynor J. William, Gerdes Marsha, Zackai Elaine H., Bernbaum Judy, Wernovsky Gil, Clancy Robert R., Newman Mark F., Saunders Ann M., Heagerty Patrick J., D'Agostino Jo Ann. Apolipoprotein E genotype and neurodevelopmental sequelae of infant cardiac surgery. J Thorac Cardiovasc Surg. 2003 Dec;126(6):1736–1745. doi: 10.1016/s0022-5223(03)01188-7. [DOI] [PubMed] [Google Scholar]
- Lantos J. D. The "inclusion benefit" in clinical trials. J Pediatr. 1999 Feb;134(2):130–131. doi: 10.1016/s0022-3476(99)70400-2. [DOI] [PubMed] [Google Scholar]
- 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]
- 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]
- Schmidt B., Gillie P., Caco C., Roberts J., Roberts R. Do sick newborn infants benefit from participation in a randomized clinical trial? J Pediatr. 1999 Feb;134(2):151–155. doi: 10.1016/s0022-3476(99)70428-2. [DOI] [PubMed] [Google Scholar]
- Singhal Nalini, Oberle Kathleen, Burgess Ellen, Huber-Okrainec Joelene. Parents' perceptions of research with newborns. J Perinatol. 2002 Jan;22(1):57–63. doi: 10.1038/sj.jp.7210608. [DOI] [PubMed] [Google Scholar]
- Smith R. Babies and consent: yet another NHS scandal. But it should lead to improvements in research governance within the NHS. BMJ. 2000 May 13;320(7245):1285–1286. [PMC free article] [PubMed] [Google Scholar]
- Snowdon C., Elbourne D. R., Garcia J. Perinatal pathology in the context of a clinical trial: attitudes of bereaved parents. Arch Dis Child Fetal Neonatal Ed. 2004 May;89(3):F208–F211. doi: 10.1136/adc.2003.041392. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Stenson B. J., Becher J-C, McIntosh N. Neonatal research: the parental perspective. Arch Dis Child Fetal Neonatal Ed. 2004 Jul;89(4):F321–F323. doi: 10.1136/adc.2002.021931. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Tait Alan R., Voepel-Lewis Terri, Malviya Shobha. Factors that influence parents' assessments of the risks and benefits of research involving their children. Pediatrics. 2004 Apr;113(4):727–732. doi: 10.1542/peds.113.4.727. [DOI] [PubMed] [Google Scholar]
- Zupancic J. A., Gillie P., Streiner D. L., Watts J. L., Schmidt B. Determinants of parental authorization for involvement of newborn infants in clinical trials. Pediatrics. 1997 Jan;99(1):E6–E6. doi: 10.1542/peds.99.1.e6. [DOI] [PubMed] [Google Scholar]