Assessment of parental decision-making in neonatal cardiac research: A pilot study

Journal of Medical Ethics

Volumn 36, Issue 2, 2010, Pages 106-110

  Nathan, Aruna T ^a   Hoehn, K Sarah ^b   Ittenbach, Richard F ^c   Gaynor, J William ^d,e   Nicolson, Susan ^a,d   Wernovsky, Gil ^d,e   Nelson, Robert M ^f  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

^b ST CHRISTOPHER'S HOSPITAL FOR CHILDREN   (United States)

^c CINCINNATI CHILDREN'S HOSPITAL MEDICAL CENTER   (United States)

^d CHILDREN S HOSPITAL OF PHILADELPHIA   (United States)

^e UNIVERSITY OF PENNSYLVANIA   (United States)

^f CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; ARTICLE; CONGENITAL HEART MALFORMATION; DECISION MAKING; ETHICS; FEMALE; HUMAN; MALE; MEDICAL RESEARCH; NEWBORN; PARENT; PARENTAL CONSENT; PATIENT PARTICIPATION; PILOT STUDY; PSYCHOLOGICAL ASPECT;

ADULT; BIOMEDICAL RESEARCH; DECISION MAKING; FEMALE; HEART DEFECTS, CONGENITAL; HUMANS; INFANT, NEWBORN; MALE; PARENTAL CONSENT; PARENTS; PATIENT PARTICIPATION; PILOT PROJECTS;

EID: 77952525307     PISSN: 03066800     EISSN: 14734257     Source Type: Journal    
DOI: 10.1136/jme.2009.030676     Document Type: Article

References (23)

1. Morris MC, Nadkarni VM, Ward FR, et al. Exception from informed consent for pediatric resuscitation research: Community consultation for a trial of brain cooling following in-hospital cardiac arrest. Pediatrics 2004;114:776-81.
2. Kohrman A, Clayton EW. Informed consent, parental permission, and assent in pediatric practice. Committee on Bioethics, American Academy of Pediatrics. Pediatrics 1995;95:314-17
3. Beauchamp TL, Childress JF. Principles of Biomedical Ethics 5th edn. New York: Oxford University Press; 2001:79-80.
4. Hoehn KS, Nathan A, White LE, et al. Parental perception of time and decisionmaking in neonatal research. J Perinatol 2009;29:508-11.
5. Mason SA, Allmark PJ. Obtaining informed consent to neonatal randomised controlled trials: interviews with parents and clinicians in the Euricon study. Lancet 2000;356:2045-51.
6. Stenson BJ, Becher JC, McIntosh N. Neonatal research: the parental perspective. Arch Dis Child Fetal Neonatal Ed 2004;89:F321-3.
7. Hoehn KS, Wernovsky G, Rychik J, et al. Parental decision-making in congenital heart disease. Cardiol Young 2004;14:309-14.
8. Hoehn KS, Wernovsky G, Rychik J, et al. What factors are important to parents making decisions about neonatal research? Arch Dis Child Fetal Neonatal Ed 2005;90:267-9.
9. Appelbaum PS, Grisso T. MacCAT-CR: MacArthur competence assessment tool for clinical research. Sarasota: Professional Resource Press; 2001.
10. Carpenter WT Jr, Gold JM, Lahti AC, et al. Decisional capacity for informed consent in schizophrenia research. Arch Gen Psychiatry 2000;57:533-8.
11. Kovnick JA, Appelbaum PS, Hoge SK, et al. Competence to consent to research among long-stay inpatients with chronic schizophrenia. Psychiatr Serv 2003;54:1247-52.
12. Palmer BW, Dunn LB, Appelbaum PS, et al. Assessment of capacity to consent to research among older persons with schizophrenia, Alzheimer disease, or diabetes mellitus: comparison of a 3-item questionnaire with a comprehensive standardized capacity instrument. Arch Gen Psychiatry 2005;62:726-33.
13. Appelbaum PS, Grisso T, Frank E, et al. Competence of depressed patients for consent to research. Am J Psychiatry 1999;156:1380-4.
14. Karlawish JH, Casarett DJ, James BD. Alzheimer's disease patients' and caregivers' capacity, competency, and reasons to enroll in an early-phase Alzheimer's disease clinical trial. J Am Geriatr Soc 2002;50:2019-24.
15. Kim SY, Caine ED, Currier GW, et al. Assessing the competence of persons with Alzheimer's disease in providing informed consent for participation in research. Am J Psychiatry 2001;158:712-17.
16. Appelbaum PS. Assessment of patients' competence to consent for treatment. N Engl J Med 2007;357:1834-40.
17. Mason SA. Obtaining informed consent for neonatal randomised controlled trials e an elaborate ritual? Arch Dis Child Fetal Neonatal Ed 1997;76:143F-5.
18. Licht DJ, Wang J, Silvestre DW, et al. Preoperative cerebral blood flow is diminished in neonates with severe congenital heart defects. J Thorac Cardiovasc Surg 2004;128:841-9.
19. Moser DJ, Arndt S, Kanz JE, et al. Coercion and informed consent in research involving prisoners. Compr Psychiatry 2004;45:1-9.
20. Burgess E, Singhal N, Amin H, et al. Consent for clinical research in the neonatal intensive care unit: a retrospective survey and a prospective study[erratum in Arch Dis Child Fetal Neonatal Ed 2004; 89: F83]Arch Dis Child Fetal Neonatal Ed 2003;88: F280-5; discussion F285-6.
21. Zupancic JA, Gillie P, Streiner DL, et al. Determinants of parental authorization for involvement of newborn infants in clinical trials. Pediatrics 1997;99:E6
22. Dunn LB, Nowrangi MA, Palmer BW, et al. Assessing the decisional capacity in clinical research or treatment: a review of instruments. Am J Psych 2006;163:1323-34.
23. Breden TM, Vollmann J. The cognitive based approach of capacity assessment in psychiatry: a philosophical critique of the MacCAT-T. Health Care Anal 2004;12:273-83; discussion 265-72.