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Parents' Perceptions of Research With Newborns

Journal of Perinatology volume 22, pages 57–63 (2002)Cite this article

Abstract

OBJECTIVE: To examine beliefs and attitudes of parents about research with babies.

STUDY DESIGN: Survey of 72 parents of newborn babies in the neonatal intensive care unit (NICU), and 159 parents of normal newborns using instrument designed for the study. The instrument included questions with graded responses and five research scenarios with varied risks and benefits. Statistical analysis included χ2 analysis and Fisher's exact test.

RESULTS: Parents showed generally favorable attitudes toward research with babies. There were few differences between the two groups of parents, but there was a trend toward more trust in doctors by “NICU parents.” Couples with newborns in NICU were significantly more likely to enroll their newborn in a study involving moderate risk and possible major direct benefit. Almost a third of the sample in both groups was willing to enroll their newborn in a study with moderate risk and no direct benefit.

CONCLUSION: Parents believe research is necessary and want to be asked for consent, but many feel they have limited knowledge and would depend on their physician's advice. The fact, that some might enroll their newborn in a study involving a risky procedure that would not benefit the newborn, supports the notion of vulnerability and emphasizes the fact that physicians must be alert to the possibility of coercion and undue influence.

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References

  1. Glantz LH . Conducting research with children: Legal and ethical issues J Am Acad Child Adolesc Psychiatry 1996 34: 1283–91

    Article  Google Scholar 

  2. Berglund CA . Children in medical research: Australian ethical standards Child: Care, Health Dev 1995 21: 149–59

    CAS  Google Scholar 

  3. National Institute of Health. NIH policy and guidelines on the inclusion of children as participants in research involving human subjects Available from URL http://www.nih.gov/grants/guide/notice-files/not98-024.html

  4. Tri-Council Policy Statement. Ethical conduct for research involving humans Available from URL http://www.mrc.gc.ca

  5. Consent panel task force of the National Council on Bioethics in Human Research (NCBHR). Report on research involving children 1982 28–45

  6. Mason S . Obtaining informed consent for neonatal randomised controlled trials — an “elaborate ritual”? Arch Dis Child 1997 76: F143–5

    Article  CAS  Google Scholar 

  7. Committee on Bioethics. Informed consent, parental permission, and assent in pediatric practice Pediatrics 1995 95: 314–7

  8. Meran JG . Ethics of consent for babies in randomised clinical trials [letter] Lancet 1995 345: 1370

    Article  CAS  Google Scholar 

  9. Editorial. Your baby is in trial Lancet 1995 345: 805–6

  10. Modi N . Neonatal research [letter] Lancet 1998 351: 530

    Article  CAS  Google Scholar 

  11. Pierro A, Spitz L . Informed consent in clinical research: The crisis in pediatrics [letter] Lancet 1997 349: 1703

    Article  CAS  Google Scholar 

  12. Kodish ED, Pentz RD, Noll RB, Ruccione K, Buckley J, Lange BJ . Informed consent in the children's cancer group Cancer 1998 12: 2467–81

    Google Scholar 

  13. Elbourne D, Garcia K, Snowdon C . Clinical trials and neonatal intensive care Arch Dis Child Fetal Neonat Edn 1995 72: (1) F79

    Article  CAS  Google Scholar 

  14. Shields-Poe D, Pinelli J . Variables associated with parental stress in neonatal intensive care units Neonat Netw 1997 29–37

  15. Oberle K, Singhal N, Huber J, Burgess E . Development of an instrument to investigate parents' perceptions of research with newborns Nurs Ethics 2000 7: (4) 327–38

    Article  CAS  Google Scholar 

  16. Tait AR, Voepel-Lewis T, Siewert M, Malviya S . Factors that influence parents' decisions to consent to their child's participation in clinical anesthesia research Pediatr Anesthesiol 1998 86: 50–3

    CAS  Google Scholar 

  17. Zupancic JAF, Gillie P, Streiner DL, Watts JL, Schmidt B . Determinants of parental authorization for involvement of newborn infants in clinical trials Pediatrics [serial online] 1997 99: (1):six screens. Available from URL htp://www.pediatrics.org/cgi/content/full/99/1/e6

  18. Harth SC, Thong YH . Parental perceptions and attitudes about informed con-sent in clinical research involving children Soc Sci Med 1995 40: 1573–7

    Article  CAS  Google Scholar 

  19. Hamelin K, Saydak M, Bramadat I . Interviewing mothers of high-risk infants. What are their support needs? Can Nurse 1997 93: (6) 35–8

    CAS  PubMed  Google Scholar 

  20. Seideman RY, Watson MA, Corff KE, Odle P, Haase J, Bowerman JL . Parent stress and coping in NICU and PICU J Pediatr Nurs 1997 12: 169–77

    Article  Google Scholar 

  21. Meyer EC, Garcia Coll CT, Seifer R, Ramos A, Kilis E, Oh W . Psychological distress in mothers of preterm infants Dev Behav Pediatr 1995 16: 412–7

    Article  CAS  Google Scholar 

  22. Harth SC, Thong YH . The psychological profile of parents who volunteer their children for clinical research: A controlled study J Med Ethics 1992 18: 86–93

    Article  CAS  Google Scholar 

  23. Langley JM, Halperin SA, Mills EL, Eastwood B . Parental willingness to enter a child in a controlled vaccine trial Clin Invest Med 1998 21: (1) 12–6

    CAS  PubMed  Google Scholar 

Download references

Acknowledgements

Financial support for this study was provided by the Calgary Regional Health Authority and University of Calgary Research Services.

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Authors and Affiliations

  1. Faculty of Medicine, University of Calgary, Calgary, Alberta, Canada

    Nalini Singhal MD & Ellen Burgess MD

  2. Regional Neonatal Services, Calgary Regional Health Authority, Calgary, Alberta, Canada

    Nalini Singhal MD & Ellen Burgess MD

  3. Faculty of Nursing, University of Calgary, Calgary, Alberta, Canada

    Kathleen Oberle PhD

  4. University of Calgary, Calgary, Alberta, Canada

    Joelene Huber-Okrainec MSc

Authors
  1. Nalini Singhal MD
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  2. Kathleen Oberle PhD
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  3. Ellen Burgess MD
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  4. Joelene Huber-Okrainec MSc
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Singhal, N., Oberle, K., Burgess, E. et al. Parents' Perceptions of Research With Newborns. J Perinatol 22, 57–63 (2002). https://doi.org/10.1038/sj.jp.7210608

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