Research with newborn participants: Doing the right research and doing it right

Journal of Perinatal and Neonatal Nursing

Volumn 19, Issue 2, 2005, Pages 177-186

  Franck, Linda S ^a  

^a GREAT ORMOND STREET HOSPITAL   (United Kingdom)

Author keywords

Ethics; Neonatal; Research

Indexed keywords

ETHICS; FAMILY; HEALTH CARE; HEALTH SERVICE; HUMAN; INFANCY; MEDICAL RESEARCH; NEWBORN INTENSIVE CARE; NURSE; NURSING; REVIEW;

EID: 20444397001     PISSN: 08932190     EISSN: None     Source Type: Journal    
DOI: 10.1097/00005237-200504000-00015     Document Type: Review

References (52)

1. World Medical Association. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Latest version. Revised October 2000. http://www.wma:net/e/policy/pdf/17c.pdf. Accessed April 12, 2005.
2. Arford PH. Working with human research protections. J Nurs Sch. 2004;36(3):265-271.
3. Department of Health and Human Services, National Institutes of Health, Office for Protection from Research Risks. Code of Federal Regulations. Title 45, Part 46: Protection of human subjects. 2001. Available at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Accessed December 17, 2004.
4. Korenman SG. Research in children: assessing risks and benefits. Pediatr Res. 2004;56(2):165-166.
5. Committee on Clinical Research Involving Children. The Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press; 2004.
6. McIntosh N, Bates P, Brykczynska G, et al. Guidelines for the ethical conduct of medical research involving children. Royal College of Paediatrics, Child Health: Ethics Advisory Committee. Arch Dis Child. 2000;82(2):177-182.
7. Gill D. Ethical principles and operational guidelines for good clinical practice in paediatric research. Recommendations of the Ethics Working Group of the Confederation of European Specialists in Paediatrics (CESP). Eur J Pediatr. 2004;163(2):53-57.
8. Glantz LH. Research with children. Am J Law Med. 1998;24(2/3):213-244.
9. 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;134(2):151-155.
10. Ray MA. Communal moral experience as the starting point for research in health care ethics. Nurs Outlook. 1994;42(3):104-109.
11. Cunningham N, Hutchinson S. Neonatal nurses and issues in research ethics. Neonatal Netw. 1990;8(5):29-48.
12. Peters J, Charles-Edwards I, Franck LS. Exploring issues of parental consent to research: a case-study approach. Br J Nurs. 2004;13(12):740-743.
13. Orb A, Eisenhauer L, Wynaden D. Ethics in qualitative research. J Nurs Sch. 2001;33(1):93-96.
14. Normand C, Meyer J, Bentley J. Research ethics and complex studies. Nurs Times Res. 2003;8(1):17-26.
15. Global Forum on Health Research. 10/90 report on health research 2003-2004. Available at: http://www.globalforumhealth.org/pages/index.asp. Accessed December 17, 2004.
16. Reproductive Health Online. Special report: reducing perinatal and neonatal mortality. 2004. Available at: http://www.reproline.jhu.edu/english/ 2mnh/perinatal.htm. Accessed April 12, 2005.
17. Cochrane Library, Issue 4. 2004. Available at: http://www.nelh.nhs.uk/ cochrane.asp. Accessed April 12, 2005.
18. The Agency for Healthcare Research and Quality. Advancing excellence in health care. 2004. Available at: http://www.ahcpr.gov/about/profile.htm. Accessed April 12, 2005.
19. Stevens K. Evidence-based neonatal nursing practice. In: Kenner C, Wright Lott J, eds. Comprehensive Neonatal Nursing: A Physiologic Perspective. St Louis: Saunders; 2003:39-42.
20. Franck LS. Some pain, some gain: reflections on the past two decades of neonatal pain research and treatment. Neonatal Netw. 2002;21(5):37-41.
21. Stevens B, Yamada J, Ohlsson A. Sucrose for analgesia in newborn infants undergoing painful procedures. Cochrane Database Syst Rev. 2004;3:2004.
22. Harrison H, Lucas D, Franck LS. Collaborative research in neonatal nursing. In: Kenner C, Wright Lott J, eds. Comprehensive Neonatal Nursing: A Physiologic Perspective. St Louis: Saunders; 2003:63-78.
23. Franck LS, Cox S, Allen A, Winter I. Quantifying NICU-related parental stress: validation of the parental stressor scale: NICU for use with parents in the United Kingdom. J Adv Nurs. 2005;49(6):608-615.
24. Franck LS, Spencer C. Parent visiting and participation in infant caregiving activities in a neonatal unit. Birth. 2003;30(1):31-35.
25. Sizun J, Westrup B. Early developmental care for preterm neonates: a call for more research. Arch Dis Child Fetal Neonatal Ed. 2004;89(5):F384-F388.
26. Stevens B, Franck LS. Assessment and management of pain in neonates. Paediatr Drugs. 2001;3(7):539-558.
27. Mason SA, Allmark PJ. Obtaining informed consent to neonatal randomised controlled trials: interviews with parents and clinicians in the Euricon study. Lancet. 2000;356(9247):2045-2051.
28. Stenson BJ, Becher JC, McIntosh N. Neonatal research: the parental perspective. Arch Dis Child Fetal Neonatal Ed. 2004;89(4):F321-F323.
29. Burgess E, Singhal N, Amin H, McMillan DD, Devrome H. Consent for clinical research in the neonatal intensive care unit: a retrospective survey and a prospective study. Arch Dis Child. 2003;88(4):280-285.
30. Taylor HA, Wilfond BS. Ethical issues in newborn screening research: lessons from the Wisconsin cystic fibrosis trial. J Pediatr. 2004;145(3):292-296.
31. Snowdon C, Garcia J, Elbourne D. Making sense of randomization: responses of parents of critically ill babies to random allocation of treatment in a clinical trial. Soc Sci Med. 1997;45(9):1337-1355.
32. Franck LS, Winter I. Research participate information sheets are difficult to read. Bull Med Ethics. 2004;195:13-16.
33. Broyles S, Sharp C, Tyson J, Sadler J. How should parents be informed about major procedures? An exploratory trial in the neonatal period. Early Hum Dev. 1992;31(1):67-75.
34. Gill D, Crawley FP, LoGiudice M, et al. Guidelines for informed consent in biomedical research involving paediatric populations as research participants. Eur J Pediatr. 2003;162(7/8):455-458.
35. Dalla-Vorgia P, Mason S, Megone C, et al. Overview of European legislation on informed consent for neonatal research. Arch Dis Child Fetal Neonatal Ed. 2001;84(1):F70-F73.
36. Stephenson T, Walker DA. Gaining patients' consent. Telling parents all relevant details might reduce recruitment of children to trials. BMJ. 1996;313(7053):362-363.
37. Franck LS, Pendleton E, Pittam B, Preece M, Aynsley-Green A. Practical issues and policy implications of implementing the UK Department of Health research governance framework in the hospital setting. Int J Health Care Qual Assur. 2004;17(5):239-247.
38. Taylor KM. Integrating conflicting professional roles: physician participation in randomized clinical trials. Soc Sci Med. 1992;35(2):217-224.
39. Walterspiel JN. Informed consent: influence on patient selection among critically ill premature infants. Pediatrics. 1990;85(1):119-121.
40. Pierro A, Spitz L. Informed consent in clinical research: the crisis in paediatrics. Lancet. 1997;349(9066):1703.
41. Silverman WA. Informed consent in customary practice and in clinical trials. In: Goldworth A, Silverman W, Stevenson DK, Young EW, eds. Ethics and Perinatology. New York: Oxford University Press; 2004:245-262.
42. Kenkre JE, Semple M. Research fraud: why nurses should become aware. Nurs Times Res. 2004;8(1):47-56.
43. Legge A. Hospital criticised for not obtaining proper consent. BMJ. 2000;320(7245):1291.
44. Learning From Bristol: The Report of the Public Inquiry Into Children's Heart Surgery at the Bristol Royal Infirmary 1984-1995. London: Department of Health, The Stationary office; 2002. CM 5363.
45. Colbourne L, Sque M. Split personalities: role conflict between the nurse and the nurse researcher. Nurs Times Res. 2004;9(4):297-304.
46. Hewlett S. Consent to clinical research - adequately voluntary or substantially influenced? J Med Ethics. 1996;22(4):232-237.
47. Lutz KF, Shelton KC, Robrecht LC, Hatton DC, Beckett AK. Use of certificates of confidentiality in nursing research. J Nurs Sch. 2000;32(2):185-188.
48. Royal College of Paediatrics and Child Health. Safeguarding Informed Parental Involvement in Clinical Research Involving Newborn Babies and Infants: A Position Statement. London: Royal College of Paediatrics and Child Health; 1999.
49. Gale G, Franck LS, Kools S, Lynch M. Parents' perceptions of their infant's pain experience in the NICU. Int J Nurs Stud. 2004;41(1):51-58.
50. Council for International Organisations of Medical Sciences, World Health Organization. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva: Council for International Organisations of Medical Sciences, World Health Organization; 1993.
51. Tod AM, Nicolson P, Allmark P. Ethical review of health service research in the UK: implications for nursing. J Adv Nurs. 2002;40(4):379-386.
52. Council for International Organisations of Medical Sciences. International ethical guidelines for biomedical research involving human subjects. Bull Med Ethics. 2002;182:17-23.