Evaluation of informed consent: A pilot study

Journal of Advanced Nursing

Volumn 59, Issue 2, 2007, Pages 146-154

  Länsimies Antikainen, Helena ^a   Pietilä, Anna Maija ^b   Laitinen, Tomi ^a   Schwab, Ursula ^a   Rauramaa, Rainer ^b   Länsimies, Esko ^a  

^a KUOPIO UNIVERSITY HOSPITAL   (Finland)

^b UNIVERSITY OF EASTERN FINLAND   (Finland)

Author keywords

Ethics; Human rights; Informed consent; Interview; Nursing; Pilot study; Voluntary participation

Indexed keywords

EID: 34250775477     PISSN: 03092402     EISSN: 13652648     Source Type: Journal    
DOI: 10.1111/j.1365-2648.2007.04279.x     Document Type: Article

References (37)

1. Agrawal M., Grady C., Fairclough D.L., Meropol N.J., Maynard K. Emanuel E.J. (2006) Patients' decision-making process regarding participation in phase I oncology research. Journal of Clinical Oncology 24 (27 4479 4484.
2. Beauchamp T.L. Childress J.F. (2001) Principles of Biomedical Ethics, 5th edn. Oxford University Press, New York.
3. Burns N. Grove S.K. (2001) The Practice of Nursing Research. Conduct, Critique & Utilization, 4th edn. W.B. Saunders Company, Philadelphia, PA.
4. Chan E.C.Y., Vernon S.W., O'Donnell F.T., Ahn C., Greisinger A. Aga D.W. (2003) Informed consent for cancer screening with prostate-specific antigen: how well are men getting the message? American Journal of Public Health 93 (5 779 785.
5. Chappuy H., Doz F., Blanche S., Gentet J.C., Pons G. Tréluyer J.M. (2006) Parental consent in paediatric clinical research. Archives of Disease in Childhood 91 (2 112 116.
6. Denberg T.D., Wong S. Beattie A. (2005) Women's misconceptions about cancer screening: implications for informed decision-making. Patient Education and Counseling 57, 280 285.
7. European Commission (2001) Implementation of Good Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Human Use. Directive 2001/20/EC of the European Parliament and the Council, Brussels.
8. European Commission (2004) Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human use. European Commission CT-12-EN rev5 mars04, Brussels.
9. Federman D.D. (2003) Minimizing risk in clinical research. Annals of Internal Medicine 139 (1 71 72.
10. Franck L.S., Winter I. Oulton K. (2006) The quality of parental consent for research with children: a prospective repeated measure self-report survey. International Journal of Nursing Studies. Retrieved from http://www. sciencedirect.com on 14 January 2007.
11. Fry S.T. (1998) Rights of human subjects. In Encyclopedia of Nursing Research (Fitzpatrick J.J., ed. Springer Publishing Company Inc., New York, pp. 502 503.
12. Higgins P.A. Daly B.J. (2002) Knowledge and beliefs of nurse researchers about informed consent principles and regulations. Nursing Ethics 9 (6 663 671.
13. Idänpää-Heikkilä J.E. (1994) WHO guidelines for goop clinical practice (GCP) for trials on pharmaceutical products: responsibilities of the investigator. Annals of Medicine 26, 89 94.
14. Johnston S.C., Rootenberg J.D., Katrak S., Smith W.S. Elkins J.S. (2006) Effect of a US National Institute of Health programme of clinical trials on public health and costs. Lancet 367, 1319 1327.
15. Jokinen P., Lappalainen M., Meriläinen P. Pelkonen M. (2002) Ethical issues in ethnographic nursing research with children and elderly people. Scandinavian Journal of Caring Sciences 16, 165 170.
16. Kanerva A.M. (2006) Tietoinen suostumus päiväkirurgisen potilaan hoidossa - analyysi tietoisen suostumuksen toteutumisesta ja sairaanhoitajan osuudesta. Informed consent in a day surgery patient's care - analysis of the realisation of informed consent and a nurse's implication (Finnish, abstract in English). Doctoral thesis, University of Turku, Finland.
17. Kanerva A.M., Suominen T. Leino-Kilpi H. (1999) Informed consent for short-stay surgery. Nursing Ethics 6 (6 483 493.
18. Kay R. Siriwardena A.K. (2001) The process of informed consent for urgent abdominal surgery. Journal of Medical Ethics 27, 157 161.
19. Koren G., Kearns G.L., Reed M. Pons G. (2003) Use of healthy children as volunteers in drug studies: the ethical debate. Clinical Pharmacology & Therapeutics 73 (3 147 152.
20. Länsimies-Antikainen H. (2005) Tietoon perustuva suostumus: tutkimushenkilöiden tiedonsaanti ja päätöksenteko pilottitutkimuksen kohteena. Informed consent: the information and decision-making process of research participants (Finnish, abstract in English). Master's thesis, University of Kuopio, Finland.
21. Leino-Kilpi H. (2004) We need more nursing ethics research. Journal of Advanced Nursing 45 (4 345 346.
22. Leino-Kilpi H., Välimäki M., Arndt M., Dassen T., Gasull M., Lemonidou C., Scott P.A., Bansemir G., Cabrera E., Papaevangelou H. Parland J.M. (2002) Patient's Autonomy, Privacy and Informed Consent, 2nd edn. IOS press Ohmsha, Amsterdam.
23. Leino-Kilpi H., Välimäki M., Dassen T., Gasull M., Lemonidou C., Scott P.A., Schopp A., Arndt M. Kaljonen A. (2003) Perceptions of autonomy, privacy and informed consent in the care of elderly people in five European countries: comparison and implications for the future. Nursing Ethics 10 (1 58 66.
24. Matsui K., Kita Y. Ueshima H. (2005) Informed consent, participation in, and withdrawal from a population based cohort study involving genetic analysis. Journal of Medical Ethics 31 (7 385 392.
25. McLaughlin K.J., Brindley A.F. Crowther C.A. (2002) Informational video for potential participants of clinical studies used in the process of seeking informed consent. Cochrane Database of Systematic Reviews 2002, Issue 3.
26. Moll A. (1902) Ärztliche Ethik. Die Pflichten des Arztes in allen Beziehungen deiner Thätigkeit. Verlag von Ferdinand Enke, Stuttgart.
27. Musil C.M. (1998) Pilot study. In Encyclopedia of Nursing Research (Fitzpatrick J.J., ed. Springer Publishing Company Inc., New York, 439 pp.
28. Nyrhinen T., Leino-Kilpi H., Välimäki M., Dassen T., Gasull M., Lemonidou C., Scott P.A. Arndt M. (2001) Eettisiä kysymyksiä synnyttäneiden äitien hoitotyössä. Ethical issues in the care of postpartum mothers (Finnish, abstract in English). Hoitotiede 13 (6 319 329.
29. O'Neill O. (2003) Some limits of informed consent. Journal of Medical Ethics 29, 4 7.
30. Rabin C. Tabak N. (2006) Healthy participants in phase I clinical trials: the quality of their decision to take part. Journal of Clinical Nursing 15 (8 971 979.
31. Russel M.L., Moralejo D.G. Burgess E.D. (2000) Paying research subjects: participants' perspectives. Journal of Medical Ethics 26, 126 130.
32. Schopp A., Välimäki M., Leino-Kilpi H., Dassen T., Gasull M., Lemonidou C., Scott P.A., Arndt M. Kaljonen A. (2003) Perceptions of informed consent in the care of elderly people in five European countries. Nursing Ethics 10 (1 48 57.
33. Steinke E.E. (2004) Research ethics, informed consent, and participant recruitment. Clinical Nurse Specialist 18 (2 88 95.
34. Turner S.T. (1998) Informed consent. In Encyclopedia of Nursing Research (Fitpatrick J.J., ed. Springer Publishing Company Inc., New York, pp. 269 721.
35. Vähäkangas K. (2004) Ethical aspects of molecular epidemiology of cancer. Carcinogenesis 25 (4 465 471.
36. Vollmann J. Winau R. (1996) Informed consent in human experimentation before the Nuremberg code. British Medical Journal 313, 1445 1447.
37. World Medical Association 2004) World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Retrieved from http://www.wma.net/e/policy/b3.htm on 14 January 2007.