期刊论文详细信息
BMC Medical Ethics
Ethical aspects in tissue research: thematic analysis of ethical statements to the research ethics committee
Kirsi Vähäkangas3  Mari Vesalainen3  Anna-Maija Pietilä1  Arja Halkoaho2 
[1] Faculty of Health Sciences, University of Eastern Finland, Social and Health Care Services, Kuopio, Finland;Faculty of Health Sciences, University of Eastern Finland, Research Unit/Research Ethics Committee, University Hospital of Kuopio, P.O Box 1777, 70210 , Kuopio, Finland;Faculty of Health Sciences, University of Eastern Finland, Kuopio, Finland
关键词: Recruitment;    Informed consent;    Application to ethics committee;    Ethical views of scientists;    Thematic content analysis;   
Others  :  800031
DOI  :  10.1186/1472-6939-13-20
 received in 2011-09-13, accepted in 2012-07-30,  发布年份 2012
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【 摘 要 】

Background

Many studies have been published about ethics committees and the clarifications requested about the submitted applications. In Finland, ethics committees require a separate statement on ethical aspects of the research in applications to the ethics committee. However, little is known about how researchers consider the ethical aspects of their own studies.

Methods

The data were collected from all the applications received by the official regional ethics committee in the Hospital District of Northern Savo during 2004–2009 (n = 688). These included a total of 56 studies involving research on tissue other than blood. The statements by the researchers about the ethics about their own research in these applications were analyzed by thematic content analysis under the following themes: recruitment, informed consent, risks and benefits, confidentiality and societal meaning.

Results

The researchers tended to describe recruitment and informed consent process very briefly. Usually these descriptions simply stated who the recruiter was and that written consent would be required. There was little information provided on the recruitment situation and on how the study recruiters would be informed. Although most of the studies were clinical, the possibility was hardly ever discussed that patients could fail to distinguish between care and research.

Conclusion

The written guidelines, available on the webpages of the ethics committee, do not seem to be enough to help researchers achieve this goal. In addition to detailed guidelines for researchers, investigators need to be taught to appreciate the ethical aspects in their own studies.

【 授权许可】

   
2012 Halkoaho et al.; licensee BioMed Central Ltd.

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【 参考文献 】
  • [1]WMA: 2011 World medical association. Declaration of Helsinki. 2011. http://www.wma.net/en/30publications/10policies/b3/index.html webcite. read 6.4
  • [2]Beauchamp TL, Childress JF: Principles of Biomedical Ethics. Fifth edition, Oxford University Press; 2001.
  • [3]Medical Research Act 488/1999, 294/2004, 794/2010). 2011. http://www.finlex.fi/fi/laki/alkup/2010/20100794 webcite read 6.4
  • [4]Bueno M, Brevidelli MM, Cocarelli T, Santos G, Ferraz MA, Mion D: Reason for resubmission of research projects to the research ethics committee of university hospital in São Paulo Brazil. Clinics 2009, 64:831-836.
  • [5]Keinonen T, Nieminen S, Saano V, Ylitalo P: Acceptability and Profile of the Clinical Drug Trials Underway in Finnish University Hospitals in the 1990s: Applications Reviewed by Ethics Committees. Methods Find Exp Clin Pharmacol 2001, 23:415-423.
  • [6]Angell E, Dixon-Woods M: Do research ethics committees identify process errors in applications for ethical approval? J Med Ethics 2009, 35:130-132.
  • [7]Porcu L, Poli D, Torri V, Di Tullio MC, Cinquini M, Bajetta E, Labianca R, DiCostanzo F, Nitti D, Floriani I: Impact of recent legislative bills regarding clinical research on Italian ethics committee activity. J Med Ethics 2008, 34:47-750.
  • [8]Seiler CM, Kellmayer P, Kienle P, Büchler MW: Knabel HB & INSECT Study Group: assessment of the ethical review process for non-pharmacological multicentre studies in Germany on the basis of a randomized surgical trial. J Med Ethics 2007, 33:113-118.
  • [9]Driscoll A, Currey J, Worral-Carter L, Steward S: Ethical dilemmas of a large national multi-center study in Australia: time for some consistency. J Clin Nurs 2006, 17:2212-2220.
  • [10]Whitney SN, Alcer K, Schneider CE, McCullough LB, McGuire AL, Volk RJ: Principal Investigator Views of the IRB system. Int J Med Sci 2008, 5:68-72.
  • [11]Paul C: Health researcher views of ethics committee functioning in New Zealand. N Z Med J 2000, 113:210-214.
  • [12]Taylor HA, Currie P, Kass NE: A study to evaluate the effect of investigator attendance on the efficiency of IRB review. IRB 2008, 30:1-5.
  • [13]Vähäkangas K: Ethical aspects of molecular epidemiology of cancer. Carcinogenesis 2004, 25:465-471.
  • [14]Merlo DF, Knudsen LE, Matusiewicz KM, Niebroj L, Vähäkangas K: Ethics in studies on children and environmental health. J Med Ethics 2009, 33:408-413.
  • [15]Athula Sumathipala A, Siribaddana S, Hewage S, Lekamwattage M, Athukorale M, Siriwardhana C, Murray J, Prince M: Informed consent in Sri Lanka: a survey among ethics committee members. BMC Med Ethics 2008, 9:10. BioMed Central Full Text
  • [16]Campbell AV, McLean SAM, Gutridge K: Human tissue legislation:listening to the professionals. J Med Ethics 2008, 34:104-108.
  • [17]Van Veen EB: Obstacles to European research projects with data and tissue: solution and further challenges. Eur J Cancer 2008, 44:1438-1450.
  • [18]Siegel A, Anderson MW, Schmidt TC, Younger SJ: Informed consent to tissue donation: policies and practice. Cell Tissue Bank 2009, 10:235-240.
  • [19]Steinmann M: Under the pretence of autonomy: contradictions in the guidelines for human tissue donation. Med Health Care Philos 2009, 12:281-289.
  • [20]Halkoaho A, Pietilä AM, Dumez B, VanDamme K, Heinonen S, Vähäkangas K: Ethical aspects of human placental perfusion: interview of the mothers donating placenta. Placenta 2010, 31:686-690.
  • [21]Lind U, Knudsen LE, Mose T: Participation in environmental health research by placenta donation - a perception study. Environ Health 2007, 6:36. BioMed Central Full Text
  • [22]Halkoaho A, Vähäkangas K, Häggman-Laitila A, Pietilä AM: Views of midwives about ethical aspects: participation in placental perfusion studies. Midwifery 2012, 28:131-137.
  • [23]Halkoaho A, Pietilä AM, Vähäkangas K: Ethical aspects in placental perfusion studies: views of the researchers. Placenta 2011, 32:511-515.
  • [24]Hsieh H-F, Shannon SE: Three approaches to qualitative content analysis. Qual Health Res 2005, 15:1277.
  • [25]Tong A, Sainsbury P, Craig J: Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qualt Health Care 2007, 19:349-357.
  • [26]Antes L, Wang X, Mumford M, Brown R, Connelly S, Devenport L: Evaluating the effects that existing instructions on responsible conduct of research has on ethical decision making. Acad Med 2010, 85:519-526.
  • [27]Anderson M, Horn A, Risbey K, Ronning E, De Vries R, Martinson B: What do mentoring and training in the responsible conduct of research have to do with scientists misbehavior? Findings from a National Survey of NIH-Funded Scientists. Acad Med 2007, 82:853-860.
  • [28]McCormick J, Boyce A, Cho M: Biomedical scientists perceptions of ethical and social implications: is there a role for research ethics consultations? PLoS One 2009, 4(3):e4659.
  • [29]Behrendt C, Gölz T, Roesler C, Bertz H, Wunsch A: What do our patients understand about their trial participation? Assessing patientsunderstanding of their informed consent consultation about randomised clinical trials. J Med Ethics 2011, 37–74:74-80.
  • [30]Länsimies-Antikainen H, Pietilä AM, Kiviniemi V, Rauramaa R, Laitinen T: Evaluation of participant comprehension of information received in an exercise and diet intervention trial: the DRs EXTRA study. Gerontology 2010, 56:291-297.
  • [31]Lynöe N, Näsström B, Sandlund M: Study of the quality of information given to the patients participating in a clinical trial regarding chronic hemodialysis. Scand J Urol Nephrol 2004, 38:517-520.
  • [32]Lidz CW, Appelbaum PS, Grisso T, Renaud M: Therapeutic misconception and the appreciation of risks in clinical trials. Soc Sci Med 2004, 58:1689-1697.
  • [33]Appelbaum PS, Lidz CW: Re-evaluating the therapeutic misconception: response to Miller and Joffe. Kennedy Inst Ethics J 2006, 16:367-373.
  • [34]Lavori PW, Wilt TJ, Sugarman J: Quality assurance questionnaire for professionals fails to improve the quality of informed consent. Clin Trials 2007, 4:638-649.
  • [35]Jerosch-Herold C, Shepstone L, Vaughan S, Barrett B, Larson D, Chojnowski A: A questionnaire-based survey of participants' decisions regarding recruitment and retention in a randomized controlled trial - lessons learnt from the SCoRD trial. Contemp Clin Trials 2011, 32:363-368.
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