期刊论文详细信息
BMC Medical Ethics
Biobanking research on oncological residual material: a framework between the rights of the individual and the interest of society
Renzo Pegoraro2  Pamela Tozzo1  Luciana Caenazzo1 
[1]Department of Molecular Medicine, University of Padova, Via Falloppio 50, 35121 Padua, Italy
[2]Fondazione Lanza, Via Dante 55, 35139 Padua, Italy
关键词: Solidarity;    Research;    Ethics;    Informed consent;    Residual materials biobanks;    Cancer biobanks;    Oncological residual material;    Consent;    Biobanks;   
Others  :  799960
DOI  :  10.1186/1472-6939-14-17
 received in 2012-07-11, accepted in 2013-03-20,  发布年份 2013
PDF
【 摘 要 】

Background

The tissue biobanking of specific biological residual materials, which constitutes a useful resource for medical/scientific research, has raised some ethical issues, such as the need to define which kind of consent is applicable for biological residual materials biobanks.

Discussion

Biobank research cannot be conducted without considering arguments for obtaining the donors’ consent: in this paper we discuss to what extent consent in biobank research on oncological residual materials has to be required, and what type of consent would be appropriate in this context, considering the ethical principles of donation, solidarity, protection of the donors’ rights and the requirements of scientific progress. Regarding the relationship between informed consent and tissue collection, storage and research, we have focused on two possible choices related to the treatment of data and samples in the biobank: irreversible and reversible anonymization of the samples, distinguishing between biobank research on residual materials for which obtaining consent is necessary and justified, and biobank research for which it is not. The procedures involve different approaches and possible solutions that we will seek to define. The consent for clinical research reported in the Helsinki Declaration regards research involving human beings and for this reason it is subordinate to specific and detailed information on the research projects.

Summary

An important ethical aspect in regard to the role of Biobanks is encouraging sample donation. For donors, seeing human samples being kept rather than discarded, and seeing them become useful for research highlights the importance of the human body and improves the attitude towards donation. This process might also facilitate the giving of informed consent more willingly, and with greater trust.

【 授权许可】

   
2013 Caenazzo et al.; licensee BioMed Central Ltd.

【 预 览 】
附件列表
Files Size Format View
20140707073421606.pdf 176KB PDF download
【 参考文献 】
  • [1]Hoeyer K, Olofsson BO, Mjörndal T, Lynöe N: Informed consent and biobanks: a population-based study of attitudes towards tissue donation for genetic research. Scand J Public Health 2004, 32:224-229.
  • [2]Johnsson L, Hansson MG, Eriksson S, Helgesson G: Patients’ refusal to consent to storage and use of samples in Swedish biobanks: cross sectional study. BMJ 2008, 337:a345.
  • [3]Greer CE, Peterson SK, Kiviat NB, Manos MM: PCR amplification from paraffin-embedded tissues. Effects of fixative and fixation time. Am J Clin Path 1991, 95:117-124.
  • [4]Miething F, Hering S, Hanschke B, Dressler J: Effect of fixation to the degradation of nuclear and mitochondrial DNA in different tissues. J Histochem Cytochem 2006, 54:371-374.
  • [5]Hewitt SM, Lewis FA, Cao Y, Conrad RC, Cronin M, Danenberg KD, Goralski TJ, Langmore JP, Raja RG, Williams PM, Palma JF, Warrington JA: Tissue handling and specimen preparation in surgical pathology. Arch Pathol Lab Med 2008, 132:1929-1935.
  • [6]Fracasso T, Heinrich M, Hohoff C, Brinkmann B, Pfeiffer H: Ultrasound-accelerated formalin fixation improves the preservation of nucleic acids extraction in histological sections. Int J Legal Med 2009, 123:521-525.
  • [7]Farrugia A, Keyser C, Ludes B: Efficiency evaluation of a DNA extraction and purification protocol on archival formalin-fixed and paraffin-embedded tissue. Forensic Sci Int 2009, 194:e25-e28.
  • [8]Botti G, Franco R, Carbone A: Sample conservation: freezing, fixation and quality control. Pathologica 2008, 100:81-85.
  • [9]Morente MM, Mager R, Alonso S, Pezzella F, Spatz A, Knox K, Kerr D, Dinjens WN, Oosterhuis JW, Lam KH, Oomen MH, van Damme B, van de Vijver M, van Boven H, Kerjaschki D, Pammer J, Lopez-Guerrero JA, Llombart Bosch A, Carbone A, Gloghini A, Teodorovic I, Isabelle M, Passioukov A, Lejeune S, Therasse P, van Veen EB, Ratcliffe C, Riegman PH: TuBaFrost 2: standardizing tissue collection and quality control procedures for a European virtual frozen tissue bank network. Eur J Cancer 2006, 42:2684-2691.
  • [10]Mager SR, Oomen MH, Morente MM, Ratcliffe C, Knox K, Kerr DJ, Pezzella F, Riegman PH: Standard operating procedures for the collection of fresh frozen tissue samples. Eur J Cancer 2007, 43:828-834.
  • [11]Micke P, Ohshima M, Tahmasebpoor S, Ren ZP, Ostman A, Pontén F, Botling J: Biobanking of fresh frozen tissue: RNA is stable in nonfixed surgical specimens. Lab Invest 2006, 86:202-211.
  • [12]Ericsson C, Franzen B, Nister M: Frozen tissue biobanks. Tissue handling, cryopreservation, extraction, and use for proteomic analysis. Acta Oncol 2006, 45:643-661.
  • [13]Rosolen A: Biobanks: the scientific point of view. In Biobanks in the Mediterranean area. Edited by Caenazzo L, Pegoraro R. Padova, Italy: Proget Edizioni; 2011:19-27.
  • [14]Allen J, McNamara B: Reconsidering the value of consent in biobank research. Bioethics 2011, 25:155-166.
  • [15]Simon CM, L’heureux J, Murray JC, Winokur P, Weiner G, Newbury E, Shinkunas L, Zimmerman B: Active choice but not too active: public perspectives on biobank consent models. Genet Med 2011, 13:821-831.
  • [16]World Medical Association: WMA Declaration of Helsinki: ethical principles for medical research involving human subjects. http://www.wma.net/en/30publications/10policies/b3/index.html webcite
  • [17]Gefenas E, Dranseika V, Serepkaite J, Cekanauskaite A, Caenazzo L, Gordijn B, Pegoraro R, Yuko E: Turning residual human biological materials into research collections: playing with consent. JME 2012, 38:355-351.
  • [18]Axler RE, Irvine R, Lipworth W, Morrell B, Kerridge IH: Why might people donate tissue for cancer research? Insights from organ/tissue/blood donation and clinical research. Pathobiology 2008, 75:323-329.
  • [19]Caulfield T, Upshur RE, Daar A: DNA databanks and consent: a suggested policy option involving an authorization model. BMC Med Ethics 2003, 4:E1. BioMed Central Full Text
  • [20]Hansson MG: Ethics and biobanks. Br J Cancer 2009, 100:8-12.
  • [21]Petrini C: “Broad” consent, exceptions to consent and the question of using biological samples for research purposes different from the initial collection purpose. Soc Sci Med 2010, 70:217-220.
  • [22]Beskow LM, Friedman JY, Hardy NC, Lin L, Weinfurt KP: Developing a simplified consent form for biobanking. PLoS One 2010, 5:e13302.
  • [23]Budimir D, Polasek O, Marusić A, Kolcić I, Zemunik T, Boraska V, Jeroncić A, Boban M, Campbell H, Rudan I: Ethical aspects of human biobanks: a systematic review. Croat Med J 2011, 52:262-279.
  • [24]Beier K: Conclusion. In The Ethical and Legal Regulation of Human Tissue and Biobank Research in Europe. Proceedings of the Tiss.EU Project. Edited by Beier K, Schnorrer S, Hoppe N, Lenk C. Göttingen, Germany: Universitätsverlag Göttingen; 2011:161-170.
  • [25]Council of Europe Committee of Ministers: Appendix to the Recommendation Rec(2006)4 of the Committee of Ministers to member states on research on biological materials of human origin. https://wcd.coe.int/ViewDoc.jsp?id=977859 webcite
  • [26]Chan TW, Mackey S, Hegney DG: Patients’ experiences on donation of their residual biological samples and the impact of these experiences on the type of consent given for the future research use of the tissue: a systematic review. Int J Evid Based Healthc 2012, 10:9-26.
  • [27]Sándor J, Bard P: Anonymity and Privacy in Biobanking. In Biobanks and Tissue Research;The Public, the Patient and the Regulation. Edited by Lenk C, Sándor J, Gordijn B. Springer Dordrecht Heidelberg New York London: International Library of Ethics, Law and Technology; 2011. Vol. 8:213–230
  • [28]Fullerton SM, Lee SS-J: Secondary uses and the governance of de-identified data: lessons from the human genome diversity panel. BMC Med Ethics 2011, 12:16. BioMed Central Full Text
  • [29]Morrell B, Lipworth W, Axler R, Kerridge I, Little M: Cancer as rubbish: donation of tumor tissue for research. Qual Health Res 2010, 21:75-84.
  • [30]Hoedemaekers R, Gordijn B, Pijnenburg M: Solidarity and justice as guiding principles in genomic research. Bioethics 2007, 21:342-350.
  • [31]Hoedemaekers R, Gordijn , Pijnenburg M: Does an appeal to the common good justify individual sacrifices for genomic research? Theor Med Bioeth 2006, 27:415-431.
  • [32]Mitchell R, Conley JM, Davis AM, Cadigan RJ, Dobson AW, Gladden RQ: Genomics, biobanks, and the trade-secret model. Science 2011, 332:309-310.
  文献评价指标  
  下载次数:6次 浏览次数:22次