ETHICAL ASPECTS OF USING BIOSPECIMENS IN RESEARCH
Keywords:
biospecimens, ethics in research, bioethics, legal aspects, informed consentAbstract
The paper presents some considerations regarding bioethical aspects in using and storing biospecimens. One of the most important concerns is the way the general informed consent is adapted to this specific problem, taking into account ethical principles. Another aspect is related to the challenges raised in obtaining a valid informed consent. For a better approach to these specific issues, building on the experience of USA in this field, the situation in Romania concerning the use of biospecimens is presented from a legal point of view, in order to determine where we are and what is needed to meet the international bioethical standards.
Aspecte etice privind folosirea probelor biologice în cercetare. Lucrarea prezintă câteva considerații privind aspectele bioetice în utilizarea și depozitarea probelor biologice. Una dintre cele mai importante preocupări este modul în care consimțământul informat general este adaptat la această problemă specifică, ținând seama de principiile etice. Un alt aspect este legat de provocările ridicate de obținerea unui consimțământ informat valid. Pentru o mai bună abordare a acestor probleme specifice, pe baza experienței din SUA în acest domeniu, este prezentată, din punct de vedere juridic, situația din România cu privire la utilizarea probelor biologice, în scopul de a determina unde ne aflăm și ce este necesar de făcut pentru a îndeplini standardele bioetice internaționale.
Cuvinte-cheie: probe biologice, etică în cercetare, bioetică, aspect legale, consimţământ informat
References
George J. Annas, Michael A. Grodin - The Nuremberg Code, in Oxford Textbook of Clinical Research Ethics, Emanuel EJ, Grady C, Crouch RA, Lie RK, Miller FG, Wendler D (eds). New York, NY: Oxford University Press, pp. 136-140, 2008
Tom L. Beaucham - The Belmont Report, in Oxford Textbook of Clinical Research Ethics, Emanuel EJ, Grady C, Crouch RA, Lie RK, Miller FG, Wendler D (eds). New York, NY: Oxford University Press, pp. 149-155
Dan W. Brock - Philosophical Justification of Informed Consent in Research, in Oxford Textbook of Clinical Research Ethics, Emanuel EJ, Grady C, Crouch RA, Lie RK, Miller FG, Wendler D (eds). New York, NY: Oxford University Press, pp. 606-612, 2008
Joseph Goldfarb – Informed Consent, PowerPoint Lectures, 2014
Amy L. McGuire, Laura M. Beskow - Informed Consent in Genomics and Genetic Research, Annual Review of Genomics and Human Genetics, Vol. 11, Mc Guire, p. 361-381, 2010, available at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3216676/.
Jimmie B. Vaught, Nicole Lockhart, Karen S. Thiel, Julie A. Schneider - Ethical, Legal, and Policy Issues: Dominating the Biospecimen Discussion, in Cancer Epidemiology Biomarkers Preview, December 2007, issue 16 (12), American Association for Cancer Research, p. 2521-2523, available at http://cebp.aacrjournals.org/content/16/12/2521.full.
*** - National Cancer Institute Best Practices for Biospecimen Resources, National Cancer Institute, National Institute of Health, US Department of Health and Human Services, 2011, available at http://biospecimens.cancer.gov/bestpractices/2011-NCIbestpractices.pdf.
*** - What are Biospecimens and Biorepositories, National Cancer Institute, Biorepository and Biospecimen Research Branch, available at http://biospecimens.cancer.gov/patientcorner/.
*** - The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research, Washington, DC: Dep. Health Educ. Welfare, 1979, available at http://videocast.nih.gov/pdf/ohrp_appendix_belmont_report_vol_2.pdf.
*** - WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects, World Medical Association, available at http://www.wma.net/en/30publications/10policies/b3/.
*** - Code of Federal Regulations, Title 45 – Public Welfare, US Department of Health and Human Services, Part 46, Protection of Human Subjects, 2009, available at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.
*** - Informed Consent Form Templates, World Health Organization (WHO), available at http://www.who.int/rpc/research_ethics/informed_consent/en/.
*** - Hotărârea nr. 39/27.10.2006 referitoare la aprobarea Ghidului privind buna practică în studiul clinic, Agenția Națională a Medicamentului/Resolution no. 39/ 27.10.2006 on the approval of the Guide on good practices in clinical studies, National Agency of Medicines, available at http://www.anm.ro/anmdm/med_studii_legislatie.html.
*** - Legea nr. 282/2005 privind organizarea activităţii de transfuzie sanguină, donarea de sânge şi componente sanguine de origine umană, precum şi asigurarea calităţii şi securităţii sanitare, în vederea utilizării lor terapeutice, republicată în M. Of. nr. 188 din 17 martie 2014 / Law no. 282/2005 on the Organization of Blood Transfusions, Human Blood and Blood Component Donation, as well as Quality Assurance and Safety in Healthcare, for Therapeutic Use, Republished in the Official Monitor no. 188 of 17 March 2014, available at http://www.clr.ro/rep_htm/L282_2005_Rep1.htm.
*** - Legea nr.95 din 14 aprilie 2006, privind reforma în domeniul sănătăţii, republicată în M.Of. nr. 652 din 28 august 2015 / Law no.95 of 14 April 2006, on healthcare reform, republished in Official Gazette no. 652 of 28 August 2015, available at http://www.cdep.ro/pls/legis/legis_pck.htp_act_text?idt=72105.
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