BibTex RIS Kaynak Göster

Araştrımada Sorumluluklar: Sponsorların Rolü

Yıl 2010, Cilt: 67 Sayı: 4, 189 - 197, 01.12.2010

Öz

Bilimsel çalışmaların kamu denetiminde yapılması gerektiği kavramının ortaya çıkmasının dışında, sorumluluk ilkesinin de çağdaş bilimsel yaklaşım içinde özel bir durum taşıdığı kabul edilmektedir. Bu yazıda, ahlaki çatışmalar ortaya çıktığında farklı kurumlar, ulusal ve uluslararası kuruluşlar ve ilaç endüstrisinden sponsorlarca bu bağlamda yerine getirilen rollerin yansıtılması amaçlanmıştır. Denek olarak insanların kullanıldığı araştırmaların karmaşıklığı nedeniyle, bu konudaki tartışmaların bazı sosyal ve endüstriel paydaşları da kapsayacak şekilde genişletilmesi zorunluluğu ortaya çıkmıştır.Bu özel durum farmasötik endüstriyi ilgilendiren problemlerin dışında yeralabilecek olası sponsorları tanımlama ihtiyacını doğurmuştur. Literatürde en çok adı geçen sponsorlar; özellikle yeni ilaçlar, aşılar ve tıbbi ürün ve ekipmanlar geliştirmek için uluslararası araştırmalar yürüten farmasötik endüstrisi; epidemiyolojik çalışmalar ile ihmal edilmiş hastalıklar için ilaç ve aşı geliştirmeye yönelik çalışmalar yapan uluslararası organizasyonlar; bölgesel ve ulusal düzeyde özel sağlık problemleri konusunda çalışan ulusal organizasyonlar ve araştırma alanında kendi politikalarına göre çalışmalar yapan araştırma ve akademi enstitüleridir. Bu derlemede, araştırma protokol sonuçlarının hazırlık, çalışma ve dağıtım basamaklarındaki etik sorumluluğun farklı paydaşlar arasında paylaşılması gerektiği varsayılmaktadır. Bununla beraber, sponsorlar yürütülen çalışmaların bütünlüğünün sağlanmasında gönüllülerin ve daha geniş anlamda toplumun korunması açısından kritik bir role sahiptir

Kaynakça

  • Guilhem D. Ethical responsibility in research: institutions and sponsors. Rev Saúde Dist Fed, 2004; 15(1/2):33-40
  • Benatar SR, Singer PA. Responsibilities in international research: a new look revisited. J Med Ethics, 2010; 36(4):194-7.
  • Macklin R. Double standards in medical research in developing countries. Cambridge: Cambridge University Press, 2004.
  • Guilhem D. Research ethics: advances and challenges. RECIIS – Elec. J Commun Inf Innov Health, 2008; 2 (Sup1): 87- 92.
  • Schüklenk U, Hare D. Ethical issues in international research and multicentre studies. RECIIS – Elec. J Commun Inf Innov Health, 2008; 2(Sup1): 19- 29.
  • Freeman RE, Harrison JS, Wicks AC. Managing for Stakeholders; Survival Reputation and Success. New Haven: Yale University Press; 2008.
  • Stieb JA. Assessing Freeman’s stakeholder theory. J Bus Ethics, 2009; 87: 401- 14.
  • Greish J. De La gnose au príncipe responsibilité. Um entretien avec Hans Jonas. Esprit, 1991; 171:5- 21.
  • Bonfim JR. Reprodução assistida, bioética e discurso científico: estratégias discursivas da Revista Veja. [Dissertação]. Brasília (DF): Universidade de Brasília; 2003:14.
  • Jonas H. Técnica, ética e medicina: la práctica del principio de responsabilidad. 1th Ed. Barcelona: Paidós; 1997
  • Jonas H. El Princípio de Responsabilidad: Ensayo de una Etica para la Civilización tecnológica. 1th Ed. Barcelona: Editorial Herder, 1995.
  • Rorty R. Contingência, Ironia e Solidariedade. Rio de Janeiro: Martins Editora, 2007.
  • Cortina A. Cuidadanos del mundo. Madrid: Alianza Editorial, 2001.
  • Chilenge R. An ethics perspective on responsibilities of investigators, sponsors and research participants. Acta Trop, 2009; 112S:S53- S62.
  • US National Institutes of Health. U.S. Department of Health & Human Services. Available at: http://www. clinicaltrials.gov.
  • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Harmonized tripartite guideline for good clinical practice (ICH_GCP). Geneva: ICH, 1996. Available at: http://www.ich.org/LOB/media/ MEDIA482.pdf.
  • UNICEF/UNDP/WB/WHO. Special Programme for Research and Training in Tropical Diseases. Grants. Available at: http://apps.who.int/tdr/svc/grants.
  • U.S. National Institutes of Health. Department of Health & Human services. Grants & fundings opportunities. Available at: www.nih.gov/grants/oer.htm.
  • Ford Foundation. Grants. Available at: http://www. fordfoundation.org/Grants.
  • Vancouver Coastal Health Research Institutes. Grants & award winners. Available at: http://vchri.ca/s/ grantingagencies.asp.
  • Wellcome Trust. Funding and Grants. Available at: http://www.wellcome.ac.uk/.
  • Brazil. Ministry of Health. Secretary of Science, Technology and Strategic Goods (SCTIE). Department of Science and Technology (DECIT). Pesquisa para Saúde: desenvolvimento e inovação para o SUS: 22 a 24 de outubro de 2007: relatório final. Brasília: Ministério da Saúde, 2008. Available at: http://bvsms.saude.gov.br/ bvs/publicacoes/pesquisa_para_saude_relatorio.pdf.
  • Brazil. Ministry of Science and Technology. The National Council for Scientific and Technological Development (CNPq). Editais. Available at: http://www.cnpq.br/ editais/index.htm.
  • Brazil. Ministry of Science and Technology. Financiadora de Estudos e Projetos – FINEP. Chamadas públicas. Available at: http://www.finep.gov.br/como_obter_ financiamento/editais_financiamento_ini.asp.
  • Brazil. Ministry of Education. Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. Editais abertos. Available at: http://www.capes.gov.br/ editais/abertos.
  • Minas Gerais State. Fundação de Amparo à Pesquisa do Estado de Minas Gerais- FAPEMIG. Editais. Available at: http://www.fapemig.br/modalidades_de_apoio/ editais/index.php.
  • Ministério da Saúde. Secretaria de Ciência, Tecnologia e Insumos Estratégicos. Departamento de Ciência e Tecnologia. National clinical research network: Brazilian response and mitigation of international dependency. Rev Saúde Pública, 2010; 44(3):575-8.
  • Ministério da Saúde. Secretaria de Ciência, Tecnologia e Insumos Estratégicos. Departamento de Ciência e Tecnologia. Rede nacional de terapia celular – RNTC. Available at: http://www.rntc.org.br/htm/arntc.htm.
  • Guilhem D, Greco DB. Research ethics in Brazil: regulations, legal framework and the Brazilian system of research ethics review. Brasilia Médica. 2009; 46(sup.1):6-18. Available at: http://www.ambr.com. br/rb/arquivos/03_suplemento_1_etica%20em%20 pesquisa.pdf.
  • Atkinson TN, Gilleland DS. The scope of social responsibility in the university research environment. Res Manag Rev, 2006; 15(2):1-8.
  • World Medical Association. Declaration of Helsinki. Seoul: WMA, 2008.
  • Council for International Organizations of Medical Sciences. International ethical guidelines for biomedical research involving human subjects. Geneva: CIOMS/ OMS, 2002.
  • Council for International Organizations of Medical Sciences. International Ethical Guidelines for Epidemiological Studies. Geneva: CIOMS/OMS, 2002.
  • Nuffield Council on Bioethics. The Ethics of Clinical Research in Developing Countries. London: NCB, 1999.
  • Nuffield Council on Bioethics. The ethics of research related to healthcare in developing countries: a follow up discussion paper. South Africa: NCB, 2005.
  • World Health Organization, 2000. Operational Guidelines for Ethics Committees that Review Biomedical Research. Geneva: WHO/TDR, 2000.
  • United Nations Educational, Scientific and Cultural Organization. Universal declaration on bioethics and human rights. Paris: UNESCO, 2005. Available at: http:// unesdoc.unesco.org/images/0014/001461/146180e. pdf
  • Brazil. Ministry of Health. National Council of Health. Resolution No. 196/1996 on Research involving human subjects. Brasília: CNS; 1996. Available at: conselho. saude.gov.br/docs/Resolucoes/reso_196_english.doc.
  • Emanuel EJ, Wendler D, Killen J, Grady C. What makes clinical research in developing countries ethical? The benchmarks of ethical research. JID, 2004; 189: 930-7.
  • Tauil PL, Guilhem D. Method and Ethics: Indissoluble fundamentals of the scientific practice context. Brasília Med. 2009; 46(Supl1):19- 26. Available at: http://www. ambr.com.br/rb/arquivos/04_suplemento_1_metodo_ etica.pdf
  • Queiroz W. Clinical Research: Ethical, scientific and regulatory issues. Brasília Med. 2009; 46(Supl1): 27-32. Available at: http://www.ambr.com.br/rb/ arquivos/05_suplemento_1_pesquisa_clinica_.pdf.
  • Angell M. The ethics of clinical Research in the third world. N Engl J Med, 1997; 337:847-9.
  • Lurie P, Wolfe SM. Unethical trials of interventions to reduce perinatal transmission of HIV in developing countries. N Engl J Med, 1997; 337:1003-5.
  • Cutcliffe JR, Ramcharan P. Leveling the playing field? Exploring the merits of the ethics-as-process approach for judging qualitative research proposals. Qualit Health Res, 2002; 12(7):1000-10.
  • Guilhem D, Novaes MRCG. Ética em pesquisa social em saúde. In: Fleischer S, Schuch P. Ética e regulamentação na pesquisa antropológica. Brasília: LetrasLivres; Editora UnB, 2010. p. 217-36.

Responsibilities in Research: The Roles of Sponsors

Yıl 2010, Cilt: 67 Sayı: 4, 189 - 197, 01.12.2010

Öz

The principle of responsibility assumed special status in the contemporary scenery besides de emergence of the conception related to necessity of public control of the scientific practice. The aim of this paper was to reflect about the roles carried out by sponsors from different institutions, national and international organizations, and pharmaceutical industries when moral conflicts emerge in this context. The complexity in the daily practice of researches involving human subjects points out the obligation to enlarge the panorama of the discussion on this theme, including several social and institutional partners. In this specific case became necessary to know the potential sponsors, exceeding the question concerning to the pharmaceutical industry. The most frequent sponsors listed in the literature were: the pharmaceutical industry, specially related to international research for development of new drugs, vaccines and medical products and equipments; international organizations in the case of epidemiological studies, drugs and vaccines for neglected diseases and research strengthening capabilities; national organizations working with specific health problems of the countries or regions populations; and research and academic institutions that have their own policies for research. This paper assumes the position that an ethical conduct during the preparation, development and dissemination of a research protocol results need to be shared between different partners. However, the sponsors have a crucial role to maintain the integrity of researches, to guarantee the protection of volunteers and society at large

Kaynakça

  • Guilhem D. Ethical responsibility in research: institutions and sponsors. Rev Saúde Dist Fed, 2004; 15(1/2):33-40
  • Benatar SR, Singer PA. Responsibilities in international research: a new look revisited. J Med Ethics, 2010; 36(4):194-7.
  • Macklin R. Double standards in medical research in developing countries. Cambridge: Cambridge University Press, 2004.
  • Guilhem D. Research ethics: advances and challenges. RECIIS – Elec. J Commun Inf Innov Health, 2008; 2 (Sup1): 87- 92.
  • Schüklenk U, Hare D. Ethical issues in international research and multicentre studies. RECIIS – Elec. J Commun Inf Innov Health, 2008; 2(Sup1): 19- 29.
  • Freeman RE, Harrison JS, Wicks AC. Managing for Stakeholders; Survival Reputation and Success. New Haven: Yale University Press; 2008.
  • Stieb JA. Assessing Freeman’s stakeholder theory. J Bus Ethics, 2009; 87: 401- 14.
  • Greish J. De La gnose au príncipe responsibilité. Um entretien avec Hans Jonas. Esprit, 1991; 171:5- 21.
  • Bonfim JR. Reprodução assistida, bioética e discurso científico: estratégias discursivas da Revista Veja. [Dissertação]. Brasília (DF): Universidade de Brasília; 2003:14.
  • Jonas H. Técnica, ética e medicina: la práctica del principio de responsabilidad. 1th Ed. Barcelona: Paidós; 1997
  • Jonas H. El Princípio de Responsabilidad: Ensayo de una Etica para la Civilización tecnológica. 1th Ed. Barcelona: Editorial Herder, 1995.
  • Rorty R. Contingência, Ironia e Solidariedade. Rio de Janeiro: Martins Editora, 2007.
  • Cortina A. Cuidadanos del mundo. Madrid: Alianza Editorial, 2001.
  • Chilenge R. An ethics perspective on responsibilities of investigators, sponsors and research participants. Acta Trop, 2009; 112S:S53- S62.
  • US National Institutes of Health. U.S. Department of Health & Human Services. Available at: http://www. clinicaltrials.gov.
  • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Harmonized tripartite guideline for good clinical practice (ICH_GCP). Geneva: ICH, 1996. Available at: http://www.ich.org/LOB/media/ MEDIA482.pdf.
  • UNICEF/UNDP/WB/WHO. Special Programme for Research and Training in Tropical Diseases. Grants. Available at: http://apps.who.int/tdr/svc/grants.
  • U.S. National Institutes of Health. Department of Health & Human services. Grants & fundings opportunities. Available at: www.nih.gov/grants/oer.htm.
  • Ford Foundation. Grants. Available at: http://www. fordfoundation.org/Grants.
  • Vancouver Coastal Health Research Institutes. Grants & award winners. Available at: http://vchri.ca/s/ grantingagencies.asp.
  • Wellcome Trust. Funding and Grants. Available at: http://www.wellcome.ac.uk/.
  • Brazil. Ministry of Health. Secretary of Science, Technology and Strategic Goods (SCTIE). Department of Science and Technology (DECIT). Pesquisa para Saúde: desenvolvimento e inovação para o SUS: 22 a 24 de outubro de 2007: relatório final. Brasília: Ministério da Saúde, 2008. Available at: http://bvsms.saude.gov.br/ bvs/publicacoes/pesquisa_para_saude_relatorio.pdf.
  • Brazil. Ministry of Science and Technology. The National Council for Scientific and Technological Development (CNPq). Editais. Available at: http://www.cnpq.br/ editais/index.htm.
  • Brazil. Ministry of Science and Technology. Financiadora de Estudos e Projetos – FINEP. Chamadas públicas. Available at: http://www.finep.gov.br/como_obter_ financiamento/editais_financiamento_ini.asp.
  • Brazil. Ministry of Education. Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. Editais abertos. Available at: http://www.capes.gov.br/ editais/abertos.
  • Minas Gerais State. Fundação de Amparo à Pesquisa do Estado de Minas Gerais- FAPEMIG. Editais. Available at: http://www.fapemig.br/modalidades_de_apoio/ editais/index.php.
  • Ministério da Saúde. Secretaria de Ciência, Tecnologia e Insumos Estratégicos. Departamento de Ciência e Tecnologia. National clinical research network: Brazilian response and mitigation of international dependency. Rev Saúde Pública, 2010; 44(3):575-8.
  • Ministério da Saúde. Secretaria de Ciência, Tecnologia e Insumos Estratégicos. Departamento de Ciência e Tecnologia. Rede nacional de terapia celular – RNTC. Available at: http://www.rntc.org.br/htm/arntc.htm.
  • Guilhem D, Greco DB. Research ethics in Brazil: regulations, legal framework and the Brazilian system of research ethics review. Brasilia Médica. 2009; 46(sup.1):6-18. Available at: http://www.ambr.com. br/rb/arquivos/03_suplemento_1_etica%20em%20 pesquisa.pdf.
  • Atkinson TN, Gilleland DS. The scope of social responsibility in the university research environment. Res Manag Rev, 2006; 15(2):1-8.
  • World Medical Association. Declaration of Helsinki. Seoul: WMA, 2008.
  • Council for International Organizations of Medical Sciences. International ethical guidelines for biomedical research involving human subjects. Geneva: CIOMS/ OMS, 2002.
  • Council for International Organizations of Medical Sciences. International Ethical Guidelines for Epidemiological Studies. Geneva: CIOMS/OMS, 2002.
  • Nuffield Council on Bioethics. The Ethics of Clinical Research in Developing Countries. London: NCB, 1999.
  • Nuffield Council on Bioethics. The ethics of research related to healthcare in developing countries: a follow up discussion paper. South Africa: NCB, 2005.
  • World Health Organization, 2000. Operational Guidelines for Ethics Committees that Review Biomedical Research. Geneva: WHO/TDR, 2000.
  • United Nations Educational, Scientific and Cultural Organization. Universal declaration on bioethics and human rights. Paris: UNESCO, 2005. Available at: http:// unesdoc.unesco.org/images/0014/001461/146180e. pdf
  • Brazil. Ministry of Health. National Council of Health. Resolution No. 196/1996 on Research involving human subjects. Brasília: CNS; 1996. Available at: conselho. saude.gov.br/docs/Resolucoes/reso_196_english.doc.
  • Emanuel EJ, Wendler D, Killen J, Grady C. What makes clinical research in developing countries ethical? The benchmarks of ethical research. JID, 2004; 189: 930-7.
  • Tauil PL, Guilhem D. Method and Ethics: Indissoluble fundamentals of the scientific practice context. Brasília Med. 2009; 46(Supl1):19- 26. Available at: http://www. ambr.com.br/rb/arquivos/04_suplemento_1_metodo_ etica.pdf
  • Queiroz W. Clinical Research: Ethical, scientific and regulatory issues. Brasília Med. 2009; 46(Supl1): 27-32. Available at: http://www.ambr.com.br/rb/ arquivos/05_suplemento_1_pesquisa_clinica_.pdf.
  • Angell M. The ethics of clinical Research in the third world. N Engl J Med, 1997; 337:847-9.
  • Lurie P, Wolfe SM. Unethical trials of interventions to reduce perinatal transmission of HIV in developing countries. N Engl J Med, 1997; 337:1003-5.
  • Cutcliffe JR, Ramcharan P. Leveling the playing field? Exploring the merits of the ethics-as-process approach for judging qualitative research proposals. Qualit Health Res, 2002; 12(7):1000-10.
  • Guilhem D, Novaes MRCG. Ética em pesquisa social em saúde. In: Fleischer S, Schuch P. Ética e regulamentação na pesquisa antropológica. Brasília: LetrasLivres; Editora UnB, 2010. p. 217-36.
Toplam 45 adet kaynakça vardır.

Ayrıntılar

Birincil Dil Türkçe
Bölüm Derleme
Yazarlar

Dirce Guilhem Bu kişi benim

Luciana Neves Da Silva Bampi Bu kişi benim

Roberto Cañete Villafranca Bu kişi benim

Yayımlanma Tarihi 1 Aralık 2010
Yayımlandığı Sayı Yıl 2010 Cilt: 67 Sayı: 4

Kaynak Göster

APA Guilhem, D., Bampi, L. N. D. S., & Villafranca, R. C. (2010). Araştrımada Sorumluluklar: Sponsorların Rolü. Türk Hijyen Ve Deneysel Biyoloji Dergisi, 67(4), 189-197.
AMA Guilhem D, Bampi LNDS, Villafranca RC. Araştrımada Sorumluluklar: Sponsorların Rolü. Turk Hij Den Biyol Derg. Aralık 2010;67(4):189-197.
Chicago Guilhem, Dirce, Luciana Neves Da Silva Bampi, ve Roberto Cañete Villafranca. “Araştrımada Sorumluluklar: Sponsorların Rolü”. Türk Hijyen Ve Deneysel Biyoloji Dergisi 67, sy. 4 (Aralık 2010): 189-97.
EndNote Guilhem D, Bampi LNDS, Villafranca RC (01 Aralık 2010) Araştrımada Sorumluluklar: Sponsorların Rolü. Türk Hijyen ve Deneysel Biyoloji Dergisi 67 4 189–197.
IEEE D. Guilhem, L. N. D. S. Bampi, ve R. C. Villafranca, “Araştrımada Sorumluluklar: Sponsorların Rolü”, Turk Hij Den Biyol Derg, c. 67, sy. 4, ss. 189–197, 2010.
ISNAD Guilhem, Dirce vd. “Araştrımada Sorumluluklar: Sponsorların Rolü”. Türk Hijyen ve Deneysel Biyoloji Dergisi 67/4 (Aralık 2010), 189-197.
JAMA Guilhem D, Bampi LNDS, Villafranca RC. Araştrımada Sorumluluklar: Sponsorların Rolü. Turk Hij Den Biyol Derg. 2010;67:189–197.
MLA Guilhem, Dirce vd. “Araştrımada Sorumluluklar: Sponsorların Rolü”. Türk Hijyen Ve Deneysel Biyoloji Dergisi, c. 67, sy. 4, 2010, ss. 189-97.
Vancouver Guilhem D, Bampi LNDS, Villafranca RC. Araştrımada Sorumluluklar: Sponsorların Rolü. Turk Hij Den Biyol Derg. 2010;67(4):189-97.