Ética na inclusão de gestantes como participantes de pesquisas
Ética e pesquisa em gestantes
Palavras-chave:
Ética em pesquisa, Gestantes, Feto, Estudo sobre Vulnerabilidade em saúdeResumo
A inclusão de mulheres como participantes de pesquisas tem sido promovida, com o intuito de preencher lacunas existentes no conhecimento sobre a saúde e a doença em mulheres. Apesar disso, a inclusão de gestantes como participantes de pesquisa é cercada de apreensões sobre os efeitos no binômio materno-fetal. Embora existam preocupações com a inclusão de grávidas em estudo de novas drogas e procedimentos invasivos, é fundamental reconhecer que excluir as gestantes também é prejudicial. A exclusão sistemática pode colocar os fetos em risco devido à falta de conhecimento aplicável, impedindo o conhecimento de informações sobre os efeitos maternos e fetais de determinada droga ou intervenção. As gestantes não devem ser consideradas vulneráveis simplesmente porque estão grávidas, e há o dever de promover pesquisas destinadas a obter conhecimentos relevantes nesta população específica. É necessário promover a inclusão ética e responsável de mulheres grávidas em pesquisas, por ser uma questão de equidade e justiça social.
Referências
1. Committee Opinion N. 646: Ethical Considerations for Including Women as Research Participants. Obstet Gynecol. 2015; 126(5):e100-7. doi:10.1097/AOG.0000000000001150.
2. Fintel B, Samaras AT, Carias E. The thalidomide tragedy: lessons for drug safety and regulation. 2009 [acesso em 2018 jul 22]. Disponível em: https://helix.northwestern.edu/article/thalidomide-tragedy-lessons-drug-safety-and-regulation.
3. Martínez-Frías ML. The thalidomide experience: review of its effects 50 years later. Med Clin (Barc). 2012; 139(1):25-32. Spanish. doi: 10.1016/j.medcli.2011.10.011.
4. Lenz W. Thalidomide and congenital abnormalities. In: Persaud T.V.N. (eds) Problems of Birth Defects. Springer, Dordrecht; 1962. doi: https://doi.org/10.1007/978-94-011-6621-8_28.
5. Lenz W, Knapp K. Thalidomide embryopathy. Dtsch Med Wochenschr. 1962; 87:1232-42. German. doi: 10.1055/s-0028-1111892.
6. Lenz W. A short history of thalidomide embryopathy. Teratology. 1988; 38(3):203-15. doi: 10.1002/tera.1420380303.
7. Roes KCB, van der Zande ISE, van Smeden M, van der Graaf R. Towards an appropriate framework to facilitate responsible inclusion of pregnant women in drug development programs. Trials. 2018; 19(1):123. doi: 10.1186/s13063-018-2495-9.
8. Little MO, Wickremsinhe MN. Research with pregnant women: a call to action. Reprod Health. 2017; 14(Suppl 3):156. doi: 10.1186/s12978-017-0419-x.
9. Matsui D. Ethics of studies of drugs in pregnancy. Paediatr Drugs. 2015; 17(1):31-5. doi: 10.1007/s40272-014-0104-2.
10. Rogers W, Lange MM. Rethinking the vulnerability of minority populations in research. Am J Public Health. 2013; 103(12):2141-6. doi: 10.2105/AJPH.2012.301200.
11. Lange MM, Rogers W, Dodds S. Vulnerability in research ethics: a way forward. Bioethics. 2013; 27(6):333-40. doi: 10.1111/bioe.12032.
12. Levine C, Faden R, Grady C, Hammerschmidt D, Eckenwiler L, Sugarman J. Consortium to Examine Clinical Research Ethics. The limitations of "vulnerability" as a protection for human research participants. Am J Bioeth. 2004; 4(3):44-9. doi: 10.1080/15265160490497083.
13. van der Zande ISE, van der Graaf R, Oudijk MA, van Delden JJM. Vulnerability of pregnant women in clinical research. J Med Ethics. 2017; 43(10):657-63. doi: 10.1136/medethics-2016-103955.
14. Emanuel EJ, Wendler D, Killen J, Grady C. What makes clinical research in developing countries ethical? The benchmarks of ethical research. J Infect Dis. 2004; 189(5):930-7. doi: 10.1086/381709.
15. Blehar MC, Spong C, Grady C, Goldkind SF, Sahin L, Clayton JA. Enrolling pregnant women: issues in clinical research. Womens Health Issues. 2013; 23(1):e39-45. doi: 10.1016/j.whi.2012.10.003.
16. Krubiner CB, Faden RR. Pregnant women should not be categorized as a 'vulnerable population' in biomedical research studies: ending a vicious cycle of 'vulnerability'. J Med Ethics. 2017; 43(10):664-5. doi: 10.1136/medethics-2017-104446.
17. Nickel PJ. Vulnerable populations in research: the case of the seriously ill. Theor Med Bioeth. 2006; 27(3):245-64. doi: 10.1007/s11017-006-9000-2.
18. Reid R, Susic D, Pathirana S, Tracy S, Welsh AW. The ethics of obtaining consent in labour for research. Aust N Z J Obstet Gynaecol. 2011; 51(6):485-92. doi: 10.1111/j.1479-828X.2011.01341.x.
19. American College of Obstetricians and Gynecologists. Committee on Ethics; American Academy of Pediatrics. Committee on Bioethics. Committee opinion no. 501: Maternal-fetal intervention and fetal care centers. Obstet Gynecol. 2011; 118(2 Pt 1):405-10. doi: 10.1097/AOG.0b013e31822c99af.
20. Lyerly AD, Mitchell LM, Armstrong EM, Harris LH, Kukla R, Kuppermann M, et al. Risk and the pregnant body. Hastings Cent Rep. 2009; 39(6):34-42. [acesso em 2019 ago 26]. Disponível em: https://www.ncbi.nlm.nih.gov/pubmed/20050369.
21. Department of Health and Human Services. Code of Federal Regulations Title 45 Part 46 Protection of Human Subjects. 2009. [acesso em 2018 jul 22]. Disponível em: http://www.hhs.gov/ohrp/policy/ohrpregulations.pdf.
22. Brasil. Conselho Nacional de Saúde. Resolução n. 466, de 12 de dezembro de 2012. [acesso em 2018 mar 18]. Disponível em: http://bvsms.saude.gov.br/bvs/saudelegis/cns/2013/res0466_12_12_2012.html.
23. Neill KM. Research subject advocate: a new protector of research participants. Account Res. 2003; 10(3):159-74. doi: 10.1080/714906094.
24. Chervenak FA, McCullough LB. An ethically justified framework for clinical investigation to benefit pregnant and fetal patients. Am J Bioeth. 2011; 11(5):39-49. doi: 10.1080/15265161.2011.562595.
25. McCullough LB, Chervenak FA. The fetus as a patient and the ethics of human subjects research: response to commentaries on "An ethically justified framework for clinical investigation to benefit pregnant and fetal patients". Am J Bioeth. 2011; 11(5):W3-7. doi: 10.1080/15265161.2011.576939.
26. CIOMS. International ethical guidelines for health-related research involving humans. Geneva; 2016. [acesso em 2018 jul 22]. Disponível em: https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf.
27. van Delden JJ, van der Graaf R. Revised CIOMS International Ethical Guidelines for Health-Related Research Involving Humans. JAMA. 2017; 317(2):135-6. doi: 10.1001/jama.2016.18977.
28. Saenz C, Cheah PY, van der Graaf R, Henry LM, Mastroianni AC. Ethics, regulation, and beyond: the landscape of research with pregnant women. Reprod Health. 2017; 14(Suppl 3):173. doi: 10.1186/s12978-017-0421-3.
29. Saenz C, Alger J, Beca JP, Belizán JM, Cafferata ML, Guzmán JAC, et al. An ethics call to include pregnant women in research: Reflections from the Global Forum on Bioethics in Research. Rev Panam Salud Publica. 2017; 41. pii: e13. Epub 2017 Feb 8. Spanish.
30. Premkumar A, Gates E. Rethinking the Bioethics of Pregnancy: Time for a New Perspective? Obstet Gynecol. 2016; 128(2):396-9. doi: 10.1097/AOG.0000000000001509.
31. Bracken-Roche D, Bell E, Macdonald ME, Racine E. The concept of 'vulnerability' in research ethics: an in-depth analysis of policies and guidelines. Health Res Policy Syst. 2017;15(1):8. doi: 10.1186/s12961-016-0164-6. Retratação de Bracken-Roche, Bell E, Macdonald ME, Racine E. In: Health Res Policy Syst. 2017; 15(1):29.
32. Hunt A, Banner N, Littler K. The global forum on bioethics in research meeting, "ethics of research in pregnancy": emerging consensus themes and outputs. Reprod Health. 2017; 14(Suppl 3):158. doi: 10.1186/s12978-017-0431-1.
2. Fintel B, Samaras AT, Carias E. The thalidomide tragedy: lessons for drug safety and regulation. 2009 [acesso em 2018 jul 22]. Disponível em: https://helix.northwestern.edu/article/thalidomide-tragedy-lessons-drug-safety-and-regulation.
3. Martínez-Frías ML. The thalidomide experience: review of its effects 50 years later. Med Clin (Barc). 2012; 139(1):25-32. Spanish. doi: 10.1016/j.medcli.2011.10.011.
4. Lenz W. Thalidomide and congenital abnormalities. In: Persaud T.V.N. (eds) Problems of Birth Defects. Springer, Dordrecht; 1962. doi: https://doi.org/10.1007/978-94-011-6621-8_28.
5. Lenz W, Knapp K. Thalidomide embryopathy. Dtsch Med Wochenschr. 1962; 87:1232-42. German. doi: 10.1055/s-0028-1111892.
6. Lenz W. A short history of thalidomide embryopathy. Teratology. 1988; 38(3):203-15. doi: 10.1002/tera.1420380303.
7. Roes KCB, van der Zande ISE, van Smeden M, van der Graaf R. Towards an appropriate framework to facilitate responsible inclusion of pregnant women in drug development programs. Trials. 2018; 19(1):123. doi: 10.1186/s13063-018-2495-9.
8. Little MO, Wickremsinhe MN. Research with pregnant women: a call to action. Reprod Health. 2017; 14(Suppl 3):156. doi: 10.1186/s12978-017-0419-x.
9. Matsui D. Ethics of studies of drugs in pregnancy. Paediatr Drugs. 2015; 17(1):31-5. doi: 10.1007/s40272-014-0104-2.
10. Rogers W, Lange MM. Rethinking the vulnerability of minority populations in research. Am J Public Health. 2013; 103(12):2141-6. doi: 10.2105/AJPH.2012.301200.
11. Lange MM, Rogers W, Dodds S. Vulnerability in research ethics: a way forward. Bioethics. 2013; 27(6):333-40. doi: 10.1111/bioe.12032.
12. Levine C, Faden R, Grady C, Hammerschmidt D, Eckenwiler L, Sugarman J. Consortium to Examine Clinical Research Ethics. The limitations of "vulnerability" as a protection for human research participants. Am J Bioeth. 2004; 4(3):44-9. doi: 10.1080/15265160490497083.
13. van der Zande ISE, van der Graaf R, Oudijk MA, van Delden JJM. Vulnerability of pregnant women in clinical research. J Med Ethics. 2017; 43(10):657-63. doi: 10.1136/medethics-2016-103955.
14. Emanuel EJ, Wendler D, Killen J, Grady C. What makes clinical research in developing countries ethical? The benchmarks of ethical research. J Infect Dis. 2004; 189(5):930-7. doi: 10.1086/381709.
15. Blehar MC, Spong C, Grady C, Goldkind SF, Sahin L, Clayton JA. Enrolling pregnant women: issues in clinical research. Womens Health Issues. 2013; 23(1):e39-45. doi: 10.1016/j.whi.2012.10.003.
16. Krubiner CB, Faden RR. Pregnant women should not be categorized as a 'vulnerable population' in biomedical research studies: ending a vicious cycle of 'vulnerability'. J Med Ethics. 2017; 43(10):664-5. doi: 10.1136/medethics-2017-104446.
17. Nickel PJ. Vulnerable populations in research: the case of the seriously ill. Theor Med Bioeth. 2006; 27(3):245-64. doi: 10.1007/s11017-006-9000-2.
18. Reid R, Susic D, Pathirana S, Tracy S, Welsh AW. The ethics of obtaining consent in labour for research. Aust N Z J Obstet Gynaecol. 2011; 51(6):485-92. doi: 10.1111/j.1479-828X.2011.01341.x.
19. American College of Obstetricians and Gynecologists. Committee on Ethics; American Academy of Pediatrics. Committee on Bioethics. Committee opinion no. 501: Maternal-fetal intervention and fetal care centers. Obstet Gynecol. 2011; 118(2 Pt 1):405-10. doi: 10.1097/AOG.0b013e31822c99af.
20. Lyerly AD, Mitchell LM, Armstrong EM, Harris LH, Kukla R, Kuppermann M, et al. Risk and the pregnant body. Hastings Cent Rep. 2009; 39(6):34-42. [acesso em 2019 ago 26]. Disponível em: https://www.ncbi.nlm.nih.gov/pubmed/20050369.
21. Department of Health and Human Services. Code of Federal Regulations Title 45 Part 46 Protection of Human Subjects. 2009. [acesso em 2018 jul 22]. Disponível em: http://www.hhs.gov/ohrp/policy/ohrpregulations.pdf.
22. Brasil. Conselho Nacional de Saúde. Resolução n. 466, de 12 de dezembro de 2012. [acesso em 2018 mar 18]. Disponível em: http://bvsms.saude.gov.br/bvs/saudelegis/cns/2013/res0466_12_12_2012.html.
23. Neill KM. Research subject advocate: a new protector of research participants. Account Res. 2003; 10(3):159-74. doi: 10.1080/714906094.
24. Chervenak FA, McCullough LB. An ethically justified framework for clinical investigation to benefit pregnant and fetal patients. Am J Bioeth. 2011; 11(5):39-49. doi: 10.1080/15265161.2011.562595.
25. McCullough LB, Chervenak FA. The fetus as a patient and the ethics of human subjects research: response to commentaries on "An ethically justified framework for clinical investigation to benefit pregnant and fetal patients". Am J Bioeth. 2011; 11(5):W3-7. doi: 10.1080/15265161.2011.576939.
26. CIOMS. International ethical guidelines for health-related research involving humans. Geneva; 2016. [acesso em 2018 jul 22]. Disponível em: https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf.
27. van Delden JJ, van der Graaf R. Revised CIOMS International Ethical Guidelines for Health-Related Research Involving Humans. JAMA. 2017; 317(2):135-6. doi: 10.1001/jama.2016.18977.
28. Saenz C, Cheah PY, van der Graaf R, Henry LM, Mastroianni AC. Ethics, regulation, and beyond: the landscape of research with pregnant women. Reprod Health. 2017; 14(Suppl 3):173. doi: 10.1186/s12978-017-0421-3.
29. Saenz C, Alger J, Beca JP, Belizán JM, Cafferata ML, Guzmán JAC, et al. An ethics call to include pregnant women in research: Reflections from the Global Forum on Bioethics in Research. Rev Panam Salud Publica. 2017; 41. pii: e13. Epub 2017 Feb 8. Spanish.
30. Premkumar A, Gates E. Rethinking the Bioethics of Pregnancy: Time for a New Perspective? Obstet Gynecol. 2016; 128(2):396-9. doi: 10.1097/AOG.0000000000001509.
31. Bracken-Roche D, Bell E, Macdonald ME, Racine E. The concept of 'vulnerability' in research ethics: an in-depth analysis of policies and guidelines. Health Res Policy Syst. 2017;15(1):8. doi: 10.1186/s12961-016-0164-6. Retratação de Bracken-Roche, Bell E, Macdonald ME, Racine E. In: Health Res Policy Syst. 2017; 15(1):29.
32. Hunt A, Banner N, Littler K. The global forum on bioethics in research meeting, "ethics of research in pregnancy": emerging consensus themes and outputs. Reprod Health. 2017; 14(Suppl 3):158. doi: 10.1186/s12978-017-0431-1.
Downloads
Publicado
2019-12-15
Como Citar
Nomura, R. (2019). Ética na inclusão de gestantes como participantes de pesquisas: Ética e pesquisa em gestantes. Cadernos De Ética Em Pesquisa, 1(1), 9–16. Recuperado de https://cadernosdeeticaempesquisa.emnuvens.com.br/Caderno19/article/view/8
Edição
Seção
Artigos originais
Licença
Declaro que o conteúdo da obra cedida é de minha autoria, em colaboração com os co-autores mencionados, da qual assumo qualquer responsabilidade moral e/ou material em virtude de possível impugnação da obra por parte de terceiros.
