Ética na inclusão de gestantes como participantes de pesquisas
Ética e pesquisa em gestantes
Palabras clave:
Ética em pesquisa, Gestantes, Feto, Estudo sobre Vulnerabilidade em saúdeResumen
Se ha promovido la inclusión de las mujeres como participantes en la investigación para llenar los vacíos en el conocimiento sobre la salud y la enfermedad en las mujeres. Sin embargo, la inclusión de mujeres embarazadas como participantes de la investigación está rodeada de preocupaciones sobre los efectos sobre el binomio materno-fetal. Aunque existen preocupaciones sobre la inclusión de mujeres embarazadas en el estudio de nuevos medicamentos y procedimientos invasivos, es crucial reconocer que excluir a las mujeres embarazadas también es perjudicial. La exclusión sistemática puede poner en riesgo a los fetos debido a la falta de conocimiento aplicable, evitando el conocimiento de la información sobre los efectos maternos y fetales de un medicamento o intervención dada. Las mujeres embarazadas no deben considerarse vulnerables simplemente porque están embarazadas, y existe el deber de promover la investigación dirigida a obtener conocimientos relevantes en esta población específica. Es necesario promover la inclusión ética y responsable de las mujeres embarazadas en la investigación, ya que es una cuestión de equidad y justicia social.
Citas
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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.
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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.
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2019-12-15
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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 a partir de https://cadernosdeeticaempesquisa.emnuvens.com.br/Caderno19/article/view/8
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