Ética na inclusão de gestantes como participantes de pesquisas
Ética e pesquisa em gestantes
Keywords:
Ética em pesquisa, Gestantes, Feto, Estudo sobre Vulnerabilidade em saúdeAbstract
The inclusion of women as research participants has been promoted in order to fill gaps in the knowledge about health and disease. Despite this, the inclusion of pregnant women as research participants is surrounded by concern about the maternal-fetal side effects. Although there are fears about the inclusion of pregnant women in the study of new drugs and invasive procedures, it is fundamental to recognize that excluding pregnant women is also harmful. Systematic exclusion can place fetuses at risk due to a lack of applicable knowledge, impairing knowledge of the maternal and fetal side effects of a particular drug or intervention. Pregnant women should not be considered vulnerable simply because they are pregnant, and there is a duty to support research aimed to acquire relevant knowledge of this specific population. It is necessary to promote the ethical and responsible inclusion of pregnant women in research, as it is a issue of equity and social justice.
References
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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.
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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.
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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. Retrieved from https://cadernosdeeticaempesquisa.emnuvens.com.br/Caderno19/article/view/8
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