O papel do comitê de ética em pesquisa na avaliação de testes estatísticos

Spiandorello, Wilson Paloschi

doi:10.1590/1983-80422014223030

Resumos

A ética em pesquisa no Brasil tem passado por transformações desde que se estabeleceu a Plataforma Brasil, em 2011, e a Resolução CNS 466/12, em 2013. No entanto, as implicações éticas do uso de testes estatísticos na pesquisa quantitativa têm sido pouco discutidas. Alguns defendem que os comitês de ética em pesquisa não devem se envolver com análises estatísticas, ao passo que outros advogam o contrário. Por meio de levantamento na literatura, este artigo revisa algumas implicações éticas do uso de testes estatísticos e analisa as consequências de desvios estatísticos sobre os resultados finais dos estudos, defendendo que os comitês devem assumir responsabilidade quanto à adequação das análises estatísticas nos projetos avaliados. Diante das atuais dificuldades de estruturação do sistema de avaliação da ética em pesquisa no Brasil, propõe-se aqui orientações básicas para a avaliação da análise estatística, apontando solução para esse impasse por meio da pesquisa reproduzível.

Ética em pesquisa; Estatística e dados numéricos; Pesquisa; Métodos

Brazilian's research ethics has being transformed since the deployments of Platform Brazil, in 2011, and the Resolution CNS 466/12, in 2013. However, the ethical implication of statistical tests uses in quantitative research has been little discussed. While some advocate that the research ethics committees should not be involved with statistical analyzes, others argue the opposite. This paper reviews the role of the ethical implications of the statistical work of research, analyzes the consequences of statistical deviations on the final results of the work and concludes that the committee should take responsibility for the adequacy of the statistical analyzes in research projects. Facing current difficulties regarding establishing an ethic assessment system in research in Brazil, some basic orientation is proposed to statistical analyzes assessment, pointing out a solution to this issue by the so called reproducible research.

Research, ethics; Statistics and numerical data; Research; Methods

Brasil ha pasado por transformaciones en el campo de la ética en las investigaciones, desde que fue creada la Plataforma Brasil, en 2011, y la Resolución CNS 466/12, en 2013. Sin embargo, las implicaciones éticas del uso de las pruebas estadísticas en la investigación cuantitativa se han discutido muy poco. Mientras que algunos defienden que los comités de ética en investigación no deben estar involucrados en análisis estadísticos, otros dicen lo contrario. Este artículo examina con el análisis de la literatura, el papel de las implicaciones éticas del uso de pruebas estadísticas y analiza las consecuencias de las desviaciones estadísticas sobre los resultados finales de los estudios y se llega a la conclusión de que los comités deberían asumir la responsabilidad de la adecuación de los análisis estadísticos en los proyectos evaluados. Frente a las dificultades de estructuración del sistema de evaluación de la ética en investigación en Brasil, se propone aquí orientaciones básicas para la evaluación de los análisis estadísticos, destacando una solución para este impase por medio de la investigación reproducible.

Ética en investigación; Estadística y dados numéricos; Investigación; Métodos

¹
May WW. The composition and function of ethical committees. J Med Ethics. 1975 fev;1(1):23-9.
²
Altman DG. Statistics and ethics in medical research: VII-Interpreting results. Br Med J. 1980;281(6.255):1.612-4.
³
Altman DG. Statistics and ethics in medical research: VI-Presentation of results. Br Med J. 1980;281(6.254):1.542-4.
⁴
Altman DG. Statistics and ethics in medical research: V-Analysing data. Br Med J. 1980;281(6.253):1.473-5.
⁵
Altman DG. Statistics and ethics in medical research: collecting and screening data. Br Med J. 1980;281(6.252):1.399-401.
⁶
Altman DG. Statistics and ethics in medical research: III-How large a sample? Br Med J. 1980;281(6.251):1.336-8.
⁷
Altman DG. Statistics and ethics in medical research: study design. Br Med J. 1980;281(6.250):1.267-9.
⁸
Altman DG. Statistics and ethics in medical research: misuse of statistics is unethical. Br Med J. 1980;281(6.249):1.182-4.
⁹
Altman DG. Statistics and ethics in medical research: VIII-Improving the quality of statistics in medical journals. Br Med J (Clin Res Ed). 1981;282(6.257):44-7.
¹⁰
Gilbert JP, McPeek B, Mosteller F. Statistics and ethics in surgery and anesthesia. Science. 1977;198(4.318):684-9.
¹¹
Rathnam A. TAPVC vital statistics: ethics and moral values. Am Heart J. 1977;93(5):676.
¹²
Clarke MR. Statistics and ethics in medical research. Br Med J (Clin Res Ed). 1981;282(6.262):480.
¹³
Dobbing J. Statistics and ethics in medical research. Br Med J (Clin Res Ed). 1981;282(6.268):990.
¹⁴
Zander LI. The place of confinement: a question of statistics or ethics?. J Med Ethics. 1981;7(3):125-7.
¹⁵
Kulcar Z, Hrabak-Zerjavic V. [The ethics of medical statistics]. Lijec Vjesn. 1983;105(11-12):488-90.
¹⁶
Yates FE. Contribution of statistics to ethics of science. Am J Physiol. 1983 ;244(1):R3-5.
¹⁷
Browner WS. Ethics, statistics, and technology assessment: the use of a stopping rule and an independent policy and data monitoring board in a cohort study of perioperative cardiac morbidity. The study of Perioperative Ischemia Research Group. Clin Res. 1991;39(1):7-12.
¹⁸
Royall RM, Bartlett RH, Cornell RG, Byar DP, Dupont WD, Levine RJ et al Ethics and statistics in randomized clinical trials. Stat Sci. 1991;6(1):52-88.
¹⁹
Anez MS, Canelon FM. [Research, publications, statistics and ethics]. G E N. 1992;46(4):328-30.
²⁰
Perel ML. Ethics and the three faces of statistics. Implant Dent. 1998;7(4):249-50.
²¹
DeMets DL. Statistics and ethics in medical research. Sci Eng Ethics. 1999 jan;5(1):97-117.
²²
Gasko R. [Discussion of the article by T. Haas "Ethics and statistics - difficult approaches to data"]. Cas Lek Cesk. 2000;139(19):607
²³
Haas T. [Ethics and statistics: difficult approaches to data]. Cas Lek Cesk. 2000;139(3):88-94.
²⁴
Upshur RE. The ethics of alpha: reflections on statistics, evidence and values in medicine. Theor Med Bioeth. 2001;22(6):565-76.
²⁵
Scheen AJ. Clinical study of the month. Premature interruption of ASCOT and CARDS clinical trials of cardiovascular prevention with atorvastatin in patients with arterial hypertension or diabetes mellitus: compromise between ethics and statistics in evidence-based medicine. Rev Med Liege. 2003;58(9):585-90.
²⁶
Cassel CK. Statistics and ethics: models for strengthening protection of human subjects in clinical research. Proc Natl Acad Sci U S A. 2009;106(52):22.037-8.
²⁷
Pitak-Arnnop P. Statistics or ethics? Decision to treat drooling. Arch Otolaryngol Head Neck Surg. 2010;136(3):315.
²⁸
Abhaya I. Basic of medical studies. In: Press C, editor. Medical biostatistics. 3ª ed. Londres: Chapman & Hall/CRC Biostatistics Series; 2013. p. 54-61.
²⁹
Conselho Nacional de Saúde. Resolução nº 466, de 12 de dezembro de 2012. Aprova as diretrizes e normas regulamentadoras de pesquisas envolvendo seres humanos. [Internet]. CNS; 2012 [acesso 20 out 2013]. Disponível: http://conselho.saude.gov.br/resolucoes/2012/Reso466.pdf
³⁰
Hochman B, Nahas FX, Oliveira Filho RS de, Ferreira LM. Desenhos de pesquisa. Acta Cir Bras. [Internet]. 2005[acesso nov 2014];20(Supl. 2):2-9. Disponível: http://dx.doi.org/10.1590/S0102-86502005000800002
³¹
Upton G, Cook I. Oxford dictionary of statistics. 2^nded. New York: Oxford University Press; 2006. Statistics; p. 408.
³²
Organização Mundial da Saúde. Divisão de Saúde Mental. Grupo WHOQOL no Brasil. WHOQOL - abreviado. In: Fleck MPA, coordenador. Instrumentos de avaliação da qualidade: versão em português. [Internet]. Porto Alegre: Universidade Federal do Rio Grande do Sul; 1998 [acesso 1º nov 2013]. Disponível: http://www.ufrgs.br/psiquiatria/psiq/breve.PDF
³³
Cassel CK. Statistics and ethics: models for strengthening protection of human subjects in clinical research. Proc Natl Acad Sci U S A. 2009;106(52):22.037-8.
³⁴
Gross J, Ligges U. Nortest: tests for normality version 1.0-2. [Internet]. 2012 [acesso 1º nov 2013]. Disponível: http://CRAN.R-project.org/package=nortest
³⁵
Gore SM, Jones IG, Rytter EC. Misuse of statistical methods: critical assessment of articles in BMJ from January to March 1976. Br Med J. 1977;1:85-7.
³⁶
Curran-Everett D, Taylor S, Kafadar K. Fundamental concepts in statistics: elucidation and illustration. Journal of Applied Physiology. 1998;85(3):775-86.
³⁷
Haas T. [Ethics and statistics: difficult approaches to data]. Cas Lek Cesk. 2000;139(3):88-94.
³⁸
Altman DG. The scandal of poor medical research. Br Med J. [Internet]. 1994 [acesso nov 2014];308(6.924):283-4. Disponível: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2539276/pdf/bmj00425-0005.pdf
³⁹
National Research Ethics Service. Health Research Authority. [Internet]. London: NHS/HRA; [acesso 15 ago 2014]. Disponível: http://www.nres.nhs.uk
⁴⁰
RECs in the News. 2009 jun;(57). Disponível: http://www.nres.nhs.uk/search/?q=statistics
⁴¹
Gandrud C. Reproducible research with R and RStudio. Boca Raton: CRC Press; 2014. p. 3-16.
⁴²
R Foundation for Statistical Computing. The R Project for Statistical Computing. [Internet]. Version 3.0.3. 6 mar 2014 [acesso 15 ago 2014]. Disponível: http://www.r-project.org
⁴³
RStudio Inc. RStudio. [Internet]. Boston: RStudio; 2014 [acesso 15 ago 2014]. Disponível: http://www.rstudio.com
» link
⁴⁴
LaTeX Project. LaTeX: a document preparation system. [Internet]. 2008 [acesso 15 ago 2014]. Disponível: http://www.latex-project.org
⁴⁵
Fireball D. Markdown. [Internet]. Version 1.0.1. 17 feb 2004 [acesso 15 ago 2014]. Disponível: http://daringfireball.net/projects/markdown
⁴⁶
Yihui Xie. Knitr: elegant, flexible and fast dynamic report generation with R. [Internet]. 2011 [acesso 15 ago 2014]. Disponível: http://yihui.name/knitr
⁴⁷
Levine DM, Stephan DF, Krehbiel TC, Berenson ML. Estatística: teoria e aplicações. Usando o Microsoft Excel em português. 6ª ed. Rio de Janeiro: Gen/LTC; 2012. p. 604.

Datas de Publicação

Publicação nesta coleção
05 Jan 2015
Data do Fascículo
Dez 2014

Histórico

Aceito
18 Out 2014
Revisado
18 Mar 2014
Recebido
19 Nov 2013

This work is licensed under a Creative Commons Attribution 4.0 International License.

[1] ¹
May WW. The composition and function of ethical committees. J Med Ethics. 1975 fev;1(1):23-9.

[2] ²
Altman DG. Statistics and ethics in medical research: VII-Interpreting results. Br Med J. 1980;281(6.255):1.612-4.

[3] ³
Altman DG. Statistics and ethics in medical research: VI-Presentation of results. Br Med J. 1980;281(6.254):1.542-4.

[4] ⁴
Altman DG. Statistics and ethics in medical research: V-Analysing data. Br Med J. 1980;281(6.253):1.473-5.

[5] ⁵
Altman DG. Statistics and ethics in medical research: collecting and screening data. Br Med J. 1980;281(6.252):1.399-401.

[6] ⁶
Altman DG. Statistics and ethics in medical research: III-How large a sample? Br Med J. 1980;281(6.251):1.336-8.

[7] ⁷
Altman DG. Statistics and ethics in medical research: study design. Br Med J. 1980;281(6.250):1.267-9.

[8] ⁸
Altman DG. Statistics and ethics in medical research: misuse of statistics is unethical. Br Med J. 1980;281(6.249):1.182-4.

[9] ⁹
Altman DG. Statistics and ethics in medical research: VIII-Improving the quality of statistics in medical journals. Br Med J (Clin Res Ed). 1981;282(6.257):44-7.

[10] ¹⁰
Gilbert JP, McPeek B, Mosteller F. Statistics and ethics in surgery and anesthesia. Science. 1977;198(4.318):684-9.

[11] ¹¹
Rathnam A. TAPVC vital statistics: ethics and moral values. Am Heart J. 1977;93(5):676.

[12] ¹²
Clarke MR. Statistics and ethics in medical research. Br Med J (Clin Res Ed). 1981;282(6.262):480.

[13] ¹³
Dobbing J. Statistics and ethics in medical research. Br Med J (Clin Res Ed). 1981;282(6.268):990.

[14] ¹⁴
Zander LI. The place of confinement: a question of statistics or ethics?. J Med Ethics. 1981;7(3):125-7.

[15] ¹⁵
Kulcar Z, Hrabak-Zerjavic V. [The ethics of medical statistics]. Lijec Vjesn. 1983;105(11-12):488-90.

[16] ¹⁶
Yates FE. Contribution of statistics to ethics of science. Am J Physiol. 1983 ;244(1):R3-5.

[17] ¹⁷
Browner WS. Ethics, statistics, and technology assessment: the use of a stopping rule and an independent policy and data monitoring board in a cohort study of perioperative cardiac morbidity. The study of Perioperative Ischemia Research Group. Clin Res. 1991;39(1):7-12.

[18] ¹⁸
Royall RM, Bartlett RH, Cornell RG, Byar DP, Dupont WD, Levine RJ et al Ethics and statistics in randomized clinical trials. Stat Sci. 1991;6(1):52-88.

[19] ¹⁹
Anez MS, Canelon FM. [Research, publications, statistics and ethics]. G E N. 1992;46(4):328-30.

[20] ²⁰
Perel ML. Ethics and the three faces of statistics. Implant Dent. 1998;7(4):249-50.

[21] ²¹
DeMets DL. Statistics and ethics in medical research. Sci Eng Ethics. 1999 jan;5(1):97-117.

[22] ²²
Gasko R. [Discussion of the article by T. Haas "Ethics and statistics - difficult approaches to data"]. Cas Lek Cesk. 2000;139(19):607

[23] ²³
Haas T. [Ethics and statistics: difficult approaches to data]. Cas Lek Cesk. 2000;139(3):88-94.

[24] ²⁴
Upshur RE. The ethics of alpha: reflections on statistics, evidence and values in medicine. Theor Med Bioeth. 2001;22(6):565-76.

[25] ²⁵
Scheen AJ. Clinical study of the month. Premature interruption of ASCOT and CARDS clinical trials of cardiovascular prevention with atorvastatin in patients with arterial hypertension or diabetes mellitus: compromise between ethics and statistics in evidence-based medicine. Rev Med Liege. 2003;58(9):585-90.

[26] ²⁶
Cassel CK. Statistics and ethics: models for strengthening protection of human subjects in clinical research. Proc Natl Acad Sci U S A. 2009;106(52):22.037-8.

[27] ²⁷
Pitak-Arnnop P. Statistics or ethics? Decision to treat drooling. Arch Otolaryngol Head Neck Surg. 2010;136(3):315.

[28] ²⁸
Abhaya I. Basic of medical studies. In: Press C, editor. Medical biostatistics. 3ª ed. Londres: Chapman & Hall/CRC Biostatistics Series; 2013. p. 54-61.

[29] ²⁹
Conselho Nacional de Saúde. Resolução nº 466, de 12 de dezembro de 2012. Aprova as diretrizes e normas regulamentadoras de pesquisas envolvendo seres humanos. [Internet]. CNS; 2012 [acesso 20 out 2013]. Disponível: http://conselho.saude.gov.br/resolucoes/2012/Reso466.pdf

[30] ³⁰
Hochman B, Nahas FX, Oliveira Filho RS de, Ferreira LM. Desenhos de pesquisa. Acta Cir Bras. [Internet]. 2005[acesso nov 2014];20(Supl. 2):2-9. Disponível: http://dx.doi.org/10.1590/S0102-86502005000800002

[31] ³¹
Upton G, Cook I. Oxford dictionary of statistics. 2^nded. New York: Oxford University Press; 2006. Statistics; p. 408.

[32] ³²
Organização Mundial da Saúde. Divisão de Saúde Mental. Grupo WHOQOL no Brasil. WHOQOL - abreviado. In: Fleck MPA, coordenador. Instrumentos de avaliação da qualidade: versão em português. [Internet]. Porto Alegre: Universidade Federal do Rio Grande do Sul; 1998 [acesso 1º nov 2013]. Disponível: http://www.ufrgs.br/psiquiatria/psiq/breve.PDF

[33] ³³
Cassel CK. Statistics and ethics: models for strengthening protection of human subjects in clinical research. Proc Natl Acad Sci U S A. 2009;106(52):22.037-8.

[34] ³⁴
Gross J, Ligges U. Nortest: tests for normality version 1.0-2. [Internet]. 2012 [acesso 1º nov 2013]. Disponível: http://CRAN.R-project.org/package=nortest

[35] ³⁵
Gore SM, Jones IG, Rytter EC. Misuse of statistical methods: critical assessment of articles in BMJ from January to March 1976. Br Med J. 1977;1:85-7.

[36] ³⁶
Curran-Everett D, Taylor S, Kafadar K. Fundamental concepts in statistics: elucidation and illustration. Journal of Applied Physiology. 1998;85(3):775-86.

[37] ³⁷
Haas T. [Ethics and statistics: difficult approaches to data]. Cas Lek Cesk. 2000;139(3):88-94.

[38] ³⁸
Altman DG. The scandal of poor medical research. Br Med J. [Internet]. 1994 [acesso nov 2014];308(6.924):283-4. Disponível: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2539276/pdf/bmj00425-0005.pdf

[39] ³⁹
National Research Ethics Service. Health Research Authority. [Internet]. London: NHS/HRA; [acesso 15 ago 2014]. Disponível: http://www.nres.nhs.uk

[40] ⁴⁰
RECs in the News. 2009 jun;(57). Disponível: http://www.nres.nhs.uk/search/?q=statistics

[41] ⁴¹
Gandrud C. Reproducible research with R and RStudio. Boca Raton: CRC Press; 2014. p. 3-16.

[42] ⁴²
R Foundation for Statistical Computing. The R Project for Statistical Computing. [Internet]. Version 3.0.3. 6 mar 2014 [acesso 15 ago 2014]. Disponível: http://www.r-project.org

[43] ⁴³
RStudio Inc. RStudio. [Internet]. Boston: RStudio; 2014 [acesso 15 ago 2014]. Disponível: http://www.rstudio.com
» link

[44] ⁴⁴
LaTeX Project. LaTeX: a document preparation system. [Internet]. 2008 [acesso 15 ago 2014]. Disponível: http://www.latex-project.org

[45] ⁴⁵
Fireball D. Markdown. [Internet]. Version 1.0.1. 17 feb 2004 [acesso 15 ago 2014]. Disponível: http://daringfireball.net/projects/markdown

[46] ⁴⁶
Yihui Xie. Knitr: elegant, flexible and fast dynamic report generation with R. [Internet]. 2011 [acesso 15 ago 2014]. Disponível: http://yihui.name/knitr

[47] ⁴⁷
Levine DM, Stephan DF, Krehbiel TC, Berenson ML. Estatística: teoria e aplicações. Usando o Microsoft Excel em português. 6ª ed. Rio de Janeiro: Gen/LTC; 2012. p. 604.

Brasil

Brasil

O papel do comitê de ética em pesquisa na avaliação de testes estatísticos

The role of the committee on ethics in research in the assessment of the ethical implications of the use of statistical tests

El papel del comité de ética en investigación en la evaluación de pruebas estadísticas

Resumos

Datas de Publicação

Histórico