ETHICAL AND LEGAL ISSUES RELATED TO SECONDARY DATA USE IN RESEARCH: PROPOSITION OF A GUIDING MODEL FOR PLANNING, COLLECTING AND ANALYZING INFORMATION IN BRAZIL

Autores

Palavras-chave:

secondary data, legislation, health research.

Resumo

Technological advances have resulted in the collection, compilation, and archiving of enormous amounts of information, generating a vast database that can be easily accessible for different purposes around the world. Therefore, despite the potential use of secondary data for research, key issues make it difficult to exploit these resources. Furthermore, it is essential that researchers are aware of these challenges and the legal regulations that may exist on this topic. Thus, within this context, this paper conducts a review of the state of knowledge and documentary research to elucidate some interesting questions about the use of secondary data: What issues are being considered most important in the recent literature on the use of secondary data in research? How is this issue regulated in Brazil, and what are the main legislation and their implications for health research using secondary data?. What precautions should researchers take to ensure the ethical conduct of their work when using health data? Finally, as a result of this essential discussion, a framework is presented containing twenty-three recommendations for clinical investigators and ethics committees in human research, and which may be useful in all phases of research to ensure the ethical conduct of their work when using health data.

Downloads

Não há dados estatísticos.

Biografia do Autor

Leandro Silva Costa, IFRN

Formado em biologia (licenciatura e bacharelado) com mestrado e doutorado (em conclusão) em bioquímica. Atua também como pesquisador na área de ensino de ciências, desenvolvendo trabalhos de pesquisa na região do Trairí/RN.

Lenina Lopes Soares Silva, Federal Institute of Rio Grande do Norte (IFRN)

Graduated in Pedagogy at the Federal University of Rio Grande do Norte and in Social Sciences at the Lutheran University of Brazil, with Master's and Doctorate degrees in the Graduate Program in Social Sciences at the Federal University of Rio Grande do Norte. Leader of the Research Center in Education, Science, Technology, and Labor (Necttra/CNPq). Professor, advisor, and researcher in the Graduate Program in Professional Education and in the Graduation courses in Mathematics and Physics at IFRN. Researcher at the Observatory of Human Resources in Health at the Federal University of Rio Grande do Norte (Observatório RH-UFRN) of the ObservaRH Network in Brazil and academic member of the Brazilian Society of History of Medicine.

 

Lorena Antunes Silva, Federal University of Rio Grande do Norte (UFRN)

Technician in Computer Science at the Federal Institute of Education, Science and Technology of Rio Grande do Norte (2015-2018), in the integrated technical education modality. Fellow in the development of research projects at IFRN. Undergraduate student of Biological Sciences at the Federal University of Rio Grande do Norte.

PABLO CASTRO SANTOS, State University of Rio Grande do Norte (UERN)

Graduated in Biological Sciences from the Federal University of Rio Grande (UFRN). Master's and PhD in Biochemistry from the Graduate Program in Biochemistry at UFRN. Post-doctorate in Education from the Institute of Education at the University of Lisbon (ULisboa). Professor and researcher of the Dentistry Course of the Rio Grande do Norte State University (UERN) and of the Professional Master in Biology Teaching in the National Network (PROFBIO - UERN/UFMG). Member of the Research Ethics Committee of UERN and of the Brazilian Society of Bioethics (SBB).

 

Referências

Amorim, K. P. C. (2019). Ética em pesquisa no sistema CEP-CONEP brasileiro: reflexões necessárias. Ciencia & saude coletiva, 24(3), 1033–1040. https://doi.org/10.1590/1413-81232018243.35292016

Antommaria, A. H. M., Brothers, K. B., Myers, J. A., Feygin, Y. B., Aufox, S. A., Brilliant, M. H., Conway, P., Fullerton, S. M., Garrison, N. A.,

Horowitz, C. R., Jarvik, G. P., Li, R., Ludman, E. J., McCarty, C. A., McCormick, J. B., Mercaldo, N. D., Myers, M. F., Sanderson, S. C., Shrubsole, M. J., … Holm, I. A. (2018). Parents’ attitudes toward consent and data sharing in biobanks: A multisite experimental survey. AJOB Empirical Bioethics, 9(3), 128–142. https://doi.org/10.1080/23294515.2018.1505783

Azer, S. A. (2017). Social media channels in health care research and rising ethical issues. AMA Journal of Ethics, 19(11), 1061–1069. https://doi.org/10.1001/journalofethics.2017.19.11.peer1-1711

Ballantyne, A., & Schaefer, G. O. (2020). Public interest in health data research: laying out the conceptual groundwork. Journal of Medical Ethics, 46(9), 610–616. https://doi.org/10.1136/medethics-2020-106152

Brasil. (2018). Lei n. 13.709, de 14 de agosto de 2018. Lei Geral de Proteção de Dados Pessoais (LGPD). Brasília: Presidência da República, 2018. Disponível em: http://www.planalto.gov.br/ccivil_03/_ato2015-2018/2018/lei/l13709.htm.

Burton, P. R., Banner, N., Elliot, M. J., Knoppers, B. M., & Banks, J. (2017). Policies and strategies to facilitate secondary use of research data in the health sciences. International Journal of Epidemiology, 46(6), 1729–1733. https://doi.org/10.1093/ije/dyx195

Canaway, R., Boyle, D. I., Manski-Nankervis, J.-A. E., Bell, J., Hocking, J. S., Clarke, K., Clark, M., Gunn, J. M., & Emery, J. D. (2019). Gathering data for decisions: best practice use of primary care electronic records for research. The Medical Journal of Australia, 210 Suppl 6(S6), S12–S16. https://doi.org/10.5694/mja2.50026

Chico, V. (2018). The impact of the General Data Protection Regulation on health research. British Medical Bulletin, 128(1), 109–118. https://doi.org/10.1093/bmb/ldy038

Cole, A. P., & Trinh, Q.-D. (2017). Secondary data analysis: Techniques for comparing interventions and their limitations. Current Opinion in Urology, 27(4), 354–359. https://doi.org/10.1097/mou.0000000000000407

Cowie, M. R., Blomster, J. I., Curtis, L. H., Duclaux, S., Ford, I., Fritz, F., Goldman, S., Janmohamed, S., Kreuzer, J., Leenay, M., Michel, A., Ong, S., Pell, J. P., Southworth, M. R., Stough, W. G., Thoenes, M., Zannad, F., & Zalewski, A. (2017). Electronic health records to facilitate clinical research. Clinical Research in Cardiology: Official Journal of the German Cardiac Society, 106(1), 1–9. https://doi.org/10.1007/s00392-016-1025-6

Entzeridou, E., Markopoulou, E., & Mollaki, V. (2018). Public and physician’s expectations and ethical concerns about electronic health record: Benefits outweigh risks except for information security. International Journal of Medical Informatics, 110, 98–107. https://doi.org/10.1016/j.ijmedinf.2017.12.004

Fiume, M., Cupak, M., Keenan, S., Rambla, J., de la Torre, S., Dyke, S. O. M., Brookes, A. J., Carey, K., Lloyd, D., Goodhand, P., Haeussler, M., Baudis, M., Stockinger, H., Dolman, L., Lappalainen, I., Törnroos, J., Linden, M., Spalding, J. D., Ur-Rehman, S., … Scollen, S. (2019). Federated discovery and sharing of genomic data using Beacons. Nature Biotechnology, 37(4), 480. https://doi.org/10.1038/s41587-019-0094-2

Goodin, A., Delcher, C., Valenzuela, C., Wang, X., Zhu, Y., Roussos-Ross, D., & Brown, J. D. (2017). The power and pitfalls of big data research in obstetrics and gynecology: A consumer’s guide. Obstetrical & Gynecological Survey, 72(11), 669–682. https://doi.org/10.1097/OGX.0000000000000504

Hammack-Aviran, C. M., Brelsford, K. M., McKenna, K. C., Graham, R. D., Lampron, Z. M., & Beskow, L. M. (2020). Research use of electronic health records: Patients’ views on alternative approaches to permission. AJOB Empirical Bioethics, 11(3), 172–186. https://doi.org/10.1080/23294515.2020.1755383

Hemingway, H., Asselbergs, F. W., Danesh, J., Dobson, R., Maniadakis, N., Maggioni, A., van Thiel, G. J. M., Cronin, M., Brobert, G., Vardas, P., Anker, S. D., Grobbee, D. E., Denaxas, S., & Innovative Medicines Initiative 2nd programme, Big Data for Better Outcomes, BigData@Heart Consortium of 20 academic and industry partners including ESC. (2018). Big data from electronic health records for early and late translational cardiovascular research: challenges and potential. European Heart Journal, 39(16), 1481–1495. https://doi.org/10.1093/eurheartj/ehx487

Hicks, J. L., Althoff, T., Sosic, R., Kuhar, P., Bostjancic, B., King, A. C., Leskovec, J., & Delp, S. L. (2019). Best practices for analyzing large-scale health data from wearables and smartphone apps. Npj Digital Medicine, 2(1), 45. https://doi.org/10.1038/s41746-019-0121-1

Holm, S., & Ploug, T. (2017). Big Data and health research-the governance challenges in a mixed data economy. Journal of Bioethical Inquiry, 14(4), 515–525. https://doi.org/10.1007/s11673-017-9810-0

Hunter, R. F., Gough, A., O’Kane, N., McKeown, G., Fitzpatrick, A., Walker, T., McKinley, M., Lee, M., & Kee, F. (2018). Ethical issues in social media research for public health. American Journal of Public Health, 108(3), 343–348. https://doi.org/10.2105/AJPH.2017.304249

Hutchings, E., Loomes, M., Butow, P., & Boyle, F. M. (2020). A systematic literature review of researchers’ and healthcare professionals’ attitudes towards the secondary use and sharing of health administrative and clinical trial data. Systematic Reviews, 9(1), 240. https://doi.org/10.1186/s13643-020-01485-5

Jacquemard, T., Doherty, C. P., & Fitzsimons, M. B. (2021). The anatomy of electronic patient record ethics: a framework to guide design, development, implementation, and use. BMC Medical Ethics, 22(1), 9. https://doi.org/10.1186/s12910-021-00574-x

Kalkman, S., Mostert, M., Gerlinger, C., van Delden, J. J. M., & van Thiel, G. J. M. W. (2019). Responsible data sharing in international health research: a systematic review of principles and norms. BMC Medical Ethics, 20(1), 21. https://doi.org/10.1186/s12910-019-0359-9

Lousana G. (2019). A Lei Geral de Proteção de Dados e a pesquisa clínica [Internet]. Brasília, DF; 2019. https://maragabrilli.com.br/a-lei-geral-de-protecao-de-dados-e-a-pesquisa-clinica/

Madanian, S., Parry, D. T., Airehrour, D., & Cherrington, M. (2019). mHealth and big-data integration: promises for healthcare system in India. BMJ Health & Care Informatics, 26(1), e100071. https://doi.org/10.1136/bmjhci-2019-100071

Manchola, C. (2017). Tres apuestas por una bioética práctica. Revista Bioética, 25(2), 264–274. https://doi.org/10.1590/1983-80422017252186

Martins, V., Junqueira, M., & de Araujo, R. (2021). Ética da Pesquisa em Sistemas de Informação: Por que e como submeter meu projeto ao Comitê de Ética? In Tópicos Especiais em Sistemas de Informação: Minicursos SBSI 2021 (pp. 31–58). SBC.

Meneses-Oliveira, C. (2019). Uso dos Registos Clínicos Eletrónicos para Investigação: Novos Desafios Éticos e Soluções Possíveis. Acta medica portuguesa, 32(5), 332–334. https://doi.org/10.20344/amp.11280

Meystre, S. M., Lovis, C., Bürkle, T., Tognola, G., Budrionis, A., & Lehmann, C. U. (2017). Clinical data reuse or secondary use: Current status and potential future progress. Yearbook of Medical Informatics, 26(01), 38–52. https://doi.org/10.1055/s-0037-1606528

Mooney, S. J., & Pejaver, V. (2018). Big data in public health: Terminology, machine learning, and privacy. Annual Review of Public Health, 39(1), 95–112. https://doi.org/10.1146/annurev-publhealth-040617-014208

Mouton Dorey, C. (2016). Rethinking the ethical approach to health information management through narration: pertinence of Ricœur’s ‘little ethics.’ Medicine, Health Care, and Philosophy, 19(4), 531–543. https://doi.org/10.1007/s11019-016-9713-6

Nalbandian, A., Sehgal, K., Gupta, A., Madhavan, M. V., McGroder, C., Stevens, J. S., Cook, J. R., Nordvig, A. S., Shalev, D., Sehrawat, T. S., Ahluwalia, N., Bikdeli, B., Dietz, D., Der-Nigoghossian, C., Liyanage-Don, N., Rosner, G. F., Bernstein, E. J., Mohan, S., Beckley, A. A., … Wan, E. Y. (2021). Post-acute COVID-19 syndrome. Nature Medicine, 27(4), 601–615. https://doi.org/10.1038/s41591-021-01283-z

Neves, A. L., Poovendran, D., Freise, L., Ghafur, S., Flott, K., Darzi, A., & Mayer, E. K. (2019). Health care professionals’ perspectives on the secondary use of health records to improve quality and safety of care in England: Qualitative study. Journal of Medical Internet Research, 21(9), e14135. https://doi.org/10.2196/14135

Nunes, C. M. (Org.). (2019). Lei 13.709/18–lei geral de proteção de dados (LGPD) e os reflexos no campo da pesquisa clínica (Vol. 5, Número 2). Revista de Direito, Governança e Novas Tecnologias.

O’Brien, E. C., Rodriguez, A. M., Kum, H.-C., Schanberg, L. E., Fitz-Randolph, M., O’Brien, S. M., & Setoguchi, S. (2019). Patient perspectives on the linkage of health data for research: Insights from an online patient community questionnaire. International Journal of Medical Informatics, 127, 9–17. https://doi.org/10.1016/j.ijmedinf.2019.04.003

O’Keefe, C. M., & Connolly, C. J. (2010). Privacy and the use of health data for research. The Medical Journal of Australia, 193(9), 537–541. https://doi.org/10.5694/j.1326-5377.2010.tb04041.x

Ong, T. C., Kahn, M. G., Kwan, B. M., Yamashita, T., Brandt, E., Hosokawa, P., Uhrich, C., & Schilling, L. M. (2017). Dynamic-ETL: a hybrid approach for health data extraction, transformation and loading. BMC Medical Informatics and Decision Making, 17(1). https://doi.org/10.1186/s12911-017-0532-3

Pereira, PMF. (2019). Responsabilidade civil nos ensaios clínicos. Editora Foco. (Original work published 2019)

Ramos, E. M. B., Madureira, A. S., Sena, J. P., & Leal, P. do S. T. (2021). Questões éticas e perspectiva jurídica da proteção de dados. Cadernos Ibero-Americanos de Direito Sanitário, 10(3), 172–190. https://doi.org/10.17566/ciads.v10i3.796

Ranjan, Y., Rashid, Z., Stewart, C., Conde, P., Begale, M., Verbeeck, D., Boettcher, S., Hyve, Dobson, R., Folarin, A., & RADAR-CNS Consortium. (2019). RADAR-Base: Open source mobile health platform for collecting, monitoring, and analyzing data using sensors, wearables, and mobile devices. JMIR MHealth and UHealth, 7(8), e11734. https://doi.org/10.2196/11734

Riso, B., Tupasela, A., Vears, D. F., Felzmann, H., Cockbain, J., Loi, M., Kongsholm, N. C. H., Zullo, S., & Rakic, V. (2017). Ethical sharing of health data in online platforms – which values should be considered? Life Sciences, Society and Policy, 13(1). https://doi.org/10.1186/s40504-017-0060-z

Robertson, A. R. R., Nurmatov, U., Sood, H. S., Cresswell, K., Smith, P., & Sheikh, A. (2016). A systematic scoping review of the domains and innovations in secondary uses of digitised health-related data. Journal of Innovation in Health Informatics, 23(3), 611–619.

https://doi.org/10.14236/jhi.v23i3.841

Robinson, K. (2021). A false promise of COVID-19 “big” health data? Health data integrity and the ethics and realities of Australia’s health information management practice. Health Information Management : Journal of the Health Information Management Association of Australia, 50(1–2), 9–12. https://doi.org/10.1177/1833358320941190

Rumbold, J., & Pierscionek, B. (2018). Contextual anonymization for secondary use of big data in biomedical research: Proposal for an anonymization matrix. JMIR Medical Informatics, 6(4), e47. https://doi.org/10.2196/medinform.7096

Safran, C., Bloomrosen, M., Hammond, W. E., Labkoff, S., Markel-Fox, S., Tang, P. C., Detmer, D. E., & Expert Panel. (2007). Toward a national framework for the secondary use of health data: an American Medical Informatics Association White Paper. Journal of the American Medical Informatics Association: JAMIA, 14(1), 1–9. https://doi.org/10.1197/jamia.M2273

Sanderson, S. C., Brothers, K. B., Mercaldo, N. D., Clayton, E. W., Antommaria, A. H. M., Aufox, S. A., Brilliant, M. H., Campos, D., Carrell, D. S., Connolly, J., Conway, P., Fullerton, S. M., Garrison, N. A., Horowitz, C. R., Jarvik, G. P., Kaufman, D., Kitchner, T. E., Li, R., Ludman, E. J., … Holm, I. A. (2017). Public attitudes toward consent and data sharing in biobank research: A large multi-site experimental survey in the US. The American Journal of Human Genetics, 100(3), 414–427. https://doi.org/10.1016/j.ajhg.2017.01.021

Shahin, M. H., Bhattacharya, S., Silva, D., Kim, S., Burton, J., Podichetty, J., Romero, K., & Conrado, D. J. (2020). Open data revolution in clinical research: Opportunities and challenges. Clinical and Translational Science, 13(4), 665–674. https://doi.org/10.1111/cts.12756

Snäckerström, T., & Johansen, C. (2019). De-identified linkage of data across separate registers: a proposal for improved protection of personal information in registry-based clinical research. Upsala Journal of Medical Sciences, 124(1), 29–32. https://doi.org/10.1080/03009734.2018.1527420

Universal declaration on bioethics and human rights: UNESCO. (2005, December 16). Unesco.Org. http://portal.unesco.org/en/ev.phpURL_ID=31058&URL_DO=DO_TOPIC&URL_SECTION=201.html

United Nations Educational, Scientific and Cultural Organization (UNESCO). (2018). Records of the General Conference, 39th session, Paris, 30 October-14 November 2017, v. 1: Resolutions - UNESCO Digital Library. https://unesdoc.unesco.org/ark:/48223/pf0000260889.page=116

van Veen, E.-B. (2018). Observational health research in Europe: understanding the General Data Protection Regulation and underlying debate. European Journal of Cancer (Oxford, England: 1990), 104, 70–80. https://doi.org/10.1016/j.ejca.2018.09.032

Yoon, J., Drumright, L. N., & van der Schaar, M. (2020). Anonymization through data synthesis using generative adversarial networks (ADS-GAN). IEEE Journal of Biomedical and Health Informatics, 24(8), 2378–2388. https://doi.org/10.1109/JBHI.2020.2980262

Zhang, R., Simon, G., & Yu, F. (2017). Advancing Alzheimer’s research: A review of big data promises. International Journal of Medical Informatics, 106, 48–56. https://doi.org/10.1016/j.ijmedinf.2017.07.002

Downloads

Publicado

02/03/2022

Como Citar

Costa, L. S., Silva, L. L. S., Silva, L. A., & SANTOS, P. C. (2022). ETHICAL AND LEGAL ISSUES RELATED TO SECONDARY DATA USE IN RESEARCH: PROPOSITION OF A GUIDING MODEL FOR PLANNING, COLLECTING AND ANALYZING INFORMATION IN BRAZIL. HOLOS, 3. Recuperado de https://www2.ifrn.edu.br/ojs/index.php/HOLOS/article/view/13726

Edição

v. 3 (2022)

Seção

Dossier - Aspectos éticos en la investigación con seres humanos: avances y desafíos en América Latina

Licença

Copyright (c) 2022 HOLOS

Creative Commons License

Este trabalho está licenciado sob uma licença Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Artigos mais lidos pelo mesmo(s) autor(es)

Artigos Semelhantes

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 > >> 

Você também pode iniciar uma pesquisa avançada por similaridade para este artigo.