Legal Aspects and Ethical Considerations in the Disease Registry: A Scoping Review

Document Type : مقاله مروری نقلی

Authors
Leila Shahmoradi 1
Roya Naemi 2
1 Associate Professor, Health Information Management, Department of Health Information Management, School of Allied Medical Sciences, Tehran University of Medical Sciences, Tehran, Iran
2 PhD Student, Health Information Management, Department of Health Information Management, School of Allied Medical Sciences, Tehran University of Medical Sciences, Tehran AND Department of Health Information Management, School of Allied Medical Sciences, Ardebil University of Medical Sciences, Ardebil, Iran
10.22122/him.v16i2.3813
Abstract
Collecting accurate data in registries enables the governments to prevent dangerous diseases. However, concerns regarding disclosure have increased due to government involvement. The purpose of the present study was to investigate the legal and ethical aspects of the disease registry including the key elements of confidentiality in disease registry, privacy impact assessment, actions to preserve confidentiality, data ownership, and the consent of participants. This was a scoping review, collecting information through a search in Scopus, PubMed, Web of Science, and Google Scholar databases without time limitation. The findings declare that people's sureness in the confidentiality of information increases the information offered to the registry, and consequently, analysis of this information will improve people's health. Therefore, it is necessary to develop requirements for the use, analysis, sharing, and protection of registry data.

Keywords

  1. Krent HJ, Gingo N, Kapp M, Moran R, Neal M, Paulas M, et al. Whose business is your pancreas? Potential privacy problems in New York City's mandatory diabetes registry. Ann Health Law 2008; 17(1): 1-37.
  2. Asher AL, McGirt MJ, Glassman SD, Groman R, Resnick DK, Mehrlich M, et al. Regulatory considerations for prospective patient care registries: Lessons learned from the National Neurosurgery Quality and Outcomes Database. Neurosurg Focus 2013; 34(1): E5.
  3. Nerenz DR. Ethical issues in using data from quality management programs. Eur Spine J 2009; 18(Suppl 3): 321-30.
  4. McCabe LL, McCabe ER. Down syndrome: Issues to consider in a national registry, research database and biobank. Mol Genet Metab 2011; 104(1-2): 10-2.
  5. Hopper L, Hughes S, Burke T, Irving K. A National dementia registry for Ireland: A feasibility analysis. Proceedings of SPHeRE Network 3rd Annual Conference; 2017 Jan 12; Dublin, Ireland.
  6. Gliklich RE, Dreyer NA, Leavy MB. Registries for evaluating patient outcomes: A user's guide. 3rd ed. Rockville, MD: Agency for Healthcare Research and Quality (US); 2014.
  7. Di Iorio CT, Carinci F, Azzopardi J, Baglioni V, Beck P, Cunningham S, et al. Privacy impact assessment in the design of transnational public health information systems: The BIRO project. J Med Ethics 2009; 35(12): 753-61.
  8. Zaletel M, Kralj M. Methodological guidelines and recommendations for efficient and rational governance of patient registries. Ljubljana, Slovenia: National Institute of Public Health; 2015.
  9. Levesque E, Leclerc D, Puymirat J, Knoppers B. Developing registries of volunteers: Key principles to manage issues regarding personal information protection. J Med Ethics 2010; 36(11): 712-4.
  10. European Network of Cancer Registries Working Group on Confidentiality. Guidelines on confidentiality and ethics for population-based cancer registration and linked activities in Europe (Version 3). European Network of Cancer Registries, International Agency for Research on Cancer, May 2011 [Online]. [cited 2018]; Available from: URL: https://www.encr.eu/sites/default/files/pdf/ENCR_Eurocouse_GuidelinesConfidentialityEthics.pdf
  11. Saracci R, Olsen J, Seniori-Costantini A, West R. Epidemiology and the planned new Data Protection Directive of the European Union: A symposium report. Public Health 2012; 126(3): 253-5.
  12. Johnston M, Campbell C, Godlovitch G, Day L, Wysocki J, Dagenais L, et al. Online neurological registries. Can J Neurol Sci 2013; 40(4 Suppl 2): S41-S45.
  13. Ludvigsson JF, Haberg SE, Knudsen GP, Lafolie P, Zoega H, Sarkkola C, et al. Ethical aspects of registry-based research in the Nordic countries. Clin Epidemiol 2015; 7: 491-508.
  14. Rare Disease Task Force. Patient Registries in the Field of Rare Diseases, Apr 2009 Update Jun 2011 [Online]. [Cited 2018]; Available from: URL: https://congenitalhi.org/wp-content/uploads/2017/12/RareDiseaseTaskForce_patient-registries-in-the-field-of-rare-diseases-2011.pdf
  15. Richesson RL, Vehik K. Patient registries. In: Richesson RL, Andrews JE, editors. Clinical research informatics. London, UK: Springer London; 2012. p. 233-52.
  16. Myers J, Frieden TR, Bherwani KM, Henning KJ. Ethics in public health research: privacy and public health at risk: Public health confidentiality in the digital age. Am J Public Health 2008; 98(5): 793-801.
  17. Kass NE. An ethics framework for public health. Am J Public Health 2001; 91(11): 1776-82.