Skip to main content

Challenges of Ethical Clearance in International Health Policy and Social Sciences Research: Experiences and Recommendations from a Multi-Country Research Programme

Abstract

Background: Research ethics review practices vary considerably across countries and this variability poses a challenge for international research programmes. Although published guidelines exist, which describe underlying principles that should be considered and pragmatic approaches that could be followed in seeking ethics approval, most have roots in biomedical and clinical research. The result is that there is generally less clarity around institutional and/or country-level structures for ethics review of health policy and social sciences research. This is an important gap that needs to be addressed in order to ensure ethical practices in multi-country research programmes.

Context and purpose: This paper explores research ethics requirements for a multicountry health policy research programme and provides recommendations based on experiences in seeking ethics approval. The context for this paper is a five-year, cross-country, European Commission-funded international programme: Research into Policy to enhance Physical Activity (REPOPA).

Results: Ethics requirements and review processes for health policy and social sciences research varied considerably across the seven REPOPA countries. Specifically, requirements and infrastructure for ethics approval have been influenced by how the purpose and domain of health research are defined in legislation, what types of research have been most prominently funded, and international requirements for ethics approval by external funders and journal editors.

Significance: Multi-country research programmes provide an opportunity to enhance and build transparent ethics review practices and to strengthen ethics review structures at all levels. Such programmes also enable reciprocal learning about relevant practices and processes for the ethical conduct of research.

References

  1. World Medical Association. WMA Declaration of Helsinki–ethical principles for medical research involving human subjects. WMA; 2008. Available from URL: http://www.wma.net/en/30publications/10policies/b3/ (Accessed 19 September 2012).

    Google Scholar 

  2. National Institutes of Health. Pursuing potential research participants protections: guiding principles for ethical research. NIH; 2012. Available from URL: http://www.nih.gov/health/clinicaltrials/highlights/2012–08-ethicalresearch. htm (Accessed 28 November 2012).

    Google Scholar 

  3. World Health Organization. Operational guidelines for ethics committees that review biomedical research. Geneva: WHO; 2000. Available from URL: http://www.who.int/tdr/publications/documents/ethics.pdf (Accessed 19 September 2012)

    Google Scholar 

  4. Council for International Organizations of Medical Sciences. International ethical guidelines for epidemiological studies. Am J Epidemiol. 2009;170: 1451–2.

    Article  Google Scholar 

  5. World Association of Medical Editors Publication Ethics Committee. Publication ethics policies for medical journals. WAME; 2012. Available from URL: http://www.wame.org/resources/ethics-resources/publication-ethics-policies-for-medical-journals/ (Accessed 19 September 2012).

    Google Scholar 

  6. Nuffield Council on Bioethics. Public health: ethical issues. London: Nuffield Council on Bioethics; 2007. Available from URL: http://www.nuffieldbioethics.org/sites/default/files/Public%20health%20-%20ethical%20issues.pdf (Accessed 19 September 2012).

    Google Scholar 

  7. Research into Policy to Enhance Physical Activity. REPOPA; 2011. Available from URL: www.repopa.eu (Accessed 19 September 2012).

    Google Scholar 

  8. European Commission. Getting through ethics review. CORDIS Community Research and Development Information Service. EC; updated 15 June 2011. Available from URL: http://cordis.europa.eu/fp7/ethics_en.html (Accessed 19 September 2012).

    Google Scholar 

  9. European Commission. The European charter for researchers. EC; 2005. Available from URL: http://ec.europa.eu/euraxess/index.cfm/rights/european Charter (Accessed 16 January 2013).

    Google Scholar 

  10. European Union. Charter of fundamental rights of the European Union. Official J Eur Communities. 2000;364:1–22.

    Google Scholar 

  11. Act on Research ethics Review of Health Research Projects. Denmark. 1 November 2012. Available from URL: http://www.cvk.sum.dk/English/actonabiomedicalresearch.aspx (Accessed 19 September 2012).

    Google Scholar 

  12. The Danish Data Protection Agency. Compiled version of the Act on Processing of Personal Data. Denmark. 31 May 2000, updated 10 May 2011. Available from URL: http://www.datatilsynet.dk/english/the-act-on-processing-of-personal-data/read-the-act-on-processing-of-personal-data/compiled-version-of-the- act-on-processing-of-personal-data/ (Accessed 19 September 2012).

    Google Scholar 

  13. Israel M, Hay I. Research Ethics for Social Scientists. Pine Forge Press; 2006. p.54.

    Google Scholar 

  14. National Advisory Board on Research Ethics. Ethical principles of research in the humanities and social and behavioural sciences and proposals for ethical review. Helsinki. 2009.

    Google Scholar 

  15. National Committee on Medical Research Ethics. Medical Research Act. Finland. 2010. Available from URL: http://www.finlex.fi/en/laki/kaannokset/1999/en19990488.pdf (Accessed 16 January 2013).

    Google Scholar 

  16. Personal Data Protection Act. Netherlands. Updated 15 December 2005. Available from URL: http://www.ivir.nl/legislation/nl/personaldataprotectionact.html (Accessed 16 January 2013).

    Google Scholar 

  17. Regulations on medical research involving human subjects (Medical Research (Human Subjects) Act. The Netherlands. 1 March 2006. Available from URL: http://www.ccmo-online.nl/hipe/uploads/downloads_catw/Medical%20 Research%20involving%20Human%20Subjects%20Act%20March%2001 %202006.pdf (Accessed 17 January 2013).

    Google Scholar 

  18. Central Committee on Research inv. Human Subjects. CCMO; 2004, updated September 2012. Available from URL: http://www.ccmo-online.nl/main.asp?pid=1&taal=1 (Accessed 26 September 2012).

    Google Scholar 

  19. National Ethics Code. Romania. Official Monitor. 4 June 2004. Available from URL: www.monitoruljuridic.ro/act/lege-nr-206-din-27-mai-2004-privind-buna-conduita-in-cercetarea-stiintifica-dezvoltarea-tehnologica-si-inovare-emitent- parlamentul-publicat-52457.html (Accessed 16 January 2013). [In Romanian]

    Google Scholar 

  20. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada. Tri-Council policy statement: ethical conduct for research involving humans. Her Majesty the Queen in Right of Canada; December 2010._Available from URL: http://www.pre.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf (Accessed 19 September 2012).

    Google Scholar 

  21. Claudot F, Alla F, Fresson J, Calvez T, Coudane H, Bonaïti-Pellié C. Ethics and observational studies in medical research: various rules in a common framework. Int J Epidemiol. 2009;38:1104–8.

    Article  PubMed  PubMed Central  Google Scholar 

  22. Greene SM, Geiger AM. A review finds that multicenter studies face substantial challenges but strategies exist to achieve Institutional Review Board approval. J Clin Epidemiol. 2006;59:784–90.

    Article  PubMed  Google Scholar 

  23. Cuttini M, Saracci R. Commentary: can we facilitate the ethical approval of international observational studies? Int J Epidemiol. 2009;38:1108–9.

    Article  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Nancy Edwards RN, PhD, FCAHS.

Rights and permissions

Open Access  This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made.

The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder.

To view a copy of this licence, visit https://creativecommons.org/licenses/by/4.0/.

The Creative Commons Public Domain Dedication waiver (https://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Reprints and permissions

About this article

Cite this article

Edwards, N., Viehbeck, S., Hämäläinen, RM. et al. Challenges of Ethical Clearance in International Health Policy and Social Sciences Research: Experiences and Recommendations from a Multi-Country Research Programme. Public Health Rev 34, 11 (2012). https://doi.org/10.1007/BF03391663

Download citation

  • Published:

  • DOI: https://doi.org/10.1007/BF03391663

Key Words