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Human dignity as a basis for providing post-trial access to healthcare for research participants: a South African perspective

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Abstract

This paper discusses the need to focus on the dignity of human participants as a legal and ethical basis for providing post-trial access to healthcare. Debate about post-trial benefits has mostly focused on access to products or interventions proven to be effective in clinical trials. However, such access may be modelled on a broad fair benefits framework that emphasises both collateral benefits and interventional products of research, instead of prescribed post-trial access alone (Legal and ethical regulation of biomedical research in developing countries p. 134, 2016). The wording of the current version of the Declaration of Helsinki could in fact be interpreted to broaden the scope to include other collateral benefits by applying such a broad fair benefits framework. We argue that this possibility should be utilised by low and middle income countries’ (LMICs) health research ethics committees (RECs) in order to ensure that research participants who enrol in clinical trials so as to receive medical care continue to access care after the trial is concluded, as befits their dignity. Although each LMIC has unique concerns, nonetheless there are common challenges based especially on emerging issues, such as post-trial access to healthcare. Accordingly, the South African perspective is used to draw lessons that can benefit other LMICs.

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Notes

  1. S 73 of the National Health Act no.61 of 2003.

  2. Quoted in Wemos report, 2013 p. 12.

  3. The revision introduced paragraph 30 stating that “at the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study.”

  4. Adopted by the 64th World Medical Association General Assembly, Fortaleza, Brazil, October 2013.

  5. The Brazilian National Health Council. Resolution 251/1997, Article IV.1, cited in Wang & Ferraz 2012.

  6. Brazil, Federal Constitution Article 196 provides that “Health is a right of all and a duty of the State.”

  7. Participants of the 2001 Conference on Ethical Aspects of Research in Developing Countries.

  8. Quoted in Wemos Foundation 2013, p. 30.

  9. Universal Declaration of Human Rights (UDHR), G.A. Res. 217 A (III) (1948). Available at http://www.un.org/en/documents/udhr/.

  10. UNESCO, Universal Declaration on the Human Genome and Human Rights, 1997, Arts 1 and 2. Available at http://portal.unesco.org/en/ev.php-URL_ID=13177&URL_DO=DO_TOPIC&URL_SECTION=201.html.

  11. HIV/AIDS Clinical Trial Participant, Kenya 2006, quoted in Colona and Schipper (2015, p. 1).

  12. General Principles, para 9.9.2 vii.

  13. General Principles, para 9.9.1.3.

  14. General Principles, para 9.9.1.1.

  15. See also s 4b of the National Health Act.

  16. Commentaries on Guidelines 2 and 4, respectively.

  17. The Constitution of South Africa, ss 1 (a) and 10.

  18. Para. 1.2.

  19. Para. 8.1.

  20. No. R. 719, issued in terms of Sect. 71 read with Sect. 90(1) of the National Health Act on 19 September 2014.

  21. National Department of Health, Audit of health research ethics committees project, final report, (September 2012).

  22. s 72 (6) (b).

  23. Guiding principle 2.1.

  24. Guiding principle 4.7.

  25. Para 3.1.8.

  26. Para 3.2.

  27. Emphasis added.

  28. No. R. 719, issued in terms of Sect. 71 read with Sect. 90(1) of the National Health Act on 19 September 2014.

  29. Para 3.1.7.

  30. Principle 2.13.

  31. Professor M Tikly, quoted in the Wemos Foundation 2013, p. 31.

  32. Para 3.1.4.

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Acknowledgements

We would like to thank Naana Halm for her research assistance during the preparation of this manuscript.

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  1. School of Law, University of the Witwatersrand, Johannesburg, South Africa

    Pamela Andanda & Jane Wathuta

  2. University of the Witwatersrand, Private Bag 3, WITS, Johannesburg, 2050, South Africa

    Pamela Andanda

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Andanda, P., Wathuta, J. Human dignity as a basis for providing post-trial access to healthcare for research participants: a South African perspective. Med Health Care and Philos 21, 139–155 (2018). https://doi.org/10.1007/s11019-017-9782-1

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