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Avoiding Gender Exploitation and Ethics Dumping in Research with Women

Published online by Cambridge University Press:  02 June 2020

JULIE COOK
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Abstract

There is a long history of women being underrepresented in biomedical and health research. Specific women’s health needs have been, and in some cases still are, comparatively neglected areas of study. Concerns about the health and social impacts of such bias and exclusion have resulted in inclusion policies from governments, research funders, and the scientific establishment since the 1990s. Contemporary understandings of foregrounding sex and gender issues within biomedical research range from women’s rights to inclusion, to links between human rights, women’s health and sustainable development, and the increasing scientific and funding expectation for studies to consider the sex (biological) and gender (cultural) implications of research design, results and impact. However, there are also exploitation issues to consider when foregrounding the inclusion of women as research participants, especially for research ethics committees and institutional review boards. A hidden risk is that exploitative research designs and practices may be missed, particularly by reviewers who may not have a nuanced understanding of gender-based harm. Utilizing contemporary case studies of ethics dumping, this paper highlights some of the concerns, and makes recommendations for IRBs/research ethics reviewers to help ensure that essential research is undertaken to the highest ethical standards.

Keywords

Ethics DumpingInstitutional Review BoardsGender biasWomen’s health
Type
Departments and Columns
Information
Cambridge Quarterly of Healthcare Ethics , Volume 29 , Issue 3 , July 2020 , pp. 470 - 479
Copyright
© Cambridge University Press 2020

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References

Notes

1. European Commission & Stanford University. Research & Innovation Science With And For Society. Gendered Innovations in Science, Health & Medicine, Engineering, and Environment. Policy Timeline; available at http://ec.europa.eu/research/swafs/gendered-innovations/index_en.cfm?page=index.html (last accessed 6 Feb 2020).

2. Adamson, GD, Kennedy, S, Hummelshoj, L. Creating solutions in endometriosis: global collaboration through the world endometriosis research foundation. Journal of Endometriosis and Pelvic Pain Disorders 2010; 2(1):3–6Google Scholar.

3. Mazure, CM, Jones, DP. Twenty years and still counting: Including women as participants and studying sex and gender in biomedical research. BMC Women’s Health 2015; 15(94):1–16CrossRefGoogle ScholarPubMed.

4. Liu, KA, Dipietro Mager NA. Women’s involvement in clinical trials: Historical perspective and future implications. Pharmacy Practice 2016. 14(1):708CrossRefGoogle Scholar.

5. See note 4, Liu, Dipietro Mager 2016, 1–2.

6. See for example, Institute of Medicine Board on Health Sciences Policy Committee on Understanding the Biology of Sex and Gender Differences. In: Wizemann, TM, Pardue, MHL, eds. Exploring the biological contributions to human health: Does sex matter? Washington, DC: Institute of Medicine; 2001Google Scholar.

7. Moss, NE. Gender equity and socioeconomic inequality: A framework for the patterning of women's health. Social Science & Medicine 2002;54(5):649–61CrossRefGoogle ScholarPubMed.

8. See note 1, European Commission & Stanford University.

9. See note 1, European Commission & Stanford University.

10. UN Women. Fourth World Conference on Women 1995; available at http://www.un.org/womenwatch/daw/beijing/platform/ (last accessed 6 Feb 2020).

11. Desai M. Hope in hard times: Women’s empowerment and human development. Human Development Research Paper, 14 2010. UNDP; available at http://hdr.undp.org/sites/default/files/hdrp_2010_14.pdf (last accessed 6 Feb 2020).

12. UN Sustainable Development Goals Knowledge Platform. Gender Equality and Women’s Empowerment; available at https://sustainabledevelopment.un.org/topics/genderequalityandwomensempowerment (last accessed 6 Feb 2020).

13. United Nations Environment Programme. Convention on Biodiversity. 1992; available at https://www.cbd.int/convention/ (last accessed 6 Feb 2020).

14. See for example, Braidotti, R, Charkiewicz, E, Hausler, S, Wieringa, S. Women, the Environment and Sustainable Development, Towards a Theoretical Synthesis. London: Zed Books; 1994Google Scholar.

15. See note 12, UN Sustainable Development Goals Knowledge Platform.

16. Guideline 18, Individuals in hierarchical relationships, In: Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for Health-related Research Involving Humans, 4th ed. Geneva: ;2016: 57; available at https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf (last accessed 6 Feb 2020).

17. “Women’s sexual and reproductive health is related to multiple human rights, including the right to life, the right to be free from torture, the right to health, the right to privacy, the right to education and the prohibition of discrimination.” United Nations Office of the High Commissioner on Human Rights. Women’s Rights are Human Rights 2014; available at http://www.ohchr.org/Documents/Events/WHRD/WomenRightsAreHR.pdf (last accessed 6 Feb 2020).

18. Baptiste, D, Kapungu, C, Khare, MH, Lewis, Y, Barlow-Mosha, L.Integrating women's human rights into global health research: An action framework. Journal of Women’s Health 2010;19(11):2091–9CrossRefGoogle Scholar.

19. See note 12, UN Sustainable Development Goals Knowledge Platform.

20. See note 3, Mazure, Jones 2015.

21. See note 4, Liu, Dipietro Mager 2016.

22. For example, the United States National Institutes of Health (NIH) 2015 funding guideline. Its core element is the classification of sex as a biological variable, taking the potentially relevant sex/gender related anatomical and physiological characteristics into account, as a key element of rigorous study design. National Institutes of Health Office of Extramural Research. Consideration of Sex as a Biological Variable in NIH-funded Research. Notice Number: NOT-OD-15-102: June 9, 2015; available at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-102.html (last accessed 6 Feb 2020).

23. Drake, C, Gahagan, J. Working “upstream”: why we shouldn’t use heterosexual women as health promotion change agents in HIV-prevention interventions aimed at heterosexual men. Health Care for Women International 2015;36:11:1270–89CrossRefGoogle ScholarPubMed.

24. European Commission. Horizon 2020. Ethics; available at https://ec.europa.eu/programmes/horizon2020/en/h2020-section/ethics (last accessed 6 Feb 2020).

25. Schroeder, D, Cook, J, Hirsch, F, Fenet, S, Muthuswamy, V. Introduction, In: Schroeder, D, Cook, J, Hirsch, F, Fenet, S, Muthuswamy, V, eds. Ethics Dumping – Case Studies from North-South Research Collaborations. New York, NY: Springer Open; 2018:2CrossRefGoogle Scholar.

26. World Medical Association. Declaration Of Helsinki – Ethical Principles For Medical Research Involving Human Subjects 2013; available at https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ (last accessed 6 Feb 2020).

27. See note 16, CIOMS 2016.

28. For example, The TRUST Project. The Global Code of Conduct for Research in Resource-Poor Settings 2018; available at http://www.globalcodeofconduct.org/ (last accessed 6 Feb 2020).

29. Schroeder, D, Cook, J, Hirsch, F, Fenet, S, Muthuswamy, V, eds. Ethics Dumping: Case Studies from North-South Research Collaborations. New York, NY: Springer Open; 2018CrossRefGoogle Scholar; available at https://www.springer.com/gb/book/9783319647302 (last accessed 6 Feb 2020).

30. van Niekerk, J, Wynberg, R. Human food trial of a transgenic fruit. In: Schroeder, D, Cook, J, Hirsch, F, Fenet, S, Muthuswamy, V, eds. Ethics Dumping – Case Studies from North-South Research Collaborations. New York, NY: Springer Open; 2018: 91–8CrossRefGoogle Scholar.

31. Food security is the condition in which all people, at all times, have physical, social and economic access to sufficient safe and nutritious food that meets their dietary needs and food preferences for an active and healthy life. See http://www.fao.org/cfs/home/about/en/ (last accessed 6 Feb 2020).

32. Food sovereignty is asserted by advocacy groups as right of peoples to healthy and culturally appropriate food produced through ecologically sound and sustainable methods, and their right to define their own food and agriculture systems. See https://en.wikipedia.org/wiki/Food_sovereignty (last accessed 6 Feb 2020).

33. Community Alliance for Global Justice. Agra Watch Press Release. Over 57,000 Express Concern with Human Feeding Trials of GMO Bananas. Seattle: February 11, 2016; available at https://cagj.org/2016/02/agra-watch-press-release-over-57000-express-concern-with-human-feeding-trials-of-gmo-bananas/ (last accessed 6 Feb 2020).

34. Li, S, Nugroho, A, Li, S, Rocheford, T, White, WS. Vitamin A equivalence of the β-carotene in β-carotene–biofortified maize porridge consumed by women. The American Journal of Clinical Nutrition 2010;92(5):1105–12CrossRefGoogle ScholarPubMed.

35. Lewis T. A group of scientists plans to pay young women $900 to eat genetically modified bananas. Business Insider 2016 Feb 23; available at http://uk.businessinsider.com/scientsts-are-paying-people-to-eat-gmo-bananas-2016-2?r=US&IR=T (last accessed 6 Feb 2020).

36. Leys T. ISU still plans GMO banana trial, despite controversy. Des Moines Register 2016 Feb 17; available at http://www.desmoinesregister.com/story/news/health/2016/02/17/isu-still-plans-gmo-banana-trial-despite-controversy/80507378/ (last accessed 6 Feb 2020).

37. Banana 21; available at http://www.banana21.org/about.html (last accessed 6 Feb 2020).

38. World Health Organization. Micronutrient deficiencies: Vitamin A deficiency; available at http://www.who.int/nutrition/topics/vad/en/ (last accessed 6 Feb 2020).

39. Macklin, R. Double Standards in Research in Developing Countries. Cambridge: Cambridge University Press; 2004CrossRefGoogle Scholar.

40. See note 16, CIOMS 2016.

41. Bompart, F. Healthy volunteers for clinical trials in resource-poor settings: national registries can address ethical and safety concerns. Cambridge Quarterly of Healthcare Ethics 2019;28(1):134–43CrossRefGoogle Scholar.

42. Leentjens, AFG, Levenson, JL. Ethical issues concerning the recruitment of university students as research subjects. Journal of Psychosomatic Research 2013;75(4):394–8CrossRefGoogle ScholarPubMed.

43. Joint Economic Committee, United States Congress, April 2016; available at https://www.jec.senate.gov/public/_cache/files/0779dc2f-4a4e-4386-b847-9ae919735acc/gender-pay-inequality----us-congress-joint-economic-committee.pdf (last accessed 6 Feb 2020).

44. Srinivasan, S, Johari, V, Jesani, A. Cervical Cancer Screening in India. In Schroeder, D, Cook, J, Hirsch, F, Fenet, S, Muthuswamy, V, eds. Ethics Dumping – Case Studies from North-South Research Collaborations. New York, NY: Springer Open; 2018:33–47CrossRefGoogle Scholar.

45. Suba, EJ, Ortega, RE, Mutch, DG. Unethical US government-funded cervical screening study in India: US freedom of information act disclosures. The Journal of Healthcare, Science and the Humanities 2018;(8)2:57–77Google Scholar

46. Bayer, R. The debate over maternal-fetal HIV transmission prevention trials in Africa, Asia, and the Caribbean: racist exploitation or exploitation of racism? American Journal of Public Health 1998;88(4):567–70CrossRefGoogle ScholarPubMed.

47. Angell, M. The ethics of clinical research in the third world. New England Journal of Medicine 1997;337(12): 847–9CrossRefGoogle ScholarPubMed.

48. See note 16, CIOMS 2016, guideline 15, regarding poverty and group vulnerability.

49. UN Committee on the Elimination of Discrimination against Women (CEDAW); available at https://sustainabledevelopment.un.org/index.php?page=view&type=30022&nr=108&menu=3170 (last accessed 6 Feb 2020).

50. Schroeder, D, Gefenas, E. Vulnerability – too vague and too broad?. Cambridge Quarterly of Healthcare Ethics 2009;18(2):113–21CrossRefGoogle ScholarPubMed.

51. Alverez-Castillo, F, Cook Lucas, J, Cordillera Castillo, R. Gender and vulnerable populations in benefit sharing: an exploration of conceptual and contextual points. Cambridge Quarterly of Healthcare Ethics 2009;18(2):130–7, at 132Google Scholar.

52. See note 16, CIOMS 2016, Guideline 15, regarding vulnerability and contextual factors such as lack of access to medical care.

53. See note 16, CIOMS 2016. For example CIOMS Guideline 18 refers to how in some settings, women may be exploited in research through some level of coercion to take part (lack of truly informed consent), become socially vulnerable when participating in research due to their subordinate social position, or put at heightened social, physical, or legal risk when participating.

54. See note 44, Bayer 1998.