Patients’ roles and rights in research: Where is Africa?
We welcome the editorial by Wicks et al on patients’ roles and rights in research (Wicks, Richards, & Godlee, 2018) and agree entirely that patients in low-income countries are particularly sidelined. In Africa, the challenges are far greater due to the large educational and societal gap between researchers and patients. Thus, city-based foreign or local university-educated researchers may be studying an issue affecting those who have never attended school and whose life experience is completely different from that of the research team. This can lead to well-meaning but misplaced research questions, unsuitable consent processes, or protocol and outcomes that are inappropriate for the local context.
There is an ongoing important mismatch between patients, clinicians and research communities (Crowe, Fenton, Hall, Cowan, & Chalmers, 2015). In women’s health, for example, Western researchers and funders working in sub-Saharan Africa have concentrated on maternal mortality and largely neglected the blight of infertility. Many rural women, however, consider infertility to be the more pressing problem due to its high prevalence and the dire social consequences in which it causes marriage breakdown, social stigma, and psychological distress. Their voice, however, is rarely heard.
Similarly, the patient information sheets (PIS) used as part of the informed consent process are based on those designed by Western ethics committees and rarely have patient input. This results in long and complex forms full of legal jargon which, far from providing clear information, can hide important information (Grady, 2015; Khalique Qc, 2015). This is akin to the ‘small print’ information used by banks and computer companies which is rarely read before signing or clicking ‘I agree’. In this situation, the public would be better served by independent advisors highlighting the key, controversial sections in a short summary.
Patient involvement is also critical in selecting clinical study outcomes. In rural settings where women commonly have haemoglobins of 60 or 70 g/l, the use of Hb < 90g/l or blood loss over 500mls and an outcome in studies of postpartum haemorrhage correlates very poorly with the effect on key home activities that are so important for women in rural settings.
Our ongoing project on public involvement in women’s health clinical trials in Uganda assesses recent PIS using linguistic readability scores. We are also working with the James Lind Alliance (Cowan & Oliver, 2013) to develop a context-specific approach to understanding the important research questions with women and the public in Uganda. We are also designing appropriate ways of delivering research information to women in these settings. Our preliminary study findings suggest that women fare better with short and pictorial information on a flip chart compared to the standard 6-7 pages of participant information, but we are running a randomised trial to demonstrate this. We would welcome the chance to work with the BMJ in progressing this important topic in Africa.
Cowan, K., & Oliver, S. (2013). James Lind Alliance Guidebook (Version 5). (James Lind Alliance, Ed.). Southampton: James Lind Alliance. Retrieved from www.jla.nihr.ac.uk
Crowe, S., Fenton, M., Hall, M., Cowan, K., & Chalmers, I. (2015). Patients’, clinicians’ and the research communities’ priorities for treatment research: there is an important mismatch. Research Involvement and Engagement, 1(1), 2. https://doi.org/10.1186/s40900-015-0003-x
Grady, C. (2015). Enduring and Emerging Challenges of Informed Consent. New England Journal of Medicine, 372(9). https://doi.org/10.1056/NEJMra1411250
Khalique Qc, N. (2015). Informed consent: The dawning of a new era. British Journal of Oral and Maxillofacial Surgery, 53(6), 479–484. https://doi.org/10.1016/j.bjoms.2015.04.014
Wicks, P., Richards, T., & Godlee, F. (2018). Patients ’ roles and rights in research. BMJ, 3193(July), 1–2. https://doi.org/10.1136/bmj.k3193
Competing interests: No competing interests