BEYOND PROCEDURAL ETHICS IN RESEARCH GOVERNANCE

Over the past decade, I have been involved in bioethics teaching, particularly through research ethics workshops conducted across Pakistan. During this time, I have become increasingly uncomfortable with the trends shaping global health research in the country.

Ethical review processes, as they have evolved over the decades, centre on procedural compliance. These tend to ensure that informed consent documents are adequate, that confidentiality safeguards are in place, and that the potential benefits of research are weighed against possible harms. Research is often justified in the name of the social value of research or for the greater good.

However, in practice, the “greater good” often never materializes. Across decades of health research in Pakistan, there appears to be a recurring pattern in the types of studies conducted: repeated trials in similar communities, addressing similar conditions, often with marginal variation. These include randomized placebo-controlled trials assessing the effectiveness of micronutrients for malnutrition, large-scale surveys on immunization coverage and its barriers. Increasingly, technological interventions are tested, promising cost-effective solutions to complex, structural problems such as the management of non-communicable diseases in disadvantaged populations.

I have increasingly grappled with the realisation that such research remains morally problematic. I find myself uneasy when granting ethical approval to studies that promise “more robust data,” despite knowing that in the past such data has rarely translated into meaningful health policy. These studies adhere to checklists and meet all ethical requirements: consent processes are sound, conflicts of interest are minimal, and minimum harm is promised to participants.

However, such processes often overlook a substantial harm being created: the erosion of trust in the research enterprise, once regarded as a public good. This harm also includes loss of dignity experienced by participants whose repeated involvement yields little tangible benefit for themselves or their communities in the foreseeable future. More worrisome is the gradual loss of moral sensitivity among researchers, for whom participants risk becoming mere data points.

Critiques of research ethics as overly procedural are not new. Governance mechanisms such as Institutional Review Boards and Data Safety and Monitoring Boards have long relied on rule-based compliance. While such compliance is necessary, it alone remains insufficient. As Tom Koch argues in Thieves of Virtue (2012), IRBs have become “compliant partners in the research enterprise” (p. 244).¹

However, moving beyond procedural ethics requires acknowledging our complicity in reproducing these structural harms, and confronting more difficult questions. Why is a new study being conducted when similar data already exists? Investigators often justify this by pointing to the absence of data in a newer location, or the outdated nature of previous studies. Yet many social determinants of health, such as barriers to immunization, are slow to change, raising questions about the marginal value of repeated inquiry.

In a country where malnutrition is rampant, leading to widespread stunting among children, where the poor health of the mother will naturally translate into poor health of the newborn child, it is irrelevant to test the effectiveness of a new micronutrient. It is of little or no value to test how nutritional outcomes may be improved through modification of ingredients in a chapati. Such research approaches risk obscuring economic and social determinants of health.

During a workshop, a participant shared an incident that has stayed with me. Researchers had approached a community to explore how its members understood health and what improvement would mean in their context. At the door, one resident responded bluntly: “If you want to improve the health of our children, provide us with running water.” This remark was not rhetorical. Families in that area, living near a highway, had lost children, who were forced to cross a dangerous road daily to fetch water.

Researchers may respond to this by arguing that it is not their responsibility to improve socioeconomic determinants of health. But under such abject circumstances, one can, and ought to, question how research, no matter how methodologically sound or procedurally compliant it is, can meaningfully benefit communities or their future generations.

The real challenge, then, is not merely to refine ethical procedures, although that too holds considerable importance. It is to confront the substantive, more uncomfortable, largely ignored ethical question that lies beneath: should such studies be conducted at all?

Reference:

1. Koch T. Thieves of virtue: when bioethics stole medicine. Mit Press; 2014 Aug 29.