Expanding the horizon of ethical research: Strengthening Institutional Review Board capacity in the global South

Sir,

I read with interest the editorial ‘From compliance to conscience: Working with the Institutional Review Board’ detailing the pivotal role of Institutional Review Boards (IRBs). ¹ The authors eloquently reframe IRBs not as adversarial bureaucratic obstacles, but as essential guardians of scientific and moral integrity. As a member of the Institutional Ethics Committee (IEC) at my institution, I strongly agree with the assertion that a well-functioning IEC/IRB is a researcher's best ally.

An Ethics Committee (EC) should be an independent body composed of members with expertise in both scientific and non-scientific arenas that functions to ensure the protection of human rights and the well-being of research subjects, based on six basic principles: autonomy, justice, beneficence, non-maleficence, confidentiality, and honesty. ²

The ‘Nuremberg Code’ was one of the first international ethical standards to set out ten principles for the protection of human research participants. Its core principles were the requirement of voluntary consent from human subjects and respect for human autonomy. ³

The Declaration of Helsinki, adopted by the World Medical Association in Finland in 1964 and revised at regular intervals, affirmed the principles highlighted in the Nuremberg Code, stating that research should be conducted in a manner that upholds the interests and rights of human subjects. For the first time, it was proposed that a research protocol be submitted to an ethics committee before the study begins. ⁴

The description of 12 core goals provides a comprehensive roadmap for ethical oversight. However, I wish to expand upon a critical theme, briefly raised in the editorial: the surge of context-specific clinical research emerging from the Global South, and the unique, practical challenges faced by IRBs in Low- and Middle-Income Countries (LMICs).

With a population of 1.4 billion, India requires clinical research relevant to its healthcare needs to build evidence that drives policy. In India, the requirement for an EC to oversee clinical research was first established in the Indian Council of Medical Research (ICMR) Policy Statement on Ethics, published in 1980. ⁵

As the editorial notes, local health priorities and frugal innovations are increasingly driving research in the Global South. This decentralisation of biomedical research represents a welcome democratisation of science. Yet, the moral architecture described, viz. respect for persons, beneficence, and justice, must be supported by a robust administrative infrastructure. In many LMICs, IRBs are severely under-resourced. They frequently operate with limited financial support, lack access to dedicated digital review platforms, and rely heavily on volunteer members who are already burdened with immense clinical and academic responsibilities.

Often, the IEC/IRB is blamed for interfering with the scientific content of a proposal, rather than focusing simply on ethical considerations. Consequently, the perception of the IRB as a ‘slow, overly cautious’ gatekeeper is sometimes an unfortunate byproduct of systemic capacity constraints rather than a lack of ethical commitment.

To fulfil Goal 11, that is, improving efficiency without diluting rigour, there must be a concerted global effort to invest in the physical and administrative infrastructure of ethics committees in resource-limited settings.

The editorial rightly mentions children, prisoners, and those with impaired decision-making capacity as vulnerable groups (Goal 7). However, in many LMICs, vulnerability is heavily compounded by extreme poverty, low health literacy, language barriers, and limited access to baseline healthcare. In these contexts, the line between an ethical incentive and undue inducement can become dangerously blurred. When clinical trial participation is a marginalised patient's only reliable access to a physician or basic therapeutics, the principle of true voluntariness is inherently challenged.

As rightly mentioned by the authors, every act of deception or negligence, however small, erodes confidence not only in a single study but in medical science itself. IRBs in these regions require specialised, ongoing training (Goal 8) to navigate these complex socio-economic realities and ensure that the principle of justice is actively upheld. International grant-making bodies and multinational sponsors should allocate specific funding streams to support the operational budgets and continuous education of local IRBs. Additionally, fostering regional ethics networks and mutual recognition agreements can help streamline multi-centre reviews, thereby fulfilling the mandate for cost-effectiveness while preserving rigorous, localised oversight.

In conclusion, I commend the authors for the timely and profound reminder of the moral imperatives guiding clinical research. For the IRB truly to transcend its role as a bureaucratic hurdle and become a vital partner in the Global South, we must recognise that ethical oversight requires sustained investment. Only by empowering these committees with the necessary resources and training can we ensure that the legacy of the Belmont Report continues to protect participants, build public trust, and elevate medical science worldwide.