Ethical Dimensions of Public Health Actions and Research: Need for Guidelines in Indian Context

INTRODUCTION

The term “ethics” originates from the Greek word “ethos,” which can refer to custom, tradition, personality, or disposition. While ethical principles in healthcare trace back to the era of Hippocrates, the field of “bioethics” only emerged after World War II. The traditional focus of bioethics has been on individual choices and rights. Recently, there have been initiatives to expand ethical analysis in healthcare to address public health issues more explicitly. Public health encompasses a wide range of activities and professional disciplines, such as sanitation, health protection and promotion, epidemiology, surveillance, and clinical care. Given its population-based focus, public health continually faces dilemmas concerning the appropriate extent of its reach and at what point the work of public health professionals is infringing on individual liberties in ethically troublesome ways. Protecting an individual’s rights to privacy, confidentiality, and autonomy may conflict with the community’s right to safeguard itself against health threats and may involve prioritization of principles of beneficence and justice over autonomy. Therefore, Public Health Ethics relates to the dual obligations of protecting and restoring public health while respecting individual autonomy.

PUBLIC HEALTH ETHICS

There is a significant need to develop specific guiding principles and frameworks based on general ethical considerations for public health policy and practice. This involves defining these principles, understanding their scope, and establishing criteria for resolving conflicts. A review of the literature reveals the existence of many propositions but there is lacunae of such efforts in the Indian context.¹

The Centers for Disease Control (CDC) in the US defines public health ethics: “As a field of study, public health ethics seeks to understand and clarify principles and values which guide public health actions. Principles and values provide a framework for decision-making and a means of justifying decisions. As a field of practice, public health ethics is the application of relevant principles and values to public health decision-making. Public health ethics inquiry carries out three core functions:

1. Identifying and clarifying the ethical dilemma posed

2. Analyzing it in terms of alternative courses of action and their consequences

3. Resolving the dilemma by deciding which course of action best incorporates and balances the guiding principles and values (CDC).”²

ETHICAL FRAMEWORK FOR PUBLIC HEALTH POLICIES AND PRACTICE

Public health measures often raise complex questions about not only the responsibilities of the government policymakers that they have toward the individuals and organizations who are influenced by the policies but also about the responsibilities individuals have toward one another. Who will help us to lead a healthy life? Who should guide us in managing our diet and alcohol intake, staying physically active, getting immunized, and protecting ourselves and our children from disease? It becomes imperative for the Government to answer these questions, but a significant debate in public health ethics is whether and to what extent the so-called “precautionary principle” imposed by the Government public health policies (e.g., COVID vaccination and mandatory wearing of masks) should be followed and how much the benefits outweigh the risks.

Utilitarianism, liberalism, and communitarianism are philosophical views invoked in public health discourse, while issues such as effectiveness, proportionality, necessity, least infringement, and public justification are necessary for decision-making regarding the implementation of public health interventions.

Public health practices such as notification, contact tracing, surveillance, isolation, and quarantine frequently pose ethical dilemmas. Upholding the principle of individual autonomy becomes especially challenging during these activities, particularly when addressing stigmatized diseases such as tuberculosis, human immunodeficiency virus, sexually transmitted infections, leprosy, and mental health conditions. All these issues point to the fact that there is an imminent need to devise frameworks for ethical review of public health programs in the Indian setting, which will equip public health professionals with skills to make informed decisions by weighing the risks versus benefits of public health programs, and additionally mechanisms such as advisory committees to critically review policies and implementation guidelines from an ethical viewpoint before implementing them at the district or peripheral level.

Several such frameworks are present in the literature review, notable among them being Kass, who proposed a comprehensive Framework of Public Health in the United States comprising six essential questions for decision-making concerning the balance of risks and benefits in public health programs.³ This is an analytic tool designed to help public health professionals consider the ethical implications of proposed interventions, policy proposals, research initiatives, and programs. Six questions are as follows:

1. What are the public health goals of the proposed program?

2. How effective is the program in achieving its stated goals?

3. What are the known or potential burdens of the program?

4. Can burdens be minimized? Are there alternative approaches?

5. Is the program implemented fairly?

6. How can the benefits and burdens of a program be fairly balanced?

Evaluating alternatives using this public health ethics framework should yield an ethically acceptable option, though it might not align with the politically preferred choice at a particular time. However, the unpredictable nature of politics does not justify neglecting ethical analysis when discussing a public health proposal. A similar framework was proposed for public health and human rights by Gostin and Lazzarini.⁴ The European Framework on Public Policies, Law, and Bioethics (2006) provides important guidance for creating and implementing public health policies and programs across the European Union.⁵ The Nuffield Council on Bioethics framework (2007) addresses public health ethics issues for a diverse range of stakeholders, including policymakers in government, industry, organizations, and individuals. This framework introduces two analytical tools to aid decision-making. The first tool, the “Stewardship Model,” defines acceptable goals and restrictions for public health policy [Box 1], aiming to achieve desired health outcomes while minimizing restrictions on individual freedom. It also highlights the importance of consent and the care of vulnerable populations.⁶ The second tool, the “Intervention Ladder,” classifies public health policies based on their degree of invasiveness regarding individual choices [Box 2]. This ladder illustrates the “stronger justification” required for an intervention or program as it becomes more intrusive to individual choices.⁶ The “Principles of the Ethical Practice of Public Health” (2002), established by the Public Health Leadership Society and later adopted by the American Public Health Association, provides a code of ethics for public health institutions.⁷

Recalling the COVID-19 management advisories issued by the Government of India, which, although well-intentioned, faced significant criticism from various sectors of society, it is imperative that India develops its own Code of Public Health Ethics. Such a code would not only provide a framework for addressing issues and principles in public health disagreements but also establish standards of accountability and guide practitioners in reviewing public health policies and programs before implementation.

PUBLIC HEALTH RESEARCH ETHICS

In public health, research typically occurs outside the controlled environment, in real-world settings in a particular social, political, and economic context, which necessitates additional ethical considerations. Research involving public health interventions or research conducted during public emergencies, such as natural disasters and disease outbreaks, has unique ethical challenges. Furthermore, in public health research, an understanding or familiarity with the community in which the research will be done is essential for the ethical conduct of research. The distinction between community consent and community consultation while conducting cluster randomized trials, when and how should individual-level data, including incidental and secondary findings, be communicated to research participants, ethical challenges of handling big data, and handling breaches of confidentiality in qualitative research are some more sensitive issues that require informed reasoning skills. Shrinking budgets for public health activities have led many health departments to explore alternative approaches to financing public health research, leading to questions about what constitutes an appropriate partnership and to concerns about real or perceived conflicts of interest. For example, should the government collaborate with vaccine manufacturers to research the potential adverse effects of a vaccine?

Hence, specific guidelines for careful examination of ethical principles and values applicable to public health research would help to clarify thinking and, ultimately, lead to more effective and just conduction of scientific research in public health. Although the existing “National Ethical Guidelines for Biomedical and Health Research Involving Human Participants” formulated by ICMR address primarily the ethical concerns in epidemiological research on public health, nonetheless, the development of comprehensive ethical guidelines in different domains of public health research, such as research on big data, qualitative research including participatory actions research, operations research, research during disasters, and implementation research ethics is the need of the hour.⁸

WAY FORWARD

Much work needs to be done in the Indian setting to develop robust and comprehensive ethical guidelines in different domains of public health, inclusive of research and practice. In other words, there is the imminent necessity of formulation of the Indian “Code of Public Health Ethics” in line with other such codes existing in countries like the United States, the United Kingdom, and Canada.^7,9,10 By adhering to these ethical guidelines, public health institutions can ensure that their actions are driven by community involvement, informed decision-making based on evidence, and a dedication to honoring the values and needs of diverse populations.

Furthermore, it is crucial to create awareness and enhance the ethical reasoning of public health professionals regarding public health programs. In-service training can effectively achieve this goal. Training programs that use a case-based approach, in which professionals engage in stimulating discussions about common ethical challenges, can greatly enhance their capacity building and improve ethical decision-making skills in public health practice. Implementing structured ethics education on different public health research designs with dedicated modules and credits should be integral to public health education at the postgraduate level. This is in line with the latest Postgraduate Medical Regulations (2023) issued by the National Medical Commission, which has made training on ethics in research mandatory during the postgraduate period.¹¹ The training of public health professionals in ethics is thus essential to ensure that they feel more confident in handling the wide array of ethical conflicts, be it in public health actions or research.