Exploiting Vulnerability: The Ethical and Legal Implications of Clinical Trials on Impoverished Populations

Paper Details 

Paper Code: RP-VBCL-39-2025

Category: Research Paper

Date of Publication: April 20, 2025

Citation: Mr. Sridhar Babu R, “Exploiting Vulnerability: The Ethical and Legal Implications of Clinical Trials on Impoverished Populations", 2, AIJVBCL, 567, 567-587 (2025).

Author Details: Mr. Sridhar Babu R, Research Scholar, School of Law, Ramaiah University of Applied Science, Bengaluru

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ABSTRACT

This article critically examines the intersection of clinical trials and poverty, focusing on how multinational corporations (MNCs) exploit vulnerable populations in low- and middle-income countries (LMICs) for pharmaceutical research. While clinical trials are crucial for medical advancements, ethical concerns arise when participants from impoverished backgrounds are enrolled under coercive conditions or inadequate regulatory oversight. The historical context, including cases like the Tuskegee Syphilis Study (1932–1972) and Pfizer’s Trovan trials in Nigeria (1996), underscores the longstanding ethical challenges in human experimentation. In India, regulatory frameworks have evolved from the Drugs and Cosmetics Act, 1940, to the New Drugs and Clinical Trials (NDCT) Rules, 2019, yet concerns persist regarding weak enforcement, inconsistent ethics committees, and transparency issues in trial reporting. This article explores key factors leading to exploitation, including economic coercion, where financial incentives compromise voluntary consent; lack of education, which hinders participants’ understanding of the risks, and social pressures, which compel enrollment due to community influence. Furthermore, the role of ethics dumping, where research that would not be approved in developed countries is conducted in LMICs, highlights a critical regulatory gap. The paper also examines how NGOs, whistleblowers, and the media play a vital role in exposing unethical practices and advocating for stronger safeguards. To address these issues, the article proposes actionable reforms, such as third-party consent verification, stricter penalties for non-compliance, and greater transparency through public disclosure of trial protocols. The conclusion emphasizes the urgent need for a unified global regulatory framework to harmonize ethical standards and protect human rights in clinical research. Achieving this balance is imperative to ensure that scientific progress does not come at the expense of the dignity and welfare of the most vulnerable populations.

Keywords: Clinical Trials, Ethical Standards, Vulnerable Populations, Regulatory Oversight, Multinational Corporations.

INTRODUCTION

Clinical trials play a pivotal role in advancing medical science, offering the foundation for evaluating the safety and efficacy of novel treatments. However, while these trials are essential for scientific progress, they often raise profound ethical dilemmas, particularly when conducted in low- and middle-income countries (LMICs) where poverty and systemic vulnerabilities heighten the risk of exploitation. The dual imperative of fostering innovation while safeguarding human rights creates a complex ethical landscape that demands rigorous scrutiny.

Historically, unethical clinical research practices have left an indelible mark on the medical community. One of the most notorious examples is the Tuskegee Syphilis Study (1932–1972), wherein African American men were deliberately left untreated to study the natural progression of syphilis, despite the availability of penicillin as an effective cure. This egregious violation of human rights not only resulted in preventable deaths but also eroded trust in medical institutions, particularly among marginalized communities.[1] Similarly, the Nazi medical experiments during World War II led to the formulation of the Nuremberg Code (1947), a foundational document establishing the principle of voluntary, informed consent in human experimentation.[2]

In the modern era, the globalization of clinical research has intensified these ethical challenges. Multinational pharmaceutical corporations increasingly conduct trials in LMICs, drawn by lower operational costs, diverse populations, and regulatory frameworks that may lack the stringent oversight present in high-income countries. This phenomenon, often referred to as “ethics dumping”, involves exporting research practices that may be deemed unethical or non-compliant in the researchers' home countries to jurisdictions with weaker protections.

India has become a focal point in this global dynamic. Its vast population and comparatively lower clinical trial costs have positioned it as a hub for pharmaceutical research. However, this surge in clinical trials has not been without controversy. Vulnerable populations—particularly those living below the poverty line—are frequently recruited without fully comprehending the implications of participation. Financial incentives, often viewed as lifelines by economically disadvantaged participants, blur the line between voluntary participation and economic coercion. Reports have highlighted that participants are sometimes inadequately informed about potential risks, raising significant concerns about the legitimacy of the informed consent process.

The Journal of the American Medical Association (2009) reported that economically disadvantaged individuals are disproportionately enrolled in clinical trials, with questions arising about the voluntariness of their consent and the potential for coercion in the absence of robust regulatory oversight. In India, regulatory frameworks like the New Drugs and Clinical Trials (NDCT) Rules, 2019 have attempted to address these issues, but challenges persist, particularly concerning enforcement, transparency, and the consistency of ethics committee oversight.[3]

This article aims to critically analyze the intersection of clinical trials and poverty, with a focus on both global and Indian contexts. By examining historical precedents, current regulatory frameworks, and case studies, the article seeks to highlight systemic vulnerabilities and propose actionable reforms. The ultimate objective is to ensure that the pursuit of medical innovation does not come at the expense of the dignity, rights, and welfare of the most vulnerable populations.

HISTORICAL CONTEXT OF CLINICAL TRIALS AND ETHICAL VIOLATIONS

The evolution of clinical trials is deeply intertwined with ethical violations that have shaped modern research frameworks. These historical incidents underscore the importance of ethical vigilance and regulatory oversight in protecting human subjects, particularly vulnerable populations. Both global milestones and India’s regulatory evolution reflect how past abuses have informed contemporary ethical standards.

a) Global Milestones

i) Tuskegee Syphilis Study (1932–1972)

The Tuskegee Syphilis Study, conducted by the U.S. Public Health Service, is one of the most infamous cases of unethical research. The study aimed to observe the natural progression of untreated syphilis in African American men under the false pretense of providing free medical care. Participants were deliberately misled—they were neither informed of their diagnosis nor provided with penicillin, even after it became the standard treatment in 1947.[4]

The study continued for 40 years, resulting in preventable deaths, long-term health complications, and the spread of syphilis to family members. This egregious breach of medical ethics ultimately led to public outrage and the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1974, which played a key role in shaping ethical guidelines like the Belmont Report.[5]

ii) Nazi Experiments and the Nuremberg Code (1947):

During World War II, Nazi physicians conducted inhumane medical experiments on concentration camp prisoners without their consent. These experiments included forced sterilizations, exposure to extreme conditions, and testing unproven drugs, resulting in death and severe suffering. The subsequent Nuremberg Trials brought global attention to these atrocities, leading to the formulation of the Nuremberg Code in 1947. This code established ten foundational principles for human experimentation, most notably the requirement of voluntary informed consent, the necessity to avoid unnecessary suffering, and the right for participants to withdraw from studies at any time.[6]

iii) Declaration of Helsinki (1964):

Building on the principles of the Nuremberg Code, the World Medical Association adopted the Declaration of Helsinki in 1964 to provide comprehensive ethical guidelines for medical research involving human subjects. Unlike the Nuremberg Code, which was primarily focused on protecting subjects from harm, the Declaration emphasized the need for independent ethical review boards to oversee research protocols, ensuring that the well-being of participants is prioritized over scientific or societal interests. The Declaration also introduced the principle that research results should be made publicly available to promote transparency and prevent the suppression of unfavorable findings. Despite these advancements, the Declaration has undergone multiple revisions to address emerging ethical dilemmas, particularly in multinational trials where disparities in regulatory frameworks persist.[7]

b) India's Evolution

i) Drugs and Cosmetics Act, 1940:

India's regulatory journey began with the Drugs and Cosmetics Act of 1940, aimed at controlling the import, manufacture, distribution, and sale of drugs and cosmetics. This act marked the first legislative effort to ensure the safety and efficacy of pharmaceutical products in India. However, its provisions for clinical trials were rudimentary and lacked robust mechanisms for protecting human subjects, particularly in the context of informed consent and ethical oversight.[8]

ii) Transition from Schedule Y to the New Drugs and Clinical Trials (NDCT) Rules, 2019:

Schedule Y of the Drugs and Cosmetics Rules, 1945, introduced detailed requirements for conducting clinical trials in India, including the need for Ethics Committee approvals and defined protocols for obtaining informed consent. However, inconsistencies in enforcement and ethical oversight led to widespread criticism, particularly in cases involving vulnerable populations.

In response to growing concerns over unethical practices, the New Drugs and Clinical Trials (NDCT) Rules were introduced in 2019, replacing Schedule Y. The NDCT Rules provide more comprehensive guidelines on the conduct of clinical trials, emphasizing transparency, ethical accountability, and participant protection. Notably, the rules mandate the registration of Ethics Committees, outline detailed procedures for informed consent, and establish frameworks for compensating participants in cases of trial-related injuries or deaths. Despite these reforms, challenges persist, particularly regarding the uniform implementation of these rules across India’s diverse regions.[9]

POVERTY AND CLINICAL TRIALS: THE EXPLOITATION OF VULNERABILITY

Poverty plays a critical role in shaping systemic vulnerabilities that expose individuals to potential exploitation in clinical trials. Economic desperation, limited educational opportunities, and social pressures intersect to create environments where informed consent may not be genuinely voluntary. This section delves into how these factors compromise the ethical integrity of clinical research, particularly in low- and middle-income countries (LMICs) like India.

a) Economic Coercion

The principle of voluntary participation is a cornerstone of ethical clinical research, enshrined in documents like the Declaration of Helsinki and the Belmont Report. However, when financial incentives are offered to individuals living below the poverty line, the voluntariness of their consent becomes questionable. The line between compensation for time and undue inducement is often blurred, particularly when participation in a clinical trial represents a rare or sole source of income for economically disadvantaged individuals.

A study published in the Journal of Medical Ethics revealed that 65% of respondents believed participants are coerced when financial offers compel them to participate in research they would otherwise avoid. Additionally, 82% agreed that monetary compensation could make individuals feel they have no reasonable alternative but to enroll in trials, especially in regions where employment opportunities are scarce.[10]

b) Lack of Education and Awareness

Informed consent is a foundational ethical requirement in clinical trials, ensuring that participants fully understand the nature, risks, and benefits of the research before agreeing to participate. However, illiteracy and low health literacy present significant barriers to obtaining genuine informed consent, particularly in LMICs.[11]

In rural areas, these challenges are more pronounced, with studies showing that a significant proportion of participants possess low health literacy levels.[12]

This lack of understanding can lead to misconceptions about the nature of the research, the associated risks, and the voluntariness of participation. Consequently, individuals may consent to participate without fully comprehending the implications, thereby compromising the ethical integrity of the informed consent process.

c) Social and Cultural Pressures

Community dynamics, especially in rural settings, can significantly influence individuals' decisions to participate in clinical trials. Social hierarchies, cultural norms, and communal expectations may pressure individuals into participation, even when they are hesitant. For instance, in some communities, there is an inherent trust in medical professionals and authorities, leading individuals to consent to participation without question.

Additionally, the desire to conform to community expectations or the fear of social ostracism can compel individuals to enroll in studies against their better judgment. These social and cultural pressures further complicate the ethical landscape of clinical research, as they may undermine participants' autonomy and the voluntariness of their consent.

THE ROLE OF MNCS IN CLINICAL TRIALS: ETHICAL OUTSOURCING OR EXPLOITATION?

Multinational corporations (MNCs) have increasingly conducted clinical trials in low—and middle-income countries (LMICs), driven by various motivations that raise ethical considerations. This section examines the factors influencing this trend, focusing on cost reduction, regulatory environments, ethics dumping, and the tension between profit motives and human rights.

a) Cost Reduction and Regulatory Loopholes

MNCs often prefer conducting clinical trials in countries such as India, Nigeria, and Brazil due to significant cost advantages and more lenient regulatory frameworks. The lower operational costs in these regions, including reduced expenses for participant recruitment and site management, make them attractive destinations for clinical research. Additionally, the regulatory environments in many LMICs may lack the stringent oversight present in developed nations, allowing for expedited trial processes. For instance, a study highlighted that barriers to conducting clinical trials in developing countries include ethical and regulatory system obstacles, such as delays in approval decisions and unskilled authorities, which can be exploited by MNCs to expedite trials.[13]

A comparison between regulatory frameworks reveals disparities that MNCs might exploit. Developed countries typically have rigorous ethical guidelines and regulatory bodies that enforce strict compliance, leading to longer approval times and higher costs. In contrast, some developing nations may have less comprehensive regulations, limited enforcement capabilities, and a lack of resources to monitor trials effectively. This regulatory leniency can result in faster trial approvals and reduced scrutiny, making these countries appealing for MNCs aiming to minimize expenses and accelerate drug development timelines.

b) Ethics Dumping

The term "ethics dumping" refers to the practice of conducting research in LMICs that would be ethically unacceptable or subject to stricter regulations in the researchers' home countries. This often involves exploiting weaker ethical oversight and regulatory frameworks in host countries. A publication in BMC Medical Ethics defines ethics dumping as the export of unethical research practices from higher-income to lower-income settings, highlighting the intentional or unintentional disregard for ethical standards in vulnerable populations.[14]

An illustrative case is the 1996 Pfizer Trovan trial in Nigeria, where the company tested an experimental antibiotic during a meningitis epidemic without proper informed consent from participants. The trial led to legal actions and widespread criticism, underscoring the ethical breaches that can occur when conducting research in settings with inadequate regulatory oversight.

c) The Profit Motive vs. Human Rights

The pursuit of profit by MNCs can sometimes overshadow ethical considerations, particularly when conducting trials in vulnerable populations. The drive to reduce costs and expedite drug development may lead to compromises in participant welfare and ethical standards. A publication in EMBO Reports discusses the ethical concerns arising from conducting clinical trials in LMICs, emphasizing the need to balance economic interests with the protection of human rights.[15]

Furthermore, the lack of stringent regulatory oversight in some LMICs can result in inadequate protection for trial participants, raising concerns about exploitation and the violation of human rights. MNCs must adhere to international ethical standards and ensure that the rights and welfare of participants are prioritized over financial gains.

REGULATORY LOOPHOLES: INDIA AND THE GLOBAL CONTEXT

The integrity of clinical trials is paramount to ensuring ethical standards and participant safety. However, regulatory weaknesses can lead to the exploitation of vulnerable populations. This section examines such regulatory gaps within India and in the global context.

a) India’s Regulatory Gaps

India's regulatory framework for clinical trials has evolved, notably with the introduction of the New Drugs and Clinical Trials (NDCT) Rules in 2019. Despite these advancements, several challenges persist:

i) Weak Enforcement of NDCT Rules, 2019:

While the NDCT Rules were established to enhance clinical trial oversight, enforcement remains inconsistent. A review highlighted that issues around payment of compensation in cases of clinical trial-related injury, disability, and death have long remained open, indicating gaps in the effective implementation of these rules.[16]

ii) Inconsistent Functioning of Ethics Committees Across Regions:

Ethics Committees (ECs) are pivotal in safeguarding participant rights. However, their performance varies significantly across India. A study noted major changes affecting ECs after the implementation of the NDCT Rules, emphasizing the need for uniformity in their operations.[17]

iii) Lack of Transparency in Reporting Trial Results:

Transparency is crucial for public trust in clinical research. The NDCT Rules mandate the registration of clinical trials and the disclosure of results. However, compliance is sporadic, leading to concerns about selective reporting and the suppression of unfavorable outcomes. This opacity undermines the ethical foundation of clinical research.

b) Global Regulatory Issues

On the international stage, regulatory bodies face challenges in overseeing clinical trials conducted beyond their jurisdictions:

i) FDA’s Limited Oversight on Foreign Trials Submitted for Drug Approval in the U.S.:

The U.S. Food and Drug Administration (FDA) accepts data from foreign clinical studies not conducted under an Investigational New Drug (IND) application, provided they adhere to Good Clinical Practice (GCP) standards. However, the FDA acknowledges challenges in verifying data integrity and participant protection in these foreign trials, given limited direct oversight.[18]

ii) Challenges Faced by the European Medicines Agency (EMA) in Ensuring Ethical Standards in Outsourced Trials:

The EMA relies on data from global trials for drug approvals within the European Union. Ensuring that these trials meet ethical standards poses significant challenges, especially when conducted in countries with varying regulatory frameworks. The EMA emphasizes the importance of GCP compliance but faces hurdles in monitoring and enforcing these standards uniformly across diverse regions.

 CASE STUDIES AND LEGAL PRECEDENTS

Examining case studies and legal precedents provides critical insights into the exploitation of impoverished populations in clinical trials. This section delves into notable instances within India and internationally, highlighting the ethical breaches and regulatory challenges that have arisen.

a) Indian Cases

i) Swasthya Adhikar Manch v. Union of India (2013): Addressing Unethical Trials and Regulatory Failures

In 2012, the non-governmental organization Swasthya Adhikar Manch filed a Public Interest Litigation (PIL) in the Supreme Court of India, alleging widespread unethical practices in clinical trials. The petition highlighted instances where vulnerable groups, including children, the mentally challenged, tribals, and Dalits, were subjected to trials without proper informed consent. The Supreme Court's intervention led to a temporary halt on new clinical trials until a more robust regulatory framework was established. This case underscored significant deficiencies in the oversight of clinical research in India.[19]

ii) Bhopal Gas Tragedy (1984): Corporate Negligence and Its Impact on Vulnerable Populations

Although not a clinical trial, the Bhopal Gas Tragedy remains a poignant example of corporate negligence affecting impoverished communities. In December 1984, a gas leak at the Union Carbide pesticide plant in Bhopal exposed over 500,000 people to methyl isocyanate gas. The immediate death toll was estimated at 2,259, with subsequent deaths and chronic health issues affecting thousands more. The disaster highlighted the vulnerability of low-income populations to corporate malfeasance and the long-term struggles for justice and adequate compensation.[20]

b) International Cases

i) Pfizer’s Trovan Trials in Nigeria (1996): Unethical Testing on Children During a Meningitis Outbreak

During a 1996 meningitis epidemic in Kano, Nigeria, Pfizer conducted a clinical trial of its antibiotic, Trovan (trovafloxacin), on approximately 200 children. Allegations arose that the trial was conducted without proper informed consent and lacked necessary regulatory approvals. A Nigerian government report concluded that Pfizer's trial was an "illegal trial of an unregistered drug." The incident led to legal actions and settlements, highlighting ethical breaches in conducting research in vulnerable populations.[21]

ii) AZT Trials in Sub-Saharan Africa (1990s): Testing of Anti-HIV Drugs on Pregnant Women Without Proper Consent

In the 1990s, trials were conducted in Sub-Saharan Africa to test the efficacy of a short-course regimen of zidovudine (AZT) in preventing mother-to-child transmission of HIV. Critics argued that these trials involved the use of placebos, despite the existence of proven effective treatments, and that participants were not fully informed about the nature of the study or the availability of alternative therapies. The ethical controversy centered on the standard of care provided to participants and the adequacy of informed consent processes in resource-limited settings.[22]

ETHICAL FRAMEWORKS: CURRENT STANDARDS VS. IDEAL PRACTICES

The ethical conduct of clinical research is governed by several foundational documents that establish principles to protect human participants. However, these frameworks have limitations, particularly concerning the protection of impoverished populations.

a) Current Ethical Standards

i) Declaration of Helsinki

Established by the World Medical Association, the Declaration of Helsinki provides ethical guidelines for medical research involving human subjects. It emphasizes principles such as informed consent, the necessity of research protocols, and the prioritization of participant welfare over scientific interests. Despite its comprehensive nature, the Declaration has faced criticism for its lack of enforceability and varying interpretations across different jurisdictions. For instance, disparities in its application have led to ethical controversies in international research settings.[23]

ii) Belmont Report

The Belmont Report, published in 1979, outlines three core principles: respect for persons, beneficence, and justice. While these principles provide a foundational ethical framework, the report does not offer detailed guidance on their application in diverse cultural contexts, particularly in low- and middle-income countries. This omission can result in ethical ambiguities when conducting research in settings with differing societal norms and economic conditions.[24]

iii) Good Clinical Practice (GCP) Guidelines

GCP guidelines are internationally recognized standards for designing, conducting, and reporting clinical trials. They ensure that the rights, safety, and well-being of trial participants are protected. However, the implementation of GCP can be challenging in resource-limited settings due to infrastructural constraints and varying regulatory standards. This disparity can lead to inconsistent adherence to ethical practices in different regions.[25]

b) What is Ought to Be

To enhance the ethical conduct of clinical trials, especially involving impoverished populations, the following measures are proposed:

i) Mandatory International Consent Protocols

Establishing standardized international consent protocols can ensure that all participants, regardless of location, receive comprehensive information about the research. These protocols should be culturally sensitive and account for varying literacy levels to facilitate genuine informed consent. Implementing such standards can mitigate the risk of exploitation due to misunderstandings or lack of information.

ii) Strengthening Local Ethics Committees with Independent Oversight

Empowering local ethics committees is crucial for context-specific ethical oversight. Providing these committees with resources and training can enhance their effectiveness. Additionally, establishing independent international bodies to oversee and audit these committees can ensure adherence to global ethical standards, thereby reducing the potential for ethical lapses.

By addressing the limitations of current ethical frameworks and implementing these improvements, the protection of impoverished participants in clinical research can be significantly enhanced.

THE ROLE OF NGOS, WHISTLEBLOWERS, AND MEDIA IN EXPOSING UNETHICAL TRIALS

External actors such as whistleblowers, non-governmental organizations (NGOs), and the media play a pivotal role in exposing unethical practices in clinical trials, thereby holding multinational corporations (MNCs) accountable. Their interventions have led to significant reforms in research ethics and increased public awareness of ethical violations.

a) Whistleblowers

Whistleblowers are individuals who courageously expose unethical or illegal activities within organizations, often at great personal risk. Their disclosures have been instrumental in uncovering unethical practices in clinical research.

i) Peter Buxtun and the Tuskegee Syphilis Study

In 1972, Peter Buxtun, a U.S. Public Health Service investigator, revealed the unethical nature of the Tuskegee Syphilis Study. This study, conducted from 1932 to 1972, involved observing the progression of untreated syphilis in African American men without their informed consent, even after penicillin became the standard treatment. Buxtun's disclosure led to the termination of the study and significant reforms in medical ethics, including the establishment of stricter ethical oversight of medical studies at research institutions.[26]

ii) Dr. John Pesando and the Hutchinson Center Trials

Dr. John Pesando, a physician at the Fred Hutchinson Cancer Research Center, raised concerns about a clinical trial in which leukemia patients were subjected to potentially harmful treatments without proper informed consent. Despite facing significant opposition, Dr. Pesando's persistence in exposing these unethical practices underscored the critical role of whistleblowers in safeguarding patient rights[27]

b) NGO Advocacy

Non-governmental organizations have been at the forefront of advocating for ethical conduct in clinical research, often bringing to light unethical practices and pushing for systemic change.

i) Public Citizen

In 1997, Public Citizen, a U.S.-based consumer advocacy organization, highlighted unethical clinical trials in low- and middle-income countries. They reported that participants were given placebos instead of the standard of care, violating ethical principles. This advocacy led to increased scrutiny and reforms in international research ethics.[28]

ii) Médecins Sans Frontières (Doctors Without Borders)

Médecins Sans Frontières (MSF) has been instrumental in advocating for ethical medical research, particularly in vulnerable populations. They have highlighted issues related to access to essential medicines and the ethical implications of clinical trials conducted in resource-limited settings. MSF's efforts have led to increased awareness and policy changes aimed at ensuring ethical standards in medical research.[29]

c) Media’s Role

Investigative journalism has been crucial in uncovering hidden clinical trial scandals, informing the public, and prompting regulatory action.

i) The Seattle Times Investigation

In the early 2000s, The Seattle Times conducted an investigation into unethical clinical trials at the Fred Hutchinson Cancer Research Center. The series, titled "Uninformed Consent," revealed that patients were enrolled in high-risk studies without proper informed consent, leading to several deaths. This investigation prompted policy changes and increased oversight in clinical research practices.[30]

ii) PBS Coverage of Unethical Medical Research

PBS has highlighted historical instances of unethical medical research, such as the Tuskegee Syphilis Study, through documentaries and articles. Their coverage has educated the public on the importance of ethical standards in medical research and the need for vigilance to prevent future ethical breaches.[31]

SUGGESTIVE REFORM MEASURES

To prevent the exploitation of vulnerable populations in clinical trials, it is imperative to implement comprehensive reforms that enhance ethical standards, regulatory oversight, and community engagement. The following recommendations aim to address these critical areas:

a) Strengthen Informed Consent Processes

i) Introduce Third-Party Consent Verification for Vulnerable Populations

Ensuring genuine informed consent is paramount, especially among vulnerable groups who may face challenges in understanding the complexities of clinical trials. Implementing third-party consent verification involves appointing impartial observers to oversee the consent process, thereby safeguarding participants' autonomy and comprehension. The U.S. Food and Drug Administration (FDA) regulations authorize Institutional Review Boards (IRBs) to observe or have a third party observe the consent process to enhance subject protection.[32]

This approach is particularly beneficial when dealing with populations that have limited literacy or are susceptible to coercion, ensuring that consent is truly informed and voluntary.

b) Increase Regulatory Oversight

i) Propose Stricter Penalties for Non-Compliance

To deter unethical practices, it is essential to establish and enforce stringent penalties for non-compliance with ethical standards in clinical trials. Regulatory bodies should implement clear guidelines outlining the consequences of violations, which may include substantial fines, suspension of trial activities, and legal action against responsible entities. Such measures would underscore the seriousness of ethical adherence and promote accountability among researchers and sponsors.

ii) Establish Independent International Monitoring Bodies for Trials Conducted in Low-Income Regions

The globalization of clinical research necessitates the creation of independent international monitoring bodies tasked with overseeing trials in low-income regions. These bodies would function to ensure that trials adhere to ethical standards, regardless of local regulatory limitations. The World Health Organization (WHO) has released guidance to improve the design, conduct, and oversight of clinical trials across countries of all income levels, aiming to support stronger country-led research and development ecosystems.[33]

By providing an additional layer of oversight, these international bodies can help prevent ethical breaches and protect vulnerable populations from exploitation.

c) Enhance Transparency and Community Engagement

i) Mandatory Public Disclosure of Trial Protocols and Results

Transparency in clinical trials is crucial for maintaining public trust and ensuring ethical conduct. Mandating the public disclosure of trial protocols and results would allow for external scrutiny and accountability. This practice can prevent selective reporting and promote the dissemination of comprehensive findings, contributing to the scientific community's integrity.

ii) Engage Local Communities Through Community Advisory Boards

Active involvement of local communities in the research process fosters trust and ensures that the studies address relevant health concerns. Establishing Community Advisory Boards (CABs) allows for meaningful dialogue between researchers and community members, facilitating culturally sensitive study designs and ethical conduct. CABs can provide valuable insights into local contexts, assist in the informed consent process, and ensure that the research aligns with the community's needs and values.

Implementing these recommendations requires a collaborative effort among stakeholders, including regulatory authorities, research institutions, sponsors, and communities. Strengthening informed consent processes, increasing regulatory oversight, and enhancing transparency and community engagement can significantly improve the ethical conduct of clinical trials, thereby protecting vulnerable populations from exploitation.

CONCLUSION

Clinical trials are indispensable for advancing medical science. They offer pathways to discover new treatments, improve existing therapies, and ultimately enhance global health outcomes. However, this scientific progress often conflicts with fundamental human rights, particularly when research is conducted in low-income regions where regulatory oversight may be weaker and populations are more vulnerable to exploitation.

This article has critically examined the multifaceted ethical issues surrounding clinical trials conducted by multinational corporations (MNCs) in impoverished communities. Key arguments have highlighted the systemic vulnerabilities created by poverty, the inconsistencies in regulatory frameworks both in India and globally, and the frequent prioritization of profit over ethical obligations. Through case studies, such as the Swasthya Adhikar Manch v. Union of India and Pfizer’s Trovan trials in Nigeria, it becomes evident that unethical practices continue to pervade the clinical research landscape, often at the expense of vulnerable populations.

The ethical dilemma at the heart of this issue lies in balancing the pursuit of scientific innovation with the imperative to protect human dignity and rights. While clinical research aims to improve global health, it must not come at the cost of exploiting those who are economically disadvantaged or inadequately protected by legal frameworks. Informed consent, regulatory compliance, and ethical oversight are not merely procedural requirements but essential components of safeguarding the autonomy and welfare of research participants.

To address these challenges, a unified global approach to clinical trial regulation is urgently needed. International bodies, such as the World Health Organization (WHO), have begun laying the groundwork for more equitable and ethical research practices across diverse socioeconomic contexts. However, these efforts must be strengthened by harmonizing ethical standards, establishing independent international monitoring bodies, and fostering greater transparency and community engagement in all regions where trials are conducted.

Ultimately, ethical vigilance is paramount. Protecting the rights of clinical trial participants—especially those from marginalized and impoverished communities—requires a concerted effort from researchers, regulatory authorities, NGOs, and the global scientific community. Only through rigorous ethical practices and robust legal safeguards can we ensure that the benefits of scientific discovery are shared equitably without compromising the dignity and rights of the most vulnerable.

* Research Scholar, School of Law, Ramaiah University of Applied Science, Bengaluru

[1]Elizabeth Nix, ‘Tuskegee Experiment: The Infamous Syphilis Study’, History, https://www.history.com/news/the-infamous-40-year-tuskegee-study, accessed 2 February 2025.

[2]The Nuremberg Code (1947), https://www.cirp.org/library/ethics/nuremberg/

[3] Neal Dickert, ‘Enrollment of Economically Disadvantaged Participants in Clinical Research’, AMA Journal of Ethics, https://journalofethics.ama-assn.org/article/enrollment-economically-disadvantaged-participants-clinical-research/2009-01, accessed 2 February 2025.

[4]Supra at 1

[5]The Belmont Report, Ethical Principles and Guidelines for the Protection of Human Subjects of Research, U.S. Department of Health and Human Services, https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html

[6]Supra at 2

[7] ‘WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects’, World Medical Association, 18th WMA General Assembly, Helsinki, Finland, https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/, accessed 2 February 2025.

[8]The Drugs and Cosmetics Act, 1940, No. 23 Acts of Parliament, 1940, (India)

[9]The Drugs and Cosmetics Act, 1940, No. 23 Acts of Parliament, 1940, (India), Schedule Y

[10] Emily A Largent, Christine Grady, Franklin G Miller, Alan Wertheimer, ‘Money, Coercion, and Undue Inducement: A Survey of Attitudes About Payments to Research Participants’, National Library of Medicine, NIH, https://pmc.ncbi.nlm.nih.gov/articles/PMC4214066/, accessed 2 February 2025.

[11] ‘Language and Literacy’, Healthy People 2030, Office of Disease Prevention and Health Promotion,  https://odphp.health.gov/healthypeople/priority-areas/social-determinants-health/literature-summaries/language-and-literacy, accessed 3 February 2025.

[12] Terry C Davis, Connie L Arnold, ‘Health Literacy Research in Rural Areas’, https://pmc.ncbi.nlm.nih.gov/articles/PMC8590389/, accessed 3 February 2025.

[13] Chalachew Alemayehu, Geoffrey Mitchell, Jane Nikles, ‘Barriers for conducting clinical trials in developing countries- a systematic review’, National Library of Medicine, NIH, https://pmc.ncbi.nlm.nih.gov/articles/PMC5863824/, accessed 3 February 2025.

[14] Novoa-Heckel Germán, Bernabe Rosemarie, ‘A survey in Mexico about ethics dumping in clinical research’, BMC Medical Ethics, https://bmcmedethics.biomedcentral.com/articles/10.1186/s12910-019-0378-6, accessed 4 February 2025.

[15] Katrin Weigmann, ‘The Ethics of Global Clinical Trials, EMBO Press, https://www.embopress.org/doi/full/10.15252/embr.201540398, accessed 4 February 2025.

[16] Ashwin Sapra, Biplab Lenin, Kartik Jain, ‘New Drugs and Clinical Trials Rules, 2019 – A Regulatory Overview’, Cyril Amarchand Mangaldas Blogs, https://corporate.cyrilamarchandblogs.com/2019/07/new-drugs-clinical-trials-rules-2019-regulations-india/, accessed 6 February 2025.

[17] Neelu Singh, Nivedita J Madkaikar, Partha M Gokhale, Deven V Parmar, ‘New drugs and clinical trials rules 2019: Changes in responsibilities of the ethics committee’, National Library of Medicine, NIH, https://pmc.ncbi.nlm.nih.gov/articles/PMC7034142/, accessed 6 February 2025.

[18] ‘Guidance for Industry and FDA Staff FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND Frequently Asked Questions’, FDA, https://www.fda.gov/media/83209/download, accessed 8 February 2025.

[19]Swasthya Adhikar Manch, Indore v. UOI, IA No. No. 13 of 2014, WP (C) No. 33 of 2012

[20]Union Carbide Corporation vs UOI, 1990 AIR 273, 1989 SCC (2) 540

[21]Abdullahi v. Pfizer, Inc., 562 F.3d 163 (2d Cir. 2009), https://casetext.com/case/abdullahi-v-pfizer-inc

[22] Claire L. Wendland, ‘Research, Therapy, and Bioethical Hegemony: The Controversy over Perinatal AZT Trials in Africa’, Cambridge University Press, https://www.cambridge.org/core/journals/african-studies-review/article/abs/research-therapy-and-bioethical-hegemony-the-controversy-over-perinatal-azt-trials-in-africa/9BCDE4A6EB63834DAA2E505673B80788, accessed 8 February 2025.

[23] WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Participants, https://www.wma.net/policies-post/wma-declaration-of-helsinki/

[24] The Belmont Report, Ethical Principles and Guidelines for the Protection of Human Subjects of Research, U.S. Department of Health and Human Services, https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html

[25] A Vijayananthan, O Nawawi, ‘The Importance of Good Clinical Practice Guidelines And Its Role in Clinical Trials’, National Library of Medicine, NIH, https://pmc.ncbi.nlm.nih.gov/articles/PMC3097692/, accessed 8 February 2025.

[26] ‘Tuskegee Experiment Whistleblower Peter Buxtun ’71’, San Francisco UC Law, https://www.uclawsf.edu/2024/07/26/tuskegee-whistleblower-peter-buxtun/, accessed 8 February 2025.

[27] Duff Wilson and David Heath, ‘The Whistleblower - He saw the tests as a violation of 'trusting, desperate human beings'’, Uninformed Consent, The Seattle Times, https://special.seattletimes.com/o/uninformed_consent/whistleblower/story1.html, accessed 9 February 2025.

[28] Bobbi M Bittker, ‘The Ethical Implications of Clinical Trials in Low and Middle-Income Countries’, American Bar Association, https://www.americanbar.org/groups/crsj/resources/human-rights/archive/ethical-implications-clinical-trials-low-middle-income-countries/, accessed 9 February 2025.

[29] ‘The MSF ethics review board’, Médecins Sans Frontières, https://www.msf.org/msf-ethics-review-board, accessed 9 February 2025.

[30]Supra at 27

[31] ‘Unethical moments in U.S. medical research history’, PBS News Hour, https://www.pbs.org/newshour/classroom/posts/2025/01/review-highlights-unethical-moments-in-medical-research-history, accessed 9 February 2025.

[32] ‘Informed Consent, Guidance for IRBs, Clinical Investigators, and Sponsors’, FDA, https://www.fda.gov/media/88915/download, accessed 9 February 2025.

[33] ‘New global guidance puts forward recommendations for more effective and equitable clinical trials’, World Health Organization, https://www.who.int/news/item/25-09-2024-new-global-guidance-puts-forward-recommendations-for-more-effective-and-equitable-clinical-trials, accessed 9 February 2025.