This article is written by Bijli Muthamma MP of 1st Semester of BBA LLB of OP Jindal Global Law School, an intern under Legal Vidhiya.
ABSTRACT
Bioethical committees play a crucial role in handling ethical dilemmas in the field of healthcare, medical research and public health. In a global landscape influenced by different social, political, and economic contexts, these committees create a formal framework to navigate through the complex ethical challenges that arise, ensuring that decisions are in accordance with moral, legal, and societal values. This article addresses the role and purpose of bioethics committees, especially within the context of work performed in medical disputes, case reviews, resolving conflicts and making ethical decisions. Through the use of case studies, including the COVID-19 pandemic, the article represents the role that bioethics committees play in ensuring that fair and just decision are made. The article discusses the challenges of bioethics committees, especially in low- and middle-income countries, where resources and transparencies are lacking and political pressures may affect their performance. Ultimately, it supports the improvement of global bioethics systems for the protection of human dignity, autonomy, and fair healthcare practice.
KEYWORDS
Bioethics Committees, Medical Disputes, Healthcare Ethics, Public health, Autonomy, Deliberative democracy, Informed consent, Ethical guidelines.
INTRODUCTION
In a pluralistic society shaped by a variety of social, political, economic, and historical contexts, public opinion should be regarded as an integral part of policy-making. Neglecting the public opinions would lead to social tension and disintegration. Thus, in this respect, bioethics committees are significant. Bioethics committees have become an important part of the fast and ever changing fields of medicine and life science. They guarantee responsible innovation. Therefore, these committees act as significant agencies for ethical deliberation, addressing the complex issues from stem cell research to clinical trials to scientific advances with human dignity and societal values. They are set up in order to address challenges such as human rights abuses, discrimination, and injustice due to medical advancement and practice.
In the last two decades, bioethics committees have been established in many countries. Their structures and compositions differ, but their purposes are similar. They play the most basic roles in facilitating public discourse on contentious bioethical matters, providing multidisciplinary perspectives, and issuing recommendations to guide public policy and decision-making. Such committees gather expertise from a wide range of professionals, including scientists, physicians, lawyers, philosophers, and laypersons, ensuring that all aspects of ethical issues are addressed and considered.
DEFINITION
The term “bioethics” was first coined by Fritz Jahr in 1926; however, it was an American biochemist, Van Rensselaer Potter, who pronounced the more inclusive concept of bioethics as “global ethics” in his book, Bioethics: A Bridge to the Future in 1971. Thus, Potter defined bioethics as:
“A bridge between biology and ethics,” emphasizing its role in connecting scientific advancements with moral values to ensure the survival and flourishing of both humanity and the environment.
Additionally, the Encyclopedia of Bioethics offers a widely recognized definition, describing bioethics as:
“The systematic study of the moral dimensions—including moral vision, decisions, conduct, and policies—of the life sciences and healthcare, employing a variety of ethical methodologies in an interdisciplinary setting.”
These definitions point out the broad and multidisciplinary nature of bioethics, which delas with ethical issues in medicine, biology, and social values. Bioethics has grown greatly in the last century, especially within the last fifty years, showing its increasing importance in addressing complex scientific and health-care ethical issues.
ROLE AND RELEVANCE OF BIOETHICS COMMITTEES
Bioethics committees have emerged as important to provide a formal framework for the resolution of complex and uncertain issues in healthcare. They, therefore, play a critical role in the protection of public health and guidance through the ethical issues that emerge in medical practice. Major areas of their impacts include end-of-life care decisions, trafficking of organs being prevented, opposing human cloning, dignity and rights in trials or experiments being secured, equal opportunity in healthcare service, genetic engineering being controlled or other cutting-edge technologies such as UK’s mitochondrial replacement therapy facilitating in vitro fertilization.
The Role of Bioethics Committees have been highlighted under Article 19 of UNESCO’s Universal Declaration on Bioethics and Human Rights.
Article 19 – Ethics Committees
Establish, promote, and support independent, multidisciplinary, and pluralist ethics committees at the appropriate levels to:
(i) evaluate the ethical, legal, scientific and social issues relevant to research projects on human beings;
(ii) offer advice on ethical problems in the clinical setting;
(iii) evaluate scientific and technological developments, formulate recommendations and contribute to guidelines on matters covered by this declaration;
And
(iv) promote debate, education and public awareness of, and engagement in, bioethics.
Recognizing fundamental freedoms and the dignity of every individual is both necessary and a challenge in today’s diverse societies. This becomes more important in the health care sector because bioethics committees have very crucial roles in ensuring that the autonomy aspect, which is central to human dignity, is not compromised. Bioethics committees thus help move healthcare away from paternalistic models by encouraging participation in decision-making and shared, democratic decision-making. Their role is central to building respect for the rights of each individual and ensuring that healthcare systems place dignity and autonomy at the top of the agenda for each patient.
ROLE IN MEDICAL DISPUTES
Bioethics committees have several important roles in medical disputes. They navigate the complex moral and ethical dilemmas of decisions and ensure that decisions are made in accordance with moral, legal, and professional standards. Local advisory boards attend to biomedical issues relevant to specific political regions, while national and international advisory boards concentrate on the ethically complex political decisions associated with medical research and practice. These committees operate at different levels and provide ethical clarity in the process of navigating moral complexities within healthcare and research, both locally and internationally.
- Advisory Role – Bioethical committees play an advisory role by offering guidance on ethical issues that arise in medical disputes, ensuring that decisions are consistent with fundamental ethical principles such as autonomy, beneficence, and justice. For instance, a bioethics committee might provide recommendations on whether a terminally ill patient should be granted the right to refuse life-sustaining treatment, thereby ensuring respect for their autonomy and dignity.
- Conflict Resolution – Bioethical committees help in conflict resolution by acting as neutral arbitrators between healthcare providers, patients, and families in an attempt to resolve disputes arising from many issues, including treatment decisions, end-of-life care, resource allocation, etc. For instance, a dispute between healthcare providers and a patient’s family can be mediated on the number of limited ICU resources allocated in a crisis by a bioethics committee.
- Case Reviews – Bioethics committee panels review specific cases that involve ethical issues like rejection of treatment, informed consent, or an experimental procedure. After reviewing a case, the panel provides recommendations regarding the dispute in question. An example would be a case in which a bioethics committee reviews a case in which a patient is approached to participate in an experimental drug study, decides whether the patient’s informed consent has been properly obtained, and determines if the risks of the procedure are ethically acceptable.
- Education and Awareness – Bioethics committees provide education for health care providers about ethical principles and how to address potential disputes. They also try to enhance awareness of ethical concerns in healthcare practice among patients and their families
- Legal and Institutional Liaison – Bioethics committees ensure compliance of medical practices to legal and institutional ethical standards. They may also serve courts with expert opinions in medico-legal cases where ethical issues are involved.
LEGAL BASIS AND REGULATORY FRAMEWORK FOR BIOETHICS
Law and bioethics represent two different social and communicative systems, which seek to create their peculiar social realities; they are structured through certain norms and exercise different social functions. They are also different in their goal, methodology, epistemological basis for argumentation, and their way of interacting with expertise, values, and burdens of proof. Yet, despite these differences, law and bioethics are deeply interrelated. The legal system can take and incorporate insights from bioethics committees, depend on their advisory role, and assign particular responsibilities to them. It is important, though, to draw a clear line of distinction between law and bioethics so as not to confuse law with religion or ethics.
The legal framework of bioethics around the globe is very diverse, reflecting different types of legal systems, cultures, and societal interests. In most nations, the basis of bioethics relies on constitutional provisions for human dignity, health, and life under implementing legislation. In the United States, there is regulation of research ethics and patient rights through a mix of federal and state laws and guidelines articulated in the Belmont Report. Europe incorporates the principles of bioethics through the European Convention on Human Rights and the Oviedo Convention. In India, constitutional provisions besides guidelines from bodies like the Indian Council of Medical Research (ICMR) form the bed of bioethics. Internationally, such frameworks include UNESCO’s Universal Declaration on Bioethics and Human Rights, and there exist further regulations often reinforced by the decisions of courts, professional codes of ethics, and ethical guidelines issued by regulatory authorities.
In this regard, the role of the bioethics committee is critical since it sets the bridge between the regulatory framework and its practice. These regulatory frameworks integrate ethical oversight with medico-legal liability, thus ensuring that medical research complies with the requirements of human dignity, safety, and justice and also provides mechanisms redressing issues like negligence, misconduct, or harm. Bioethics committees assume a very important role in navigating these regulations, striving to balance ethical concerns with legal accountability.
Cases Demonstrating the Role of Bioethics Committees:
There are many examples that illustrate the contribution of bioethics committees toward supporting legal matters and safeguarding individual rights. For example;
- The Biddison v. Facey Medical Group case, a medical malpractice suit over the death of a California man who died waiting for a pacemaker to be replaced. In this case, bioethical monitoring could have avoided such a problem. Thus, there is a need for bioethics input in medicine to ensure that all practices in the medical field are right.
- The case of Aruna Ramchandra Shanbaug v. Union of India & Ors. (2011) demonstrates the significance of bioethics in forming judicial judgments about matters such as euthanasia. Aruna, who had been in a persistent vegetative state for 42 years, became the focus of a Supreme Court petition seeking passive euthanasia. The Court rejected the plea on the grounds that the hospital staff was dedicated to her care, but it legalized passive euthanasia under strict safeguards requiring approval from High Courts after consulting medical experts and considering ethical implications. This case highlights the importance of bioethics committees in assessing medical conditions, protecting the rights of patients, and upholding ethical integrity that harmonizes human dignity with legal and medical considerations.
- Another landmark case in the United States was Quinlan (1976), which emphasized the role of bioethics committees in medical decision-making. A young woman in a persistent vegetative state, Karen Ann Quinlan, became the center of a legal battle when her parents sought to remove her from a ventilator, arguing it was her right to die with dignity. The New Jersey Supreme Court ruled in their favor, and the court accepted the right of the patient to refuse life-sustaining treatment, which may be exercised by family members or legal guardians. The case emphasizes the need for hospital ethics committees to guide sensitive decisions that have medical facts, ethical considerations, and legal standards in balance. This pivotal case established bioethics committees as mediators in the protection of patient autonomy and navigating end-of-life dilemmas.
- Zenith Lab v. Bristol-Myers Squibb Co. – The issue in this case was whether the antibiotic by Zenith, Cefadroxil DC, infringed the patent by Bristol-Myers Squibb for Bouzard monohydrate. The question was that whether after consumption inside the human body, Cefadroxil DC may convert into Bouzard monohydrate. The court relied on lab test evidence since the same was unethical to be done on human subjects. Medical ethicist Robert Levine explained: “Research ethics boards would refuse to approve an experiment like that on human beings,” and highlighted ethical limits on research. Judge Wolin sided with Bristol-Myers Squibb, demonstrating how bioethics assists in overcoming ethical issues in scientific controversies.
- Planned Parenthood Fed’n of Am. v. Ashcroft – This case concerned the constitutionality of the Partial-Birth Abortion Act of 2003, which banned a specific abortion procedure. Congress asserted that the procedure was unethical and unnecessary, but the court brought up medical ethics and previous cases such as Stenberg v. Carhart. Experts testified that there was no clear ethical agreement on these procedures and banning them could harm medical integrity. The court determined that such a prohibition should be accompanied by exceptions for the patient’s health, reinforcing patient rights and autonomy for an aspect of bioethics.
These cases illustrate the role and the need for bioethics committees. Bioethics committees make sure such difficult medical and research decisions taken are in harmony with human dignity, protection of rights of the individual, and integrity of the profession by integrating ethical oversight into legal frameworks.
CASE STUDY OF THE COVID-19 PANDEMIC
The coronavirus pandemic highlighted the need for bioethics committees, as a number of ethical challenges emerged across various countries. These committees played an important role in providing timely guidance on how medical professionals and governments should address these challenges.
Two such examples of the role bioethics committees played in medical disputes during the pandemic are:
- Allocation of Scarce Medical Resources in France: The French National Consultative Ethics Committee (CCNE) made historic inputs concerning how ventilators and ICU beds should be rationally managed during the pandemic when the former were in short supply. Such inputs prioritized who to treat based on the medical need and the possibility of recovery, not age or social status.
- UK vaccine distribution: The Nuffield Council on Bioethics in UK provided direction through the issuing of ethical considerations for who should be prioritised for the COVID-19 vaccine. According to these ethical considerations, the vulnerable groups were given top priority, including health care professionals and other underlying medical conditions. This has helped significantly in directing the roll out of the vaccine in the UK in an ethical and efficient manner.
These examples show the significance of bioethics committees during the current COVID-19 pandemic crisis in guiding ethical decision-making. Bioethics committees ensure medical treatment that is fair, equitable, and just without any person being treated unjustly. Within this period of crisis, these committees fulfilled their responsibility by advocating for the importance for public health.
DRAWBACKS
This question remains complex: whether or not a national ethics committee is the right model for all countries. Where bioethics committees are necessary to guide ethical decision making, they have often been criticized for the potential of serving hidden interests or for being influenced by dogmatic ideologies. These challenges are stark in low- and middle-income countries, which typically struggle with problems such as outdated information, a lack of online presence, and unclear ethical standards. In addition, corruption and resource scarcity can impede the functioning of these committees. In extreme situations, such as the recent Belarusian case, even research on public health threats like the Chernobyl disaster is suppressed, with researchers being put behind bars, which again indicates the challenges these bioethics committees face in some contexts.
CONCLUSION
While the institution of bioethics committees is a significant step, ensuring that they work effectively will be as vital for their sustenance and effect. The committee should be supported with adequate means, knowledge on new scientific and medical technologies emerging, and capacity to handle problems in a timely and efficient manner. It must be made certain that the committees are legally mandated, independent, diverse in membership, transparent, and sufficiently funded. This ensures that they not only address ethical concerns but also gain the confidence of the medical community as well as the public at large.
Emerging technologies like AI in healthcare, gene editing (e.g., CRISPR), and synthetic biology pose challenges to bioethics because of issues such as privacy, equity, and safety. Additionally, advancements in neurotechnology, such as brain-computer interfaces, raise concerns regarding issues such as cognitive privacy and autonomy. Bioethics committees play an important role in addressing these problems, by seeing to that innovation aligns with ethical standards and societal values.
In this era of globalized biomedical research, good ethics management requires every country, regardless of their economic development, to have a functional research ethics review system. Such systems are important to safeguard the dignity, integrity, and safety of citizens participating in research, while promoting a globally consistent approach to ethical challenges in healthcare.
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