Chapter-18: BIOethICS

Points to be covered in this topic

➜ 18.1 INTRODUCTION TO BIOETHICS
➜ 18.2 HISTORY OF BIOETHICS
➜ 18.3 PRINCIPLE OF BIOETHICS
➜ 18.4 BRIEF OVERVIEW OF ICMR'S NATIONAL ETHICAL GUIDELINES
FOR BIOMEDICAL AND HEALTH RESEARCH INVOLVING HUMAN
PARTICIPANTS

18.1 INTRODUCTION TO BIOETHICS

• The term bioethics (Greek bios, "life"; ethos, "moral nature, behavior") was
coined in 1927 by Fritz Jahr in an article about a "bioethical imperative" regarding
the use of animals and plants.
• Bioethics is branch of applied ethics that studies the
philosophical, social and legal issues arising in medicine
and the life sciences.
• It is chiefly concerned with human life and well-being.
• Focused primarily on issues arising out of the physician-patient relationship.
• The ancient Hippocratic literature enjoins doctors to use their knowledge and
powers to benefit the sick, to heal and not to harm, to preserve life,
• These basic values and principles remain an essential part of contemporary
bioethics.

18.2 HISTORY OF BIOETHICS

• The first font of bioethics was related to human experimentation.
• In 1947, in this respect, the Nuremberg Tribunal, drafted a code (The Nuremberg
Code) which prescribes that no experiment should be performed on humans,
without their informed consent.
• Then, in 1948, the Universal Declaration of Human Rights, of the United Nations,
cherished the same principle. Still some cases about abuse in human beings have
been reported.
• So, in 1953, the National Institutes of Health (NIH) of United States specified that
every investigation in human beings should be approved by Ethical Committees.
• In 1964, these standards were approved through the famous "Declaration of
Helsinki" which was a milestone in the construction of bioethics. In 1975 in Tokyo,
this declaration was reviewed and amended at the Medical Assembly.
• In 1989, National Academy of Sciences publishes a book for educating scientists
in training on responsible conduct in research.
• In 1990, in Nancy Cruzan Case, there was a landmark decision "right to die"
which led to a nationwide surge in advance directives.
• In 1993, Researchers successfully clone human embryo.
• In 1997, UNESCO issued a document Universal Declaration on the Human
Genome and Human Rights making a statement against human cloning and abuse
of human genome against human dignity.
• During 2000-2010s Graduate training in bioethics made available at 50+
institutions. There was legislation on human cloning; Mr. Bushera bans on
embryonic stem cell research are lifted by the Obama administration.
• In 2019-2020, Covid-19 pandemic had significant ethical implications with regard
to limited resource allocation, healthcare disparities, personal liberties, care for
confined patients in pandemic, development and experimentation of novel vaccines
etc.
• A second front of bioethics came from new technologies.
• In 1959, meetings with scientists, philosophers and other professionals were
happened to discuss the advances in biomedical sciences. As a result of these
meetings, Institute of Society, Ethics and Life Sciences was created at Hastings
(New York).
• In 1970 and 1971, Massachusetts General Hospital and the Hennepin Country
Medical Centre had come up with innovative technologies for the treatment of
terminal patients.
• A third front of bioethics was related with ecological ethics.
• Dr. Potter proposed the term "Bioethics" through his article titled "Bioethics, the
Science of Survival" and a book related with ecological ethics. His concern was
with the responsibility of genetic engineering to improve the quality of human life,
and with the preservation of an ecosystem which makes the earth sustainable for
humankind living.
• The fourth front of bioethics is related to religion.
• In 1972, André Hellegers promoted a brotherly discussion between the great
ethical-religious flow in Western society. This led to the creation of the bioethics
Institute, "The Kennedy Institute of Ethics" for the Study of Human Reproduction
and Bioethics.
• Around 1980, Professors in religious studies promoted an important series of talks
that led to the creation, of the International Study Group of Bioethics which brought
theological knowledge with scientific progress together.
18.3 PRINCIPLE OF BIOETHICS
• Ideally, for a medical practice to be considered "ethical", it must respect all four of
these principles:
• These four principles cannot be arranged in particular sequence (non-
hierarchical), meaning no one principle routinely defeats another.
• These are four commonly accepted principles of Bioethics.
1. Respect for autonomy
2. Nonmaleficence
3. Beneficence
4. Justice
1. The principle of Respect for Autonomy
• This principle was affirmed in a court decision with the order that, "Every human
being of adult years and sound mind has a right to determine what shall be done
with his own body".
• This principle is the basis for the practice of "informed consent" in the
physician/patient transaction. Healthcare professionals that follow bioethics usually
prioritise autonomy.
2. The Principle of Non-maleficence
• This principle is a version of the Latin term "primum non nocere" which is
embodied in the phrase "first, do not harm". It means "First of all, do not harm the
patient" which is a moral requirement of the medical practice.
• The principle of non-maleficence states that the healthcare professional should not
intentionally harm or make injury to the patient.
• This principle provides a proper standard of care that avoids or minimizes the risk
of harm.
3. The Principle of Beneficence
• This refers to the actions that promote the welfare of others. In the medical
context this means looking after the interest of patients and their families.
• This principle's common interpretation is that healthcare professionals have an
obligation to act in the patient's best interest.
• The objective of delivering benefit can be extended to the patient, their family,
and the community at large.
• The healthcare professionals are responsible for ensuring that the treatment's
advantages and hazards are balanced.
4. The principle of justice
• Aristotle once said, “Giving to each that which is his due.”
• Principle of justice means that the benefits and resources should be fairly
distributed. Justice is a moral principle and holds that all patients should have
access to decent healthcare.
• Distributive justice is more pertinent towards bioethics. Distributive justice refers
to fair, equitable and appropriate distribution of healthcare resource.

18.4 BRIEF OVERVIEW OF ICMR'S NATIONAL ETHICAL GUIDELINES

FOR BIOMEDICAL AND HEALTH RESEARCH INVOLVING HUMAN
PARTICIPANTS
• The Indian Council of Medical Research (ICMR) is the apex body in India for the
formulation, coordination and promotion of biomedical research.
• The ICMR is funded by the Government of India through the Ministry of Health
and Family Welfare.
• The Indian Council of Medical Research (ICMR) has been at the forefront in
setting up the ethical guidance for the conduct of biomedical and health research in
India.
• The National Ethical Guidelines for Biomedical and Health Research Involving
Human Participants, 2017, were released on October 12, 2017 by the Hon'ble
Union Minister of Health and Family Welfare at ICMR.
✓ Guidelines
• Guidance on transfer of human biological material for research
• Dietary guidelines for Indians
• Cancer Management Guidelines
• Guidelines for Good Clinical Laboratory Practices
• Ethical Guidelines for Biomedical Research on Human Participants
• Guidelines for Management of Type 2 Diabetes
✓ Statement of general principles in biomedical Research involving human
participants
Shall be known as the ICMR Code and shall consist of the following:
• General Principles on Research using Human Participants in Biomedical Research
• Specific Principles on Research using Human Participants in specific areas of
Biomedical Research
✓ General statement
Medical and related research using human beings as research participants must
necessarily ensure that –
1. The Purpose, of such research is that it should be directed towards the
increase of knowledge about the human condition in relation to its social and
natural environment.
2. Such research is Conducted under conditions that no person or persons
become a mere means for the betterment of others and that human beings
who are subject to any medical research.
 3. Such research must be subjected to a regime of evaluation at all stages of the
proposal i.e., research design and experimentation, declaration of results.
18.4.1 Sections of Guidance
✓ Section 1: Statement of General Principles
• The four basic principles namely; respect for persons (autonomy), beneficence,
nonmaleficence and justice must guide research in order to protect the dignity,
rights, safety and
• well-being of research participants while conducting Biomedical and Health
Research.
• These basic principles have been further expanded into 12 general principles:
1. Principle of essentiality
2. Principle of voluntariness
3. Principle of non-exploitation
4. Principle of privacy and confidentiality
5. Principle of professional competence
6. Principle of risk minimization
7. Principle of accountability and transparency
8. Principle of Maximization of Benefit
9. Principle of Institutional Arrangements
10. Principle of Social Responsibility
11. Principle of Totality of Responsibility
12. Principle of Environmental Protection
✓ Section 2: Statement of General Principles
• There are some general issues that must be kept in focus during the conduct of
biomedical and health research involving human participants.
• It provides
(i) Benefit-risk assessment
(ii) Privacy and confidentiality
(iii) Distributive justice
(iv) Payment for participation
(v) Compensation for research related harm
(vi) Conflict of interest
(vii) Community engagement
(viii) Post-research access and benefit sharing
(ix) Storage of Biological Material/datasets
(x) Collaboration in research
(xi) Public health and socio behavioural research
(xii) Role of Agencies / Sponsors & Governance of Research
(xiii) Biosafety in laboratories and hospitals
✓ Section 3: Responsible Conduct of Research (RCR)
• Major components of RCR are values and policies; planning and conducting
research; reviewing and reporting research; responsible authorship and publication
aspects.
• The following should be established prior to conducting research:
(i) Conflict of Interest policies
(ii) Safeguards for data acquisition, management, sharing and ownership
(iii) Policies for handling research misconduct including fabrication, falsification
and plagiarism
✓ Section 4: Ethical Review Procedures
• Procedures Section 4 gives details about composition, structure, roles, and
responsibilities of ethics committee (EC) established by the institution involved in
health and biomedical research.
• The EC is responsible for scientific and ethical review of research proposals and
should have well defined standard operating procedures (SOPs) for all functions.
• The EC should be multidisciplinary, competent and independent in its functioning
with the chairperson and 50% members as non-affiliates.
• Ethical issues related to reviewing a protocol:
(i) Social values
(ii) Scientific design and conduct of study
(iii) Benefit-risk assessment
(iv) Selection and recruitment of participants
(v) Payment for participation
(vi) Protection of privacy and confidentiality
(vii) Community considerations
(viii) Review of informed consent process
(ix) Disclosure of conflict of interest
(x) Qualification of researchers and adequacy of study sites
✓ Section 5: Informed Consent Process
• Informed consent is a continuous process involving three main components:
(a) Providing relevant information to potential participants
(b) Ensuring competence and comprehension of the information and
(c) Voluntariness of participation
• Essential components of ICD (Informed Consent Document):
(i) Statement mentioning that it is research
(ii) Purpose and methods
(iii) Duration, frequency, methods
(iv) Benefits to participant, community or others
(v) Foreseeable risks, discomfort or inconvenience
(vi) Confidentiality of records
(vii) Payment/reimbursement for participation
(viii) Treatment and/or compensation for injury
(ix) Freedom to participate/withdraw
(x) Identity of research team and contact persons
✓ Section 6: Vulnerability
• Vulnerable Persons are individuals/belonging to certain groups of persons who are
relatively or absolutely incapable of protecting their own interests.
• Individuals are considered to be vulnerable if they are:
(i) Socially, economically or politically disadvantaged and susceptible to
exploitation
(ii) Incapable of making a voluntary informed decision for themselves or if their
autonomy is compromised temporarily or permanently
Able to give consent, but their voluntariness or understanding is compromised due
to their situational conditions
(iii) Unduly influenced either by the expectation of benefits or fear of retaliation in
case of refusal to participate, which may lead them to give consent.
✓ Section 7: Clinical Trials of Drugs and Other Interventions
• Clinical trials must be conducted in accordance with the Indian GCP guidelines,
Declaration of Helsinki, National Ethical Guidelines for Biomedical and Health
Research Involving Human Participants (2017), amendments to the Drugs &
Cosmetics Act (1940), and Rules (1945) and other applicable regulations and
guidelines.
• Clinical trial interventions could be of drugs, vaccines, biosimilars, biologics,
phytopharmaceuticals, radiopharmaceuticals, diagnostic agents, public health or
technologies, devices, surgical techniques or traditional systems of medicine, etc.
• Clinical trials must be prospectively registered with CTRI, which is mandatory for
trials under the purview of CDSCO.
• Clinical trials with stem cells should follow the National Guidelines for Stem Cell
Research, 2017.
• Trials on devices should follow the same requirements as for new drugs.
Similarly, surgical interventions must also follow the ethical guidelines.
✓ Section 8: Public Health Research
• Ethics in public health apply to both practice and research, both of which utilize
epidemiology and methods of other disciplines to ensure better societal conditions
for healthier lives.
• Benefits and risks in public health research may not be limited to an individual,
but may influence communities, populations and the environment.
• Public health practice involves data collection through surveillance, vital statistics,
disease reporting and registries.
• Principles of public health research ethics
(i) Principle of respect for autonomy, rights and dignity
(ii) Principle of beneficence
(iii) Principle of non-maleficence
(iv) Principle of social justice
(v) Principle of reciprocity
(vi) Principle of solidarity
(vii) Principle of accountability and transparency
✓ Section 9: Social and Behavioural Sciences Research for Health
• Social and behavioural sciences is often different from clinical, biomedical and
public health research.
• Social and behavioural sciences include, but are not limited to, anthropology,
sociology, psychology, philosophy, political science, economics, history,
communications and education.
• Safety measures should be in place to protect the privacy and confidentiality of
research participants and/or research teams in the field collecting sensitive data.
✓ Section 10: Human Genetics Testing and Research
• Genetic test results have familial/societal implications, therefore, maintaining
confidentiality and providing pre- and post-test non-directive counselling by
qualified persons is important.
• Written consent should be obtained for genetic screening, confirmatory tests,
specific interventions, pre-symptomatic testing, next generation sequencing,
prenatal or carrier testing, genomic studies, use of embryos/foetal tissue, etc.
• Genetic screening should be purposive, with established provisions for disease
management, treatment and counselling.
✓ Section 11: Biological materials, Biobanking and Datasets
• Biological material may be prospectively collected or may be left over from
earlier studies or clinical services, e.g. biological fluids, dried blood spots, tissues,
organs, etc.
• Ethical issues such as ownership of samples or data, transfer of biospecimens,
custodianship, secondary use, return of results, etc. are important.
• Informed consent should provide information about the commercial value of
samples or data, if applicable, with clarity about benefit sharing.
• Material transfer agreement (MTA) should be executed if the biospecimens are
likely to be shipped to collaborators within or outside the country.
✓ Section 12: Research during humanitarian Emergencies and Disasters
• A humanitarian emergency or disaster is an event or series of events that
represents a critical threat to the health, safety, security or well-being of a
community or other large group of people, usually covering a wide land area.
• For the purpose of these guidelines, humanitarian emergencies and disasters
include both man-made and natural ones, some of which occur at periodic
frequency.