ETHICAL GUIDELINES IN CLINICAL RESEARCH
GENERAL INTRODUCTION
Ethical guidelines in clinical research refer to the general
principles of biomedical research involving human participants.
In India, these guidelines are issued by the Indian Council of Medical
Research (ICMR) and are commonly known as the ICMR Code of
Ethics.
ICMR CODE CONSISTS OF:
a) Statement of General Principles on research involving
human participants in biomedical research.
b) Statement of Specific Principles on research involving
human participants in specific areas of biomedical research.
These statements and principles may be modified, amended,
substituted, or added from time to time as per scientific and ethical
advancements.
GENERAL STATEMENT
Medical and related research involving human beings as research
participants should ensure that:
1.
Purpose of Research
The research should be directed towards the advancement of knowledge
about the human condition and for the benefit of society as a
whole.
2.
Conduct of Research
Research must be conducted in a morally, ethically, and professionally
sound manner.
The dignity, well-being, transparency, and fair professional treatment
of participants must be maintained.
3.
Evaluation and Safety
Continuous evaluation at all stages of research is mandatory
to ensure the safety and protection of human life.
GENERAL ETHICAL PRINCIPLES
All research involving human subjects must be conducted in accordance with three
basic ethical principles, namely:
- Respect for Persons
- Beneficence
- Justice
These guidelines focus on the application of these principles in biomedical
research involving human participants.
a) RESPECT FOR PERSONS
Respect for persons includes two fundamental ethical considerations:
1.
Respect for Autonomy
- Every
individual has the right to make informed and voluntary decisions.
- Autonomy
requires:
- Rational capacity
- Freedom from coercion
or undue influence
- Researchers
must respect the decisions of autonomous individuals.
2.
Protection of Persons with Impaired or
Diminished Autonomy
- Some
individuals (e.g., children, mentally ill, unconscious patients) may not
be capable of self-determination at all times.
- Such
participants require special protection and additional safeguards.
b) BENEFICENCE
Beneficence refers to the ethical obligation to:
- Maximize possible
benefits
- Minimize potential
harms, risks, and wrongs
Researchers must ensure that the risk-benefit ratio is
favorable and scientifically justified.
c) JUSTICE
In research ethics, justice primarily refers to distributive justice,
which means:
- Equitable selection of
research participants
- Fair distribution of
both the burdens and benefits of
research
No group should be unfairly burdened or unjustly
excluded from the benefits of research.
TWELVE BASIC ETHICAL PRINCIPLES
(Common to all areas of Biomedical Research involving Human
Participants)
1) Principle of Essentiality
All biomedical research involving human subjects must be absolutely
essential and undertaken only after careful consideration of
all possible alternatives.
Human participants should be used only when the research question
cannot be answered otherwise.
2) Principle of Voluntariness and Informed Consent
The concepts of voluntariness and informed consent must
apply:
- To
the community as a whole, and
- To
each individual research participant
Participation should be free, voluntary, informed, and without
coercion or undue influence.
3) Principle of Non-Exploitation
Irrespective of socio-economic status, literacy, or education level,
all research participants must be:
- Fully
informed about risks, benefits, and consequences of the
research
- Protected
from exploitation, inducement, or unfair advantage
4) Principle of Privacy and Confidentiality
The identity, data, and records of research participants
must be:
- Kept
confidential
- Not
disclosed without valid scientific or legal justification
5) Principle of Precaution and Risk Minimization
Due care and caution must be taken to ensure that:
- Participants
are exposed to minimum possible risk
- Irreversible harm
is avoided
- Risks
are reasonable in relation to anticipated benefits
6) Principle of Professional Competence
All biomedical research must be conducted only by competent,
trained, and qualified persons who have:
- Adequate
scientific knowledge
- Appropriate
ethical training and experience
7) Principle of Accountability and Transparency
Research must be conducted in a:
- Fair, honest, impartial,
and transparent manner
- Research
records and data must be accurately maintained and
preserved for a reasonable period
8) Principle of Maximization of Public Interest and
Distributive Justice
Research should be conducted to:
- Benefit
humanity as a whole, and
- Not
only the socially or economically privileged sections
There must be equitable distribution of benefits and burdens.
9) Principle of Institutional Arrangements
All necessary institutional approvals, ethics committee clearances,
and administrative arrangements must be:
- Made
in a bonafide and transparent manner
- Properly
documented, maintained, and preserved
10) Principle of Public Domain
After due experimentation and evaluation:
- Research
results should be brought into the public domain
- Dissemination
should occur through scientific publications, in
accordance with laws and regulations in force
11) Principle of Totality of Responsibility
All persons directly or indirectly involved in research
have the responsibility to:
- Continuously monitor and
review the research
- Take
appropriate remedial action at all stages to safeguard
participants
12) Principle of Compliance
All stakeholders must strictly adhere to:
- Applicable
rules, regulations, ethical guidelines, and norms
- Directions
issued by regulatory authorities and ethics committees
BASIS OF THESE GUIDELINES
These ethical principles are based on national and international frameworks
including:
- ICMR
– Indian Council of Medical Research
- COC / COSCO
– Codes of Conduct
- CCP
– Clinical and Community Practice principles
- International Ethical
Guidelines (e.g., Declaration of
Helsinki, CIOMS)
ETHICS REVIEW BOARD (ERB)
DEFINITION
An Ethics Review Board (ERB) is an independent body
consisting of medical/scientific and non-medical/non-scientific members,
whose primary responsibility is to protect the rights, safety, dignity,
and well-being of human participants involved in biomedical and
clinical research.
ERB IS ALSO KNOWN AS:
- Institutional Ethics
Committee (IEC)
- Institutional Review
Board (IRB)
- Ethics Committee (EC)
(All terms are used interchangeably in different regulatory frameworks.)
ROLE AND FUNCTIONS OF ERB
- Ethical
review of research protocols
- Risk–benefit
assessment
- Protection
of vulnerable populations
- Review
of informed consent process
- Ongoing
monitoring of approved research
- Ensuring
compliance with ethical and regulatory guidelines
COMPOSITION / CONSTITUTION OF IRB (IEC)
The composition of the IRB should ensure adequate expertise,
independence, diversity, and ethical competence to review the scientific,
medical, and ethical aspects of proposed research.
NUMBER OF MEMBERS
- The
IRB should consist of minimum 7–15 members
(ICMR recommends at least 7 members; many institutions have 9–15)
TYPICAL COMPOSITION OF IRB / IEC
1.
Chairperson
- Preferably
from outside the institution
- Ensures
independence and impartiality
2.
Basic Medical Scientist(s)
(1–2)
- From
disciplines such as pharmacology, physiology, microbiology, etc.
3.
Clinician(s) (1–2)
- Preferably
from different specialties
- May
be from the same or different institutions
4.
Legal Expert / Retired Judge
- Provides
guidance on legal and regulatory compliance
5.
Social Scientist / Social Worker
- Represents
social, cultural, and community perspectives
6.
Philosopher / Ethicist / Theologian
- Addresses
ethical, moral, and value-based issues
7.
Lay Person / Community Representative
- Represents
the general public’s viewpoint
- Should
be non-scientific and non-medical
8.
Member Secretary
- Usually
from within the institution
- Responsible
for coordination, documentation, and communication
IMPORTANT POINTS (FOR EXAMS)
- Chairperson
should be external → ensures independence
- Combination
of scientific + non-scientific members is mandatory
- Lay
person ensures community perspective
- Legal
expert ensures regulatory compliance
- Member
Secretary handles administrative functions
