ICMR ETHICAL GUIDELINES FOR
BIOMEDICAL RESEARCH ON HUMAN
SUBJECTS IN INDIA
NAME AND AFFILIATION OF FACULTY-IN-CHARGE:
NANDAKUMAR U.P.
ASSISTANT PROFESSOR
DEPARTMENT OF PHARMACY PRACTICE
NGSMIPS
CONTENTS
Introduction
General ethical principles
ICMR ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH
ON HUMAN SUBJECTS IN INDIA
These guidelines cover almost all areas of research on human subjects and
are further divided into various statements:
Statement of General Principles on Ethical Considerations involving
Human Participants
Statement of Specific Principles for Clinical Evaluation of
Drugs/Devices/Diagnostics/Vaccines/Herbal Remedies
Statement of Specific Principles for Epidemiological Studies
Statement of Specific Principles for Human Genetics and Genomics
Research
Statement of Specific Principles for Research in Transplantation
Statement of Specific Principles for Assisted Reproductive Technologies
According to ICMR guidelines, medical and related research using human
beings as research participants must necessarily ensure that:
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.
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 or scientific experimentation are
dealt with in a manner conducive to and consistent with their dignity and
well-being.
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
and use of the results thereof.
Accordingly, twelve general ethical principles have been proposed.
1. Principle of essentiality:
The research involving the use of human participants should be undertaken
only when it is considered to be absolutely essential after a due
consideration of all alternatives in the light of the existing knowledge.
2. Principle of voluntariness, informed consent and community
agreement:
Research participants should be fully apprised of the research, its impact
and risk of such research on the participant and others; and the research
participants must retain the right to abstain from further participation in the
research irrespective of any legal or other obligation.
Where any such research entails treating any community or group of
persons as a research participant, these principles of voluntariness and
informed consent shall apply to the community as a whole and to each
individual member who is the participant of the research or experiment.
In case the human participant is incapable of giving consent and research or
experimentation is considered essential to be conducted on such a person
incompetent to give consent, such consent and voluntariness shall be
obtained and exercised on behalf of such research participants by someone
who is empowered and under a duty to act on their behalf.
3. Principle of non-exploitation:
As a general rule, research participants should be remunerated for their
involvement in the research or experiment; and irrespective of the social
and economic condition or status, or literacy or educational levels attained
by the research participants, they should be kept fully apprised of all the
dangers arising in and out of the research.
4. Principle of privacy and confidentiality :
The identity and records of the human participants of the research or
experiment should be kept confidential as far as possible and no details about
identity should be disclosed without valid scientific and legal reasons.
5. Principle of precaution and risk minimisation:
Due care and caution should be taken at all stages of the research to ensure
that the research participants are subjected to minimum risk and suffer from
no known irreversible adverse effects
6. Principle of professional competence:
The research should be conducted at all times by competent and qualified
persons who act with total integrity and impartiality.
7. Principle of accountability and transparency:
The research or experiment should be conducted in a fair, honest, impartial
and transparent manner. Full and complete records of the research,
inclusive of data and notes, should be retained for a reasonable period of
time as it may be prescribed or considered necessary for the purposes of
post research monitoring, evaluation of the research, conducting further
research etc.
8. Principle of the maximisation of the public interest and of
distributive justice:
The research or experiment and its subsequent applicative use should be
conducted and used to benefit all human kind and not just those who are
socially better off.
9. Principle of institutional arrangements:
There shall be a duty on all persons connected with the research to ensure
that all the procedures required to be complied with and all institutional
arrangements required to be made in a bonafide and transparent manner.
10. Principle of public domain:
Any research, experimentation or evaluation should be brought into the
public domain so that its results are generally made known through
scientific and other publications.
11. Principle of totality of responsibility:
The professional and moral responsibility for the due observance of all the
principles and guidelines laid down generally or in respect of the research
devolves on all those directly or indirectly connected with the research.
12. Principle of compliance:
There is a general and positive duty on all persons, conducting, associated
or connected with any research entailing the use of a human participant to
ensure that the norms, directions and guidelines laid down are scrupulously
observed and duly complied with.
For more information, please refer:
Clinical Research Fundamentals and Practices- By, Vishal Bhansal, First
Edition, Chapter 4- Ethical issues in drug development, page no: 55-58.
