for mbbs students

1. Medical Ethics in view of
Medical Research
Dr. Anil Kumar
Associate Professor
Microbiology Department

2. • Nowadays, conflicts of interests between the
government & medical institutions, between medical
institutions and medical personnel, between physicians
and patients are getting more and more serious and
complex.

3. Ethics are not …
• Ethics is not the same as feelings
• Ethics is not religion
• Ethics is not following the law
• Ethics is not following culturally
accepted norms
• Ethics is not science

4. Ethics are …
• Moral Principles
• What is good and bad
• What is right and wrong
• Based on value system
• Ethical norms are not
universal – depends on the sub
culture of the society

5. Medical Ethics are …
• the rules of etiquette
adopted by the medical
profession to regulate
professional conduct with
each other, also towards
their individual patients
and towards society, and
includes considerations of
the motives behind that
conduct.

6. Research Ethics and Integrity
• Research, in all domains, is
an important activity of
every human society
• Represents a major
commitment on the part of
the various people
involved, whether in the
public or private sector.
• So, it is essential that the
research itself be
conducted with integrity, in
a responsible manner and
in accordance with high
ethical standards.
6

7. Purpose of Research …..
• The PURPOSE, of research is that it should
be directed towards the increase of
knowledge about the human condition in
relation to its social and natural
environment
• Mindful, that the human species is one of
the many species in a planet in which the
no less from the human species as any
other, and that such research is for the
betterment of all, especially the least
advantaged.

8. Proposed guidelines by WHO
•In 1982,the World Health Organisation (WHO) and the
The Council for International Organizations of Medical
Sciences (CIOMS) issued the ‘Proposed International
Guidelines for Biomedical Research involving Human
Subjects.’
•‘International Guidelines for Ethical Review in
Epidemiological studies’
•‘International Ethical Guidelines for
Biomedical research involving human subjects’.
1
0

9. ICMR FORMULATES ITS OWN
GUIDLINES
• In February 1980, the Indian
Council of Medical Research
released a ‘Policy Statement
on Ethical Considerations
involved in Research on
Human Subjects’
• for the benefit of all those
involved in clinical research
in India.

10. ICMR GUIDELINES BECOMES SOP’S
• "Ethical guidelines for
biomedical research on
human participants"
prepared by the Indian
Council of Medical
Research in 2006 came
as a welcome step in the
process of regulation of
research on human
subjects, since clear cut
Indian guidelines were
absent earlier

11. ICMR GUIDELINES ACCEPTED AS SOP’S
The guidelines have
been accepted as
the standard
operating manual by
Institutional Ethics
Committees (IEC) in
India

12. Institutional Ethics Committees
• The IECs should be
multidisciplinary and multi-
sectorial in composition. Found in
most health care facility’s
• Usually Ten to Twelve members
1. Chairperson
2. One -two persons from basic medical
science area
3. One -two clinicians from various Institutes
4. One legal expert or retired judge
5. One social scientist/ representative of
non-governmental voluntary agency
6. One philosopher/ ethicist/ theologian
7. One lay person from the community
8. Member Secretary

15. BASIC RESPONSIBILITIES OF ETHICAL COMMITTEE
• The basic responsibility of an Institutional
Ethics Committee (IEC) is to ensure a
competent review of all ethical aspects of the
project proposals received by it in an objective
manner.
• IECs should provide advice to the researchers
on all aspects of the welfare and safety of the
research participants after ensuring the
scientific soundness of the proposed research
through appropriate Scientific Review
Committee

16. SUBMISSION OF APPLICATION
• The researcher should submit an application in
a prescribed format along with the study
protocol as prescribed in SOP of IEC
concerned. The protocol should include the
following : -
1. The title with signature of Principal
Investigator (PI) and Co- investigators as
attestation for conducting the study.
2. Clear research aims and objectives

17. SUBMISSION OF APPLICATION
• Recent curriculum vitae of the Investigators
indicating qualification and experience.
• Inclusion and exclusion criteria.
• Precise description of methodology of the
proposed research, including sample size (with
justification), type of study design
(observational, experimental, pilot,
randomized, blinded etc.), intended
intervention, dosages of drugs, route of
administration, duration of treatment and
details of invasive procedures if any.

18. SUBMISSION OF APPLICATION
• Plan for statistical analysis of the study.
-- Informed consent .
-- informed consent forms in English and local
languages.
-- sample of patient information sheet .

19. SUBMISSION OF APPLICATION
• 14. Plans for publication of results - positive or
negative - while maintaining
• the privacy and confidentiality of the study participants.
All other relevant documents related to the study
protocol like investigator's brochure for trial on
drugs/ devices/ vaccines/ laboratory results
should be documented

20. All participants to be educated
and oriented on Ethics
before Starting the Research
Work

21. Informed Consent means
• Informed consent is a process
for getting permission before
conducting a healthcare study.
• Researcher may ask a research
participant/patient before
enrolling that person into a
clinical trial.
• Informed consent is collected
according to guidelines from
the fields of medical ethics and
research ethics.

22. Simple Signature do not End the
matters when thing go wrong
From a clinical ethics
perspective, informed
consent is a
communication
process, and should
not simply be treated
as a required form for
the patient’s signature
or Thumb Impression.

23. Informed choice linked with State
of Mind of the Patient
Similarly, the legal
concept of informed
consent refers to a
state of mind, i.e.,
understanding the
information provided
to make an informed
choice

24. Right of Participants to withdraw
from the Research assessments
• The right of participants in
research to decline to
participate, or withdraw, or
abstain from further
participation, has been
repeatedly emphasised by the
ICMR guidelines. It has been
clearly stated that the
patients can “withdraw
without penalty or loss of
benefits which the
participant would otherwise
be entitled to.”

25. Consent Forms to be Simple
and Understandable in local
language and familiar to
the participants

26. Privacy/Confidentiality
• conversations between
doctors and patients.
This concept is
commonly known as
patient- physician
privilege.

28. Look at the Matters with Human perception
and just for pureResearch

29. Things Can Go Wrong when you
do not Follow Ethics

30. • WHAT IS YOUR CHOICE MAKES
DIFFERENCE ???
• Medicine is about : “Can we?”
• Ethics is about: “Should we?”