MEDICAL ETHICS IN

RESEARCH PROPOSALS
( Indian contest )
Adopted by
Dr.T.V.Rao MD

19-06-2016

Dr.T.V.Rao MD

Why Program on Medical ethics

I wish to state this not a complete program on Medical ethics,

however it is made with many observations of the researchers and

postgraduate students who present the Thesis, research proposals
for PhD and application for ICMR projects, I wish this program can
be searched faster to make a basic idea when choosing the topic
presenting the work before the ethical committee,
Dr.T.V.Rao MD
Email doctortvrao@gmail.com
Mob 9961785124

19-06-2016

Dr.T.V.Rao MD

Ethical guidelines
The 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 search on human
subjects, since clear cut Indian guidelines
were absent earlier
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Dr.T.V.Rao MD

Research Ethics and Integrity

Research, in all domains, is an
important activity of every human
society and represents a major
commitment on the part of the
various people involved, whether
in the public or private sector.
Research results constitute the
basis for political and technical
decisions, it is essential that the
research itself be conducted with
integrity, in a responsible manner
and in accordance with high ethical
standards.
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Dr.T.V.Rao MD

History of Ethical Codes in Human

Research
The first International Statement on the ethics
of medical research using human subjects
namely, the Nuremberg Code was formulated
in 1947. Although informed consent for
participation in research was recorded in 1900,
the Nuremberg Code highlighted the
essentiality of voluntariness of this consent.
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Dr.T.V.Rao MD

Ethics incorporate Human

rights

Declaration of Human
Rights (adopted by the
General Assembly of the
United Nations)
expressed concern about
rights of human beings
being subjected to
involuntary
maltreatment
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Rights of Humans Redefined

In 1966, the International
Covenant on Civil and Political
As states -

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Rights specifically stated,

No one shall be subjected
to torture or to cruel,
inhuman or degrading
treatment or punishment.
In particular, no one shall be
subjected without his
consent to medical or

Dr.T.V.Rao MD

Helsinki Declaration
Based on the preliminary efforts
of the Council for International
Organisations of Medical
Sciences (CIOMS) in 1964 at
Helsinki, the World Medical
Association formulated general
principles and specific
guidelines on use of human
subjects in medical research,
known as the Helsinki
Declaration, which was revised
from time to time.
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Dr.T.V.Rao MD

NEW EDITION OF THE DECLARATION OF HELSINKI

In June 1964, the World
Medical Association (WMA)
has developed the
Declaration of Helsinki as a
statement of ethical
principles for medical
research involving human
subjects, including research
on identiable human
material and data.
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Proposed guidelines by WHO

In 1982,the World Health Organisation (WHO)
and the CIOMS issued the Proposed
International Guidelines for Biomedical Research
involving Human Subjects.
B -Subsequently the CIOMS brought out the
International Guidelines for Ethical Review in
Epidemiological studies in 1991 and
International Ethical Guidelines for Biomedical
Research involving Human Subjects
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ICMR FORMULATES ITS OWN GUIDLIENS

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.
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Most recent guidelines on Human

Research
The most recent documents on
ethics are
Those of UNESCOs The Universal
Declaration on Human Genome
and Human Rights (1997), The
International Declaration on
Human Gene Data (2003)and
Universal Declaration on
Bioethics and Human Rights
(2005).
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ICMR GUIDELINES BECOMES SOPS

"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
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ICMR guidelines accepted as

SOPs
The guidelines have

been accepted as
the standard
operating manual by
Institutional Ethics
Committees (IEC) in
India
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Purpose of Research to be Defined

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, mindful that the human
species is one of the many species in a planet in
which the well being of all species is under threat, no
less from the human species as any other, and and
that such research is for the betterment of all,
especially the least advantaged.
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GENERAL ETHICAL PRINCIPLES

General ethical principles of respect for
persons, duty to maximize possible benefits
and minimise possible harm are important
considerations in ethical guidelines. At the
same time it is essential that all individuals in
an epidemiological research are treated alike
keeping in mind the rules of distributive
justice
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GENERAL PRINCIPLES
The welfare of the individual has to be balanced
against the welfare of the community and
society at large. The C.I.O.M.S / W.H.O
Guidelines for Epidemiological Research
assume that the individuals or populations
being studied are capable of giving informed
consent understanding the implications of the
study.
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CONDUCTED under conditions

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, under
conditions of professional fair treatment and transparency;
and after ensuring that the participant is placed at no
greater risk other than such risk commensurate with the
well being of the participant in question in the light of the
object to the achieved.
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Regime of EVALUATION
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, and that each such evaluation shall
bear in mind the objects to be achieved, the means by
which they are sought to be achieved, the anticipated
benefits and dangers, the potential uses and abuses of the
experiment and its results, and above all, the premium that
civilised society places on saving and ensuring the safety of
each human life as an end in itself.
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STATEMENT OF GENERAL PRINCIPLES IN BIOMEDICAL

RESEARCH INVOLVING HUMAN PARTICIPANTS

Statement of Ethical Guidelines for Biomedical

Research on Human Participants shall be known as
the ICMR Code and shall consist of the following:(a) Statement of General Principles on Research
using Human Participants in Biomedical Research
(b) Statement of Specific Principles on Research
using Human Participants in specific areas of
Biomedical Research
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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
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Always assess the Technical

Appropriateness
The scientific evaluation
should ensure technical
appropriateness of the
proposed study. The IECs
should specify in writing
the authority under
which the Committee is
established.
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COMPOSITION of Ethical
Committee
The IECs should be
multidisciplinary and multi
sectorial in composition.
Independence and
competence are the two
hallmarks of an IEC. The
number of persons in an
ethics committee should be
kept fairly small
(8 - 12 members).
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All decisions are subject to Quorum

It is generally accepted that a
minimum of five persons is
required to form the quorum
without which a decision
regarding the research should
not be taken. The IEC should
appoint from among its
members a Chairman who
should be from outside the
Institution and not head of the
same
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Eligible to be a Chairman
The IEC should appoint from
among its members a
Chairman who should be
from outside the Institution
and not head of the same
members or Institute not
head of the same Institution
to maintain the
independence of the
Committee.
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Ethical Committee is composed of mixed

group of people
Other members
should be a mix of
medical/ non-medical,
scientific and nonscientific persons
including lay persons
to represent the
differed points of
view.
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The composition may be as follows

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
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As per revised Schedule Y of Drugs &

Cosmetics Act, 1940, amended in 2005,
As per revised Schedule Y of Drugs & Cosmetics Act, 1940, amended in
2005, the ethics committee approving drug trials should have in the quorum
at least one
representative from the following groups:
1. One basic medical scientist (preferably one pharmacologist).
2. One clinician
3. One legal expert or retired judge
4. One social scientist/ representative of non-governmental organisation/
philosopher/ ethicist/ theologian or a similar person
5. One lay person from the community.
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The Members can from other

Institutes too
The Ethics Committee (EC) can have as its members,
individuals from other institutions or communities with
adequate representation of age and gender to safeguard
the interests and welfare of all sections of the
community/society. If required, subject experts could be
invited to offer their views, for instance, a paediatrician for
paediatric conditions, a cardiologist for cardiac disorders
etc. Similarly, based on the requirement of research area,
for example HIV, genetic disorders etc. it is desirable to
include a member from specific patient groups in the
Committee.
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Training Ethical Committee Members

The EC members should be
encouraged to keep abreast of
all national and international
developments in ethics
through orientation courses on
related topics by its own
members or regular training
organized by constituted
body(ies), so that they become
aware of their role and
responsibilities
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Members to be trained on Good

Clinical Practice

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For drug trial review it is

preferable to train the IEC
members in Good Clinical
Practice. Any change in the
regulatory requirements
should be brought to their
attention and they should
be aware of local, social and
cultural norms, as this is the
most important social
control mechanism. .

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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 objectives and rationale for undertaking the
investigation in human participants in the light of existing
knowledge
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SUBMISSION OF APPLICATION
3. Recent curriculum vitae of the Investigators indicating qualification
and experience.
4. Participant recruitment procedures and brochures, if any.
5. Inclusion and exclusion criteria for entry of participants.
6. 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 anddetails of invasive procedures if any.
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SUBMISSION OF APPLICATION
7.Plan to withdraw or withhold standard therapies in the course of
research.
8.Plan for statistical analysis of the study.
9.Procedure for seeking and obtaining informed consent with sample
of patient information sheet and informed consent forms in English
and local languages.
10. Safety of proposed intervention and any drug or vaccine to be
tested, including results of relevant laboratory, animal and human
research.
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SUBMISSION OF APPLICATION
11. For research involving more than minimal risk, an
account of
management of such risk or injury.
12. Proposed compensation and reimbursement of
incidental expenses and management of research related
and unrelated injury/ illness during and after research
period.
13. An account of storage and maintenance of all data
collected during the trial
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SUBMISSION OF APPLICATION
14. Plans for publication of results - positive or negative - while
maintaining
the privacy and confidentiality of the study participants.
15. A statement on probable ethical issues and steps taken to tackle the
same like justification for washout of standard drug, or the use of placebo
control..

16. All other relevant documents related to the study protocol

like investigator's brochure for trial on drugs/ devices/
vaccines/ herbal remedies and statement of relevant
regulatory clearances.
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SUBMISSION OF APPLICATION
17.Agreement to comply with national and international Good Clinical
Practices (GCP) protocols for clinical trials.
18. Details of Funding agency/ Sponsors and fund allocation.
19. For international collaborative study details about foreign collaborators
and documents for review of Health Ministry's Screening
Committee(HMSC) or appropriate Committees under other
agencies/authority like Drug Controller General of India (DCGI)
20. For exchange of biological material in international collaborative study
aMoU/ Material Transfer Agreement between the collaborating partners.
21.A statement on conflict-of-interest (COI), if any.
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Standard Operating Procedures for Ethics

Committee

The guidelines have

been accepted as
the standard
operating manual by
Institutional Ethics
Committees (IEC) in
India.

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All participants to be educated and oriented

on Ethics
before Starting the Research Work

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Need for Educating many participants

and ethical committee Member
At present, ethical issues in
research in India do not get the
attention they deserve,
particularly outside major fulltime research organisations.
Utmost clarity is required to
avoid difficulties in
interpretation, or shades of
opinion not intended by the
ICMR.
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Trials on as yet non-approved drug

The guidelines state The
proposed trial should be carried
out, only after approval of the
Drugs Controller General of
India (DCGI), as is necessary
under the Schedule Y of Drugs
and Cosmetics
Act, 1940. The investigator
should also get the approval of
Ethical Committee of the
Institution before submitting the
proposal to DCGI.
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Have knowledge on Trails going on in

the Community

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Access to benefits of therapy

IT IS THE PART OF THE ETHICS

The Helsinki Declaration of the World

Medical Assembly, 2008(2), states that
at the conclusion of the study,
patients entered in to the study are
entitled to be informed about the
outcome of the study and to share any
benefits that result from it, for
example, access to interventions
identified as beneficial in the study or
to other appropriate care or benefits.
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The ICMR guidelines

After the clinical trial is over, if
indeed the drug is found
effective, it should be made
mandatory that the sponsoring
agency should provide the drug
to the patient till it is marketed
in the country and thereafter at
a reduced rate for the
participants whenever possible.
A suitable a priori agreement
should be reached on post-trial
benefits
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Informed Consent means

Informed consent is a process for
getting permission before conducting
a healthcare intervention on a person.
A health care provider may ask a
patient to consent to receive therapy
before providing it, or a clinical
researcher may ask a research
participant before enrolling that
person into a clinical trial. Informed
consent is collected according to
guidelines from the fields of medical
ethics and research ethics.
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All the Informed Consents to be Free,

Frank and Understandable to be Patients

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Getting Informed consent can be

challenging

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Consent and assent for epidemiological studies on

minors and school children
ICMR guidelines also
say: "the assent of the
child should be obtained
to the extent of the
childs capabilities such
as in the case of mature
minors from the age of
seven years up to the
age of 18 years.
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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.
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In-house monitoring and ongoing review

process
The greatest problem with the
working of the IEC in any
institute is the lack of an ongoing
monitoring process to ensure
that the guidelines have been
followed, that there is no
deviation from the protocol, and
that any adverse effects are
reported. In actual practice,
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Cohort Studies
These are longitudinal or prospective studies of a group of
individuals with differing exposure levels to suspected risk
factors. They are observed over a long period usually several
years. The rate of occurrence of the condition of interest is
measured and compared in relation to identified risk factors.
It requires a study of large number of participants for a long
time and involves asking questions, checking of records, routine
medical examination and sometimes laboratory investigations.
Individuals are being followed up as the cohort and it is
essential to identify precisely every individual to be studied.
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Follow the Principals of Cohort

Studies

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Research on archived ( retrospective}

specimens
The guidelines permit an
expedited review on research
involving clinical materials
(data, documents, records or
specimens) that have been
collected for non-research
(clinical) purposes. No further
instructions are provided as to
how this information is to be
dealt
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Waiver of consent

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ICMR guidelines mentions

that voluntary informed
consent can be waived if it
is justified that the research
involves not more than
minimal risk or when the
participant and the
researcher do not come into
contact or when it is
necessitated in emergency
situations.

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Consent Forms to be Simple and Understandable

in local language and familiar to the participants

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Trial on non-allopathic drugs and herbal

remedies

These have become more numerous in recent times,

particularly in medical colleges. The guidelines are quite
clear on this issue: when clinical trials of herbal drugs
used in recognised Indian Systems of Medicine and
Homeopathy are to be undertaken in Allopathic
hospitals, association of physicians from the concerned
system as co-investigators/collaborators / members of
the expert group is desirable
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Ethics of live operative workshops

Operative workshops call for a situation where a
visiting surgeon performs a procedure, which
may be major, on a patient whom s/he has not
seen before, or perhaps not interacted with in
any detail or any length of time before. It also
involves circumstances where's/he has no
responsibility for preoperative or postoperative
care; this is left to the parent institution
conducting the workshop.
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Support, guidance and reporting

We the Committee members have responsibility
Providing information, support and guidance to staff and students;
Administrative support for the Animal Research and Human Research
Ethics Committees;
liaising between Committees and applicants;
preliminary reviews of applications and provision of feedback to
applicants;
monitoring approved research projects;
developing, implementing, reviewing and updating policies and
procedures; and
reporting to the University, the National Health and Medical Research
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Dr.T.V.Rao MD
Council, and other organisations.

58

Look at the Matters with Human

perception and just for pure Research

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I am thankful to ..
Iam thankful to The Principal, Vice
principal, Medical Director, the great
efforts of Dr Sudha and Dr Vivek and all
the members of the Ethical committee
of Azezia Medical College Kollam Kerala
for making my job easier, and inspires
me to do work ethically
Dr.T.V.Rao MD
Chairman Intuitional Ethical Committee
Azezia Medical College Kollam Kerala
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References
Ref 1 ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCHON HUMAN
PARTICIPANTS, NDIAN COUNCIL OF MEDICAL RESEARCH NEW DELHI2006 ; M. S.
Valiathan Chairman Central Ethics Committee on Human Research ICMR, New
Delhi
2 ICMRs Ethical guidelines for biomedical research on human participants: need
for clarification N Ananthakrishnan, Shanthi AK ETHICS OF ETHICS COMMITTE.
Indian Journal of Medical Ethics Vol IX No 3 July - September 2012

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Program Created by Dr.T.V.Rao MD on

Basics to understand the Human Ethics
to Initiate the Medical research
Email
doctortvrao@gmail.com
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