INSTITUTIONAL ETHICS

COMMITTEE
SIRISHA.A
POST GRADUATE
 SLIDE INDEX
• INTRODUCTION
• DECLARATION OF HELSINKI
• ISTITUTIONAL ETHICS COMMITTEE
• STRUCTURE
• MEMBERS
• FUNCTION OF IEC
• SUBMISSION OF APPLICATION
• REVIEW
• DECISSION
• CONFLICT OF INTEREST
• CONCLUSION
 INTRODUCTION
 The ethical and scientific standards for carrying out biomedical
research on human subjects have been developed and established
in international guidelines, including

Declaration of Helsinki,

CIOMS-International Ethical Guidelines for Biomedical

Research Involving Human Subjects, and

WHO and ICH Guidelines for Good Clinical Practice.

.
National Guidelines

ICMR – Ethical guidelines for biomedical research on

human participants.

Indian GCP Guidelines

Principle of precaution and risk minimization states that due

care and caution must be taken at all stages of research to
ensure that research participant and those affected by it
including community are put to minimum risk, suffer from no
known irreversible adverse effects
 A cardinal principle of research involving human
participants is ‘respect for the dignity of persons’.

 All guidelines require the ethical and scientific review of

biomedical research alongside informed consent
DECLARATION OF HELSINKI
• The World Medical Association has developed the
Declaration of Helsinki as a statement of ethical
principles to provide guidance to physicians and other
participants in medical research involving human
subjects. Medical research involving human subjects
includes research on identifiable human material or
identifiable data.
• PRINCIPLES:
It is the duty of the physician in medical research to
protect the life, health, privacy, and dignity of the human
subject.
Medical research involving human subjects must
conform to generally accepted scientific principles
Appropriate caution must be exercised in the conduct of
research which may affect the environment
The design and performance of each experimental
procedure involving human subjects should be clearly
formulated in an experimental protocol.
The research protocol should always contain a statement
of the ethical considerations involved and should indicate
that there is compliance with the principles enunciated in
this Declaration.
This independent committee should be in conformity
with the laws and regulations of the country in which the
research experiment is performed. The committee has the
right to monitor ongoing trials
Medical research involving human subjects should be
conducted only by scientifically qualified persons and under
the supervision of a clinically competent medical person.
Every medical research project involving human subjects
should be preceded by careful assessment of predictable
risks and burdens in comparison with foreseeable benefits to
the subject or to others
Physicians should cease any investigation if the risks are
found to outweigh the potential benefits or if there is
conclusive proof of positive and beneficial results.
Medical research is only justified if there is a reasonable
likelihood that the populations in which the research is
carried out stand to benefit from the results of the research
The subjects must be volunteers and informed
participants in the research project.
Every precaution should be taken to respect the privacy
of the subject, the confidentiality of the patient’s
information and to minimize the impact of the study on
the subject’s physical and mental integrity and on the
personality of the subject.
For a research subject who is legally incompetent,
physically or mentally incapable of giving consent or is a
legally incompetent minor, the investigator must obtain
informed consent from the legally authorized
representative in accordance with applicable law
 In publication of the results of research, the investigators
are obliged to preserve the accuracy of the results.
IRB (Institutional Review Board) or
ERB (Ethics Review Board) or
REB (Research Ethics Board).
 INSTITUTIONAL ETHICS
COMMITTEE (IEC)

 Independent body constituted of medical, non-medical,

scientific and non-scientific members whose responsibility is
to ensure the protection of the rights, safety and well-being of
human subjects involved in the trial by, among other things,
reviewing, approving & providing continuing review of trial
protocol & amendments.
 STRUCTURE OF IEC
Composition:

• Multidisciplinary and multisectorial in composition

• Number of persons- 8-12

Specific members of IECs:

• Chair person should preferably be from outside the

Institution to maintain the independence of the
Committee.

• Member secretary, from same institution should conduct

the business of the Committee
 MEMBERS OF IEC
Chair person

1-2 basic medical scientists

1-2 clinicians from various institutes

One legal expert or retired judge

One social scientist/representative of NG voluntary

agency

One philosopher/ethicist/theologian

One lay person

Member Secretary
ECs should establish standard operating procedures that
state

the functions and duties of the EC,

membership requirements,

the terms of appointment,

the conditions of appointment,

the offices,

internal procedures, and

the quorum requirements

 FUNCTIONS OF IEC
To provide competent review of all ethical aspects of the
project

Undertake review free from bias and influence

Provide advice to the researchers on all aspects of welfare and

safety of research participants

To protect dignity, rights and well-being of the potential

research participants.
To ensure universal ethical values and international
scientific standards in terms of local community values
and customs.

To assist in the development and the education of

research community responsive to local health care
requirements.
 SUBMISSION OF APPLICATION OF
RESEARCH TO IEC
• The following documents must be submitted:

- Trial Protocol (in prescribed format)

- Patient Information Sheet and Informed Consent Form and its

translations

- Investigators brochure

- Principal Investigator’s current C.V.

- Insurance policy/ compensation for participation

- Investigators Agreement with the sponsor

 REVIEW OF PROJECT

• Scientific evaluation should be completed before ethical

evaluation

• Evaluate possible risks to the subjects with proper

justification

• Expected benefits
• Adequacy of documentation for ensuring privacy,
confidentiality and justice issues

• The ethical review should be done through formal

meetings and should not resort to decisions through
circulation of proposals

• Decisions are preferably arrived at by consensus

 The IEC’s member secretary shall screen the proposals
for their completeness and depending on the risk involved
categorize them into:

 Expedited review

 Full review

 Exempted from review

 FULL REVIEW

 All research proposals presenting with more than minimal

risk.
 Projects that involve vulnerable population (children,
psychiatric patients etc.,)
 Full review is carried out in cases involving
 (a) collection of blood samples
 (b) Prospective collection of biological specimens eg. Skin
appendages, excreta saliva, placenta, amniotic fluid, sputum
etc
 EXPEDITED REVIEW

• Those with no more than minimal risk to research

participants may be subjected to this review

Ex: clinical studies of drugs and medical devices

the research involves already approved drugs

when a adverse event or unexpected adverse reaction is

reported
 EXEMPTED FROM REVIEW

Proposals with less than minimal risk

Ex: research on educational practice,

• instructional technics, curricula,

• classroom management methods

Following are considered for ethical review

 Scientific design and conduct of study

 Recruitment of Research Participants

 Care and Protection of Research Participants

 Protection of research participant confidentiality

 Informed Consent Process

 SCIENTIFIC DESIGN AND CONDUCT
OF STUDY
 Appropriateness of study design
 Statistical methodology including sample size calculation
 Risk vs anticipated benefits for research participants.
 Justification for Controls used
 Withdrawal criteria of participants
 Criteria for termination of trial
 Adequacy of monitoring and auditing the conduct of
research.
 Site facilities for handling emergencies.
 Reporting and Publication issues
 RECRUITMENT OF RESEARCH
PARTICIPANTS
• Study population – demographic characteristics

• Means by which participants are contacted and recruited.

• Means by which full information is conveyed to research

participants or their representatives

• Criteria for recruitment

Inclusion criteria

Exclusion criteria
 CARE AND PROTECTION OF
RESEARCH PARTICIPANTS
• Suitability of investigator qualifications and experience for
proposed study.

• Medical care to be provided to participants during and after

research.

• Adequacy of medical supervision

• Steps taken if participants voluntarily withdraw from study

• Informed consent

• Insurance and indemnity arrangements

 PROTECTION OF RESEARCH
PARTICIPANT CONFIDENTIALITY
• Description of persons who will have access to personal
data of research participants, including medical records
and biological samples.

• Measures taken to ensure the confidentiality and security

of personal information concerning research participants.
 INFORMED CONSENT PROCESS
 Adequacy, completeness and understandability of written and
oral information given to participants or their legal
representatives

 Clear justification for intention to include research

individuals who cannot consent

 Assurance that participants will receive any new information

that becomes available

 Contact details of persons whom the participants need to

contact for any complaints or queries.
 DECISION
Out right approval (at most, only very minor changes are
suggested. The application contained all necessary
information.)

Approval with modifications (there is enough information

to judge the study, but clarification or changes are
needed)

 Resubmit with more information (there is not enough

information to judge the application appropriately

Outright disapproval (there is no way the researcher can

ethically do study)
 RECORDS

 Constitution & composition of IEC.

 CV of all members & records of training

 SOPs of the IEC

 National & International guidelines

 Copies of protocol submitted for review

 All correspondence with IEC members and

Investigators regarding application, decision and follow

up.
 Agenda of all IEC meetings and Minutes signed by

chairperson

 Copies of decisions communicated to applicants

 Notifications issued for premature termination of study

 Final report of the study

 All records must be safely maintained after

completion/termination of study for 3 years.
 REVIEW
Periodic Review:

 Ongoing research may be reviewed at regular intervals of six

months to one year

Continuing Review:

 The IEC has the responsibility to continue reviewing approved

projects for continuation, new information, adverse event
monitoring, follow up.

Interim Review:

 Interim Review – decide special circumstances for review by

sub-committee – re-examination of proposal already examined
by IEC.
 CONFLICT OF INTEREST

• A conflict of interest is a set of conditions in which

professional judgment concerning a primary interest (such as
a patient’s welfare or the validity of the research) tends to be
unduly influenced by a secondary interest (such as financial
gain)
 CONCLUSION

• An Institutional Ethics Committee is a mandatory

requirement as per the ICMR which is the over –seeing
body of medical research in India

• It is an Independent body constituted of medical, non-

medical, scientific and non-scientific members whose
responsibility is to ensure the protection of the rights,
safety and well-being of human subjects involved in the
trial
Thank U