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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).
INSTITUTIONALETHICS
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 OFAPPLICATION 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
FULLREVIEW
 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 consideredfor 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 DESIGNAND 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
CAREAND 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

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institutional ethics committee

  • 2. SLIDE INDEX • INTRODUCTION • DECLARATION OF HELSINKI • ISTITUTIONAL ETHICS COMMITTEE • STRUCTURE • MEMBERS • FUNCTION OF IEC • SUBMISSION OF APPLICATION • REVIEW • DECISSION • CONFLICT OF INTEREST • CONCLUSION
  • 3. 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. .
  • 4. 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
  • 5.  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
  • 6.
  • 7. 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
  • 8. 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
  • 9. 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
  • 10. 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.
  • 11. IRB (Institutional Review Board) or ERB (Ethics Review Board) or REB (Research Ethics Board).
  • 12. INSTITUTIONALETHICS 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.
  • 13. 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
  • 14. 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
  • 15. 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
  • 16. 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.
  • 17. 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.
  • 18. SUBMISSION OFAPPLICATION 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
  • 19. REVIEW OF PROJECT • Scientific evaluation should be completed before ethical evaluation • Evaluate possible risks to the subjects with proper justification • Expected benefits
  • 20. • 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
  • 21.
  • 22.  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
  • 23. FULLREVIEW  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
  • 24. 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
  • 25. EXEMPTED FROM REVIEW Proposals with less than minimal risk Ex: research on educational practice, • instructional technics, curricula, • classroom management methods
  • 26. Following are consideredfor 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
  • 27. SCIENTIFIC DESIGNAND 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
  • 28. 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
  • 29. CAREAND 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
  • 30. 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.
  • 31. 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.
  • 32. 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)
  • 33. 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.
  • 34.  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.
  • 35. 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.
  • 36. 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)
  • 37. 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

Editor's Notes

  1. Minimum risk would be defined as one which may be anticipated as harm or discomfort not greater than that encountered in routine daily life activities or during performance of routine examinations or tests.