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ETHICS
Ethics on biomedical research and Publication
ethics
Dr.Kathiravan
1st yr MRCPCH resident
KIMS Cuddles 1
LEARNING
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OBJECTIVES
• Ethics
• Evolution of Research Ethics
• ICMR Guidelines 2017
• Publication Ethics
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ETHICS
• ETHOS – Moral
• meaning pertaining to character or moral nature
• Rules or Guidelines that establish what conduct is right or wrong for Individuals and groups
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PRINCIPLES
• Autonomy
Enable patients to make decisions by themselves
• Non-Malefience
Above All – DO NO HARM
• Beneficience
Principle of doing good
Prevent or remove harm
• Justice
Setting aside Bias
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PRINCIPLES
Few Other:
Veracity
Accurate info in an understandable way
Fidelity
Faithful – Meeting patient's reasonable expectations
Confidentiality
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THEORIES OFMaster
ETHICStitle style
• DEONTOLOGY
Action is good Result may be good or bad
• CONSEQUENTIALISM
Action may be good or bad Result is good
• UTILITARIANISM
Greatest good for the greatest numbers
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Multiple MasterExperiments
Inhumane title style
1. Nazi doctor’s Experiments 1942 – 1945
2. Mengele experiment on twins 1943 – 1945
3. Tuskegee syphilis study 1932 - 1972
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Click toGuidelines
Ethical edit Master title style
• The Nuremberg Code of 1947 was the first international treatise on the
ethics of research involving human beings and highlighted the essentiality of
obtaining voluntary consent.
Principle ?????
Autonomy
• In 1964, the World Medical Association formulated guidelines on conducting
research on humans, known as the Declaration of Helsinki 1964. This
guidelines has undergone several revisions.
• The main comprehensive was Belmont Report. 1978
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ICMR to edit Master
Ethical title style
Guidelines
• In India, 1976-88 study undertaken by the Indian Council of Medical
Research that observed the natural course of cervical lesions in 1158
women without offering treatment until cancer developed.
• 1980
• 2000
• 2006
• 2017
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ICMR to edit Master
Ethical title2017
Guidelines style
• It has 12 Sections and 2 Annexures
• 7 new chapters were added
• 187 pages
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“
SECTIONS
1. Statement of general principles
2. General Ethical issues
3. Responsible conduct of research
4. Ethical review procedures
5. Informed consent process
6. Vulnerability
7. Clinical trial of drugs and other interventions
8. Public health research
9. Social and behavioural sciences research for health
10. Human genetics testing and research
11. Biological materials, biobanking and datasets
12. Research during humanitarian emergencies and
disasters
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1. Statement
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Master Principles
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1. Principle of Essentiality
2. Principle of Voluntariness
3. Principle of Non-exploitation
4. Principle of Social Responsibility
5. Principle of Ensuring Privacy and Confidentiality
6. Principle of Risk Minimization
7. Principle of Professional Competence
8. Principle of Maximization of Benefit
9. Principle of Institutional Arrangements
10. Principle of Transparency and Accountability
11. Principle of Totality of Responsibility
12. Principle of Environmental Protection
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2. General Ethical Issues
• Benefit risk assessment
• Informed consent process
• Privacy and Confidentiality
• Distributive Justice
• Payment for Participation
• Compensation for research related harm
• Ancillary care
• Conflict of Interest
• Selection of Vulnerable and special groups
• Community engagement
• Post-research access and benefit sharing
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3. Responsible titleof
conduct style
Research
ICMR endorses Publication Policy of ICJME
International Committee of Medical Journal Editors on authorship
1. Substantial contributions to the conception or design of the work, or the acquisition, analysis, or
interpretation of data for the work
2. Drafting the work or revising it for important intellectual content
3. Final approval of the version to be published
4. Agreement to be accountable for all aspects of the work and ensuring that questions related to the
accuracy or integrity of any part of the work are appropriately investigated and resolved
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3. Responsible conduct title style
of Research
Publication Policy
• The primary author should be the person who has done most of the research work related
to the manuscript being submitted for publication
• Thesis authorship
o IEC approval / Opportunity to the student to be given as First author
o Institutions should have authorship policies
o Journals are advised
o Research misconduct – Fabrication/Falsification/Plagiarism
• If the research results not generated from study - Fabrication
• Generated by manipulating data - Falsification
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3. Responsible titleof
conduct style
Research
International Studies
• Trial registration in the CTRI was made mandatory by CDSCO on 15 June
2009 for clinical trials
• Health ministry’s screening committee
• Any research involving exchange of biological material/specimens with
collaborating institutions outside India must sign MTA ( material transfer
agreement)
• Foreign Contributuion Regulation act 2010
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4. Ethical Master
Review title style
Procedures
Registration of IEC
• The New Drugs and Clinical Trial Rules 2019, Chapter IV, “Ethics Committee for
Biomedical and Health Research” states that all ethics committees reviewing
biomedical research should be registered with the authority designated by the
Central Government in the ministry of health and family welfare, Department of
Health Research (DHR)
• Ethics committee is registered with the Central Drugs Standard Control
Organization (CDSCO) portal (https://cdscoonline.gov.in/)
• Approving biomedical research other than clinical trials, the committee is to be
registered with the Department of Health Research (DHR) – (https://naitik.gov.in/)
5 years validity with CDSCO and renewal of registration to be done
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Registration of Trialstitle style
The Clinical Trials Registry – India, linked to WHO registry, was launched on 20 July 2007 by
ICMR, as a free and online public record system for registration of clinical trials, PG thesis and
other biomedical research being conducted in the country
Trial registration in the CTRI was made mandatory by CDSCO on 15 June 2009 for clinical
trials that are registered under the Drugs and Cosmetics Act and its rules. Registration with
CTRI is voluntary for other biomedical and health research
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4. Ethical Master
Review title style
Procedures
• EC members 7 – 15, 50% outside the institute with not more than 3yrs tenure
• 5 for the quorum (medical/non-medical/lay-person/non-affiliated/chairperson)
• One institute can have 1 or more IEC
• Two or more institutes can have one IEC
• Chair/Vice Chair, Member Secretary/Alternate, Basic Scientists, Clinicians, Legal experts, layman
persons, social scientists
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5. Informed Consent Process
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• Two Partsto edit Master title style
1. Patient/participant information sheet PIS
2. ICF
• 10 Essential points to be covered in ICF (pg-50)
• 4 Optional points can be covered
• PIS/ICF copy to participants
• Waiver of ICF may be given
Retrospective studies
Anonymized biological samples / data
Research on data available on public domain
Research during humanitarian emergencies and disaters
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6. Vulnerability
• Vulnarere – Incapable of protecting their own interests
• Children, LGBT, PMWI, BC, Tribals, Refugees, Terminally ill, Prisoners, Students
• Legal Representative Consent
• Children – Assent (7-12yrs Oral and 12-18yrs written) approved by EC
• Assent is vital and also ICF ( both parents consent is required shall be determined by the IEC)
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7. Clinical Master
Trials title style
of Drugs
• Apart from EC permission other permission as per Drugs and Cosmetic Act 1940 to be taken
• New Drugs and Clinical Trials Rules, 2019
• All clinical trials must be registered with the CTRI
• The academic clinical trial as per GSR 313(E) dated 16 March 2016
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8. Public Master
Health title style
Research
• National Programs related research
• Program evaluation research
• Implementation research
• Public surveillance research
• Community trials
Consent
• Oral consent
• Broad consent
• Group consent
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9. Social andMaster title style
Behavioural Sciences Research for
health
• Social and behavioural sciences include anthropology, sociology, psychology, philosophy,
political science, economics, history, communications and education
Consent
• Community consent
• Participant consent
• Waiver off consent
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10. Human Master title style
Testing and Research
• Genetic counselling mandatory
• The researcher cannot reveal the genetic information to family members without the participant’s
permission
• Gene therapy/gene editing
• Research on human embryo
• Pre-natal diagnosis
• Population screening on rare diseases
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11. Biological title Biobanking
Materials, style and Datasets
• Anonymous
• Anonymized ( Irreversible and Reversible )
• Identifiable
Consent
• Blanket
• Specific
• Tiered
• Delayed
• Dynamic
• Waiver
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12. Research duringtitle style
Humanitarian Emergencies
and Disasters
• Pre-emptive research preparation for future humanitarian emergency
• Waiver off can be requested but EC will decide ( based on risk vs benefit )
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2023Master title style
Objective
The purpose of these biomedical research and healthcare
guidelines is to
• Ensure ethical conduct
• Address emerging ethical challenges in the field of Artificial
Intelligence
• Provide a framework for ethical decision – making in medical
AI during the development, deployment, and adoption of AI-
based solutions.
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To conclude
• Research is a privilege given to you do not misuse
• Ethics of research is paramount
• EC approval is must
• Keep yourself about the new updates and new regulations
• Read ICMR guidelines multiple times
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THANK YOU
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