Ethical Guidelines for Biomedical Research on Human Participantscdsaindia.in/sites/default/files/03_...
Transcript of Ethical Guidelines for Biomedical Research on Human Participantscdsaindia.in/sites/default/files/03_...
Ethical Guidelines for
Biomedical Research
on Human ParticipantsDr P Paul Kumaran MBBS, BA (Psychology), MPH
Scientist E [Deputy Director Medical]
National Institute for Research in Tuberculosis (ICMR)
Madurai, Tamil Nadu, India
[email protected] +91 94432 24962
Ethics: What is it ?
Synonym: Moral Philosophy
Definition: Systematizing, defending, and recommending
concepts of right and wrong behaviour
Moral code of conduct defining the right and
wrong behaviour in a civil society and comes
from within
Different from Law which regulates the external behaviour
Context: Geographic & Cultural
Universal fact: All human beings are vulnerable, can suffer
from harm and cause harm
Humans being fallible – educating is not guaranteed success
Traditional Medical EthicsRules for a good physician
Primary duty of physicians to their patients
Prime concern: safety and best interest of patients
Maintain confidentiality
Avoid institutional entanglements that would compromise
independent judgment
Refrain from unsavory financial deals
Refrain from advertising
Professionalism with patients and colleagues
Caraka Samhita
Indian Codes of Ethics
1-2 BC Caraka Samhita
1956 Code of Medical Ethics, MCI
1980 Policy Statement on Ethical Considerations involved in
research on Human Subjects
2000 Delhi Medical Council Ethics code
2000 Revised ICMR ‘Ethical Guidelines for Biomedical
Research on Human Subjects’
2001 Indian GCP Guidelines
2002 Medical Council of India Act amended
2002 Drugs & Cosmetics Act amended
2005 Revised Schedule Y, ART Guidelines
2006 Revised ethical guidelines, Stem cell guidelines,
Bio-banking guidelines, GM Food safety guidelines
Relationship DefinitionsRef: Oxford English Dictionary 2001
Principles A general truth that is used as a basis for a theory or system of belief for governing one’s personal behaviour
Guidelines A piece of advice or an indication as to how something should be done
RegulationsLaw: A rule/system of rules
made by an authority, recognized by a country / community as governing
actions of its members that controls correct behaviour
Rule: A statement of code
of practice and discipline that must be done or not done for
control of a group, community, or country
India - Guidelines
Guidelines
for
Stem Cell Research And
Therapy
Department of Biotechnology
and
Indian Council of Medical Research
Department of Health Research 2007
Bio-Medical Ethics ?
Clinical Ethics
Service related – provider / patient relationship (social)
Targets service providers – Code of Conduct
Research Ethics
Research with special reference to commercialized
research – vested interest of sponsor / investigator
Targets supervision / monitoring of research conduct
Bioethics
What are the Basic Principles?
Beneficence & Non-maleficence Do GOOD and Do NO HARM
Autonomy Respect for persons
Justice
Fairness, equal distribution of risks & benefits
Ultimate AIM: Human participant protection
Principles: interpreted for research!
Beneficence and Non-malficence Identification of Risks – minor / major
Benefits – direct / indirect / no benefit / society
Appropriate Risk vs Benefit ratio
Respect for individuals Informed Consent / Protection of Vulnerable people
Privacy and Confidentiality
Justice Equitable selection / Equal distribution of burdens and benefits
Post trial benefits / prior agreements
Indian Council of Medical
Research (ICMR) Founded in 1911 - Indian Research Fund Association
Renamed as ICMR in 1949
Apex organization to formulate, conduct, coordinate
and promote biomedical research
Network of Permanent Institutes & Regional Medical
Research Centres
Extramural research and large number of medical
colleges, universities, research institutions as part of
programme beneficiaries
ICMR: Mandate & Role
To undertake and support basic, epidemiological,
applied & operational research in areas of national
public health importance using tools including those
of modern biology
Basic strategy to foster a Research Culture
Improving or developing infrastructure, advocacy and
lobbying, awareness building on research from highest level
to the community, fostering community support, and
promoting an environment conducive to innovative research
Ethical Guidelines for Biomedical
Research on Human Participants ICMR released first ‘Policy Statement on Ethical
considerations involved in research on Human Subjects’
in February 1980
Revised Guidelines Document released in October 2000
Re-revised Guidelines Document released in 2006
Guidelines being converted into legislation to make these
mandatory
Draft Document for Legislation ready
To be placed in the parliament for legislation
1980 ICMR Policy Statement
Institutional Ethics Committees
It must be independent
Should meet at least once every 3 months
Informed consent
Clinical trials – drugs, plants and indigenous systems
Research on Children, Mentally deficient patients,
Prisoners, Medical students, Laboratory personnel
Financial reimbursements to research participants
Publications in IJMR
Major areas identified by Central Ethics
Committee on Human Research (1996) under Justice Venkatachalaiah, Chairman, NHRC
General principles
General Issues
Ethical Review Mechanism
Clinical evaluation of drug / devices / diagnostics / vaccines /
herbal remedies
Epidemiological research
Human Genetic Research
Transplantation research including fetal tissue transplantation
Assisted Reproductive technologies
Guiding Principles for Human
Participant Research
Ethical Guidelines for Biomedical Research on
Human Participants
ICMR (Feb 1980, rev Sept 2000, Nov 2006)
– http://www.icmr.nic.in/ethical.pdf
– One of the foreign guidelines accepted by the US
Federal Government
General Principles: Ethical research
i. Essentiality
ii. Voluntariness, informed consent, community agreement
iii. Non-exploitation
iv. Privacy and confidentiality
v. Precaution and risk minimization
vi. Professional competence
Ref: Ethical Guidelines for biomedical research on human participants, ICMR 2006
vii. Accountability and transparency
viii. Maximisation of public interest and of distributive justice
ix. Institutional arrangements
x. Public domain
xi. Totality of responsibility
xii. Compliance
General Principles…
Ref: Ethical Guidelines for biomedical research on human participants, ICMR 2006
Epidemiological Research:
Principles Individual welfare balanced against Community welfare
Informed Consent:
Individual / Community
Address ‘feel reluctant to disagree / refuse’
Avoid Inducements
Explain all ‘risks’, including loss of privacy
Maintain Confidentiality
Minimize possible harm and Maximize benefits
Disclosure of Conflict Of InterestRef: Ethical Guidelines for biomedical research on human participants, ICMR,
2006: Chapter V; 56-62
Major differences between
2000 & 2006 version of
Ethical Guidelines for Biomedical
Research on Human Participants
Differences: General Principles
Essentiality
Voluntariness, informed consent
and community agreement (ECs
shall decide about waiver)
Non-exploitation
Privacy and confidentiality
Precaution and risk
minimisation
Professional competence
Accountability and
transparency
Maximisation of the public
interest
Institutional arrangements
Public domain
Totality of responsibility
Compliance
Differences: Review Procedures
Basic responsibilities of ECs – Special situations
Composition – flexibility with specification for drug trial as per Schedule Y of Drugs & Cosmetics Act
Terms of Reference, Training, Regulation
Review Procedures – Exemption from review, expedited, full review
Submission of Application
Decision Making Process
Review Process, Periodic Review, Continuing / Interim Review
Monitoring
Record Keeping, Administration and Management
Special Considerations
Additions: General Issues
Informed consent of subject – Fresh / re-consent
Waiver of consent
Conflict of interest
Post – trial access
International Collaborative Research / Assistance
in Biomedical / Health Research
Researcher’s relations with media & publication
practices
Specific Principles
Clinical Trials of Drugs, Vaccines, Surgical procedures /
Devices, Diagnostic agents, Traditional remedies
Epidemiological Studies
Human Genetics & Genomic Research: Pedigree studies,
Genetic screening, Gene therapy and research, Bio-
banking …
Transplantation Research: Transplant from live or
cadaver, Embryonic & Fetal tissue, Xeno- transplantation,
Stem cell …
Assisted Reproductive Technologies
Compliance: Indirectly mandated
Indian GCP Guidelines – 2001
Indian Medical Council Act – 2002
Drugs and Cosmetics Act – 2005 amendment
Ethical Guidelines for Biomedical
Research on Human Participants
The BillTHE BIOMEDICAL
RESEARCH ON HUMAN SUBJECTS (REGULATION,
CONTROL AND SAFEGUARDS) BILL,
2007
Biomedical Research Ethics Bill
Thank You