Ethical Guidelines for Biomedical Research on Human Participants Dr P Paul Kumaran MBBS, BA (Psychology), MPH Scientist E [Deputy Director Medical] National Institute for Research in Tuberculosis (ICMR) Madurai, Tamil Nadu, India ppaulkumaran@nirt.res.in +91 94432 24962
Ethics: What is it? Synonym: Definition: Context: Moral Philosophy 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 Universal fact: Geographic & Cultural All human beings are vulnerable, can suffer from harm and cause harm Humans being fallible educating is not guaranteed success
Traditional Medical Ethics Rules 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 Definitions Ref: 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 Regulations Law: 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
General Principles vii. Accountability and transparency viii. Maximisation of public interest and of distributive justice ix. Institutional arrangements x. Public domain xi. xii. Totality of responsibility Compliance 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 Interest Ref: 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, Biobanking 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 Bill THE BIOMEDICAL RESEARCH ON HUMAN SUBJECTS (REGULATION, CONTROL AND SAFEGUARDS) BILL, 2007 Biomedical Research Ethics Bill
Thank You