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Ethics in Medical Research
- 1. Ethics in Research Prof(Dr) C M Singh
- 2. Contents • Research andits importance • Research in Ethics • Need of ethics in research • Objectives in Research Ethics • Declaration of ethical principles • General Guidelines • General Ethical Principles of ICMR
- 3. Why Research isdone? • For advancement – which is already known should be evaluated continuously • To further knowledge in a particular area • To increase understanding • To invent or develop new strategies, equipment's, etc.
- 4. Research Ethics • Ethicsare the moral principles that govern a person’s behavior. • Research ethics may be referred to as doing what is morally and legally right in research. • Research ethics is concerned with the responsibility of the researchers to be honest and respectful to all the individuals who are involved in research study • It should not inflict harm on researcher as well as research subjects.
- 5. Need of EthicalResearch • Research ethics provides guidelines for the responsible conduct of biomedical research. • It educates and monitors scientists/researchers conducting research to ensure a high ethical standard • It involves application of fundamental ethical principles to a variety of topics involving scientific research.
- 6. Objectives in ResearchEthics • To protect human participants • To ensure that research is conducted in a way that serves interests of individuals, groups and/or society as a whole • To examine specific research activities and projects for their ethical soundness, looking at issues such as management of risk, protection of confidentiality and process of informed consent.
- 7. Declaration of EthicalPrinciples • Nuremberg code – 1947 • WMA (World Medical Association) Declaration of Helsinki – 1964 • Belmont Report – 1979 • ICMR code - 2006
- 8. General Guidelines • Everyproposal for medical research on human subjects must be reviewed and approved by an independent ethics committee before it can proceed • Medical research involving human subjects must be justifiable on scientific ground • If the risk is entirely unknown, then the researcher should not proceed with the project until some reliable data are available • Voluntary consent of human subject is absolutely essential • Research subjects have a right to privacy with regard to their personal health information
- 9. Nuremberg Code -1947 1. Research participants must voluntarily consent to research participation 2. Research aims should contribute to the good of society 3. Research must be based on sound theory and prior animal testing 4. Research must avoid unnecessary physical and mental suffering 5. No Research projects can go forward where serious injury / death are potential outcomes
- 10. 6. The degreeof risk taken with research participants cannot exceed anticipated benefits of results 7. Proper environment and protection for participants is necessary 8. Experiments can be conducted only by scientifically qualified persons 9. Human subjects must be allowed to discontinue their participation at any time 10. Scientists must be prepared to terminate the experiment if there is cause to believe that continuation will be harmful or result in injury or death
- 11. Helsinki Declaration • Laysout basic ethical principles for conducting biomedical research and specifies guidelines for research conducted either by a physician, in conjunction with medical care, or within a clinical setting.
- 12. Unique Principles developed withinThe Helsinki Declaration • The necessity of using an independent investigator to review potential research projects • Employing a medically qualified person to supervise the research and assume responsibility for the health and welfare of human subjects • The importance of preserving the accuracy of search results • Suggestions on how to obtain informed consent from research participants
- 13. • Rules concerningresearch with children and mentally incompetent persons • Evaluating and using experimental treatments on patients • The importance of determining which medical situations and conditions are appropriate and safe for research.
- 14. Belmont Report • Beneficence– Risk to human subject be justified by the value or requirement of knowledge the study is expected to generate • Respect for participant – Person should be treated autonomous, obtain informed consent from research subject • Justice – Equal distribution of research benefits and burdens
- 15. ICMR Code -2006 • Essentiality • Voluntariness, informed consent and community agreement • Non exploitation • Privacy and confidentiality • Precaution and risk minimization • Professional competence General Principles
- 16. ICMR Code -2006 • Accountability and transparency • Maximization of the public interest and of distributive justice • Institutional arrangements • Public domain • Totality of responsibility • Compliance General Principles
- 17. Moral principles ofResearch Ethics • Non maleficence – no harm to the researcher as well as research participants • Beneficence – benefit to mankind • Autonomy – rights and dignity of individuals to be considered • Justice – benefits and risk should be fairly distributed among people
- 18. Mechanism to ensureethical compliance Institutional Review / Review Committee (IEC) • Committee that reviews research to ensure that the researcher is conducting research ethically • Comprises of at least 5 members from different fields
- 19. Institutional Review /Review Committee (IEC) Composition • Chairperson – (outside the institution) • One – two persons from basic medical science area • One – two clinicians • One legal expert or retired judge • One social scientist/ NGO representative • One lay person from the community • Member Secretary – from the same institution
- 20. Responsibilities of anIEC • To protect the dignity, rights and well being of the potential research participants • To ensure that universal ethical values and international scientific standards are expressed in terms of local community values and customs • To assist in the development and the education of a research community responsive to local healthcare requirements.
- 21. Function of IEC •IEC should review every review proposal on human participants before the research is initiated • Should ensure that a scientific evaluation has been completed before ethical review is taken up
- 22. Review Procedure • Exemptedfrom review : Research on educational practices carry no risk • Expedited review : Minimal risk • Full review : higher perceived risk
- 23. Informed consent • Principalmeans by which participant autonomy is recognized and given meaning • Explain as fully as is reasonable and appropriate, and in terms meaningful to the participants Aims and nature of research Who is undertaking it Who is funding it likely duration Why it is being undertaken Possible consequences of the research How the results are to be disseminated
- 24. Informed consent • Rightto refuse participation at any time • The researcher should explain how far research participants will be afforded anonymity and confidentiality’ • Participants should have the option of rejecting the use of data gathering evidences such as video cameras. • Participants should be made aware during the consent process whether data set will be made publicly available.
- 25. References • Ethical guidelinesfor biomedical research on human participants, Indian Council of Medical Research, New Delhi, 2006 • A guide to research ethics, University of Minnesota Center for Bioethics 2003 • World Medical Association Medical Ethics Manual , 3rd edition, 2015, ISBN 978-92-990079-0-7 • WMA declaration of Helsinki- ethical principles for medical research involving human subjects.
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