Ethics in medical research

1. Ethics in Research
Prof (Dr) C M Singh

2. Contents
• Research and its 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 is done?
• 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
• Ethics are 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 Ethical Research
• 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 Research Ethics
• 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 Ethical Principles
• Nuremberg code – 1947
• WMA (World Medical Association) Declaration of Helsinki – 1964
• Belmont Report – 1979
• ICMR code - 2006

8. General Guidelines
• Every proposal 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 degree of 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
• Lays out 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
within The 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 concerning research 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 of Research 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 ensure ethical 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 an IEC
• 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
• Exempted from review : Research on educational practices carry no
risk
• Expedited review : Minimal risk
• Full review : higher perceived risk

23. Informed consent
• Principal means 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
• Right to 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 guidelines for 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.

26. Thank You