Ethical issues in research.pptx

An overview of international and Indian ethical codes for conducting research on human subjects

1. Ethical I ssues in Research RC Gupta Professor Emeritus National Institute of Medical Sciences Jaipur

2. Moral philosophy A set of moral principles W hat is right and what is wrong in human behaviour Ethics

3. Intellectual – Related to intellect i.e. ability to think logically and to understand things Honesty – Integrity/Probity/Truthfulness Intellectual Honesty A Basic Requirement of Research

4. Being honest is our moral duty This duty is particularly important when we communicate our ideas to others Communicating our ideas informs, and can persuade other people

5. Intellectual honesty is honesty in acquiring, analyzing, and communicating data/ideas We are being intellectually honest when we, knowing the truth, state that truth

6. Examples of Honesty in Research Pertinent facts and information are not purposefully omitted when they go against our hypothesis Facts are presented without bias, and are not twisted to give misleading impressions References , or earlier publications, are cited without bias where necessary

7. Research on human beings

8. For advancement of medical science, research on human subjects is unavoidable The purpose of using human subjects is: T o understand the causes, development and effects of diseases T o improve preventive, diagnostic and therapeutic methods

9. R esearch must have a strong ethical foundation, specially scientific research involving human beings

10. E thical principles common across scientific disciplines Duty to society Professional competence and discipline C onfidentiality Non-exploitation Non-discrimination Integrity Informed consent Conflict of interest Beneficence

11. The ethical principles apply to: The nature of the research project The conduct & behaviour of researchers

12. Historical events that raise new concerns Ethical lapses that require new safeguards Scientific advances that open new areas of research Changing cultural and social norms Ethics emerge, change, and evolve due to:

13. R esearch involving human participants should adhere to international ethical standards Indian ethical standards are no less exacting, and are at par with international ethical codes

14. Nuremberg Code ( 1947) Helsinki Declaration ( 1964) Belmont report ( 1978) Council for International Organizations of Medical Sciences ( 1993) Some International Ethical Codes

15. Nuremberg War Crimes Trials

16. Nuremberg Code ( 1947) Initiated discussion on: R ationale and justification for research R isk benefit analysis C ompetence of investigators V oluntary consent in research

17. Helsinki Declaration ( 1964) Brought out by World Medical Association and focused on: Individual’s rights to make informed decisions I nvestigators ’ duties R esearch participants’ welfare Revised in 1983 , 1989, 1996, 2000, 2008 and 2013

18. Belmont R eport Described the principles of autonomy, justice and beneficence E mphasized informed consent Introduced review by ethics committee

19. Council for International Organizations of Medical Sciences (CIOMS) Published International Ethical Guidelines for Biomedical Research Involving Human Subjects in 1993 which emphasized: Safety of research subjects Analysis of b enefit-risk balance Reporting of adverse drug reactions Need for pharmacovigilance

20. ICMR guidelines (2000, 2006) Genome Policy and Genetic Research (2000) Indian GCP (2001) Drugs and Cosmetics Act (2002) Assisted Reproductive Technology (2005) Stem Cell Research and Bio-banking (2006 ) Indian Ethical Codes

21. Ethical Review Procedures General Ethical Issues Clinical Evaluation of Drugs, Devices etc Epidemiological Studies Human Genetics and Genomics Research Research in Transplantation Assisted Reproductive Technologies

22. Broad e thical principles for researchers Respect for autonomy Justice Beneficence Non-maleficence

23. Respect for autonomy Autonomy is Latin for s elf-rule : We have an obligation to respect the decisions made by people concerning their own lives We must not interfere with the decisions made by competent adults, and must also empower them to make independent decisions

24. Human research subjects must be given complete autonomy They have a right to decide whether to take part in research They have a right to decide whether to continue as subjects

25. Justice All individuals should have an opportunity to participate in research unless contra-indicated W e must not impose any unfair burden on subjects We must treat all people equally, fairly and impartially

26. Beneficence We must be fair and just in our actions We must take positive steps to prevent harm While pursuing beneficence, we must not come in conflict with autonomy of people

27. Non-maleficence We must do no harm If harm cannot be avoided, we must try to minimize it

28. Informed consent Informing potential participants about the proposed research in a systematic manner and empowering them to make an informed decision to participate in the research study

29. Understand study procedures Understand risks and benefits Get all questions and concerns answered M ake a considered and informed decision to participate or not to participate Participants must be able to:

30. Informed Consent D ocument Description of research Risks Benefits Confidentiality Reimbursement and compensation Contacts Voluntary participation and withdrawal

31. Is the research procedure adequately explained in the IC form? The language - simplicity and clarity Translations and certification of translations Test of understanding Impartial witness Check list

32. Researchers and institutions : Information – discussion & explanation – comprehension – voluntary decision Participants : Must give informed , free and independent consent without coercion or force Sponsors , monitors & regulators : Assess fairness of consenting procedure - Verify consent documentation Stakeholders in informed consent process

33. Research participants should be reasonably reimbursed for costs incurred during the research e.g. travel costs They should be reimbursed reasonably for their inconvenience and time spent Compensation can be monetary or non-monetary Reimbursement Continued …

34. Non-monetary reimbursement might include free health services unrelated to the research, medical insurance, educational materials or other benefits Reimbursement must not be so large as to induce potential participants to consent to participate in the research against their better judgment

35. P articipants who suffer physical, psycho-logical or social harm as a result of taking part in research must receive free treat- ment and rehabilitation They should also be compensated for lost wages If death results from participation in research, the participant’s dependents should be given compensation Compensation

36. The research subjects should be given the option of being informed about the outcome and results of the study Information about the outcome

37. Researchers have an ethical obligation to make public the results of research They should ensure completeness and accuracy in reporting of research Negative or inconclusive results must also be made publicly available Sources of funding, institutional affiliations and conflicts of interest must be declared in the publication Publication of outcome

38. Institutional ethics committee must be formally established It should be given adequate powers and support It should ensure timely and competent review following clear and transparent procedures Ethics Committee Continued …

39. The ethics committee must have multi-disciplinary membership to ensure a complete review of proposed research Committee members must be duly qualified They should regularly update themselves about ethical issues related to health research Continued …

40. The institution must put in place adequate mechanisms to ensure independence of the ethics committee All proposals for health-related research involving humans must be submitted to the ethics committee for its clearance Continued …

41. The committee will determine whether a proposal needs ethical review and will assess its ethical acceptability The committee can exempt a proposal from ethical review (depending upon the nature of the research and upon applicable laws or regulations) Continued …

42. The researcher must obtain clearance from ethics committee before beginning the research The ethics committee can conduct further reviews as necessary, for example, when there are significant changes in the protocol Continued …

43. The researcher must have a right to appeal against the decision of ethics committee The ethics committee should have a clear procedure for hearing appeals against the decisions of ethics committee

44. The research ethics committee must be constituted according to a document that specifies the manner in which members and the chairperson will be appointed, reappointed, and replaced Research ethics committees must have members capable of providing competent and thorough review of research proposals Continued … Composition of ethics committee

45. Membership must include physicians, scientists and other professionals such as social scientists, lawyers and ethicists The committee should have some community members or representatives of patients’ groups Ideally , one or more members should have experience as study participants

46. R esponsibility of institutional ethics committee or review board Real or potential benefit to individuals/ community R ights of research participants Benefits vis-a-vis risks Will the participants and community have access to benefits of research? M echanism to provide safety, care and support to research participants

47. Changing Scenario of Research Ethics Attention to e thical issues in research is increasing Public expectations are increasing and will increase further in future Policy makers and researchers should be prepared for further strengthening of ethical codes

48. Thank you