Research ethics

1. Research ethics Shabih H. Zaidi UK

2. Imamia Medics International-E-Learning April 2016 13,Rajab ,1437H

3. Why do research The human mind is a mystery. It is curious to learn. It is a human instinct to explore. And gather knowledge And cultivate SKILLS With a certain attitude, usually called Discipline i.e. Ethics.

4. Research is necessary for evolution of mind, and human progress, as indeed for improving the quality of life It is also the pathway to human salvation through application of intellect; by serving the community, indeed humanity. And no service is better than that.

5. Research ethics For a thousand years and more, mankind has been subjected to experimentation ,on the pretext of doing research to: To improve upon the existing ways of treatment. Explore innovative ways of treatment from a myriad of illnesses. To identify new herbal and chemical remedies.

6. Research ethics Human volunteers or paid workers were the common subjects. Inmates in prisons and institutions. Forced and coerced subordinates or employees etc.

7. Research ethics Second world war may be called the watershed era for human experimentation. Nazi atrocities at various prisoners of war camps, where not just the prisoners but many hundreds of ordinary Europeans , are well documented in annals of history

8. Research ethics Dr.Mengle the doctor devil and his associates carried out unbelievable human experimentations in late1930s and early 1940s. The war tribunals at Nuremberg exposed the human tragedy and opened anew era.

9. Nuremberg code on human experimentation It was promulgated in 1946. It commenced the concept of CONSENT. Human dignity and Autonomy were recognised as the essential parts of research. ‘Voluntary consent of human subjects is absolutely essential’ So declared the International Military Tribunal at Nuremberg trial .

10. Declaration of Helsinki Came into application in 1964 Modified in 1975 in Tokyo In 1983 in Venice. Hongkong in 1989 It said ‘ A physician will act only in patients when providing medical care which might have the effect of weakening his physical and mental condition’

11. CIOMS Council for International Organisation of Medical Sciences 1982,1991,1992…. With particular conditions of research in developing countries said: ‘All research involving human subjects should be conducted with 3 basic principles namely: Respect for persons Beneficence and Justice.’

12. Good Clinical Practice/Good Medical Practice (GMP) The principles are: Helsinki declaration Fully Informed Consent Confidentiality Signed protocol/CRF Ethics review committees.

13. Basic principles of Helsinki declaration 1.Biomedical research involving human subjects : *Must conform to the scientific principles based upon adequately performed laboratory and animal experimentation. * The experimental protocol should have the input from an independent COMMITTEE. ctd

14. Helsinki declaration * Scientifically qualified persons only should conduct and supervise the research. *Research should be legitimately carried out unless the importance of the objective is in proportion to the inherent risk to the subject. *Careful assessment of predictable risks v/s benefits should be made prior to research. *Safeguarding the integrity and respect of privacy of the subject is essential.

15. ctd * Physicians should be satisfied that the Risks may not outweigh the Benefits. *Accuracy of the results must be ensured. Each subject may be given the right to withdraw at any time. If there is a possibility /risk of informed consent obtained under coercion, an independent physician should obtain a fresh consent.

16. Ctd. *In case of legal incompetence, the legal guardian should give the informed consent. *The research protocol must contain a statement of ethical consideration and compliance to the terms of current Helsinki declaration.

17. II. Medical research combined with professional care (Clinical Research) Freedom to use NEW diagnostic and therapeutic measures, if it offers hope of saving life and alleviate the suffering. Potential benefits and hazards of new methods should be weighed against the existing methods. The doctor –patient relationship should not be affected of refusal of the patient. Research can be combined with clinical care if justified by its potential value to the patient.

18. III. Non –therapeutic research involving human subjects A physician should remain the protector of life and health. Subjects should be volunteers---healthy persons or patients where illness is not related to the experimental design. An investigation should not continue, if harmful effects may occur, if continued. The well being of an individual should supersede the interest of science and society.

19. Objectives of Informed consent TO PROTECT: Subjects involved in research from abuse and exploitation. Investigators from taking unjustifiable risks. Good reputation of the institutions where research is carried out.

20. Informed consent A subject is free to refuse and may withdraw any time. Confidentiality and anonymity of subjects and data.

21. General principles General rule: No drug may be commenced without prior informed consent of the subject. Contents: Procedure: Randomisation –Single or Double blind, time table, diagnostic procedures. Drugs involved: Investigational; placebo; active. Purpose of study: Potential risks and side effects. Treatment alternatives available

22. Special groups No pressure or coercion on dependant subjects eg: students, subordinates, etc. Each should have total freedom to participate. In children and minors: Parental, preferably mother’s consent or lawful guardian. Mentally retarded / disabled: Consent of an immediate relative or legal guardian.(see mental incapacity law .UK)

23. Limitations Information about harmful effects may never be exhaustive due to lack of 100% predictability. Mention all potential side-effects may have a ‘suggestion value’. ‘Too much information could be as bad as too little information’. Eg; Cancer Poor understanding or recall of information especially in the Developing Countries.

24. Cultural differences Information may be delivered to the patient or the next of kin, observing the prevalent cultural practices. Japanese do not want the patient to be given full information about disease, diagnosis, prognosis. Indian culture is paternalistic. Let the doctor decide. English and American patients want to know everything personally.

25. Ethics committee Also called: Ethics review boards Institutional review boards Major role: To safeguard the interest of research subjects/ patients.

26. Ethics committee Composition Members from different backgrounds. Technical competence – including medicine, law and faith. Moral and ethical background. Representatives with social religious, cultural and legal competence.

27. Ethics committee Scope/Jurisdiction Powers for initial and continuous review Right to make physical spot checks to ensure ethical requirements. Power to suspend a study , in case of deviation. Power to approve or disapprove any amendments to the original research protocol.

28. Ethics committee ctd. Power to decide if the research is according to health needs of the country , especially in the developing nations.

29. Criticism on clinical trials Violation of human rights Use of placebos despite the proven efficiency of drugs. Randomisation: single and double blinded Commercialisation and payments involved Lack of health and work insurance of the subjects.

30. Abuse of human subjects In many countries, blatant violation of human rights, free will and free informed consent Abuse of inmates , prisoners, institutionalised people, students and subordinates Use of human beings as guinepigs.

31. Placebos Collective (society) ethical values are given preference over individual ethics… which may be objectionable Interest of the future patients are placed above the welfare of the actual subjects. Patients are sometimes deceived thru’ placebos Patients are deprived of ‘Best therapy’

32. Guidelines for placebos Placebos can be used provided: *No effective therapy is known for the disease in question. A condition that may disappear in due course without a sequel eg; Cold or postoperative pain. A clinical condition which may be self limiting or remain free of complications eg. Mild hypertension, headaches, migraine.

33. Placebos guidelines ctd. Placebo can not be used; (instead a standard active drug must be used as a control) if: the trial is designed for treatment of a condition ,for which a proven treatment already exists.

34. Placebo guidelines A CONTROVERSIAL ISSUE: Should a placebo be used ;if the efficacy of an existing therapy is generally accepted but not quite proven ,firmly and definitely. Can it be allowed; if a control group is given a standard and the other a placebo for a given period of time.

35. Some general remarks Protocol for a double-blind study must provide for breaking the code for a given patient/subject should a problem occur , without jeopardizing the whole trial. Wherever possible ‘Adaptive Trial Designs’ should be used in an attempt to minimize the number of patients exposed to an inferior product ( a placebo,a substandard drug, or an investigational drug) or indeed the duration of such an exposure.

36. RANDOMISATION ‘It is a process that lets chance determine the medical care a person receives’.

37. Studies Single blind study: The subject remains unaware of a drug being given. Double-blind study: Neither the investigator nor the subject knows the precise nature of drug or treatment given in an investigative study

38. Payment for trials Is allowed if the subjects volunteer for a trial after a fully informed consent PROVIDED it is reasonable and compatible to the standard of a given society. It should be free of greed or undue value. An institution may also receive a stipend or financial compensation , but NOT individually given to ahead of the deptt. etc

39. Sponsored clinical research Scientific misconduct. Must be avoided Conflict of interest . If any; must be declared. Developing countries often suffer due to surrogate consent, which is often questionable.

40. Academic fraud Fictitious records Insufficient documentation to justify conclusions Tempering with computer data-base Genuine authorship. Avoid sycophancy or abuse of authority Fabrication of results. Justifying the sponsorship.

41. Ethics of publications New standards have now been laid down to detect and avoid : Plagiarism . (soft aware available) Abuse of services Misinformation Authorship fraud Data theft and fraud Duplicate publication etc.

42. Conclusions. Follow the principles of ethics in your research. Follow the national and international codes Patient/subject’s interest must remain supreme Research is culture sensitive. Respect the norms of a population under study. Special codes of conduct for special groups must be observed. Must refrain from plagiarism and academic fraud. Acknowledgement: Late.Dr.MaqboolJafary (Iltemas e Fateha).