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The new, exclusive presentation by ubio outlines general ethics guidelines to be followed when designing and conducting clinical trials. India-specific guidelines follow declaration of Helsinki closely, so this presentation equally applies to clinical CROs that are springing up across India. This presentation, based on ICMR Ethical Guidelines, would give you a good overview of ethical principles to be followed if you are conducting clinical trials in India or elsewhere.
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© 2008 ubio. All rights reserved. 1
Ethics inClinical Trials
Ethical considerations for conducting clinical trials:India and the World
© 2008 ubio. All rights reserved. 2
Three basic principlesJustice
Respect for Persons
Beneficence and non-malaficencemaximize benefits
minimize harms and wrongs
do no harm Declaration of Helsinki
Ethical Principles for Medical Research Involving Human Subjects
by World Medical Association
first drafted in 1964
revised periodically
Principles of Clinical Trial Ethics
© 2008 ubio. All rights reserved. 3
EssentialityTest on human beings only if absolutely essential
Does all current research certify that the drug is safe? Informed Consent
Subjects should consent to participate in the study
Subjects should be fully informed about the objectives of the study
Subjects have the right to withdraw at any point during studyNo refund of remuneration should be demanded on early withdrawal
Non-exploitationProvide remuneration to test subjects
Inform subjects about all potential side effects and risks
Ensure ample compensation for accidental injuryInsurance, Rehabilitation, Life-long support
Essentiality, Consent, Non-Exploitation
© 2008 ubio. All rights reserved. 4
Privacy and ConfidentialityInform subjects about the extent to which personal info would be disclosed
Do not divulge identity and records of test subjects as far as possible
Avoid indirect exposure of identity
Providing information which will allow identity to be guessed
Ensure that the subject does not have to undergo any discrimination or stigmatization due to disclosure
PrecautionDesign the study such that risks to the subjects is minimized
Ensure there are no adverse side effects
Privacy, Confidentiality, Precaution
© 2008 ubio. All rights reserved. 5
Professional CompetenceAll personnel involved in trials should be trained and qualified
A strong sense of ethics essential for personnel Transparency and Accountability
No aspect of the study should be hidden
Except for privacy reasons
Prior disclosure of all conflicts of interest
Maintain permanent records of all research data and notes
They facilitate public scrutiny and enforces accountability
Fix responsibility for the study and its outcomes
Researchers, sponsors and funding agencies, institutions where research is conducted
Burden of Proof is always with those who conduct the trial
Competence, Transparency, Accountability
© 2008 ubio. All rights reserved. 6
Benefits of research should be equally distributedResearch on genetics should not lead to racial inequalities
Do not conduct research on economically weak sections to create advantage for those that are better off
Avoid implicit coercionDo not enroll people at a disadvantage in the study
Prisoners
Students
Subordinates/Employees
Ensure complete freedom of choice when they are enrolled
Distributive Justice
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Pregnant/Nursing WomenOnly for research to better the health of pregnant/nursing women, foetus or infants
Ensure that there is no risk to foetus or infant Children
Only trials for drugs to improve child health
Only conduct trials on children after phase 3 clinical trials on adults
Exception: drugs for diseases only affecting children
Consent from parents and/or legal guardians
Consent from child in the case of mature minors and adolescents
Except where parents have given consent and there is no other medical alternative to the tested therapy
Special Groups
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India has strong Ethics guidelines for clinical research Every clinical trial program should be reviewed by an
ethics committeeInitial review of proposed research protocols
Regular monitoring of compliance to ethics guidelines
Can be constituted by the institute where research is done
Independent
multi-disciplinary
multi-sectorial Indian biomedical research ethics guidelines available
at: ICMR Ethical Guidelines for Biomedical Research
Ethics Guidelines in India
© 2008 ubio. All rights reserved. 9
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