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Ethics inClinical Trials

Ethical considerations for conducting clinical trials:India and the World

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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

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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

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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

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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

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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

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