Ethics in Clinical Trials

Ethical considerations for conducting clinical trials: India and the World
2008 ubio. All rights reserved.

Principles of Clinical Trial Ethics

Three basic principles
Justice

Respect for Persons

Beneficence and non-malaficence
maximize benefits minimize harms and wrongs

Declaration of Helsinki
Ethical Principles for Medical Research Involving Human Subjects by World Medical Association first drafted in 1964 revised periodically

do no harm

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Essentiality, Consent, Non-Exploitation

Essentiality
Test on human beings only if absolutely essential Does all current research certify that the drug is safe? Subjects should consent to participate in the study Subjects should be fully informed about the objectives of the study

Informed Consent

Subjects have the right to withdraw at any point during study

Non-exploitation

No refund of remuneration should be demanded on early withdrawal

Provide remuneration to test subjects

Inform subjects about all potential side effects and risks

Ensure ample compensation for accidental injury
Insurance, Rehabilitation, Life-long support

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Privacy, Confidentiality, Precaution

Privacy and Confidentiality
Inform 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 Design the study such that risks to the subjects is minimized Ensure there are no adverse side effects

Precaution

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Competence, Transparency, Accountability

Professional Competence
All personnel involved in trials should be trained and qualified

Transparency and Accountability

No aspect of the study should be hidden Except for privacy reasons

A strong sense of ethics essential for personnel

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
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Distributive Justice
Benefits of research should be equally distributed
Research on genetics should not lead to racial inequalities

Avoid implicit coercion

Prisoners
Students

Do not conduct research on economically weak sections to create advantage for those that are better off
Do not enroll people at a disadvantage in the study

Subordinates/Employees Ensure complete freedom of choice when they are enrolled

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Special Groups
Pregnant/Nursing Women
Only for research to better the health of pregnant/nursing women, foetus or infants Ensure that there is no risk to foetus or infant 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

Children

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Ethics Guidelines in India

India has strong Ethics guidelines for clinical research Every clinical trial program should be reviewed by an ethics committee
Initial 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

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2008 ubio. All rights reserved.