Ethics in Clinical Trials

1. Ethics in Clinical Trials Ethical considerations for conducting clinical trials: India and the World

2. Principles of Clinical Trial Ethics • Three basic principles Justice Respect for Persons Beneficence and non-malaficence maximize 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

3. Essentiality, Consent, Non-Exploitation • Essentiality Test 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 study No refund of remuneration should be demanded on early withdrawal • Non-exploitation 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

4. 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 • Precaution Design the study such that risks to the subjects is minimized Ensure there are no adverse side effects

5. Competence, Transparency, Accountability • Professional Competence All 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

6. Distributive Justice • Benefits of research should be equally distributed Research 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 coercion Do not enroll people at a disadvantage in the study Prisoners Students Subordinates/Employees Ensure complete freedom of choice when they are enrolled

7. 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 • 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

8. 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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