thical Guidelines for Clinical Research - India and the World

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

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
Principles of Clinical Trial Ethics

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
Essentiality, Consent, Non-Exploitation

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
Privacy, Confidentiality, Precaution

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
Competence, Transparency, Accountability

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
Distributive Justice

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
Special Groups

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
Ethics Guidelines in India

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thical Guidelines for Clinical Research - India and the World

by Bishor Ibrahim on Apr 13, 2008

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thical Guidelines for Clinical Research - India and the World — Presentation Transcript