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thical Guidelines for Clinical Research - India and the World

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Information about thical Guidelines for Clinical Research - India and the World

Published on April 13, 2008

Author: bishorvi

Source: slideshare.net

Description

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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Ethics in Clinical Trials Ethical considerations for conducting clinical trials: 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

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

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

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

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

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

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

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

ubiquitous . biology www.ubio.in

ubiquitous . biology

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