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Statement of Specific Principles for Clinical Evaluation of Drugs/Vaccines/Devices/Diagnostics/Herbal Remedies etc.

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The recent developments in frontier areas like genome mapping, genetic recombinant engineering, assisted reproductive biology, stem cell research, have opened up hither to unknown practical applications of these technologies. However, these exciting areas also raise some delicate and sensitive issues regarding ethics in Bio-medical research. Accordingly, as a sequel to the “Policy Statement on Ethical Consideration involved in Research on Human Subjects” in the previous issue, this second issue provides a statement of specific principles for clinical evaluation of drugs/ vaccines/ devices/ diagnostics/ herbal remedies.

Human studies designed to evaluate the safety, effectiveness, or usefulness of an intervention include research on therapeutics, diagnostic procedures and preventive measures including vaccines. The type of experimental procedures that a patient is submitted to has become more complex and varied as the complexities of medical research have increased. It is clearly accepted that it is essential to carry out research on human subjects to discover better equally clear that such research on normal subjects and patients is associated with some degree of risk to the individual concerned. These guidelines have been framed to carry out the evaluation of drugs, vaccines, devices and other diagnostic materials on human subjects including herbal remedies, in accordance with the basic ethical principles. These guidelines are important for protection of research subjects against any avoidable risk and to guide the researchers in the preparation of research proposals/protocols.

For the clinical evaluation of proposed research intervention, the framework of guidelines is provided for the following areas:

1. Drug trials

2. Vaccine trials

3. Surgical procedures/medical devices.

4. Diagnostic agents – with special reference to use of radioactive materials and X-rays

5. Trails with herbal remedies

General principles

All the research involving human subjects should be conducted in accordance with the four basic ethical principles, namely Autonomy or respect for person/ subject, Beneficence, Non-maleficence and Justice. The guidelines laid down are directed at application of these basic principles to research involving human subjects. An investigator is the person responsible for the research trial and for protection of the rights, health and welfare of the subjects recruited for the study. He/she should have qualification competence in clinical trial research methods for proper conduct of the trial and should be aware of and comply with all requirements of the study protocol as enumerated under the General Principles and General Issues.
Specific Principles



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