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State whether the following statements are TRUE or FALSE giving suitable explanations for the false statements

Researchers involved in clinical trials should have qualification and competence in biomedical research methodology for proper conduct of the study.

Researchers involved in clinical trials should be aware of and comply with the scientific, legal and ethical requirements of the study protocol.

It is ethical to conduct research in a country or community when it is known that a product developed or knowledge generated as a result is unlikely to be made generally available or applied for the benefit of the population of that country or community.

Even in case of severe adverse reaction data of clinical trial participants should not be communicated to the drug registration authority so as to maintain confidentiality.

Conflict of interest in a clinical trial should be declared in the protocol and also mentioned when publishing the research in popular media or scientific journals.

6. It is not necessary to pay the participants of a clinical trial for expenses incurred, in connection with their participation in the trial.

7. All payments, reimbursement and medical services to be provided to research participants should be clearly stated in the protocol and approved by the IEC.

8. When a guardian is asked to give consent on behalf of an incompetent person, there is no need to provide any remuneration except a refund of out of pocket expenses.

9. Participants of a clinical trial cannot withdraw from the trial till trial completion.

10. A clinical trial can be stopped if there is low rate of patient recruitment.

11. Acceptance of ancillary care responsibilities for research subjects from economically poor countries might compel them into participating in the study and induce a strong element of volunteer bias.

Dr. Smita

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