solutions to exercise-I

[Guest guest]

Dear Madam

I am providing solutions for the following exercise:

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.

TRUE

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

TRUE

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.

FALSE

It is unethical to conduct research in a country or community if it cannot provide any benefit to the local population or those who are in need. Before planning research, it has to be confirmed whether it can serve for the population or not.

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.

FALSE

In case of SAE, the clinical data has to be communicated to the Sponsor, IEC or national regulatory authority in a defined timeline (24hrs to sponsor, 7 days to IEC) and immediate action need to be taken to avoid any mishap. The study protocol will mention all the details regarding confidentialty of the participants. In case of SAE or any premature termination of a trial, clinical trial information has to be disclosed to officals.

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.

TRUE

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

I think it is necessary to pay participants for the expenses incurred due to their participation in clinical trial. As they have been enrolled for the research purpose. ethically we have to take care of them and respect for giving enough time for research purpose for the advancement of science. therefore, we should pay them with respect to their timings, food charges, daily wages or transport (to and fro charges) etc. but it should not be a part of inducement.

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. TRUE

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. FALSE

In case of incompetent person, if guardian has to sign the consent form then all the expenses incurred (out of pocket) as well as remuneration or compensation (in special circumstances) should be paid. details related to compensation or any sort of remuneration to the participants should be clearly mentioned in the protocol or informed consent document.

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

To respect participant's autonomy, participant can withdraw at any time during the trial without giving any justification and it should not affect his/her treatment.

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

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. TRUE

Thanks and Regards

Tarun Wadhwa

The INTERNET now has a personality. YOURS! See your Homepage.

The INTERNET now has a personality. YOURS! See your Homepage.