Ethical considerations: risks and benefits

[Guest guest]

Hello Everybody,

Let's now confine the discussion to the ethical considerations in protocol writing.

All the research involving human participants should be conducted in accordance with the four basic ethical principles, namely autonomy (respect for person /participant), beneficence, non-maleficence (do no harm) and justice. The Principal Investigator is the person responsible for not only undertaking research but also for observance of the rights, health and welfare of the participants recruited for the study. S/he should have qualification and competence in biomedical research methodology for proper conduct of the study and should be aware of and comply with the scientific, legal and

ethical requirements of the study protocol.

Benefits and risks to study participants:

The investigator must ensure that risks are minimised and any anticipated risks are reasonably balanced against the potential benefits in all biomedical research involving human participants.

It is unethical to conduct research in a country or community if there is good reason to believe 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. It is therefore recommended that.

The research be responsive to the health needs and the priorities of the community in which it is to be carried out.

The exclusion of certain groups or communities that might benefit from study participation must be justified.

Overuse of certain groups, such as the poor, is unjust as they may be more easily induced to participate in exchange for small payments.

Dr. Smita

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