Role of regulatory authority in biomedical research-4.

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The role of IRB

The IRBs consist of committees of experts and lay persons who review the research as it proceeds. Special attention is given to trials that may include vulnerable subjects, such as pregnant women, children, prisoners, the elderly, or persons with diminished comprehension.

The primary responsibility of IRB is protection of human subjects

The IRBs are guided by three main principles:

i) subjects must be informed about the nature of the study – details of participation must be voluntary,ii) benefits of the research must outweigh the risks, andiii) promoting fair procedures in the selection of subjects.

Other responsibilities of IRBs

To review the protocol, or research plan, for the proposed project.

To approve or disapprove research plan or make changes

To grant approval.

To approve or disapprove the informed consent form

The IRBs undertake continuing reviews while the project is under way. These reviews ensure that:

i) risks to subjects are minimized,ii) selection of subjects is fair and equitable,iii) there are safeguards to protect subjects,iv) informed consent is employed and documented from each subject, andv) provisions exist to protect the privacy of subjects and maintain confidentiality of the data.

In US, watching the IRBs are the FDA and other federal agencies such as the National Institutes of Health (NIH), whose rules are designed to protect subjects taking part in medical research.

Kunda