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Paper Topic:

IRB Process

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IRB PROCESS

IRB or the Institutional Review Board is a committee established to review and approve research involving human subjects . Federal laws that the security of the privacy and rights of population involved in examination activities is of extreme importance have mandated it . The Health Research Extension Act of 1985 , the National Research Act Public Law 99-158 and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research provides guiding principles for human subject research to guarantee their

wellbeing and lay down the regulations of the research process . Such regulations demand that any establishment receiving and requesting funds from agency or a federal department involving human subjects must be reviewed and validated by the Institutional Review Board (King , 2006

In the initial process of reviewing all research , studies comprising of human subjects are analyzed in three ways - Central Level Review Expedited Review and Full Review . All research protocol is initiated with a complete submission of data and facts to the principal investigator 's Center Representative . The Center Investigator has to review the submission and ascertain that all necessary documents , such as a research protocol and an IRB submission form are included

The primary investigators are to work with the Center Representatives This helps in preparation of the required IRB documents in accordance with Nova Southeastern University (NSU ) policies and procedures . NSU IRB is designed to safeguard human subjects and responsible for determining that the welfare and human rights of the subjects is sufficiently provided for . It ensures that the human subjects should never be exposed to unreasonable physical , mental or mental risk to propagate research nor should the risks to the subject be overlooked due to the magnitude of the research . It is also the duty of the IRB to make sure that the researchers or scientists are qualified to conduct experiments on human subjects

Documents , which are essential to IRB , are informed consent forms from the subjects , evidence of approval by other IRB 's at other sites , data collection instruments and brochure and recruitment material . The IRB at the level of university must review the research proposal with importance if it indicates potential risk to human candidates as is to be evinced in cases . This involve administration of drugs or narcotics to the subject , research involving pregnant women or the fetus , life threatening physical conditions , physically intrusive procedures research which has previously exposed subjects to potential risks or which invades a subject 's privacy and renders him a victim of legal or civil liability (Lamb , 2004

Once the documents are duly filled up , the IRB process starts when the completed document is presented to the Center Representative . In case the documents are found satisfying , the Center Representative exempts it from further review . Otherwise , it would require a Full Review or Expedited protocol . If Full Review is required in accordance to the protocol the Center Representative forwards the submitted form to the Office of Grants and Contract . It is also...

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