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All research at Southwest Washington Medical Center involving human research
subjects must be reviewed by an IRB. The purpose of these reviews is to
determine if subjects will be placed at risk and if the benefits of the research
warrant the risk. The IRB review process assists in determining the
following:
- The potential risks to the subjects are clearly identified in the research
protocol and in the informed consent form.
- The research risks are outweighed by the benefits to the research
subjects, and the importance of the knowledge to be gained.
- The rights and welfare of all research subjects are adequately
protected.
- A process provides an adequate explanation of the potential risks and
safeguards as well as the benefits of participating in a research
study.
- The process and documentation conform to the US Food and Drug
Administration (FDA), International Conference of Harmonization for Good
Clinical Practice, the US Office of Human Research Protection (OHRP) and
Southwest Washington Medical Center IRB guidelines.
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