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Research Study or Clinical Trial Participation

Frequently Asked Questions about Participating in a Research Study or Clinical Trial

What is a Research Study or Clinical Trial?

A research study can be an investigation, survey, or study that evaluates or tests therapies, procedures, or practices and that leads to or contributes to medical/psychiatric knowledge.

Clinical Trials test the effectiveness of new or existing medications. Such trials are conducted under the close supervision of a physician and other research professionals and lead to improved knowledge concerning medication treatments.

Human Research Protection: Research and the Institutional Review Board

What is an Institutional Review Board?

An institutional review board, also known as the IRB, is a group of individuals from varied disciplines who review, monitor and approve research at an institution. Prairie St. John’s has an internal IRB that is made up of a multidisciplinary group of physicians, nurses, scientists, and other community individuals appointed by Prairie St. John’s Board of Governors. Prairie’s internal IRB reviews, approves, and monitors all non-medication related research conducted with human participants. Prairie St. John’s also contracts with external IRBs to review, approve, and monitor all studies involving new or existing medications. Prairie’s internal IRB monitors the quality of external IRBs on a regular basis.

What are the IRB responsibilities?

The IRB is responsible for:

Who regulates the IRB functions?

The IRB complies with applicable federal and state laws, rules, regulations and standards. These include regulations of appropriate governmental and private regulatory and accrediting agencies. Agencies include, but are not limited to:

Research Reviews

All research at Prairie St. John’s involving human research participants must be reviewed by an IRB (either internal or external). The purpose of these reviews is to determine if participants will be placed at risk and if the benefits of the research warrant the risk.

The IRB review process assists in determining: