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Getting Started
A
Guide for Investigators and Research Staff
What is the Role of the UIC Institutional Review Board (IRB)?
All research activities that include humans must be reviewed and approved by the IRB, receive an exemption determination, or receive a determination of not human subjects research from the OPRS/IRB. An investigator must receive a written approval, exemption determination, or not human subjects determination prior to starting the research.
This process is designed to ensure that during the conduct of the research the rights and welfare of human subjects are protected (minimizing risks, selecting subjects equitably without coercion, obtaining informed consent, ensuring privacy and confidentiality).
IRB approval is valid for a maximum of one year. Based upon the risk of the research or the inclusion of a particularly vulnerable population, the IRB may determine that a shorter approval period is appropriate. If the research is to continue beyond the current approval period, the investigator mustsubmit a progress report (Continuing Review) for the IRB to review and approve prior to expiration. IRB approval for research must be maintained until all research activities are completed (data analysis, the final paper is accepted for publication, or the study site is closed).
An investigator must obtain prospective IRB approval for any change to any aspect of the research (design, subject number, subject population, eligibility criteria, procedures, questionnaire, consent document, recruitment material). Information for submitting protocol amendments to the IRB can be found?
The investigator is required to notify the IRB promptly if subjects experience any unanticipated problems involving risks to subjects or others (physical injury, improper disclosure of private information, economic loss, other harmful or potentially harmful occurrences), subject complaint that involve unexpected risks or cannot be resolved, protocol violations, change to protocol made without prior IRB approval to eliminate apparent immediate hazard to a subject, noncompliance, or, for research conducted at the Jesse Brown Veterans Administration Medical Center (JBVAMC), any serious adverse event or unanticipated event.
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