IRB Review Procedures
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IRB Review Procedures The IRB looks at four principal issues when reviewing a proposal:
- are the rights of the human subjects safeguarded,
- does the proposal assure that the University meets relevant Federal Guidelines,
- do the procedures selected cause the least amount of risk necessary, and
- are the procedures and design sufficiently effective to justify the involvement of human subjects?
Each proposal must detail the measures taken to protect the confidentiality and privacy of the participant subjects. The depth to which proposals are examined depends on the nature of the research question, subjects, and/or methods. Work with individuals at special risk or unusually invasive procedures require more extensive justification. The Federal Government recognizes three categories of research proposal review, Full Reviews, Expedited Reviews and Exempt Reviews (in this case, exempt means “exempt from Full Review”). Exempt reviews are conducted by the IRB chair or one other specially appointed IRB member rather than by the full board. Expedited reviews are conducted by a two-person subcommittee instead of the entire IRB.
Researchers applying for exempt or expedited review, must submit three (3) copies of the completed IRB application, including three (3) copies of all informed consent forms, questionnaires, tests, and other data collection tools to be used, and one (1) copy of the full research proposal. If the research is not eligible for exempt or expedited review, the investigator must submit six (6) copies of the completed IRB application form, including all informed consent forms, questionnaires, tests, and other data collection tools to be used, and an abstract of the research proposal. IRB approval is for one year only, unless the risk level, subject population or research protocol has changed. Any change in the risk level, subject population, or research protocol requires immediate IRB review. For any project in which the use of human subjects extends beyond one year, the investigator must apply for renewal one month before the expiration date. Applications for renewal must include the last two signed consent forms from subjects and stipulate the following:
- The human subjects protocol is the same as in previous studies.
- There have been no ill effects suffered by the subjects due to their participation in the study.
- There have been no complaints by the subjects or their representatives related to their participation in the study.
- There has been neither a change in the research environment nor new information which would indicate greater risk to human subjects than that assumed when the protocol was initially reviewed and approved.
In the event that there have been either complaints or ill effects, they must be reported and sufficiently described for IRB review as soon as possible after the complaint or ill effect has occurred. Adapted from UL Lafayette 04/02/01