IRB application form

 

D​‌‍‍‍‌‍‍‌‍‌‌‍‍‍‌‍‌‌‌‍​epending on risk and subject demographic, a proposal will fall into one of three categories: exempt, expedited, or full board review. Although investigators should request the level of review they feel is appropriate for their project, this should not be a major concern. The IRB Chair, in consultation with committee members if necessary, will determine the correct level of review. Exempt means review by one IRB member, sometimes in consultation with others. The exempt process is much less rigorous than an expedited or full-committee review. A research activity may be declared exempt if it is considered low-risk and the only involvement of human subjects will be in the categories outlined in 45 CFR 46.101(b). Briefly described, these categories are: Research conducted in established or commonly accepted educational settings, involving normal educational practices. Research using anonymous or no-risk tests, surveys, interviews, or observations. Most research involving pubic officials. Research involving the collection or study of existing data if it is publicly available or with approved access to data. Expedited requires review by two more experienced reviewers. In general, research may qualify for expedited review if it is judged to involve only minimal risk, does not include intentional deception, does not employ sensitive populations or topics, and includes appropriate informed consent procedures. Reviewers conducting an expedited review may exercise all of the authority of the IRB except that they may not disapprove a study. When a subcommittee cannot approve the research under expedited review, the study is referred to the full Committee for review. A full board review is required for research that is not eligible for exempt or expedited review. In short, researc​‌‍‍‍‌‍‍‌‍‌‌‍‍‍‌‍‌‌‌‍​h that is judged to involve more than minimal risk, or involves protected populations such as children, prisoners, or disabled individuals, must undergo a full board review. Individuals intending to conduct research that requires a full board review should allow ample time to complete the review process. The following categories of research require full IRB approval: Projects for which the level of risk is determined by the IRB Chair to be greater than minimal. Projects that involve the intentional deception of subjects, such that misleading or untruthful information will be provided to participants. Projects that involve sensitive or protected populations (such as children or cognitively disabled individuals). Projects that plan to use procedures that are personally intrusive, stressful, or potentially traumatic (stress can be physical, psychological, social, financial, or legal). An approved IRB application must be on file before any work is conducted with, or data gathered from, any human subject. The researcher’s permission letters, proposed language for any announcement of research or invitation to participate, protocols and consent forms are included with the application. The purpose of submitting a proposal to this careful review is to protect and ensure the safety of all subjects, the researcher, and the university. Review the Doctoral Project Handbook, the Doctoral Project template, IRB Policies and Procedures and application. Watch the video for Chapter Three. Begin the IRB Application and requisite documents. Document include the researcher’s permission letters, proposed language for any announcement of research or invitation to participate, protocols and consent forms. CITI Training Certificate is required. Number of pages dependent on the type of s​‌‍‍‍‌‍‍‌‍‌‌‍‍‍‌‍‌‌‌‍​tudy.

 

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