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New application available for human subjects research using pre-existing data

A stack of papers, organized with multi-colored, numbered sticky tabs.

All research projects involving human subjects, regardless of funding source, must submit an application to the Miami Research Ethics and Integrity Office (MREI). Some research requires IRB review and approval (Level 2 Form) and some research will qualify for administrative review and approval by MREI (Level 1 Forms).

To aid researchers, MREI created a new Level 1 application form that is specifically for the use of data existing prior to the proposed research activity. This data may have been collected by the Miami applicant prior to their affiliation with Miami or by another research team, under the IRB approval of another institution. This also includes research using data that is publicly available. This form is calledHuman Subjects Research Level 1 Screening: Use of Pre-existing Data and can be accessed directly from the MREI application page.

When a new use for data that was collected under Miami approval is proposed and the use does not violate the original consent agreement, if the approval is still current, new researchers can simply be added to the list of personnel using normal protocol modification processes. If the approval period for the protocol has passed, the new form can be used to receive approval to use de-identified data. If data will include identifiers, the project would require regular review and approval processes (either Level 1 or Level 2).

Completed applications and questions regarding methods or status of an application should be emailed to humansubjects@miamioh.edu.


Digital data image via torange.biz. Numbered notes photo by Denise Chan via Flickr. Both used under Creative Commons license.

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