Training
In order to submit projects to OSIRIS (Online Submission for Institutional Reviews), the principal investigator and research coordinator(s) must have completed the following educational modules: Research Integrity and either Human Subject Research in Biomedical Science or Human Subject Research in Social and Behavior Sciences. The OSIRIS system is linked to the University’s Internet-based Studies in Education and Research (ISER) database and will not permit the inclusion of any co-investigator or research coordinator who has not completed the required training modules. All principal investigators, listed co-investigators, and study coordinators are also required to complete the Good Clinical Practice module if the study will be regulated by the U.S. Food and Drug Administration (FDA).
Submitting materials to OSIRIS
All IRB applications must be submitted electronically through OSIRIS. This system enables you to check on your application’s review stage and identify who is currently reviewing or has completed reviewing your proposed study. Materials can be submitted through OSIRIS at any time. However, projects requiring full board review may not appear before a committee for up to three weeks from the time of submission. Expedited and full board renewals must be submitted at least one month prior to their expiration date.
Initial screening
All IRB submissions are initially screened by the protocol processing coordinator to ensure that the application is complete and to determine whether the submission will be forwarded to the exempt/expedited team for review or to the appropriate full board meeting. OSIRIS submissions requiring full board review are assigned to committees as they are received and are reviewed based on the full board calendar.
Full screening
If your protocol requires full board review, you will receive notification of any questions posed by the committee shortly after the meeting. You will then have up to six weeks to respond. The committee will subsequently review your responses and indicate whether further clarifications are required or whether the protocol has been approved.
Additional IRB information
The IRB Office has a detailed Web site with information on all stages of the IRB process. In addition, it has established an “Ask the IRB” program for both full review and exempt/expedited review. The office also provides consultation hours by appointment and a question of the week forum.
IRB approvals and just-in-time procedures
The just-in-time protocol allows for certain types of grant application information to be submitted to NIH after initial peer review of a project that is deemed to be “within the range of possible funding.” For instance, just-in-time procedures “allow an applicant to defer certification of IRB approval of the project’s proposed use of human subjects, verification of IACUC approval of the project’s proposed use of live vertebrate animals, and evidence of compliance with the education in the protection of human research participants requirement until after completion of the peer review and just prior to funding,” according to the NIH Office of Extramural Research. IRB and IACUC approvals can be included with an application, if the investigator chooses to do so; if not, they must be submitted just-in-time. (Note that submitting other support information before it is requested may cause a delay in processing the application, or NIH may return the application without peer review.) If an IRB or IACUC number changes after initial submission, the updated information will be required just-in-time.
