In the spring and summer of 2016, a task force consisting of Principal Investigators, Department Representatives, IRB Executive Board members, staff from the Research Ethics and Compliance (REC) office, and the Chair of the Academic Senate formulated a series of recommendations for improving the IRB process at ISU. The goal of these recommendations were to streamline processes, improve consistency, and reduce the administrative burden on researchers.
In the intervening months, the leadership of the IRB, the REC staff, and the Associate Vice President of Research (who is also the Institutional Official) have worked toward implementing these recommendations. Although some recommendations have already been made (e.g. the appointment of a Vice Chair of the IRB Executive Board), substantial additional reforms will be made in the spring semester of 2018. These changes are intended to coincide with the revisions to the Common Rule that take effect on January 19, 2018.
For a project to attain exempt status, the PI submits a full protocol that is reviewed by the Department Representative, the REC Office, and the Vice Chair of the IRB. The Vice Chair has the sole authority to determine whether the project is exempt.
An abbreviated form will be made available. The PI will submit this short form electronically to the REC Office, where an exempt determination will be made by a Human Subjects Research Specialist (HSRS) in the REC Office. Although supplemental documents (e.g. consent forms, instruments, recruitment materials) will not be required for this determination, PIs will be expected to follow the principles outlined in the regulations.
For exempt-level submissions (40% of the university-wide submissions each year), substantially less time will be required to complete the abbreviated form. Furthermore, with a single, staff-level reviewer consistency and turnaround time will greatly improve. A disadvantage is that when exempt status is not granted, the PI will need to submit a full protocol, potentially delaying the start of the project. PIs will want to consult with the HSRS prior to submission if there is a question regarding whether to use the full or abbreviated form.
All protocols must first be sent to a DR, who checks the application for completeness and recommends a level of review. Next, the REC Office checks for completeness and then forwards the submission to the IRB Vice Chair (for exempt level) or the IRB Chair/Executive Committee (for expedited and full board level).
The departmental step will no longer be required and PIs may submit directly to the REC Office. Note that departments/schools may elect to retain their departmental process and/or personnel. The Human Subjects Research Specialist in the REC Office will determine whether the study is exempt (if such a determination is requested by the PI) or conduct a pre-review (for completeness and recommended review level if the study is nonexempt) before forwarding the submission to the IRB.
With the DR no longer conducting a completeness check and recommending a level of review, the Human Subjects Research Specialist in the REC Office becomes the primary point of contact with the PI. This should result in more consistent determinations and improved turnaround times. Departments/schools may retain their DR(s) for mentorship and methodological consultation even if they no longer require departmental review.
During the past two years, we have heard from numerous PIs that our proposal submission system (IRBNet) does not meet their needs. It is difficult to learn and use, and many of these usability issues cause delays in approvals and even result in lost submissions. After evaluating other submission systems, and with the unanimous support of an ad hoc PI advisory group, we have decided to make a change. Beginning in January, protocols will be submitted using Cayuse IRB, a dashboard-based submission system with web-based smart forms. This system will have several advantages:
Improved efficiency and productivity for the following reasons: (a) the time required to submit a protocol should be substantially decreased as a result of the more intuitive user interface and context-sensitive help; (b) smart forms with required fields should reduce the number of protocols returned due to missing information; (c) the ability to respond to reviewers’ comments/questions at the specific location of each comment/question should reduce the number of protocols returned due to unaddressed comments; and (d) protocols will be cross-referenced to external grants in Cayuse SP/424 making for simpler verification of congruence.
Revisions to the Common Rule were published in the Federal Register on January 19, 2017. These revisions become effective on January 19, 2018. Although most of the changes pertain to clinical trials, some will affect research at ISU. Click here for additional details.