Existing IRB guidelines are being updated to comply with the new regulations, and we are taking this opportunity to convert them to a new SOP (Standard Operating Procedure) format. Instead of one single document, these SOPs will now be available as individual links on our website. We hope this change improves transparency and openness about IRB procedures, and also allows researchers to more easily access the information.
As an SOP is written/published, the corresponding section of the old guidelines will be deleted.
Single IRB Review
Currently, IRBs have two choices with research occurring at multiple institutions:
- Enter into deferral agreements with other institutions, meaning one IRB oversees the study at multiple sites; or
- Each IRB can review the study themselves, meaning that a study may have multiple IRBs involved, each reviewing the research for their own institution.
Option #2 will no longer exist for federally funded studies. The effective date for NIH-funded studies is January 25, 2018, and January 20, 2020 for studies funded through the other federal agencies. IRBs will be required to defer oversight to one IRB, which will oversee the study at all sites.
At UWM, we already routinely do deferrals with other institutions. We do not anticipate any significant changes for researchers as a result of this change.
Definition of Research and Human Subjects
The definition of human subjects research (i.e., research requiring IRB oversight) has changed slightly. We have revised the Determination Form that is used when deciding whether or not a project needs IRB review. Changes include:
- Updating the definitions to match the new regulations
- Adding questions about work done as a consultant vs. in your role as UWM employee / faculty.
- Changes to the formatting and flow to be more user-friendly.
We welcome your comments and suggestions on the new format, and may continue to tweak the form over the next few months. For this reason, please go to our website to get the most current version of the form each time you submit a determination request.
*Note: While the new definition officially goes into effect January 21, 2019, the language is very similar so we have already begun using the new form. However, in any case where the determination of human subjects research would be different under the new Common Rule, we will defer to the older definition until Jan 2019.
Our IRBManager numbering system labels studies by fiscal year. Since the new regulations go into effect approximately halfway through the fiscal year, we are making a slight change to the numbering system beginning January 21, 2019 for the rest of FY 2019. Instead of being numbered 19.xxx, studies approved under the new regulations will be numbered 19.A.xxx. Beginning with FY 2020 (July 1, 2019), we will resume the normal numbering convention (20.xxx).