Update on the myResearch (Click) Electronic Management Program for IRB

Update on the myResearch (Click) Electronic Management Program for IRB

The staff of ORC and IT (Research) have been working diligently to customize and test myResearch for IRB with the goal of making the transition from IRBNet to myResearch as seamless as possible. Once the system is ready for ‘prime time’, expected early fall, ORC will be offering in-person workshops and other training opportunities (including sending you training materials with screenshots and instructions) so that you can hit the ground running in preparing your submissions for IRB review.

We are planning a ‘phase in’ approach for use of the system such that we will first be accepting initial (new) submissions (expedited or full review) starting November 20, 2017. Then, sometime in the Spring, we will start moving over active studies that currently live in IRBNet to myResearch via the continuing review process. More on that early next year.

In the meantime, here are some little tidbits of helpful information to start building up your knowledge about the new system:

There’s some new terminology you will need to get used to. Here are three for now (and more to follow!):

● Reportable New Information (RNI): this is the term in myResearch that is what we currently refer to as, e.g., unanticipated problems involving risks to subjects or others, protocol deviations, protocol violations, non-compliance, results of audits or inspections by external agencies or study monitors etc. That sort of thing. More on that as we get closer to launch.

● Non-committee Review: is the term used to describe all reviews done outside of a convened IRB meeting, including exemption determinations, expedited reviews, and ‘Not Human Research’ and QA/QI determinations.

● Designated Reviewer: this is the individual(s) who conducts the non-committee review. If it’s anything other than an expedited review (which requires that the designated reviewer be an actual IRB member), the designated reviewer will be a member of the ORC staff.

As you know, a standard submission in IRBNet requires (in part) completion of a registration smart form, an IRB application, and an uploaded protocol. In myResearch, the smart application form you complete within the system takes the place of the registration form. There will no longer be a separate IRB application to complete. However, in its place we have created the Protocol Template for Investigator-Initiated Studies to be submitted for studies that are initiated by you ( SBU researchers ). You will note that it is much more content-intensive than our previous template in IRBNet, but it provides all the information that is required for the SBU IRBs to assess the federally mandated approval criteria. This template is a blend of the template available through the Click ‘out of box’ program, as well as templates from fellow accredited institutions.

If you would like to “test drive” this new protocol template and start using it now, please feel free to do so. If you submit a new study in IRBNet using this template, you don’t have to also complete the IRB application.

Currently, the process for using an IRB external to SBU (e,g, Chesapeake, NCI-CIRB, or other multi-center studies in which an external IRB will serve as the IRB of record for all sites) involves an administrative process for ceding that IRB review that is a blend of IRBNet and external email. With myResearch, the entire process will occur within the system. New to the submission requirements for these studies that are not SBU investigator-initiated is the need to submit a Protocol Template Supplement: SBU-Specific Information in addition to the main (external) protocol . The information will provide information on issues pertaining to the conduct of the research here, and also provide information that will be helpful for not-for-cause monitoring visits and audits that are conducted as part of ORC’s QA efforts to maintain our high quality HRPP.

Any questions pertaining to these updates may be directed to Judy Matuk at judy.matuk@stonybrook.edu


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