Check-in Process FAQs
Although the changes to minimal risk studies implemented by the Office of Human Research Protection (OHRP) in January of 2019 have allowed increased flexibility and facilitated faster reviews by no longer requiring continuing review, they have also severely limited the ability to collect information necessary to meet oversight responsibilities.
In order to improve our ability to collect information necessary to meet HRPO and institutional oversight responsibilities, a check-in form must be submitted every three years or annually if a student is the principal investigator.
Check-in forms are required for studies that do not undergo a continuing review by the WU IRB. This includes:
- studies that qualify as exempt
- studies reviewed by expedited procedure that fit the criteria where continuing reviews are not required (i.e. not FDA regulated, research fits expedited review categories and is reviewed under the New Common rule)
- studies overseen by IRBs other than the WU IRB (i.e. studies that submitted a Request to Rely form)
Except for research conducted by a student PI, a check-in form is required every three years from the date of initial IRB approval. For request to rely forms, it is the date the RTR was approved.
A check-in form is required every year for research conducted by a student PI. In many cases, student-conducted research projects do not remain active for three years. To ensure these studies are closed prior to students leaving WU, a shorter time frame applies.
Even though WU IRB is not the IRB of record, there are components of research oversight that are considered local context, such as funding sources and financial interests of study team members. In addition, just as with studies that fall under WU IRB oversight, studies tracked by HRPO through the request to rely submission should be closed out when the research is complete.
The PI and all delegates authorized to submit forms for the study will be notified via an automated email.
You do not need to create the check-in form. When it is due you will receive an automated email notification and the form will be available in the drafts section of your inbox in myIRB.
There are only five yes/no questions in the check-in form.
- Is the study still active?
- Have subjects been enrolled? (Note: actual numbers enrolled are not required)
- Is the funding source reported accurately in myIRB?
- Are the financial interests for study team members reported accurately in myIRB?
- Have all reportable events been submitted consistent with IRB policy requirements
If you submitted your check-in form and the study is active and all funding sources, financial interests and reportable events are up to date, the form was automatically filed.
Otherwise, the form will follow the same workflow as other forms that you submit to HRPO. A HRPO staff person will communicate with you via the standard workflow process in myIRB for additional actions that are required.
The form can be viewed under the form history section found on the project summary page for your study.
The check-in form process will start on February 1, 2021. If your study has been approved for greater than three years, your first form will be due on the anniversary date of your IRB approval. For example, if your study was approved on March 5, 2013, you will receive a notice that a check-in form is required on March 5, 2021. Thereafter, the form is required every three years (or every year for research conducted by a student PI).
No. There are no fees associated with the review of check-in forms, even if the study is funded by a for-profit entity.