98 - Examining Withdrawal Rates and How Best to Mitigate Their Occurrences

Background:  Research, innovation, and creativity are the backbone of elite designated R1 institutions. We explore the possibility to significantly reduce the number of withdrawn research protocols in order to prioritize time spent on the management/handling of new (exempt, expedited, and full board) submissions, amendments, renewals, and deviation/incident reports for validated applications.

Program

Description:  Research analysts have limited schedules each workday to devote reviewing time to the vast quantity of submissions to the Office for Protection of Human Subjects (OPHS). How can OPHS ensure that quality time spent during working office hours is streamlined toward that of legitimate applications submitted? Can office written policies/procedures/FAQs be written and disseminated on our website as such to successfully manage the voluminous number of applications submitted whose fate is to ultimately be withdrawn?
To attempt to answer this inquiry, we examined the year 2018, which had one our highest number (174) of withdrawn submissions, resulting in a relatively high withdrawal rate (8%). We downloaded data from our online software, eProtocol, to examine all applications submitted in 2018 that were later withdrawn. However, the data included in this download is limited, and does not include rationale for why the application was withdrawn. We then manually looked back through each application to determine, if possible, the cause for withdrawal, and then grouped these reasons into 8 categories to analyze patterns.

Program

Assessment:  174 applications were submitted that were later withdrawn: 105 new applications, 40 amendments, 21 renewals, 6 deviations, and 2 incident reports. Of the 174 applications, 91 were expedited, 75 exempt, and 8 full board. OPHS staff provided between 0 and 5 cycles of comments, with most receiving only 1 cycle of comments. The reasons for withdrawal were categorized: 64 because of lack of response from investigators, 34 because the study was submitted on an exempt application but required non-exempt level review, 32 because of being submitted on an incorrect application (for reasons other than above), 18 because the study was closed or expired, 13 because of a PI request and/or the project not being pursued, 3 should have been determined as not human subjects research, 3 were submitted when no application was needed, and 7 were withdrawn for an unknown reason.

Limitations: Some withdrawals were resolved outside of the eProtocol system and so comments were not documented, so sometimes we had to glean rationale from other context. We are only looking at one year’s data, so other years might not follow the same trend.

Discussion:  Most applications were withdrawn because of the incorrect application type being submitted or lack of response from the investigators. There is not much that an IRB office can do to reduce the latter number, but there may be strategies for the former that can help. When an exempt application was submitted that needed non-exempt review, the categories selected were mainly Exempt Category 2 and a University defined Exempt Category 7 (now 70), though also included Exempt Categories 1 and 4. Education for whether a new exempt or non-exempt application is needed could be helpful to reduce withdrawals.