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University of Wisconsin–Madison

UW–Madison IRB Survey Results Report

Executive Summary

Nationally, there has been a dramatic increase in the time researchers must spend on administrative tasks and compliance, which in turn limits the amount of time available to conduct the research itself. The Office of the Vice Chancellor for Research and Graduate Education (OVCRGE) strives to identify strategies that will reduce administrative and research burden, while upholding the protection of human subjects, research accountability, and compliance with federal regulations.

Methods:

The OVCRGE conducted an online survey from August 29, 2016 through September 25, 2016 to obtain feedback from faculty about their experiences with human subjects regulatory mechanisms. The survey included users of the Education and Social/Behavioral Science (ED/SBS) IRB and the Health Sciences (HS) IRBs, and the data in this report reflect the perceptions and experiences of UW–Madison human subjects researchers who completed the survey.

Jan Greenberg, Associate Vice Chancellor for Research for the Social Sciences, and Ryan Moze, Assistant Director of the Office of Research Policy, led the survey drafting process. They reviewed IRB surveys administered at peer institutions, a survey administered by the HS IRB, and a survey administered by the Research Animal Resource Center (RARC). Based on this initial work, they drafted the survey with the assistance of Norman Drinkwater, the Associate Vice Chancellor for Research for the Biological Sciences.

Greenberg and Moze then sought feedback from Marsha Mailick, Vice Chancellor for Research and Graduate Education; Dan Uhlrich, (then) Associate Vice Chancellor for Research Policy; Susan Ellis Weismer, Deputy Institutional Official for Education and Social Behavioral Research; Marc Drezner, Deputy Institutional Official for Health Sciences Research; and members of the University Committee. Greenberg and Moze also met with Lillian Larson, Director of the ED/SBS IRB, and Nichelle Cobb, Director of the HS IRB, to obtain feedback and discuss the survey methodology. Based on their feedback, the survey was revised and returned to those who were consulted for additional review.

The University of Wisconsin Survey Center assisted with the wording and formatting of survey questions and programmed the survey in Qualtrics to facilitate survey administration and data analysis. A copy of the survey is provided (Appendix A).

The survey was administered to 1,257 principal investigators (PIs) or their designated staff responsible for IRB protocols. All faculty and permanent staff PIs who had an active IRB protocol within the last two years were eligible to participate. Of the 1,257, 17 had left the UW–Madison. A total of 590 responses were received (455 faculty, 125 academic staff, five postdoctoral fellows, and five doctoral students). The overall response rate was 47.6%. Of the 590 respondents, 18 had not submitted a protocol in the past two years and thus, were not eligible. This report also excludes postdoctoral fellows and graduate students. The final sample consisted of 562 respondents. The survey consisted of multiple choice and open-ended questions. Analysis of qualitative data involved coding over 97,000 words of text.

Major findings:

Survey results indicate that UW–Madison PIs hold IRB staff in high regard and value their expertise, experience, and guidance. Overall, PIs feel respected by the staff and expressed appreciation for the staff’s willingness to help them resolve problems. However, almost 50% of the respondents indicated that they had given up or almost given up pursuing a research project out of frustration of getting it through the IRB process. Primary concerns identified included:

  • Complexity of the ARROW system
  • Length of the IRB approval process
  • Inconsistency in the review process
  • High user fees
  • Over-regulation of minimal risk studies
  • A perception that IRBs are more concerned with avoiding institutional liability than properly assessing the risk to human subjects
  • A perception that IRBs extend beyond the protection of human subjects to regulating scientific approaches
  • A perception that UW–Madison has instituted layers of scrutiny beyond what is required by federal regulation

Recommendations:

  • One of the major frustrations is in the use of ARROW. In response,  the Office of the VCRGE has developed an “ARROW Optimization Plan”. This plan involves the ARROW team (i.e., the information technology group within the Office of the VCRGE) focusing additional development time specifically on improvements to the user experience, leading to improvements in transparency, usability, efficiency, and reduced duplication. As part of this effort, the ARROW team will conduct an upgrade of ARROW that will improve site navigation. This optimization plan is underway. In addition, the OVCRGE will continue to look for opportunities to streamline the application for minimal risks studies. During this process, the ARROW team will seek consultation from the IRB Directors and their staff, the office of the UW–Madison Legal Affairs, and researchers across campus.

 

  • The OVCRGE has begun a process of benchmarking UW–Madison policies and practices against those of its peer institutions, which will include a review of federal human subjects regulations and interpretation of these federal regulations on campus. The OVCGRE will analyze these benchmarking data, develop a plan to reduce the burden on human subjects researchers, and consult with the Directors of the HS and ED/SBS IRBs and the office of the UW–Madison Legal Affairs in this process.

 

  • The survey generated many ideas from respondents for improving IRB processes: developing templates with suggested language for protocols, exploring a centrally-funded IRB, and eliminating IRB fees for non-industry sponsored and non-VA protocols, learning from the RARC’s service-oriented culture, creating an ombudsman, and streamlining the application for minimal risk studies. The OVCRGE appointed a committee of faculty and academic staff researchers to review the findings of this report and the benchmarking data, and generate a prioritized list of recommendations to improve the efficiency and user-friendliness of the IRB process. In conducting its work, the committee will seek consultation from the relevant stakeholders (e.g., IRB staff, the Office of Legal Affairs, faculty researchers, permanent PIs).

 

  • One of the main problems identified by respondents was the apparent lack of uniformity in the criteria applied to reviewing protocols. Many respondents reported that they often received inconsistent and often contradictory comments from different reviewers. To achieve greater uniformity in protocol review, the OVCRGE will use the previously mentioned benchmarking process to determine how peer institutions strive to achieve consistency, and then develop a recommendation and an action step.

 

  • PIs expressed frustration with the length of time from submission of an IRB protocol to approval. The OVCGRE will use available data to better understand what factors contribute to the length of the IRB review process to help identify opportunities to reduce the time between the submission of a proposal and the approval of the protocol.

 

  • The OVCRGE will develop a short IRB survey to receive ongoing feedback. The survey will be administered automatically to an investigator each time the investigator receives notification that his/her IRB protocol has been approved. Many peer institutions have implemented such a survey and found it helpful in obtaining “real time” feedback from users.

This is an ambitious plan that will likely require additional campus resources. It also may require changes in UW–Madison campus policies regarding IRB processes and procedures. The Office of the VCRGE recognizes any effort to implement changes that improve the efficiency and user-friendliness of IRBs must simultaneously support their primary role of ensuring compliance with federal regulations. As the OVCRGE moves forward in implementing these recommendations, it will work closely with the Directors of the ED/SBS and HS IRBs and the office of the UW–Madison Legal Affairs to ensure that administrative efficiencies and changes do not hamper the IRBs’ ability to carry out their regulatory responsibility.