35 - Using a Template to Improve Consistency and Provide Regulatory Reasoning in IRB Communication

Background: IRB reviewers often request additional information to ensure approval criteria can be assessed. Submitters have indicated frustration with the IRB, sometimes due to misunderstanding why information is requested for some submissions and not others. To combat this, the IRB now provides the regulatory justification for changes in an easier-to-read format.

Program

Description: An academic medical center IRB has created and implemented a new process for requesting additional information and drafting and releasing determination letters for all initial reviews and post-approval submissions.

A subcommittee of IRB reviewers developed an internal template for communications, by compiling an extensive itemized list of requests and pairing them with regulatory reasoning. The language was then reviewed and approved by the Human Research Protections leadership. The list was then transitioned into a shared Excel table to enhance readability for IRB application submitters and sponsors (when applicable). Table columns were created for application and/or document location; the request itself; and applicable federal regulations and institutional policies to highlight the regulatory reasoning for each request.

The final template was then made available for use to all IRB reviewers. A designated IRB reviewer revisits the template on a regular basis to make updates as needed.

Program

Assessment: A pilot assessment of user satisfaction regarding the implementation of the new template was performed. Twenty-three regular IRB application submitters were polled regarding the ease with which they understood requests in this format, and whether they found these changes useful. The results show that 74% of respondents found that the requests from the IRB were easier to understand, and 79% of respondents found that having a regulatory reasoning for each request was helpful. Respondents have indicated that explicit request and rationale promotes foundational thinking, which benefits autonomy when submitting future modifications to IRB. IRB leadership will continue to collect metrics regarding the quality and timeliness of return submissions, the satisfaction of the research community, and feedback from the community and Sponsors regarding the utility of the system and its ease of use.

Limitations: Requesting changes from study teams using this method temporarily extended the time needed for IRB staff to write communications from the IRB by ~10%. However, as the staff became more familiar with the process, staff became more efficient in using this method. Also, some research staff have expressed disinterest in regulatory reasoning behind the IRB’s requests for changes.

Discussion: To improve consistency across reviewers and enhance transparency regarding regulatory reasoning for changes, the IRB has adopted a template that includes regulatory reasoning. Reviewers use consistent language and provide researchers with regulatory reasoning. This process has resulted in a measurable customer satisfaction increase and improved the quality of response submissions. Reviewers have reported that response submissions are returned with a lower rate of error and less frequent pushback from Sponsors and/or Investigators. When a new version of the template is rolled out, the IRB staff re-downloads the document to ensure that the language used across the IRB is consistent.