46 - Benefits of Adding Informed Consent Specialists to an HRPP Program

Background:  Informed consent documents (ICDs) are cornerstones to ethical research. However, only 12% of adults are proficient in health literacy. As research and the regulations that govern it grow more complex, it can be difficult to draft an ICD that meets the needs of potential participants, IRBs, Sponsors, and researchers.

Program

Description:  To ensure that ICDs meet our community’s needs, ICD specialists who are trained in ICD regulations, health literacy techniques, and Plain Language were added to our HRPP program.

ICD specialists are responsible for writing and reviewing ICDs to meet applicable regulations and local requirements while targeting a 6th-8th grade reading level. The specialists provide guidance on best practices for researchers and the IRB.
As part of a quality improvement initiative, consent templates were updated with input from the ICD specialists and key institutional stakeholders. A style guide was also developed and implemented to promote equitable information in ICDs across the institution.

Average reading level and reading ease scores (per Flesch-Kincaid) pre- and post-implementation of these changes were compared to assess effectiveness. Additionally, key performance indicators (KPIs), such as average turnaround times and time from submission to finalization, were tracked. Finally, we collected qualitative data (feedback) from the research community.

Program

Assessment:  Since implementation of these changes, ICDs have dropped by over 2 grade levels and reading ease scores have improved by over 20 points on average. Consent review turnaround times also improved from 38 days to 7 days.

Response to the addition of the ICD team has been positive. The research community sees the ICD team as a valuable resource to the start-up process as they can offload consent writing and review, which can sometimes be lengthy depending on complexity of the study and required Sponsor/CRO review.

As the quality and consistency of the ICD improved, fewer requests to modify the consent form to secure IRB approval were made (especially for external IRB submissions).

The directive to update old consents to the new consent template also allowed for a thorough program-wide quality assurance (QA) check. This QA check addressed gaps in compliance with applicable regulations, particularly the Revised 2018 Common Rule, misalignment with institutional policies, and incongruencies between the IRB-approved protocol and described procedures in the consent form.

Limitations: Measurements to assess program effectiveness were implemented late into the program’s conception, so quantitative assessments may not be fully reflective of the true impact of the ICD specialists as a whole. Instead, metrics were measured based on a randomized selection of consent forms over the 2023 Q4 and 2024 Q1 period.

Reading levels and readability scores are also generated from a single source (Flesch-Kincaid). Whereas other readability measuring tools may provide differing results.

Discussion:  ICD specialists will initiate educational efforts to train the research community to focus on health literate communications during the consent process; emphasize to IRB members the importance of reviewing the consent with health literacy in mind as an additional protection for human subjects; and initiative community needs assessments to address gaps between our community’s needs and levels of patient satisfaction with the ICD and consent process.

Health literate-forward thinking in the consent process will lead to equitable access to research, promote diversity in potential participants, and improve the quality and variances of data collected in trials.