15 - Who? What? When? Why? One Institution’s Practice for Strengthening Compliance With the Short Form Process

Background: Recruitment of non-English Speaking (NES) participants to therapeutic protocols occurs in two stages: an initial approach using a Short Form (SF) consent, followed by a further consent discussion utilizing a fully translated Informed Consent (IC). Quality Assurance (QA) reviews have identified that the second discussion is often missed.

Program

Description: Federal regulations allow for the use of a SF to enroll NES participants. Our institution’s IRB/PB standard operating procedure (SOP) requires a complete translation of the IC for NES individuals into their preferred language when enrolled with the SF to therapeutic research. Once a fully translated IC is available for participant use, upholding equity within clinical research stipulates that reasonable efforts are made to ensure NES participants have the opportunity to review the IC details in their preferred language as part of the additional consent discussion.When a translated IC is approved by the institution’s IRB, the HRPP team conducts quarterly QA reviews of electronic medical records to evaluate whether study teams are adhering to SOP requirements. This review includes, but is not limited to, ensuring that this second consent discussion occurs.

Program

Assessment: The 2022 QA of the NES consent process revealed a variety of errors; e.g., 44% of the sample NES participants had not completed this second consent discussion following initial consent using the SF. Research teams were queried as to the reasons which included: several participants were no longer on study due to disease progression or death, and therefore the second consent discussion could not be conducted; the second consent discussion was not obtained for some participants due to study team oversight or misunderstanding of institutional policy concerning NES participants. Following a thorough review of all errors in the Fall of 2022, educational resources were enhanced with feedback from the research community. Continued QA of the SF process after the implementation of the enhanced educational resources revealed a downward trend of approximately 50% in the number of NES participant consent errors.

Limitations: There are known gaps in the QA process. For example, the identified SF consents nominated for review is obtained from translation requests sent to the HRPP office by a study team. It is possible that study teams did not request a translated consent in the first place.

Discussion: The QA process of IC discussions for NES participants has identified important omissions in the process of enrollment and consent to research for this patient population. These deficits include knowledge gaps on behalf of research teams, non-adherence to institutional SOP’s and also provide educational opportunities to improve the process. Outside institutions stand to benefit from a review of their consent process for NES participants.