Development of Plain Language Supplemental Materials for the Biobank Informed Consent Process

Abstract

The U.S. Department of Health and Human Services addresses clear communication in the informed consent process as part of the Notice of Proposed Rulemaking for revisions to the Common Rule. However, prior research has shown that participants may not fully comprehend research studies despite completion of an informed consent process. Our main goal was to provide plain language information about donation processes to a cancer biobank to supplement an informed consent form. We developed and conducted cognitive testing with supplemental brochures that clearly communicated information about three different models for consent (notice, broad and study-specific) to future use of biospecimens. During the brochures development process, we conducted qualitative, semi-structured, individual, in-person cognitive interviews among 14 women to examine participants’ perceptions of the brochures. Each participant provided feedback regarding the understandability, graphics and layout, and cultural appropriateness of the brochures. Our findings demonstrate that these methods may be used to tailor consent form brochures, such as the ones developed here, to other populations. This study therefore adds to our understanding of how best to present content to help women from two different racial groups make informed decisions about participation in a cancer biobank.

Understanding Diverse Perspectives on Genetic Research Through Focus Group Talk

“…The process of group sense making, in which participants grappled with personal stories of predisposition and the perceived capabilities and limitations of science provide greater insights into what language may resonate with individuals who may be less familiar with GR. Where prior strategies have focused on the use of "plain language" for informed consent (Drake et al, 2017;Justin, Robert, & Jeff, 2014), this study suggests specific language like "bloodline" and "generation skipping" may help participants connect more familiar ideas with less familiar topics like GR and precision medicine.…”

Ethical Considerations Related to Return of Results from Genomic Medicine Projects: The eMERGE Network (Phase III) Experience

“…Overall, communicating with IRB staff prior to and during protocol review appeared to be beneficial for clarifying study considerations that were specific to genomic RoR studies and may facilitate the process and reduce the time to approval. In addition to providing supplemental explanations to an IRB regarding genomic aspects of a study, including institutionally standardized literature and study materials, may promote participant informed consent [ 19 ], and help to facilitate the review process. Concerns related to participant understanding of study results were raised by multiple site IRBs.…”

Effective Strategies Small Retail Leaders Use to Engage Employees

“…To collect data for this study, I used the semistructured interview method in audio recorded face-to-face communications of openended questions and organizational documents. When using a script or interview protocol, a researcher must remember to notify the participant of the informed consent form and obtain a signed consent to participate (Drake et al, 2016). In following the interview protocol (Appendix D), I ensured to be consistent in asking each participant to sign the consent form prior to collecting interview data and give the individuals a hard copy of the consent form before starting the interview.…”