Integrating stakeholder feedback in translational genomics research: an ethnographic analysis of a study protocol’s evolution

Abstract

Purpose This study describes challenges faced while incorporating sometimes conflicting stakeholder feedback into study design and development of patient-facing materials for a translational genomics study aiming to reduce health disparities among diverse populations. Methods We conducted an ethnographic analysis of study documents including summaries of patient advisory committee meetings and interviews, reflective field notes written by study team members, and correspondence with our institutional review board (IRB). Through this analysis, we identified cross-cutting challenges for incorporating stakeholder feedback into development of our recruitment, risk assessment, and informed consent processes and materials. Results Our analysis revealed three key challenges: (1) balancing precision and simplicity in the design of study materials, (2) providing clinical care within the research context, and (3) emphasizing potential study benefits versus risks and limitations. Conclusion While involving patient stakeholders in study design and materials development can increase inclusivity and responsiveness to patient needs, patient feedback may conflict with that of content area experts on the research team and IRBs who are tasked with overseeing the research. Our analysis highlights the need for further empirical research about ethical challenges when incorporating patient feedback into study design, and for dialogue with genomic researchers and IRB representatives about these issues.

Examining access to care in clinical genomic research and medicine: Experiences from the CSER Consortium

“…CSER has begun to fill these gaps through multiple avenues [27,87,88], including evaluating novel language-tailored genomics content and communication strategies like NYCKidSeq's GUÍA tool [61]. Continued research utilizing stakeholder engagement and community-based participatory approaches [48,64,89,90] is needed to provide further insight into the experience of LEP populations, the impact of language barriers on quality of care, and the relationship between language and literacy barriers in genomics.…”

Adaptation and early implementation of the PREdiction model for gene mutations (PREMM5™) for lynch syndrome risk assessment in a diverse population

“…The PAC feedback regarding the risk assessment consent was greatly modified by the primary site IRB [ 32 ]. Importantly, IRB input led to greatly increased literacy level of the consent for risk assessment.…”

“…The English adaptation team, English-language PAC, and CHARM study team iteratively reviewed these adapted materials (Fig. 1 ) [ 32 ]. During three PAC meetings and individual cognitive interviews, English-language PAC members provided feedback regarding the explanation of the purpose of the risk assessment, adapted question and results wording, layout of the tool, and made recommendations for where literacy aids would be helpful.…”

Integration of stakeholder engagement from development to dissemination in genomic medicine research: Approaches and outcomes from the CSER Consortium

“…Community stakeholder insight is essential to identify and prioritize key findings, guide lay language descriptions, and present opportunities to reach various community groups with broad and/or tailored messages. Their guidance can also shape professional community dissemination, including contributing to and coauthoring manuscripts [17][18][19] and copresenting at professional conferences. All projects have study materials (including consent forms, education materials, and surveys) available in both English and Spanish, some of which is publicly available at https://cser-consortium.org/cserresearch-materials.…”

“…For example, some CSER sites faced barriers to implementation of their research because of difficulty in obtaining IRB approval--a challenge that has been documented by others 37 likely exacerbated by the increasingly complex nature of genomic testing and research. CHARM researchers went on to analyze how interactions with IRB stakeholders shaped their project 18 and NYCKidSeq stakeholder members engaged their IRB to revise "standard" consent language to enhance understanding and clarity.…”