Sarah B. Garrett

EngageUC: Developing an Efficient and Ethical Approach to Biobanking Research at the University of California

Biorepositories, or biobanks, provide researchers with access to biological samples and associated data in support of translational research. Efficient operation and ethical stewardship of biobanks involves coordinated efforts among multiple stakeholders including researchers who manage and use the repository, institutional officials charged with its oversight, and patients and volunteers who contribute samples and data. As advancements in translational research increasingly involve more data derived from larger numbers of diverse samples, the size and governance challenges facing biorepositories have grown. We describe an approach to developing efficient and ethical biobank governance that includes all major stakeholders. This model provides a pathway for addressing the technical and ethical challenges that must be resolved to ensure biorepositories continue to support translational research.

The Importance Of Integrating Narrative Into Health Care Decision Making

When making health care decisions, patients and consumers use data but also gather stories from family and friends. When advising patients, clinicians consult the medical evidence but also use professional judgment. These stories and judgments, as well as other forms of narrative, shape decision making but remain poorly understood. Furthermore, qualitative research methods to examine narrative are rarely included in health science research. We illustrate how narratives shape decision making and explain why it is difficult but necessary to integrate qualitative research on narrative into the health sciences. We draw on social-scientific insights on rigorous qualitative research and our ongoing studies of decision making by patients with cancer, and we describe new tools and approaches that link qualitative research findings with the predominantly quantitative health science scholarship. Finally, we highlight the benefits of more fully integrating qualitative research and narrative analysis into the medical evidence base and into evidence-based medical practice.

Linking Broad Consent to Biobank Governance: Support From a Deliberative Public Engagement in California

Linking Broad Consent to Biobank Governance: Support From a Deliberative Public Engagement in California Sarah B. Garrett, Daniel Dohan & Barbara A. Koenig To cite this article: Sarah B. Garrett, Daniel Dohan & Barbara A. Koenig (2015) Linking Broad Consent to Biobank Governance: Support From a Deliberative Public Engagement in California, The American Journal of Bioethics, 15:9, 56-57, DOI: 10.1080/15265161.2015.1062177 To link to this article: http://dx.doi.org/10.1080/15265161.2015.1062177

Community recommendations on biobank governance: Results from a deliberative community engagement in California

United States-based biorepositories are on the cusp of substantial change in regulatory oversight at the same time that they are increasingly including samples and data from large populations, e.g. all patients in healthcare system. It is appropriate to engage stakeholders from these populations in new governance arrangements. We sought to describe community recommendations for biorepository governance and oversight using deliberative community engagement (DCE), a qualitative research method designed to elicit lay perspectives on complex technical issues. We asked for stakeholders to provide input on governance of large biorepositories at the University of California (UC), a public university. We defined state residents as stakeholders and recruited residents from two large metropolitan areas, Los Angeles (LA) and San Francisco (SF). In LA, we recruited English and Spanish speakers; in SF the DCE was conducted in English only. We recruited individuals who had completed the 2009 California Health Interview Survey and were willing to be re-contacted for future studies. Using stratified random sampling (by age, education, race/ethnicity), we contacted 162 potential deliberants of whom 53 agreed to participate and 51 completed the 4-day DCE in June (LA) and September-October (SF), 2013. Each DCE included discussion among deliberants facilitated by a trained staff and simultaneously-translated in LA. Deliberants also received a briefing book describing biorepository operations and regulation. During the final day of the DCE, deliberants voted on governance and oversight recommendations using an audience response system. This paper describes 23 recommendations (of 57 total) that address issues including: educating the public, sharing samples broadly, monitoring researcher behavior, using informative consent procedures, and involving community members in a transparent process of biobank governance. This project demonstrates the feasibility of obtaining meaningful input on biorepository governance from diverse lay stakeholders. Such input should be considered as research institutions respond to changes in biorepository regulation.

The promises of computational ethnography: Improving transparency, replicability, and validity for realist approaches to ethnographic analysis

This article argues the advance of computational methods for analyzing, visualizing and disseminating social scientific data can provide substantial tools for ethnographers operating within the broadly realist ‘normal-scientific tradition’ (NST). While computation does not remove the fundamental challenges of method and measurement that are central to social research, new technologies provide resources for leveraging what NST researchers see as ethnography’s strengths (e.g. the production of in situ observations of people over time) while addressing what NST researchers see as ethnography’s weaknesses (e.g. questions of sample size, generalizability and analytical transparency). Specifically, we argue computational tools can help: (1) scale ethnography, (2) improve transparency, (3) allow basic replications, and (4) ultimately address fundamental concerns about internal and external validity. We explore these issues by illustrating the utility of three forms of ethnographic visualization enabled by computational advances – ethnographic heatmaps (ethnoarrays), a combination of participant observation data with techniques from social network analysis (SNA), and text mining. In doing so, we speak to the potential uses and challenges of nascent ‘computational ethnography.’

Interest in initiating an early phase clinical trial: results of a longitudinal study of advanced cancer patients

Enhanced recruitment of patients with advanced cancer (ACP) to early phase (EP) trials is needed. However, selective recruitment may affect the kinds of patients who are recruited. To address whether ACP who initiate EP trial enrollment differ from those who do not, we prospectively surveyed ACP well in advance of potential trial recruitment and followed them over time to identify those who initiated the recruitment process.

Approaches to decision-making among late-stage melanoma patients: a multifactorial investigation

PurposeThe treatment decisions of melanoma patients are poorly understood. Most research on cancer patient decision-making focuses on limited components of specific treatment decisions. This study aimed to holistically characterize late-stage melanoma patients’ approaches to treatment decision-making in order to advance understanding of patient influences and supports.Methods(1) Exploratory analysis of longitudinal qualitative data to identify themes that characterize patient decision-making. (2) Pattern analysis of decision-making themes using an innovative method for visualizing qualitative data: a hierarchically-clustered heatmap. Participants were 13 advanced melanoma patients at a large academic medical center.ResultsExploratory analysis revealed eight themes. Heatmap analysis indicated two broad types of patient decision-makers. “Reliant outsiders” relied on providers for medical information, demonstrated low involvement in decision-making, showed a low or later-in-care interest in clinical trials, and expressed altruistic motives. “Active insiders” accessed substantial medical information and expertise in their networks, consulted with other doctors, showed early and substantial interest in trials, demonstrated high involvement in decision-making, and employed multiple decision-making strategies.ConclusionWe identified and characterized two distinct approaches to decision-making among patients with late-stage melanoma. These differences spanned a wide range of factors (e.g., behaviors, resources, motivations). Enhanced understanding of patients as decision-makers and the factors that shape their decision-making may help providers to better support patient understanding, improve patient-provider communication, and support shared decision-making.

Standard Versus Simplified Consent Materials for Biobank Participation: Differences in Patient Knowledge and Trial Accrual:

Replacing standard consent materials with simplified materials is a promising intervention to improve patient comprehension, but there is little evidence on its real-world implementation. We employed a sequential two-arm design to compare the effect of standard versus simplified consent materials on potential donors’ understanding of biobank processes and their accrual to an active biobanking program. Participants were female patients of a California breast health clinic. Subjects from the simplified arm answered more items correctly (p = .064), reported “don’t know” for fewer items (p = .077), and consented to donate to the biobank at higher rates (p = .025) than those from the standard arm. Replacing an extant consent form with a simplified version is feasible and may benefit patient comprehension and study accrual.