Abstract Data access committees (DAC) gatekeep access to secured genomic and related health datasets yet are challenged to keep pace with the rising volume and complexity of data generation. Automated decision support (ADS) systems have been shown to support consistency, compliance, and coordination of data access review decisions. However, we lack understanding of how DAC members perceive the value add of ADS, if any, on the quality and effectiveness of their reviews. In this qualitative study, we report findings from 13 semi-structured interviews with DAC members from around the world to identify relevant barriers and facilitators to implementing ADS for genomic data access management. Participants generally supported pilot studies that test ADS performance, for example in cataloging data types, verifying user credentials and tagging datasets for use terms. Concerns related to over-automation, lack of human oversight, low prioritization, and misalignment with institutional missions tempered enthusiasm for ADS among the DAC members we engaged. Tensions for change in institutional settings within which DACs operated was a powerful motivator for why DAC members considered the implementation of ADS into their access workflows, as well as perceptions of the relative advantage of ADS over the status quo. Future research is needed to build the evidence base around the comparative effectiveness and decisional outcomes of institutions that do/not use ADS into their workflows.
Institutional review boards (IRBs) are permitted by regulation to seek assistance from outside experts when reviewing research applications that are beyond the scope of expertise represented in their membership. There is insufficient understanding, however, of when, why, and how IRBs consult with outside experts, as this practice has not been the primary focus of any published literature or empirical study to date. These issues have important implications for IRB quality. The capacity IRBs have to fulfill their mission of protecting research participants without unduly hindering research is influenced by IRBs' access to and use of the right type of expertise to review challenging research ethics, regulatory, and scientific issues. Through a review of the regulations and standards permitting IRBs to draw on the competencies of outside experts and through examination of the needs, strategies, challenges, and concerns related to doing so, we identify critical gaps in the existing literature and set forth an agenda for future empirical research.
The participation of vulnerable populations in biomedical research—such as minors and incompetent adults—has in the past, and will continue to be a central consideration in bioethics considering they warrant special protections against potential rights violations and exposure to undue risk. These populations, however, should not be excluded from the opportunity to benefit from scientific progress through their research participation. The promises of personalized medicine for improved diagnosis and treatment of pediatric diseases further underscores this pressing need for their inclusion. This chapter provides both a retrospective and prospective analysis of research participation, with a special focus on the involvement of minors and incompetent adults in the data-intensive research typical of personalized medicine and genomic translation. The authors propose reverse vulnerability as one conceptual lens through which to examine the ethical intersectionalities associated with data-intensive research participation within both populations. The chapter includes a discussion of how situational vulnerabilities unfold for minors and incompetent adults while participating in data-intensive research, as well as how these vulnerabilities are implicated in future ethics governance in the post genomic era.
Objectives: To explore the practical barriers to, and implications of, incorporating genomic technologies in the primary care setting. In evaluating the primary care mission and anticipated role of genomic medicine in conversation with one another, I discuss the ways in which the primary care philosophy problematizes innovations afforded to clinical medicine through whole genome sequencing. I discuss these themes in relation to the evaluation frameworks that must precede full integration, specifically the Analytic validity, Clinical validity, Clinical Utility and Ethical, legal social considerations (ACCE) model. Finally, my analysis will consider the added ethical nuances for integrating genomic medicine in the wake of new standards for healthcare delivery in the U.S.Methods: I review the literature concerning 1) models for evaluating the applicability of emerging genomic technologies in the primary care setting, namely the ACCE model proposed by the Center for Disease Control, and 2) anticipated changes to primary care delivery through proposed healthcare legislation.Results: Three main facets of primary care delivery problematize full integration of genomic medicine in clinical practice. They include: primary care providers' propensity to maintain therapeutic relationships with patients over the lifecourse, acuity to community health patterns, and gaps in genetic/genomic-specific knowledge among practicing clinicians. Implementation of genomic medicine requires that technologies be adaptable to the heterogeneity of the primary care clinic, in both the diverse populations it serves and broad spectrum of resource availability.Conclusions: The rapid pace at which genomic technology has fundamentally altered the direction of medical research scene is extraordinary to say the least. The potential benefits for incorporating these innovations depict a clinical landscape that predicts and prevents disease before it manifests, and cares for patients using treatments that are tailored to their own genetic person. The primary care arena presents unique challenges to the evaluation, diffusion and translation of genomic technologies. Yet the same aspects that present limitations also reinforce the reasons why the primary care setting is a critical forum in which to operationalize genomic medicine in practice. With so much dialogue generated around ushering in a new era of medicine, it is unclear whether this is celebrating the novelty of the genomic revolution, or the reinvigoration of a longstanding clinical tradition in patient-centered primary care.
The purpose of this qualitative study is to elucidate stakeholder perceptions of, and institutional practices related to cell-based therapies and products (CTP) regulation and commercialization in Canada. The development of reproducible, safe and effective CTPs is predicated on regulatory and commercialization environments that enable innovation. Manufacturing processes constitute a critical step for CTP development in this regard. The road from CTP manufacturing to translation in the clinic, however, has yet to be paved. This study aims to fill an empirical gap in the literature by exploring how CTP manufacturing facilities navigate Canadian regulatory and commercialization environments, which together drive the translation of novel CTPs from bench to bedside. Using the multi-level model of practice-driven institutional change proposed by Smets et al., we demonstrate how CTP manufacturing practices are governed by established standards, yet meaningfully shape higher-order regulatory and commercial norms in CTP research and development. We identify four key themes that undergird such processes of innovation: 1) managing regulatory uncertainty, which stems from an inability to classify CTPs within existing regulatory categories for approval and commercialization purposes; 2) building a 'business case' whereby a CTP's market potential is determined in large part by proving its safety and effectiveness; 3) standardizing manufacturing procedures that mobilize CTPs from a research and development phase to a commercialization one; and 4) networking between researchers and regulators to develop responsible commercialization processes that reflect the uniqueness of CTPs as distinct from other biologics and medical devices.
This article describes a mixed-methods protocol to develop and test the implementation of a stewardship maturity matrix (SMM) for repositories which govern access to human genomic data in the cloud. It is anticipated that the cloud will host most human genomic and related health datasets generated as part of publicly funded research in the coming years. However, repository managers lack practical tools for identifying what stewardship outcomes matter most to key stakeholders as well as how to track progress on their stewardship goals over time. In this article we describe a protocol that combines Delphi survey methods with SMM modeling first introduced in the earth and planetary sciences to develop a stewardship impact assessment tool for repositories that manage access to human genomic data. We discuss the strengths and limitations of this mixed-methods design and offer points to consider for wrangling both quantitative and qualitative data to enhance rigor and representativeness. We conclude with how the empirical methods bridged in this protocol have potential to improve evaluation of data stewardship systems and better align them with diverse stakeholder values in genomic data science.
Abstract Data access committees (DAC) gatekeep access to secured genomic and related health datasets yet are challenged to keep pace with the rising volume and complexity of data generation. Automated decision support (ADS) systems have been shown to support consistency, compliance, and coordination of genomic data sharing of data access review decisions. However we lack understanding of how DAC members perceive the value add of ADS, if any, on the quality and effectiveness of their reviews. In this qualitative study, we report findings from 13 semi-structured interviews with DAC members from around the world to identify relevant barriers and facilitators to implementing ADS for genomic data access management. Participants generally supported pilot studies that test ADS performance for example in cataloging data types, verifying user credentials and tagging datasets for use terms. Concerns related to over-automation, lack of human oversight, low prioritization, and misalignment with institutional missions tempered enthusiasm for ADS among the DAC members we engaged. Tensions for change in institutional settings within which DACs operated was a powerful motivator for why DAC members considered the implementation of ADS into their access workflows, as well as perceptions of the relative advantage of ADS over the status quo. Future research is needed to build the evidence base around the comparative effectiveness and decisional outcomes of institutions that do/not use ADS into their workflows.
