Navigating the research-clinical interface in genomic medicine: analysis from the CSER Consortium.

PurposeThe Clinical Sequencing Exploratory Research (CSER) Consortium encompasses nine National Institutes of Health-funded U-award projects investigating translation of genomic sequencing into clinical care. Previous literature has distinguished norms and rules governing research versus clinical care. This is the first study to explore how genomics investigators describe and navigate the research-clinical interface.MethodsA CSER working group developed a 22-item survey. All nine U-award projects participated. Descriptive data were tabulated and qualitative analysis of text responses identified themes and characterizations of the research-clinical interface.ResultsSurvey responses described how studies approached the research-clinical interface, including in consent practices, recording results, and using a research versus clinical laboratory. Responses revealed four characterizations of the interface: clear separation between research and clinical care, interdigitation of the two with steps to maintain separation, a dynamic interface, and merging of the two. All survey respondents utilized at least two different characterizations. Although research has traditionally been differentiated from clinical care, respondents pointed to factors blurring the distinction and strategies to differentiate the domains.ConclusionThese results illustrate the difficulty in applying the traditional bifurcation of research versus clinical care to translational models of clinical research, including in genomics. Our results suggest new directions for ethics and oversight.

Using videoed workshops in interdisciplinary research with people who have disabilities.

BACKGROUND: Internationally, interdisciplinary research is advocated in healthcare. Such research receives great respect, particularly from funding bodies, which expect innovations in healthcare to emerge from a whole team rather than a single discipline. However, little guidance exists about the process and structures for such research. AIM: To explore and explain the use of videoed workshops and mixed-media artefacts to collect data, and explore the benefits and challenges for interdisciplinary healthcare research. DATA: sources Videoed workshops were used to ascertain the preferences of eight people who have disabilities concerning assistive technology. These workshops are used to demonstrate the method's benefits and related challenges for interdisciplinary healthcare research. DISCUSSION: This method of collecting data has important potential benefits for healthcare research. Future research in healthcare must not only be interdisciplinary, it should also involve a range of research designs that are adaptive and responsive to service users' needs and use innovative methods of collecting data. CONCLUSION: The use of video and photography in interdisciplinary research for healthcare technology is an exciting possibility, but it poses ethical and practical considerations. IMPLICATIONS FOR RESEARCH: Videos and photography area a useful aid in interdisciplinary research and can be a valuable means of non-verbal data collection, especially with participants affected by disabilities, and can support research methods, such as the use of questionnaires.

Ethical and epistemic issues in the design and conduct of pragmatic stepped-wedge cluster randomized clinical trials.

Stepped-wedge cluster randomized trial (SW-CRT) designs are increasingly employed in pragmatic research; they differ from traditional parallel cluster randomized trials in which an intervention is delivered to a subset of clusters, but not to all. In a SW-CRT, all clusters receive the intervention under investigation by the end of the study. This approach is thought to avoid ethical concerns about the denial of a desired intervention to participants in control groups. Such concerns have been cited in the literature as a primary motivation for choosing SW-CRT design, however SW-CRTs raise additional ethical concerns related to the delayed implementation of an intervention and consent. Yet, PCT investigators may choose SW-CRT designs simply because they are concerned that other study designs are infeasible. In this paper, we examine justifications for the use of SW-CRT study design, over other designs, by drawing on the experience of the National Institutes of Health's Health Care Systems Research Collaboratory (NIH Collaboratory) with five pragmatic SW-CRTs. We found that decisions to use SW-CRT design were justified by practical and epistemic reasons rather than ethical ones. These include concerns about feasibility, the heterogeneity of cluster characteristics, and the desire for simultaneous clinical evaluation and implementation. In this paper we compare the potential benefits of SW-CRTs against the ethical and epistemic challenges brought forth by the design and suggest that the choice of SW-CRT design must balance epistemic, feasibility and ethical justifications. Moreover, given their complexity, such studies need rigorous and informed ethical oversight.

Empirical validation of an automated approach to data use oversight.

The current paradigm for data use oversight of biomedical datasets is onerous, extending the timescale and resources needed to obtain access for secondary analyses, thus hindering scientific discovery. For a researcher to utilize a controlled-access dataset, a data access committee must review her research plans to determine whether they are consistent with the data use limitations (DULs) specified by the informed consent form. The newly created GA4GH data use ontology (DUO) holds the potential to streamline this process by making data use oversight computable. Here, we describe an open-source software platform, the Data Use Oversight System (DUOS), that connects with DUO terminology to enable automated data use oversight. We analyze dbGaP data acquired since 2006, finding an exponential increase in data access requests, which will not be sustainable with current manual oversight review. We perform an empirical evaluation of DUOS and DUO on selected datasets from the Broad Institute's data repository. We were able to structure 118/123 of the evaluated DULs (96%) and 52/52 (100%) of research proposals using DUO terminology, and we find that DUOS' automated data access adjudication in all cases agreed with the DAC manual review. This first empirical evaluation of the feasibility of automated data use oversight demonstrates comparable accuracy to human-based data access oversight in real-world data governance.

Crucial design issues for special access technology; a Delphi study.

PURPOSE: To develop and demonstrate a method to involve professional users of assistive technology (AT) in the development process of customisable products. Employing the ideas of user participation and mass customisation, this research addresses the need for reduced product costs and optimised product flexibility. METHOD: An adaptable six-question Delphi study was developed to establish consensus among AT professionals on design issues relating to a specified AT domain requiring innovation. The study is demonstrated for the special access technology (SAT) domain. A modified morphological matrix structures the application of the study results to the product design process. RESULTS: Fourteen professionals from the Republic of Ireland and the UK participated. Consensus was reached on prevalent parts of SAT that malfunction, primary reasons for SAT malfunction, characteristics of clients associated with SAT selection, client needs regarding SAT use and training, desirable traits of SAT and clinicians' frustrations with SAT. CONCLUSION: The study revealed a range of problems related to SAT, highlighting the complexities of successful SAT adoption. The questions led to differentiated insights and enabled design solution conceptualisation from various perspectives. The approach was found to help facilitate efficient generation and application of professional users' knowledge during the design process of customisable AT.

Interdisciplinary doctorial supervision: lessons for nurse education and practice.

BACKGROUND: This paper concerns a reflection on one interdisciplinary doctorate supervision project. It outlines key elements for success within this supervisory context. AIM: The aim of this paper is to present a reflection on interdisciplinary doctorate supervision project experience and examine these experiences in light of literature on the topic. METHODS: Reflection was carried out using Rolfe et al. (2010) framework for reflexivity. FINDINGS: The supervised engineering project aimed to develop, demonstrate and evaluate a new framework for the design of customisable assistive technology (AT) which involved professionals working with AT and users with disabilities. As this research occurs in between disciplines, it required an innovative and interdisciplinary approach, with an ultimate merger between health sciences and design engineering disciplines and external liaison with adults with disabilities and a disability service provider. CONCLUSION: Interdisciplinary research is popular contemporarily and addresses societal needs. In the case outlined, clear understandings were developed, in addition to clear territorial boundaries that helped guide the novel research. Steps to success in interdisciplinary research supervision include selecting the appropriate interdisciplinary team; ensuring open communication; establishing and agreeing boundaries of the research and supervision; keeping an open mind; tolerance of lack of expertise in some areas; regular meetings and communication; keeping the student focused and agreeing publication plans in advance.