Ethical Imperatives for Working With Diverse Populations in Digital Research.

Digital research methodologies are driving a revolution in health technology but do not yet fully engage diverse and historically underrepresented populations. In this paper, we explore the ethical imperative for such engagement alongside accompanying challenges related to recruitment, appreciation of risk, and confidentiality, among others. We critically analyze existing research ethics frameworks and find that their reliance on individualistic and autonomy-focused models of research ethics does not offer adequate protection in the context of the diversity imperative. To meet the requirements of justice and inclusivity in digital research, methods will benefit from a reorientation toward more participatory practices.

Establishing a comprehensive search strategy for Indigenous health literature reviews.

BACKGROUND: Appropriate search strategies are essential to ensure the integrity and reproducibility of systematic and scoping reviews, as researchers seek to capture as many relevant resources as possible. In the case of Indigenous health reviews, researchers are met with the special challenge of creating a search strategy that can encompass this large, diverse population group with no universally agreed upon identification criteria. MAIN BODY: With an aim to promote improved review methodologies that uphold standards of justice, autonomy, and equity for Indigenous peoples and other heterogeneous populations, we describe critical gaps and approaches to close them. We report organizational and transparency issues around how Indigenous populations are indexed in several major databases, and draw on examples of published reviews and protocols to demonstrate the challenges inherent to creating a comprehensive search strategy. CONCLUSIONS: The conduct and communication of results from health literature research on global Indigenous populations are compromised by challenges of methodology that are rooted in the complexities inherent to defining Indigenous peoples. These challenges must be urgently addressed to improve this important field of inquiry moving forward.

Closing gaps, opening doors: an experimental collaboration in stem cell intervention.

Despite years of warnings by the academic community that for most of the stem cell-based therapies offered in the private arena little evidence of efficacy exists, these services have been increasingly offered by Canadian private clinics. Recently, as the culmination of years of clashes between stem cell researchers and therapy providers, Health Canada issued a statement prohibiting any type of cell therapy that is not specifically approved. In this climate of conflict, a small group representing both these communities as well as the government gathered in Vancouver to identify common values, and agree on principles to move forward constructively. This historic moment demonstrated that even in this contentious space a meeting-of-minds in between researchers, clinicians, ethicists, entrepreneurs and other stakeholders is possible.

Medical Methods Patents in Neuromodulation.

There is a rapidly growing number of patents on methods of modulating brain regions. Despite this trend, and the massive potential of neuromodulation for treating patients, researchers and physicians who use neuromodulation techniques and technologies often have little idea of the significant ways these patents could affect their work. This article describes medical method patents, including a brief history of their development, and analyzes their potential direct and indirect effects on neuromodulation treatment and research efforts. As neuromodulation rapidly matures into a commercial and medical reality it is important to consider these effects in a forward thinking and value driven manner. The paper concludes with recommendations concerning how neuromodulation method patents may be used, or not, depending on the values of the inventor.

Canadian perspectives on the clinical actionability of neuroimaging in disorders of consciousness.

BACKGROUND: Acquired brain injury is a critical public health and socioeconomic problem in Canada, leaving many patients in vegetative, minimally conscious, or locked-in states, unresponsive and unable to communicate. Recent advances in neuroimaging research have demonstrated residual consciousness in a few exemplary patients with acquired brain injury, suggesting potential misdiagnosis and changes in prognosis. Such progress, in parallel with research using multimodal brain imaging technologies in recent years, has promising implications for clinical translation, notwithstanding the many challenges that impact health care and policy development. This study explored the perspectives of Canadian professionals with expertise either in neuroimaging research, disorders of consciousness, or both, on the potential clinical applications and implications of imaging technology. METHODS: Twenty-two professionals from designated communities of neuroimaging researchers, ethicists, lawyers, and practitioners participated in semistructured interviews. Data were analyzed for emergent themes. RESULTS: The five most dominant themes were: (1) validation and calibration of the methods; (2) informed consent; (3) burdens on the health care system; (4) implications for the Canadian health care system; and (5) possibilities for improved prognosis. CONCLUSIONS: Movement of neuroimaging from research into clinical care for acquired brain injury will require careful consideration of legal and ethical issues alongside research reliability, responsible distribution of health care resources, and the interaction of technological capabilities with patient outcome.

Disparities in Canadian indigenous health research on neurodevelopmental disorders.

OBJECTIVE: To map the landscape of research on autism (ASD), cerebral palsy (CP), and fetal alcohol spectrum disorder (FASD) in Canadian Aboriginal children. METHOD: The authors used a detailed search strategy to identify and access publications on ASD, CP, and FASD involving Canadian Aboriginal children, families, and communities from online databases. They analyzed these materials for the type of research, stated objectives, methodologies, and the level of engagement of Aboriginal Peoples. RESULTS: The authors found a total of 52 reports published since 1981 relevant to Aboriginal children. Of these, 51 focused exclusively on FASD. They also found a near-complete failure to acknowledge community involvement in research decisions or dissemination of results in any of the publications. CONCLUSIONS: The focus on FASD in Aboriginal children and the absence of research on the other 2 major childhood disorders are at odds with rates of these disorders across Canadian children. The authors argue that this trend violates fundamental principles ensuring equitable representation of all children regardless of background in research and access to benefits of research in health care and perpetuates stigma in an already marginalized population.

Untapped ethical resources for neurodegeneration research.

BACKGROUND: The research community has a mandate to discover effective treatments for neurodegenerative disorders. The ethics landscape surrounding this mandate is in a constant state of flux, and ongoing challenges place ever greater demands on investigators to be accountable to the public and to answer questions about the implications of their work for health care, society, and policy. METHODS: We surveyed US-based investigators involved in neurodegenerative diseases research about how they value ethics-related issues, what motivates them to give consideration to those issues, and the barriers to doing so. Using the NIH CRISP database we identified 1,034 researchers with relevant, active grants and invited them to complete an online questionnaire. We received 193 responses. We used exploratory factor analysis to transform individual survey questions into a smaller set of factors, and linear regression to understand the effect of key variables of interest on the factor scores. RESULTS: Ethics-related issues clustered into two groups: research ethics and external influences. Heads of research groups viewed issues of research ethics to be more important than the other respondents. Concern about external influences was related to overall interest in ethics. Motivators clustered into five groups: ensuring public understanding, external forces, requirements, values, and press and public. Heads of research groups were more motivated to ensure public understanding of research than the other respondents. Barriers clustered into four groups: lack of resources, administrative burden, relevance to the research, and lack of interest. Perceived lack of ethics resources was a particular barrier for investigators working in drug discovery. CONCLUSIONS: The data suggest that senior level neuroscientists working in the field of neurodegeneration (ND), and drug discovery specifically, are motivated to consider ethics issues related to their work, but the perceived lack of ethics resources thwarts their efforts. With bioethics centres at more than 50% of the institutions at which these respondents reside, the neuroscience and bioethics communities appear to be disconnected. Dedicated ethical, legal and social implications (ELSI) programs, such as those fully integrated into genetics and regenerative medicine, provide models for achieving meaningful partnerships not yet adequately realized for scholars and trainees interested in drug discovery for ND.

In delicate balance: stem cells and spinal cord injury advocacy.

Spinal cord injury (SCI) is a major focus for stem cell therapy (SCT). However, the science of SCT has not been well matched with an understanding of perspectives of persons with SCI. The online advocacy community is a key source of health information for primary stakeholders and their caregivers. In this study, we sought to characterize the content of SCI advocacy websites with respect to their discussion of SCT and stem cell tourism. We performed a comprehensive analysis of SCI advocacy websites identified through a web search and verified by expert opinion. Two independent researchers coded the information for major themes (e.g., scientific & clinical facts, research & funding, policy, ethics) and valence (positive, negative, balanced, neutral). Of the 40 SCI advocacy websites that met inclusion criteria, 50% (N=20) contained information about SCT. Less than 18% (N=7) contained information on stem cell tourism. There were more than ten times as many statements about SCT with a positive valence (N=67) as with a negative valence (N=6). Ethics-related SCT information comprised 20% (N=37) of the total content; the largest proportion of ethics-related content was devoted to stem cell tourism (80%, N=30 statements). Of those, the majority focused on the risks of stem cell tourism (N=16). Given the still-developing science behind SCT, the presence of cautionary information about stem cell tourism at advocacy sites is ethically appropriate. The absence of stem cell tourism information at the majority of advocacy sites represents a lost educational opportunity.

Negotiating the Relationship Between Addiction, Ethics, and Brain Science.

Advances in neuroscience are changing how mental health issues such as addiction are understood and addressed as a brain disease. Although a brain disease model legitimizes addiction as a medical condition, it promotes neuro-essentialist thinking, categorical ideas of responsibility and free choice, and undermines the complexity involved in its emergence. We propose a 'biopsychosocial systems' model where psycho-social factors complement and interact with neurogenetics. A systems approach addresses the complexity of addiction and approaches free choice and moral responsibility within the biological, lived experience and socio-historical context of the individual. We examine heroin-assisted treatment as an applied case example within our framework. We conclude with a discussion of the model and its implications for drug policy, research, addiction health care systems and delivery, and treatment of substance use problems.

An ounce of prevention is worth a pound of cure: a cost-effectiveness analysis of incidentally detected aneurysms in functional MRI research.

PURPOSE: Despite ongoing debate about best practices for managing incidentally detected findings in brain research studies using magnetic resonance imaging (MRI), this issue has not been investigated from a health economics viewpoint. We applied a decision-analytic approach to assess the benefit of various strategies for functional MRI (fMRI) studies using intracranial aneurysms (IA) as a model. METHODS: A decision tree and Markov model were created to simulate the impact on the lifetime costs and quality-adjusted life-years (QALY) of four different strategies for review of scans for the presence of IA. To populate the decision model, we used current evidence from the literature and results from a survey of experts. RESULTS: Review of the anatomical scans by a nonspecialist is not cost-effective in any of the subgroups of participants. Full clinical examination of women with a positive family history before enrollment in a study is cost-effective. Cost-effectiveness of reviewing scans obtained from women without a family history and men with a positive family history of IA depends on the willingness-to-pay (λ) for a QALY: at λ of $50,000/QALY, review of scans by a specialist is cost-effective, whereas at λ of $100,000/QALY, a full clinical workup is the best option. Compared with not reviewing any scans, a customized strategy for each subgroup of participants results in an incremental cost-effectiveness ratio of $12,503 for λ=$50,000/QALY and $32,767 for λ=$100,000/QALY. CONCLUSION: Tailored strategies based on the characteristics of research participants and λ for one QALY are needed to address the problem of incidental findings in research fMRI studies.

Direct-to-consumer advertising in black and white: racial differences in placement patterns of print advertisements for health products and messages.

If direct-to-consumer advertising (DTCA) increases consumer participation in healthcare, then it may provide a useful strategy for addressing health disparities, in part, where patient-level barriers have contributed to such disparities. However, this presumes equitable access to DTCA. Using mixed methods, we explored advertisement patterns in matched African American and general audience magazines across a range of genres and ad types. Results suggest no significant differences in ad frequencies by race. However other meaningful categorical and qualitative differences were found, suggesting that advertisers may fall short in maximizing DTCA as an adjunctive strategy for empowering populations at risk for health disparities.

Trends in US autism research funding.

This study shows that the number of autism research grants funded in the US from 1997 to 2006 significantly increased 15% per year. Although the majority of projects were concentrated in basic science (65%) compared to clinical (15%) and translational research (20%), there is a significant decrease in the proportion of basic research grants per year and a significant increase in the proportion of translational projects per year. The number of translational projects funded by the National Alliance for Autism Research and Cure Autism Now increased significantly, whereas the number of clinical projects significantly increased for the National Institutes of Health. In conclusion, this study demonstrates the shifting landscape of autism research from basic science to clinical and translational research.