Ethical Implications of Clinical Genomic Information, Records Research, and Informed Consent

Lee, Susannah W.

doi:10.31486/toj.18.0052

Cited by 3 publications

(2 citation statements)

References 16 publications

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“…Similar to inherent health disparities, there are ethical consequences to the choice of study design that are unique to each stage of research. Nevertheless, to our knowledge, a full ethical framework for cancer research has not been realized to date . Consequently, in cancer research, there is a dilemma between the strict concepts of broad ethical regulation versus study‐specific needs of inclusion.…”

Section: Introductionmentioning

confidence: 99%

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Inclusiveness and ethical considerations for observational, translational, and clinical cancer health disparity research

Behring

Hale

Ozaydin

et al. 2019

Cancer

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Background Although general trends in cancer outcomes are improving, racial/ethnic disparities in patient outcomes continue to widen, suggesting disparity‐related shortcomings in cancer research designs. Methods Using convenience sampling, a total of 24 data sources, representing several research designs and 5 high‐burden tumor types, were included for analyses. The percentages of races/ethnicities across each design/tumor type were compared with those of the 2017 US Census data. The authors used a framework based on the Belmont principles to evaluate the ethical strengths and/or weaknesses of each design. Results In all designs, white individuals were found to be overrepresented. African American and Asian individuals were underrepresented, and Native Americans had consistently poor or no representation. In general, ethical concerns varied according to the study design. Clinical trials were high with regard to respect for persons and beneficence but low for equitable subject selection related to the inclusion of race/ethnicity. Observational study designs were more inclusive for race/ethnicity compared with clinical and translational studies, but their clinical usefulness was less. Conclusions The authors proposed that ethical concerns should vary according to the study design. Because observational designs have strengths in inclusiveness for race/ethnicity, their clinical usefulness can be improved by extending the Learning Health System in hospital catchment populations, the use of health records linked to biospecimens, and minority oversampling. Likewise, minority enrollment into clinical trials can be improved through Learning Health System linking and by using National Cancer Institute–mandated Community Outreach and Engagement Cores. This will allow precision medicine for otherwise overlooked minority subgroups.

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Section: Introductionmentioning

confidence: 99%

“…Nevertheless, to our knowledge, a full ethical framework for cancer research has not been realized to date. 8,9 Consequently, in cancer research, there is a dilemma between the strict concepts of broad ethical regulation versus study-specific needs of inclusion.…”

Section: Introductionmentioning

confidence: 99%

Inclusiveness and ethical considerations for observational, translational, and clinical cancer health disparity research

Behring

Hale

Ozaydin

et al. 2019

Cancer

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Inflammatory Bowel Disease and Sleep Disturbance: As Usual, Quality Matters

2020

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Sleep disturbance in Inflammatory Bowel Disease: prevalence and risk factors – A cross-sectional study

Marinelli

Savarino

Marsilio

et al. 2020

Sci Rep

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Inflammatory bowel diseases (IBD) are chronic relapsing disorders that have a negative impact on quality of life. They can be highly disabling and have been associated with sleep disturbance. The aim of our study was to evaluate the sleep quality of a large cohort of IBD patients to identify possible associated cofactors. We prospectively recruited consecutive patients attending the IBD Unit of “Azienda Ospedaliera” of Padua from November 2018 to May 2019 and collected demographics and clinical characteristics. The patients completed the Pittsburgh Sleep Quality Index (PSQI), the IBD questionnaire (IBDQ), the IBD-Disability Index (IBD-DI) questionnaire, and the Hospital Anxiety and Depression Scale (9-HADS). A multivariate regression model was applied to assess independent risk factors of sleep disturbance among IBD-related variables, disability, quality of life, anxiety, and depression. We investigated the sleep quality of 166 patients with IBD, finding 67.5% of them suffering from sleep disturbance. In particular, low quality of life, presence of disability and extraintestinal manifestations were identified as independent risk factors of sleep disturbance. We discovered that all depressed patients were also affected by sleep disturbance, while we found no difference in sleep disturbance between patients with or without anxiety state. However, a positive correlation was reported between both anxiety and depression scores and PSQI score (Spearman correlation: r = 0.31 and r = 0.38 respectively). Our study showed that sleep quality is not directly associated with an active or inactive IBD state or with the ongoing treatment, but it is mostly correlated with the patients’ mood state, disability, and quality of life. Gastroenterologists and psychologists should join forces during clinical outpatients’ visits to evaluate emotional states for a better IBD management.

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Ethical Implications of Clinical Genomic Information, Records Research, and Informed Consent

Cited by 3 publications

References 16 publications

Inclusiveness and ethical considerations for observational, translational, and clinical cancer health disparity research

Inclusiveness and ethical considerations for observational, translational, and clinical cancer health disparity research

Inflammatory Bowel Disease and Sleep Disturbance: As Usual, Quality Matters

Sleep disturbance in Inflammatory Bowel Disease: prevalence and risk factors – A cross-sectional study

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