Communicating Risks and Benefits in Informed Consent for Research: A Qualitative Study

Nusbaum, Lika; Douglas, Brenda; Damus, Karla; Estrella-Luna, Neenah

doi:10.1177/2333393617732017

Cited by 50 publications

(40 citation statements)

References 37 publications

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“…To assess the opportunities, limitations and potential risks of AI applications at the six stages of the life cycle comprehensively the study relies on two data sourcesa systematic review and qualitative expert interviews. This combined qualitative research strategy is useful for issues which are at an early stage of systematic exploration, particularly, when established categories are not yet available, but still have to be developed [44]:…”

Section: Mixed-methods Approachmentioning

confidence: 99%

“…To provide a validated and critically forward-thinking analysis expert-interviews with software engineers involved at different stages of the software development life cycle and in different fields of engineering [45] are conducted to accomplish the review results. To avoid a bias towards the potentials of AI, explicitly software engineers who are well informed on but not directly in AI development but in general software engineering have been recruited [44]. The interviewed experts, four men and one woman, are aged between 29 and 37 and all have studied computer sciences.…”

Section: Mixed-methods Approachmentioning

confidence: 99%

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Applications of AI in classical software engineering

Barenkamp¹,

Rebstadt

Thomas

2020

AI Perspect

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Although Artificial Intelligence (AI) has become a buzzword for self-organizing IT applications, its relevance to software engineering has hardly been analyzed systematically. This study combines a systematic review of previous research in the field and five qualitative interviews with software developers who use or want to use AI tools in their daily work routines, to assess the status of development, future development potentials and equally the risks of AI application to software engineering. The study classifies the insights in the software development life cycle. The analysis results that major achievements and future potentials of AI are a) the automation of lengthy routine jobs in software development and testing using algorithms, e.g. for debugging and documentation, b) the structured analysis of big data pools to discover patterns and novel information clusters and c) the systematic evaluation of these data in neural networks. AI thus contributes to speed up development processes, realize development cost reductions and efficiency gains. AI to date depends on man-made structures and is mainly reproductive, but the automation of software engineering routines entails a major advantage: Human developers multiply their creative potential when using AI tools effectively.

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Section: Mixed-methods Approachmentioning

confidence: 99%

Section: Mixed-methods Approachmentioning

confidence: 99%

Applications of AI in classical software engineering

Barenkamp¹,

Rebstadt

Thomas

2020

AI Perspect

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“…Participants most at risk of knowledge deficits are older, sicker patients, and those with a lower educational background, or residing in a low-income country [ [92] , [93] , [94] ]. It also appears that those facilitating the IC process receive limited or indeed no training [ 90 , 95 , 96 ], and it is likely that this impacts on the participant's experience.…”

Section: Challenges Which Remain With the Informed Consent Processmentioning

confidence: 99%

Contributory factors to the evolution of the concept and practice of informed consent in clinical research: A narrative review

O’Sullivan¹,

Crowley²,

McAuliffe³

et al. 2020

Contemporary Clinical Trials Communications

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Informed consent can be defined as a freely-given decision or agreement following disclosure of relevant information. This review explores how legislation surrounding informed consent has impacted upon clinical research practices, with a focus on clinical trials involving individuals with the capacity to give consent in the non-emergency setting. We also highlight the challenges which remain with the informed consent process, including those which exist in the era of data protection legislation and genetic research. Modern ethicists agree that informed consent encompasses three principal factors: disclosure of information, capacity for decision making, and voluntariness. In the context of clinical research, informed consent is now required by regulatory and ethical frameworks as well as by law, and various guidelines govern the practice of informed consent, including the Declaration of Helsinki and the Good Clinical Practice Guidelines. Historically, however, researchers acted paternalistically and included participants in research without their knowledge or consent. Following societal and political revolution, an autonomy model of consent became prevalent, and individuals became free to make individual choices about whether to participate. Despite this, it is also recognized that an individual's community has a role in supporting their decision making, and this may be a strong influence, particularly within some societies. Research scandals and controversies and whistle-blowers which exposed unethical practices in the area of informed consent also contributed to changes in societal attitudes and legislation changed as a result. Medical journals also have an established, although indirect, role in strengthening good practices surrounding informed consent.

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“…Consequently, well-informed patients who still want to participate in a clinical trial are free to do so, assuming the risks of reversible adverse events. This is also debatable, since it is very difficult for a patient to fully understand some medical aspects of clinical trials and thus the whole perspective of their risks and benefits (20) .…”

Section: Why Is the Use Of Placebo No Longer Justified In Ibd Clinicamentioning

confidence: 99%

Placebo Use in the Context of Inflammatory Bowel Disease Clinical Trials

Lasa

Zubiaurre

Rausch

et al. 2020

Arq. Gastroenterol.

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Inflammatory bowel disease comprises two distinct conditions - Crohn’s disease and ulcerative colitis - which can be treated with immunomodulators. A non-neglectable proportion of these patients will need biologic therapy, and many patients under biologic treatment will experience either primary or secondary failure. As a consequence, clinical trials evaluating new therapeutic alternatives are being developed. These trials share common features, such as being controlled with placebo. Placebo use in clinical trials is a matter of intense debate. Those who support placebo use highlight the methodologic advantages placebo-controlled trials have. Those against placebo use argue that it would be against ethical principles in clinical research to expose a patient to placebo when a valid therapeutic alternative exists. In this review, we summarize the existing arguments for and against the use of placebo in the context of inflammatory bowel disease research. We finally suggest that it is very likely that in the near future inflammatory bowel disease trials will no longer be controlled with a placebo arm, but instead they will be non-inferiority trials with an active comparator.

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Communicating Risks and Benefits in Informed Consent for Research: A Qualitative Study

Cited by 50 publications

References 37 publications

Applications of AI in classical software engineering

Applications of AI in classical software engineering

Contributory factors to the evolution of the concept and practice of informed consent in clinical research: A narrative review

Placebo Use in the Context of Inflammatory Bowel Disease Clinical Trials

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