The trade-off between impartiality and freedom in the 21st Century Cures Act

Navarro, David Fraile; Tempini, Niccolò; Teira, David

doi:10.5195/philmed.2021.24

Cited by 3 publications

(2 citation statements)

References 38 publications

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“…What these initiatives risk creating then is something short of well-developed solidarity, but rather, an ephemeral alliance and confluence of interests between individuals who might then be find themselves to face the consequences alone. The regulatory trend towards allowing patients more freedom to experiment with treatment courses means that the risk calculus is becoming more complex just as patients gain more freedom to do it themselves (Carrieri, Peccatori, and Boniolo, 2018;Navarro, Tempini, and Teira, 2021;Tempini and Teira, 2020).…”

Section: Contribution and Participationmentioning

confidence: 99%

The ethics of data self-reporting: important issues and best practices

Tempini

2023

F1000Res

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Background: This article examines the ethics of data self-reporting, in light of the extreme challenges thrown up by the COVID-19 pandemic. In many countries the public was asked to self-report personal social and health data often through the use of mobile apps, as various datasets were mobilised for the purpose of fighting COVID-19. Policy and implications: The article observes a number of dimensions that make the governance of self-reporting projects particularly thorny. The spectrum of self-reporting is extremely diverse. Projects can be scientific, commercial or other, can raise important privacy concerns, can be vulnerable to harm due to organised manipulation and poor governance. They change over time, with a tendency to function creep. The greatest scientific potential is through linkage between heterogeneous data sources; however, these practices are also the source of the highest risks for privacy and harms. Also, people take part for the most heterogeneous of purposes. Closely controlling their hopes, aims, and beliefs is usually beyond reach. This introduces various biases in the data. It can also introduce risks of self-harm because of the conclusions that people might draw. Lastly, participation in self-reporting is not equally distributed across society. When there are benefits associated in participation, it can exacerbate existing inequalities. Recommendations: The article illustrates three areas of emerging best practice in data governance: bottom-up models such as data trusts and data cooperatives; solidarity as a touchstone principle; and proactive research ethics processes and committees beyond public research institutions. These promising innovations deserve experimentation. Conclusions: Flexible and sustained ethical oversight is key. It is important to act proactively instead of reactively. Best practices must be adapted to the local setting and improved over time.

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Section: Contribution and Participationmentioning

confidence: 99%

The ethics of data self-reporting: important issues and best practices

Tempini

2023

F1000Res

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“…to be safe and efficacious. Patient groups and drug manufacturers have advocated for patients, with the guidance of their physicians, to have the autonomy to choose their own medications, as they are the ones who experience the effects of the drugs [35][36][37][38]. When there is little time and less (good) evidence than normal, should drug regulators provide patients with more freedom to choose?…”

Section: Concepts Of Risk Attitudesmentioning

confidence: 99%

Fast Methods for Drug Approval: Research Perspectives for Pandemic Preparedness

Abdin

Pretis

Landes

2023

IJERPH

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Public heath emergencies such as the outbreak of novel infectious diseases represent a major challenge for drug regulatory bodies, practitioners, and scientific communities. In such critical situations drug regulators and public health practitioners base their decisions on evidence generated and synthesised by scientists. The urgency and novelty of the situation create high levels of uncertainty concerning the safety and effectiveness of drugs. One key tool to mitigate such emergencies is pandemic preparedness. There seems to be, however, a lack of scholarly work on methodology for assessments of new or existing drugs during a pandemic. Issues related to risk attitudes, evidence production and evidence synthesis for drug approval require closer attention. This manuscript, therefore, engages in a conceptual analysis of relevant issues of drug assessment during a pandemic. To this end, we rely in our analysis on recent discussions in the philosophy of science and the philosophy of medicine. Important unanswered foundational questions are identified and possible ways to answer them are considered. Similar problems often have similar solutions, hence studying similar situations can provide important clues. We consider drug assessments of orphan drugs and drug assessments during endemics as similar to drug assessment during a pandemic. Furthermore, other scientific fields which cannot carry out controlled experiments may guide the methodology to draw defeasible causal inferences from imperfect data. Future contributions on methodologies for addressing the issues raised here will indeed have great potential to improve pandemic preparedness.

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Treatment effectiveness, generalizability, and the explanatory/pragmatic-trial distinction

Tresker

2022

Synthese

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The trade-off between impartiality and freedom in the 21st Century Cures Act

Cited by 3 publications

References 38 publications

The ethics of data self-reporting: important issues and best practices

The ethics of data self-reporting: important issues and best practices

Fast Methods for Drug Approval: Research Perspectives for Pandemic Preparedness

Treatment effectiveness, generalizability, and the explanatory/pragmatic-trial distinction

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