ArticleClinical trials (London, England)2015
Privacy and confidentiality in pragmatic clinical trials.
Article in Clinical trials (London, England), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Specific measures for data-intensive health research without consent: a systematic review of soft law instruments and academic literature.European journal of human genetics : EJHG · 2024Pooled it
- "You would not be in a hurry to go back home": patients' willingness to participate in HIV/AIDS clinical trials at a clinical and research facility in Kampala, Uganda.BMC medical ethics · 2020Trial
- Nanoparticle Therapeutics in Clinical Perspective: Classification, Marketed Products, and Regulatory Landscape.Small (Weinheim an der Bergstrasse, Germany) · 2025Review
- Regulatory Issues in Electronic Health Records for Adolescent HIV Research: Strategies and Lessons Learned.JMIR formative research · 2024Article
- Ethics challenges in sharing data from pragmatic clinical trials.Clinical trials (London, England) · 2022Article
- Toward Meeting the Obligation of Respect for Persons in Pragmatic Clinical Trials.The Hastings Center report · 2022Article
- Justice and equity in pragmatic clinical trials: Considerations for pain research within integrated health systems.Learning health systems · 2022Article
- Responding to signals of mental and behavioral health risk in pragmatic clinical trials: Ethical obligations in a healthcare ecosystem.Contemporary clinical trials · 2022Article
- Alternative Consent Models in Pragmatic Palliative Care Clinical Trials.Journal of pain and symptom management · 2021Review
- Certificates of confidentiality and unexpected complications for pragmatic clinical trials.Learning health systems · 2021Article
- Article
- The ethical justification for inclusion of neonates in pragmatic randomized clinical trials for emergency newborn care.BMC pediatrics · 2019Article
- Kenyan health stakeholder views on individual consent, general notification and governance processes for the re-use of hospital inpatient data to support learning on healthcare systems.BMC medical ethics · 2019Article
- Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory.BMC medical research methodology · 2017Article
- Exploring the ethical and regulatory issues in pragmatic clinical trials.Clinical trials (London, England) · 2015Article
- Harmonization and streamlining of research oversight for pragmatic clinical trials.Clinical trials (London, England) · 2015Article
Corrections and comments
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Authors and funding
6 authors.
Funding
Abstract
With pragmatic clinical trials, an opportunity exists to answer important questions about the relative risks, burdens, and benefits of therapeutic interventions. However, concerns about protecting the privacy of this information are significant and must be balanced with the imperative to learn from the data gathered in routine clinical practice. Traditional privacy protections for research uses of identifiable information rely disproportionately on informed consent or authorizations, based on a presumption that this is necessary to fulfill ethical principles of respect for persons. But frequently, the ideal of informed consent is not realized in its implementation. Moreover, the principle of respect for persons—which encompasses their interests in health information privacy—can be honored through other mechanisms. Data anonymization also plays a role in protecting privacy but is not suitable for all research, particularly pragmatic clinical trials. In this article, we explore both the ethical foundation and regulatory framework intended to protect privacy in pragmatic clinical trials. We then review examples of novel approaches to respecting persons in research that may have the added benefit of honoring patient privacy considerations.
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