Clinical Trials | VOL. 19
Read

Ethics challenges in sharing data from pragmatic clinical trials

Publication Date Sep 7, 2022

Abstract

Numerous arguments have been advanced for broadly sharing de-identified, participant-level clinical trials data, and trial sponsors and journals are increasingly requiring it. However, data sharing in pragmatic clinical trials presents ethical challenges related to the use of waivers or alterations of informed consent for some pragmatic clinical trials and corresponding limitations of informed consent to guide sharing decisions; the potential for data sharing in pragmatic clinical trials to present risks not only for individual patient-subjects, but also for health systems and the clinicians within them; sharing of data from electronic health records instead of data newly collected for research purposes; and researchers’ limited capacity to control sensitive data within an electronic health record and potential implications of such limits for meeting obligations inherent to Certificates of Confidentiality. These challenges raise questions about the extent to which traditional research ethics governance structures are capable of guiding decisions about pragmatic clinical trial data sharing. This article identifies and examines these ethical challenges for pragmatic clinical trial data sharing. We suggest several areas for future empirical scholarship, including the need to identify patient and public attitudes regarding pragmatic clinical trial data sharing as well as to assess the demand for pragmatic clinical trial data and the correspondingly likely benefit of such sharing. Further conceptual work is also needed to explor...

Concepts

Pragmatic Clinical Trials Electronic Health Record Ethical Challenges Clinical Data Trial Sponsors Clinical Trial Data Conceptual Work Traditional Governance Structures Public Attitudes Consent For Trials

Round-ups are the summaries of handpicked papers around trending topics published every week. These would enable you to scan through a collection of papers and decide if the paper is relevant to you before actually investing time into reading it.

Coronavirus Research Articles published between Nov 28, 2022 to Dec 04, 2022

R DiscoveryDec 05, 2022
R DiscoveryArticles Included:  5

The coronavirus disease 2019 (COVID-19) is a contagious disease that is caused by a novel coronavirus. Bentham is offering subject-based scholarly con...

Read More

Climate change Research Articles published between Nov 28, 2022 to Dec 04, 2022

R DiscoveryDec 05, 2022
R DiscoveryArticles Included:  5

We use cookies to improve your website experience. To learn about our use of cookies and how you can manage your cookie settings, please see our Cooki...

Read More

Quality Of Education Research Articles published between Nov 28, 2022 to Dec 04, 2022

R DiscoveryDec 05, 2022
R DiscoveryArticles Included:  4

Introduction: The Internet is an extensively used source of medical education by the public. YouTube is a valuable source of information which can be ...

Read More

Gender Equality Research Articles published between Nov 28, 2022 to Dec 04, 2022

R DiscoveryDec 05, 2022
R DiscoveryArticles Included:  3

Gender equity in the classroom is important for teachers to think about in order to ensure they are creating safe environments that allow their studen...

Read More

Coronavirus Pandemic

You can also read COVID related content on R COVID-19

R ProductsCOVID-19

ONE PROBLEM . ONE PURPOSE . ONE PLACE

Creating the world’s largest AI-driven & human-curated collection of research, news, expert recommendations and educational resources on COVID-19

COVID-19 Dashboard

Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on “as is” basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The Copyright Law.