The Smartphones Study: An Analysis Of Disciplinary Differences In Research Ethics Committee Responses To Phone App-based Automated Data Collection

McCann, Maggie

doi:10.1093/eurpub/ckw164.002

Cited by 3 publications

(2 citation statements)

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“…Clinical trials need to be approved by the ethics committee (preventing unethical practice) and the data protection officer (enforcing data privacy laws). Usually, the ethics commission supports smartRCTs, if all the data privacy regulations are met (13). However, it is difficult to meet the requirements of the data privacy officer.…”

Section: Limitations and Barriers Of Smartrctsmentioning

confidence: 99%

mHealth and Application Technology Supporting Clinical Trials: Today’s Limitations and Future Perspective of smartRCTs

2017

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Nowadays, applications (apps) for smartphones and tablets have become indispensable especially for young generations. The estimated number of mobile devices will exceed 2.16 billion in 2016. Over 2.2 million apps are available in the Google Play store®, and about 1.8 million apps are available in the Apple App Store®. Google and Apple distribute nearly 70,000 apps each in the category Health and Fitness, and about 33,000 and 46,000 each in medical apps. It seems like the willingness to use mHealth apps is high and the intention to share data for health research is existing. This leads to one conclusion: the time for app-accompanied clinical trials (smartRCTs) has come. In this perspective article, we would like to point out the stones put in the way while trying to implement apps in clinical research. Further, we try to offer a glimpse of what the future of smartRCT research may hold.

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Section: Limitations and Barriers Of Smartrctsmentioning

confidence: 99%

mHealth and Application Technology Supporting Clinical Trials: Today’s Limitations and Future Perspective of smartRCTs

2017

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“…While several studies have addressed the issue of governance of big data in clinical research from the legal perspective [10][11][12] or ethical perspective [13][14][15][16], the perspective of institutional research ethics committee (REC) members is underrepresented in the current body of literature [17]. Research ethics committees (RECs) enforce research governance through a review mechanism, reviewing the study design and protocols, inclusion and exclusion criteria for participants, informed consent procedures and data safety, management and monitoring plans.…”

Section: Introductionmentioning

confidence: 99%

Ethical challenges of using remote monitoring technologies for clinical research: A case study of the role of local research ethics committees in the RADAR-AD study

Muurling,

Pasmooij,

Koychev

et al. 2023

PLoS ONE

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Introduction Clinical research with remote monitoring technologies (RMTs) has multiple advantages over standard paper-pencil tests, but also raises several ethical concerns. While several studies have addressed the issue of governance of big data in clinical research from the legal or ethical perspectives, the viewpoint of local research ethics committee (REC) members is underrepresented in the current literature. The aim of this study is therefore to find which specific ethical challenges are raised by RECs in the context of a large European study on remote monitoring in all syndromic stages of Alzheimer’s disease, and what gaps remain. Methods Documents describing the REC review process at 10 sites in 9 European countries from the project Remote Assessment of Disease and Relapse–Alzheimer’s Disease (RADAR-AD) were collected and translated. Main themes emerging in the documents were identified using a qualitative analysis approach. Results Four main themes emerged after analysis: data management, participant’s wellbeing, methodological issues, and the issue of defining the regulatory category of RMTs. Review processes differed across sites: process duration varied from 71 to 423 days, some RECs did not raise any issues, whereas others raised up to 35 concerns, and the approval of a data protection officer was needed in half of the sites. Discussion The differences in the ethics review process of the same study protocol across different local settings suggest that a multi-site study would benefit from a harmonization in research ethics governance processes. More specifically, some best practices could be included in ethical reviews across institutional and national contexts, such as the opinion of an institutional data protection officer, patient advisory board reviews of the protocol and plans for how ethical reflection is embedded within the study.

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The Ethics of Web Crawling and Web Scraping in Cybercrime Research: Navigating Issues of Consent, Privacy, and Other Potential Harms Associated with Automated Data Collection

Brewer

Westlake

Hart

et al. 2021

Researching Cybercrimes

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The Smartphones Study: An Analysis Of Disciplinary Differences In Research Ethics Committee Responses To Phone App-based Automated Data Collection

Cited by 3 publications

References 0 publications

mHealth and Application Technology Supporting Clinical Trials: Today’s Limitations and Future Perspective of smartRCTs

mHealth and Application Technology Supporting Clinical Trials: Today’s Limitations and Future Perspective of smartRCTs

Ethical challenges of using remote monitoring technologies for clinical research: A case study of the role of local research ethics committees in the RADAR-AD study

The Ethics of Web Crawling and Web Scraping in Cybercrime Research: Navigating Issues of Consent, Privacy, and Other Potential Harms Associated with Automated Data Collection

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