Expert Perspectives on Oversight for Unregulated mHealth Research: Empirical Data and Commentary

Beskow, Laura M.; Hammack-Aviran, Catherine M.; Brelsford, Kathleen M.; O’Rourke, P. Pearl

doi:10.1177/1073110520917039

Cited by 4 publications

(4 citation statements)

References 23 publications

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“…Unrelated to specific oversight models, researchers are also beginning to collect data on stakeholder opinions relevant to ethical oversight of unregulated research, including biomedical citizen science projects. For example, in the context of a study focused on unregulated mobile health (mHealth) research, Beskow et al (2020) conducted interviews with 41 individuals representing four stakeholder groups-patient and research participant advocates; researchers; legal and policy professionals; and mobile app and device developers-about the advisability of external ethical oversight and attitudes regarding how and by whom oversight should occur. Thirteen interviewees were researchers who used mHealth technologies in their studies and were defined to encompass independent researchers and citizen scientists.…”

Section: Introductionmentioning

confidence: 99%

“A Cohort of Pirate Ships”: Biomedical Citizen Scientists’ Attitudes Toward Ethical Oversight

Trejo

Canfield

Brooks

et al. 2021

CSTP

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As biomedical citizen science initiatives become more prevalent, the unique ethical issues that they raise are attracting policy attention. One issue identified as a significant concern is the ethical oversight of bottom-up biomedical citizen science projects that are designed and executed primarily or solely by members of the public. That is because the federal rules that require ethical oversight of research by institutional review boards generally do not apply to such projects, creating what has been called an ethics gap.Working to close this gap, practitioners and scholars have considered new mechanisms of ethical oversight for biomedical citizen science. To date, however, participants' attitudes about ethics and oversight preferences have not been systematically examined. This information is useful to efforts to develop ethical oversight mechanisms because it provides a basis for evaluating the likely effectiveness of specific features of such mechanisms and their acceptability from the perspective of biomedical citizen scientists.Here, we report data from qualitative interviews with 35 stakeholders in bottom-up biomedical citizen science about their general ethics attitudes and preferences regarding ethical oversight. Interviewees described ten ethical priorities and endorsed oversight mechanisms that are voluntary, community-driven, and offer guidance. Conversely, interviewees rejected mechanisms that are mandatory, hierarchical, and inflexible. Applying these findings, we conclude that expert consultation and community review models appear to align well with ethical priorities and oversight preferences of many biomedical citizen scientists, although local conditions should guide the development and use of mechanisms in specific communities.

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Section: Introductionmentioning

confidence: 99%

“A Cohort of Pirate Ships”: Biomedical Citizen Scientists’ Attitudes Toward Ethical Oversight

Trejo

Canfield

Brooks

et al. 2021

CSTP

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“…First, the distinct methodology of big data studies (based on data aggregation and mining) requires a specialized technical expertise (e.g., information systems, self-learning algorithms, and anonymization protocols). Indeed, big data projects have a strong technical component, due to data volume and sources, which brings specific challenges (e.g., collecting data outside traditional protocols on social media) [88,89]. Second, ERCs may be unfamiliar with new actors involved in big data research, such as citizen science actors or private corporations.…”

Section: Novel Weaknesses: Functional Weaknessesmentioning

confidence: 99%

Ethics review of big data research: What should stay and what should be reformed?

et al. 2021

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Background Ethics review is the process of assessing the ethics of research involving humans. The Ethics Review Committee (ERC) is the key oversight mechanism designated to ensure ethics review. Whether or not this governance mechanism is still fit for purpose in the data-driven research context remains a debated issue among research ethics experts. Main text In this article, we seek to address this issue in a twofold manner. First, we review the strengths and weaknesses of ERCs in ensuring ethical oversight. Second, we map these strengths and weaknesses onto specific challenges raised by big data research. We distinguish two categories of potential weakness. The first category concerns persistent weaknesses, i.e., those which are not specific to big data research, but may be exacerbated by it. The second category concerns novel weaknesses, i.e., those which are created by and inherent to big data projects. Within this second category, we further distinguish between purview weaknesses related to the ERC’s scope (e.g., how big data projects may evade ERC review) and functional weaknesses, related to the ERC’s way of operating. Based on this analysis, we propose reforms aimed at improving the oversight capacity of ERCs in the era of big data science. Conclusions We believe the oversight mechanism could benefit from these reforms because they will help to overcome data-intensive research challenges and consequently benefit research at large.

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“…There are several significant reasons why some form of independent oversight would be beneficial for much unregulated research. 135 First, many researchers are unable to objectively and reliably assess and monitor the ethical issues surrounding their own research. Second, whether or not research is technically subject to regulation, the same basic principles and requirements for the ethical conduct of research still apply.…”

Section: F Independent Ethics Reviewmentioning

confidence: 99%

Unregulated Health Research Using Mobile Devices: Ethical Considerations and Policy Recommendations

Rothstein¹,

Wilbanks²,

Beskow³

et al. 2020

J. Law. Med. Ethics

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Mobile devices with health apps, direct-to-consumer genetic testing, crowd-sourced information, and other data sources have enabled research by new classes of researchers. Independent researchers, citizen scientists, patient-directed researchers, self-experimenters, and others are not covered by federal research regulations because they are not recipients of federal financial assistance or conducting research in anticipation of a submission to the FDA for approval of a new drug or medical device. This article addresses the difficult policy challenge of promoting the welfare and interests of research participants, as well as the public, in the absence of regulatory requirements and without discouraging independent, innovative scientific inquiry. The article recommends a series of measures, including education, consultation, transparency, self-governance, and regulation to strike the appropriate balance.

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Expert Perspectives on Oversight for Unregulated mHealth Research: Empirical Data and Commentary

Cited by 4 publications

References 23 publications

“A Cohort of Pirate Ships”: Biomedical Citizen Scientists’ Attitudes Toward Ethical Oversight

“A Cohort of Pirate Ships”: Biomedical Citizen Scientists’ Attitudes Toward Ethical Oversight

Ethics review of big data research: What should stay and what should be reformed?

Unregulated Health Research Using Mobile Devices: Ethical Considerations and Policy Recommendations

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