Modernizing Research Regulations Is Not Enough: It's Time to Think Outside the Regulatory Box

Rivera, Suzanne M.; Cadigan, R. Jean; Harrell, Heather L.; Rothstein, Mark A.; Goldenberg, Aaron J.

doi:10.1080/15265161.2017.1328899

Cited by 10 publications

(15 citation statements)

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“…Such data usage, however, deviates from the ambit of current standards for safeguarding participants and nonparticipants against violations of integrity, such as standard informed consent and anonymization procedures, and methods of protecting data ( Barocas & Nissenbaum, 2014 ; boyd & Crawford, 2012 ; Keymolen, 2016 ; Mittelstadt & Floridi, 2016 ; Robinson et al, 2013 ). Moreover, it raises questions regarding the confidentiality of personal data, possible stigmatization, and uncertainty about who has access to the data ( boyd & Crawford, 2012 ; Gibson et al, 2017 ; Graeff & Harmon, 2002 ; Mittelstadt & Floridi, 2016 ; Rivera et al, 2017 ). Health and medical care will be prioritized in relation to science and innovation over the next 15 years ( Eurobarometer, 2014 ).…”

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confidence: 99%

“…Centralized information storage in biobanks inevitably poses a threat to participants’ privacy. The decision to participate in a biobank entails accepting unknown short-term and long-term privacy risks concerning the confidentiality of personal data, the use of such data for unintended research purposes, or possible stigmatization ( boyd & Crawford, 2012 ; Gibson et al, 2017 ; Graeff & Harmon, 2002 ; Mittelstadt & Floridi, 2016 ; Nobile et al, 2016 ; Rivera et al, 2017 ). This situation results in a social dilemma in which the collective interest of promoting the public good and the individual interest of keeping data or information private are opposed.…”

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confidence: 99%

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Trust in Centralized Large-Scale Data Repository: A Qualitative Analysis

Broekstra

Aris-Meijer

Maeckelberghe

et al. 2019

Journal of Empirical Research on Human Research Ethics

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Exponential increases in digital data and calls for participation in human research raise questions about when and why individuals voluntarily provide personal data. We conducted 36 in-depth interviews with ex-participants, participants, and nonparticipants in a biobank to identify key factors influencing trust in centralized large-scale data repository for human research. Our findings indicated that trust depends strongly on whether such data repository benefits the public, the interests of data collectors, the characteristics of the collected data, and application of informed consent for retaining control over personal data. Concerns about the aims and range of data repository appeared to influence withdrawal of participation. Our findings underscore ethical and practical issues relating to data collection and consent procedures in human research.

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confidence: 99%

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confidence: 99%

Trust in Centralized Large-Scale Data Repository: A Qualitative Analysis

Broekstra

Aris-Meijer

Maeckelberghe

et al. 2019

Journal of Empirical Research on Human Research Ethics

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“…The adoption of a more personalized approach in relation to potential participants could be facilitated through the development of new models for communicating information and recruiting participants for health research [60,61]. A limited focus on facts and consent within the prevailing generalized information and communication procedures leads to the oversimpli cation of researcher-participant interactions [8,58] that does not address the need for more layered and informative interactions in the contemporary context of data collection and research. Our ndings revealed that issues of individual or societal bene ts and risks importantly in uenced the respective decisions of ex-participants and non-participants to withdraw or not to participate at all.…”

Section: Discussionmentioning

confidence: 99%

“…They constitute valuable resources for healthcare professionals and facilitate innovations in epidemiological, genetic, and public health research [2,4]. These data repositories facilitate the e cient performance of large-scale and continuous data analyses and enable researchers and clinicians to generate individual tailored clinical care [5][6][7][8][9]. Contributing personal data to biomedical research must be voluntary [9][10][11][12][13][14].…”

Section: Introductionmentioning

confidence: 99%

Motives of contributing personal data for health research: (Non-)participation in a Dutch biobank

Broekstra

Maeckelberghe

Aris-Meijer

et al. 2020

Preprint

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Background: Large-scale, centralized data repositories are playing a critical and unprecedented role in fostering innovative health research, leading to new opportunities as well as dilemmas for the medical sciences. Uncovering the reasons as to why citizens do or do not contribute to such repositories, for example, to population-based biobanks, is therefore crucial. We investigated and compared the views of existing participants and non-participants on contributing to large-scale, centralized health research data repositories with those of ex-participants regarding the decision to end their participation. This comparison could yield new insights into motives of participation and non-participation, in particular the behavioural change of withdrawal. Methods: We conducted 36 in-depth interviews with ex-participants, participants, and non-participants of a three-generation, population-based biobank in the Netherlands. The interviews focused on the respondents’ decision-making processes relating to their participation in a large-scale, centralized repository for health research data. Results: The decision of participants and non-participants to contribute to the biobank was motivated by a desire to help others. Whereas participants perceived only benefits relating to their participation and were unconcerned about potential risks, non-participants and ex-participants raised concerns about the threat of large-scale, centralized public data repositories and public institutes, such as social exclusion or commercialization. Our analysis of ex-participants’ perceptions suggests that intrapersonal characteristics, such as levels of trust in society and public goods, participation conceived as a social norm, and basic societal values account for differences between participants and non-participants. Conclusions: Our findings indicate the fluidity of motives centring on helping others in decisions to participate in large-scale, centralized health research data repositories. Efforts to improve participation should focus on enhancing the trustworthiness of such data repositories and developing layered strategies for communication with participants and with the public. Accordingly, personalized approaches for recruiting participants and transmitting information along with appropriate regulatory frameworks are required, which have important implications for current data management and informed consent procedures.

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“…The proposals that were disseminated over the course of this recent modernization effort proved to be remarkably controversial and ultimately resulted in a final rule that was widely considered to represent only a minor update to the original regulations. 7 Given this recent history, there is little energy in the regulatory and health policy community to start this process anew. If it were necessary to revise the Common Rule to allow for the change in practice that Berkman et al 1 propose, it is unlikely that such a revision will be seriously considered in the next decade.…”

Section: Kyle B Brothers Commentsmentioning

confidence: 99%

Research Consent at the Age of Majority: Preferable but not Obligatory

Wilfond

2018

Pediatrics

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In this issue of , Berkman et al argue that parental permission to obtain samples is sufficient to continue storing them and using them for research after the pediatric participant reaches the age of majority. In this Ethics Rounds, we argue that there are important ethical reasons for obtaining consent from participants when they reach majority. However, these reasons must be balanced with the aim of efficiently and economically conducting research that benefits children. Given current guidance from the relevant regulatory bodies, it remains necessary to obtain consent for the continued use of identified pediatric samples when participants reach the age of majority unless the institutional review board grants a waiver of consent. However, we argue that waivers of consent should more frequently be granted by institutional review boards and used for this purpose.

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Modernizing Research Regulations Is Not Enough: It's Time to Think Outside the Regulatory Box

Cited by 10 publications

References 0 publications

Trust in Centralized Large-Scale Data Repository: A Qualitative Analysis

Trust in Centralized Large-Scale Data Repository: A Qualitative Analysis

Motives of contributing personal data for health research: (Non-)participation in a Dutch biobank

Research Consent at the Age of Majority: Preferable but not Obligatory

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