Controversies between regulations of research ethics and protection of personal data: informed consent at a cross-road

Gefenas, Eugenijus; Lekstutiene, Jurate; Lukaseviciene, Vilma; Hartlev, Mette; Mourby, Miranda; Cathaoir, Katharina Ó

doi:10.1007/s11019-021-10060-1

Cited by 25 publications

(18 citation statements)

References 16 publications

(16 reference statements)

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“…With regard to consent, it is subject to scholarly controversy whether broad consent, as traditionally understood and practiced in biobank research, is acceptable under the GDPR regimen, or whether GDPR consent must rather be understood along the lines of narrower consent models such as dynamic consent (Hallinan 2020, Gefenas et al 2021. As a matter of principle, should this controversy come to an end either by scholarly consensus or the force of jurisdiction, the resulting allegation might still be ethically debatable.…”

Section: The Gdpr and The Ethical Debate On Models Of Consentmentioning

confidence: 99%

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Evaluating models of consent in changing health research environments

Wiertz

Boldt

2022

Med Health Care and Philos

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While Specific Informed Consent has been the established standard for obtaining consent for medical research for many years, it does not appear suitable for large-scale biobank and health data research. Thus, alternative forms of consent have been suggested, based on a variety of ethical background assumptions. This article identifies five main ethical perspectives at stake. Even though Tiered Consent, Dynamic Consent and Meta Consent are designed to the demands of the self-determination perspective as well as the perspective of research as a public good, they are still also criticized from both perspectives. In addition, criticisms based on concerns of justice, participation and democratic deliberation, and relational concerns have been levelled at each of the models. As all of these perspectives have valid points to make, the task at hand lies in balancing these ethical perspectives. What constitutes an adequate balancing depends on contextual factors. These factors include digital infrastructure and digital literacy, data safety regulation, good scientific and clinical practice, transparent debates on ethically relevant features of research, social inequalities, anti-discrimination laws and practices, trust in health care institutions and recognition of patient preferences, and consensus on unethical research. We argue that the role of context in determining acceptable models of consent puts the ethical importance of models of consent into perspective. Since altering contextual factors can help to live up to the ethical concerns at stake in debates about models of consent, opting for such a shift of focus comes without ethical loss.

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Section: The Gdpr and The Ethical Debate On Models Of Consentmentioning

confidence: 99%

“…Consent allows research participants to be informed about research purposes, compare them to their own values, and make those purposes their own and assist them by supplying their data if they wish. Consent thus is an important part of realizing equity (Gefenas et al 2021).…”

Section: The Gdpr and The Ethical Debate On Models Of Consentmentioning

confidence: 99%

Evaluating models of consent in changing health research environments

Wiertz

Boldt

2022

Med Health Care and Philos

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“…Adicionalmente a las leyes de protección de datos, los comités de ética de la investigación juegan un rol importante para delinear el trabajo de los equipos de investigación. A pesar, de los informes, leyes y reglamentos internos de comités de ética, de acuerdo con (Gefenas et al, 2022) falta una cooperación entre los comités de ética de investigación y los organismos rectores de protección de datos, con el fin de establecer las justificaciones éticas y legales de los estudios de investigación con datos personales. Evitando contradicciones entre normas y proporcionando seguridad y privacidad a los datos personales.…”

Section: éTica En El Uso De La Información Médicaunclassified

Retos y oportunidades en la accesibilidad de datos

Calva

2022

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En el área de la salud donde existe una gran variedad y cantidad de información sensible y valiosa no es explotada en su totalidad en beneficio de las personas debido a la falta de acceso a los datos. Hay varios factores que influyen en la accesibilidad de los datos a nivel de organizaciones privadas o públicas, para determinar estos factores se utilizó una revisión bibliográfica, de los 300 artículos consultados, 23 se incluyeron en esta revisión. Entre los factores resultantes que influyen en la accesibilidad de la información se destacaron: gobiernos abiertos, sistemas de información de salud, leyes de protección de datos personales, ética en el uso de la información médica y lagos de datos. Facilitar la accesibilidad a los datos de salud derivaría en una mejora de servicios y planes de tratamientos, ahorro de los estados en recursos económicos, además impulsa la educación y la investigación.

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“…modifying the initial consent parameters (see https://conp.ca/ethics-toolkit/). Some national laws also provide alternatives for re-consenting for scientific purposes [5] . Explicitly stating in informed consent forms that the data will be made available to qualified researchers (holding an identifiable position in an academic or research enterprise wherein research activities are governed by a code of conduct on academic integrity), and that it can be removed from a sharing portal if the participant requests removal, will address this barrier.…”

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confidence: 99%

Is Collaborative Open Science Possible With Speech Data in Psychiatric Disorders?

Palaniyappan

Alonso-Sánchez

MacWhinney

2022

Schizophrenia Bulletin

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Provision of mental health care is almost entirely built on a singular medium -naturally occurring spoken-language conversations. However, datasets of spoken language from patients experiencing mental health issues are surprisingly difficult to obtain. In this commentary, we discuss some of the reasons behind this, and highlight successful approaches adopted in other areas of clinical linguistics and pose some ways forward, especially for the study of psychosis. Barriers to sharing speech dataAcross disciplines, researchers are rapidly adopting Open Science principles for datasharing. This movement encourages researchers, clinicians, and institutions to provide fully open access to research data, programs, and publications. For example the National Institutes of Health's Strategic Plan for Data Science requires that newlyfunded research projects share data in accord with the FAIR principles [1] for open access and that they include in their budget requests for the resources necessary to complete open access. Although many disciplines, funding agencies, researchers, journals, libraries, and institutions have adopted this new model, the movement has also encountered significant resistance, particularly for open sharing of spoken language data, including spoken language data from clinical populations (SLDCP). We can identify at least six barriers to open sharing of SLDCP [2]. Some of these barriers come from interpretation of regulations by various institutions, while others pertain to the prevailing public perception regarding SLDCP. Here we consider each of these barriers and ways in which systems such as TalkBank [3] or Databrary[4] manage to overcome them. With emerging collaborative efforts to study language in psychosis (e.g., https://discourseinpsychosis.org/), we anticipate the commentary here to eventually inform 'speech bank' infrastructures for psychiatric disorders.1. Informed consent. A frequent objection to the sharing of SLDCP is that it violates participants' rights of privacy and confidentiality. Such usage would be a violation if there had been no informed consent from the participants for sharing of their data -this is unfortunately the case for many existing speech samples from clinical populations, precluding retrospective sharing. In these cases, recontacting participants to obtain consent for data-sharing is an option, if a consent for such re-contact is in place. In the absence of consent to re-contact, IRBs may be able to grant a 'waiver', i.e. modifying the initial consent parameters (see https://conp.ca/ethics-toolkit/). Some national laws also provide alternatives for re-consenting for scientific purposes [5] . Explicitly stating in informed consent forms that the data will be made available to qualified researchers (holding an identifiable position in an academic or research enterprise wherein research activities are governed by a code of conduct on academic integrity), and that it can be removed from a sharing portal if the participant requests removal, will address this barrier. Qualif...

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Controversies between regulations of research ethics and protection of personal data: informed consent at a cross-road

Cited by 25 publications

References 16 publications

Evaluating models of consent in changing health research environments

Evaluating models of consent in changing health research environments

Retos y oportunidades en la accesibilidad de datos

Is Collaborative Open Science Possible With Speech Data in Psychiatric Disorders?

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