Does the new EU Regulation on clinical trials adequately protect vulnerable research participants?

Gennet, Éloïse; Andorno, Roberto; Elger, Bernice Simone

doi:10.1016/j.healthpol.2015.04.007

Cited by 9 publications

(1 citation statement)

References 19 publications

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“…10, lists special considerations for minors, incapacitated subjects, pregnant or breastfeeding women, and participation by specific groups of subjects where expertise is needed (European Parliament, 2014). These efforts to provide special protection have come under criticism for unjustified paternalism, for vague definitions of vulnerability, and for the risk that they may unduly limit the possibilities of some groups to participate in the generation of medical knowledge relevant to them (e.g., Gennet, Andorna, & Elger, 2015;Whitney, 2014). The Declaration of Helsinki provision, aimed primarily at research in impoverished countries and strengthened to require actual benefit to the group in 2013, has been criticized for failure to say more about what benefits might be required and how they may be assured (Malik & Foster, 2016).…”

Section: Groups and Identitiesmentioning

confidence: 99%

Data Re-Use and the Problem of Group Identity

Francis

2017

SSRN Journal

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Re-using existing data sets of health information for public health or medical research has much to recommend it. Much data re-purposing in medical or public health research or practice involves information that has been stripped of individual identifiers but some does not. In some cases, there may have been consent to the re-use but in other cases consent may be absent and people may be entirely unaware of how the data about them are being used. Data sets are also being combined and may contain information with very different sources, consent histories, and individual identifiers. Much of the ethical and policy discussion about the permissibility of data re-use has centered on two questions: for identifiable data, the scope of the original consent and whether the re-use is permissible in light of that scope, and for de-identified data, whether there are unacceptable risks that the data will be re-identified in a manner that is harmful to any data subjects. Prioritizing these questions rests on a picture of the ethics of data use as primarily about respecting the choices of the data subject. We contend that this picture is mistaken; data re-purposing, especially when data sets are combined, raises novel questions about the impacts of research on groups and their implications for individuals regarded as falling within these groups. These impacts suggest that the controversies about de-identification or re-consent for re-use are to some extent beside the point. Serious ethical questions are also raised by the inferences that may be drawn about individuals from the research and resulting risks of stigmatization. These risks may arise even when individuals were not part of the original data set being re-purposed. Data re-use, 143 Electronic copy available at: https://ssrn.com/abstract=3371134 re-purposing, and re-combination may have damaging effects on others not included within the original data sets. These issues of justice for individuals who might be regarded as indirect subjects of research are not even raised by approaches that consider only the implications for or agreement of the original data subject. This chapter argues that health information should be available for re-use, information should be available for use, but in a way that does not yield unexpected surprises, produce direct harm to individuals, or violate warranted trust.

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Section: Groups and Identitiesmentioning

confidence: 99%