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Regulating the Secondary Use of Data for Research: Arguments Against Genetic Exceptionalism.

ABSTRACT: As accessing, collecting, and storing personal information become increasingly easier, the secondary use of data has the potential to make healthcare research more cost and time effective. The widespread reuse of data, however, raises important ethical and policy issues, especially because of the sensitive nature of genetic and health-related information. Regulation is thus crucial to determine the conditions upon which data can be reused. In this respect, the question emerges whether it is appropriate to endorse genetic exceptionalism and grant genetic data an exceptional status with respect to secondary use requirements. Using Swiss law as a case study, it is argued that genetic exceptionalism in secondary use regulation is not justified for three reasons. First, although genetic data have particular features, also other non-genetic data can be extremely sensitive. Second, having different regulatory requirements depending on the nature of data hinders the creation of comprehensible consent forms. Third, empirical evidence about public preferences concerning data reuse suggests that exceptional protection for genetic data alone is not justified. In this sense, it is claimed that regulation concerning data reuse should treat genetic data as important, but not exceptional.

SUBMITTER: Martani A

PROVIDER: S-EPMC6951399 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Regulating the Secondary Use of Data for Research: Arguments Against Genetic Exceptionalism.

Martani Andrea A Geneviève Lester Darryl LD Pauli-Magnus Christiane C McLennan Stuart S Elger Bernice Simone BS

Frontiers in genetics 20191220

As accessing, collecting, and storing personal information become increasingly easier, the secondary use of data has the potential to make healthcare research more cost and time effective. The widespread reuse of data, however, raises important ethical and policy issues, especially because of the sensitive nature of genetic and health-related information. Regulation is thus crucial to determine the conditions upon which data can be reused. In this respect, the question emerges whether it is appr ...[more]

PMID: 31956328

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Project description:BackgroundThe SARS-CoV-2 pandemic has highlighted once more the great need for comprehensive access to, and uncomplicated use of, pre-existing patient data for medical research. Enabling secondary research-use of patient-data is a prerequisite for the efficient and sustainable promotion of translation and personalisation in medicine, and for the advancement of public-health. However, balancing the legitimate interests of scientists in broad and unrestricted data-access and the demand for individual autonomy, privacy and social justice is a great challenge for patient-based medical research.MethodsWe therefore conducted two questionnaire-based surveys among North-German outpatients (n = 650) to determine their attitude towards data-donation for medical research, implemented as an opt-out-process.ResultsWe observed a high level of acceptance (75.0%), the most powerful predictor of a positive attitude towards data-donation was the conviction that every citizen has a duty to contribute to the improvement of medical research (> 80% of participants approving data-donation). Interestingly, patients distinguished sharply between research inside and outside the EU, despite a general awareness that universities and public research institutions cooperate with commercial companies, willingness to allow use of donated data by the latter was very low (7.1% to 29.1%, depending upon location of company). The most popular measures among interviewees to counteract reservations against commercial data-use were regulation by law (61.4%), stipulating in the process that data are not sold or resold (84.6%). A majority requested control of both the use (46.8%) and the protection (41.5%) of the data by independent bodies.ConclusionsIn conclusion, data-donation for medical research, implemented as a combination of legal entitlement and easy-to-exercise-right to opt-out, was found to be widely supported by German patients and therefore warrants further consideration for a transposition into national law.

Project description:Background: In Brazil, secondary data for epidemiology are largely available. However, they are insufficiently prepared for use in research, even when it comes to structured data since they were often designed for other purposes. To date, few publications focus on the process of preparing secondary data. The present findings can help in orienting future research projects that are based on secondary data. Objective: Describe the steps in the process of ensuring the adequacy of a secondary data set for a specific use and to identify the challenges of this process. Methods: The present study is qualitative and reports methodological issues about secondary data use. The study material was comprised of 6,059,454 live births and 73,735 infant death records from 2004 to 2013 of children whose mothers resided in the State of São Paulo - Brazil. The challenges and description of the procedures to ensure data adequacy were undertaken in 6 steps: (1) problem understanding, (2) resource planning, (3) data understanding, (4) data preparation, (5) data validation and (6) data distribution. For each step, procedures, and challenges encountered, and the actions to cope with them and partial results were described. To identify the most labor-intensive tasks in this process, the steps were assessed by adding the number of procedures, challenges, and coping actions. The highest values were assumed to indicate the most critical steps. Results: In total, 22 procedures and 23 actions were needed to deal with the 27 challenges encountered along the process of ensuring the adequacy of the study material for the intended use. The final product was an organized database for a historical cohort study suitable for the intended use. Data understanding and data preparation were identified as the most critical steps, accounting for about 70% of the challenges observed for data using. Conclusion: Significant challenges were encountered in the process of ensuring the adequacy of secondary health data for research use, mainly in the data understanding and data preparation steps. The use of the described steps to approach structured secondary data and the knowledge of the potential challenges along the process may contribute to planning health research.

Project description:BackgroundThe increasing emphasis to share patient data from clinical research has resulted in substantial investments in data repositories and infrastructure. However, it is unclear how shared data are used and whether anticipated benefits are being realized.ObjectiveThe purpose of our study is to examine the current utilization of shared clinical research data sets and assess the effects on both scientific research and public health outcomes. Additionally, the study seeks to identify the factors that hinder or facilitate the ethical and efficient use of existing data based on the perspectives of data users.MethodsThe study will utilize a mixed methods design, incorporating a cross-sectional survey and in-depth interviews. The survey will involve at least 400 clinical researchers, while the in-depth interviews will include 20 to 40 participants who have utilized data from repositories or institutional data access committees. The survey will target a global sample, while the in-depth interviews will focus on individuals who have used data collected from low- and middle-income countries. Quantitative data will be summarized by using descriptive statistics, while multivariable analyses will be used to assess the relationships between variables. Qualitative data will be analyzed through thematic analysis, and the findings will be reported in accordance with the COREQ (Consolidated Criteria for Reporting Qualitative Research) guidelines. The study received ethical approval from the Oxford Tropical Research Ethics Committee in 2020 (reference number: 568-20).ResultsThe results of the analysis, including both quantitative data and qualitative data, will be available in 2023.ConclusionsThe outcomes of our study will offer crucial understanding into the current status of data reuse in clinical research, serving as a basis for guiding future endeavors to enhance the utilization of shared data for the betterment of public health outcomes and for scientific progress.Trial registrationThai Clinical Trials Registry TCTR20210301006; https://tinyurl.com/2p9atzhr.International registered report identifier (irrid)DERR1-10.2196/44875.

Project description:BackgroundNon-governmental organisations (NGOs) collect and generate vast amounts of potentially rich data, most of which are not used for research purposes. Secondary analysis of NGO data (their use and analysis in a study for which they were not originally collected) presents an important but largely unrealised opportunity to provide new research insights in critical areas, including the evaluation of health policy and programmes.MethodsA scoping review of the published literature was performed to identify the extent to which secondary analysis of NGO data has been used in health policy and systems research (HPSR). A tiered analytical approach provided a comprehensive overview and descriptive analyses of the studies that (1) used data produced or collected by or about NGOs; (2) performed secondary analysis of the NGO data (beyond the use of an NGO report as a supporting reference); and (3) analysed NGO-collected clinical data.ResultsOf the 156 studies that performed secondary analysis of NGO-produced or collected data, 64% (n = 100) used NGO-produced reports (mostly to a limited extent, as a contextual reference or to critique NGO activities) and 8% (n = 13) analysed NGO-collected clinical data. Of these studies, 55% (n = 86) investigated service delivery research topics and 48% (n = 51) were undertaken in developing countries and 17% (n = 27) in both developing and developed countries. NGOs were authors or co-authors of 26% of the studies. NGO-collected clinical data enabled HPSR within marginalised groups (e.g. migrants, people in conflict-affected areas), albeit with some limitations such as inconsistent and missing data.ConclusionWe found evidence that NGO-collected and produced data are most commonly perceived as a source of supporting evidence for HPSR and not as primary source data. However, these data can facilitate research in under-researched marginalised groups and in contexts that are hard to reach by academics such as conflict-affected areas. NGO-academic collaboration could help address issues of NGO data quality to facilitate their more widespread use in research. The use of NGO data use could enable relevant and timely research in the areas of programme evaluation and health policy and advocacy to improve health and reduce health inequalities, especially in marginalised groups and developing countries.

Project description:BackgroundThe burgeoning field of biomedical research involving the mixture of human and animal materials has attracted significant ethical controversy. Due to the many dimensions of potential ethical conflict involved in this type of research, and the wide variety of research projects under discussion, it is difficult to obtain an overview of the ethical debate. This paper attempts to remedy this by providing a systematic review of ethical reasons in academic publications on human-animal chimera research.MethodsWe conducted a systematic review of the ethical literature concerning human-animal chimeras based on the research question: "What ethical reasons have been given for or against conducting human-animal chimera research, and how have these reasons been treated in the ongoing debate?" Our search extends until the end of the year 2017, including MEDLINE, Embase, PhilPapers and EthxWeb databases, restricted to peer-reviewed journal publications in English. Papers containing ethical reasons were analyzed, and the reasons were coded according to whether they were endorsed, mentioned or rejected.ResultsFour hundred thirty-one articles were retrieved by our search, and 88 were ultimately included and analyzed. Within these articles, we found 464 passages containing reasons for and against conducting human-animal chimera research. We classified these reasons into five categories and, within these, identified 12 broad and 31 narrow reason types. 15% of the retrieved passages contained reasons in favor of conducting chimera research (Category P), while 85% of the passages contained reasons against it. The reasons against conducting chimera research fell into four further categories: reasons concerning the creation of a chimera (Category A), its treatment (Category B), reasons referring to metaphysical or social issues resulting from its existence (Category C) and to potential downstream effects of chimera research (Category D). A significant proportion of identified passages (46%) fell under Category C.ConclusionsWe hope that our results, in revealing the conceptual and argumentative structure of the debate and highlighting some its most notable tendencies and prominent positions, will facilitate continued discussion and provide a basis for the development of relevant policy and legislation.

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Regulating the Secondary Use of Data for Research: Arguments Against Genetic Exceptionalism.

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Regulating the Secondary Use of Data for Research: Arguments Against Genetic Exceptionalism.

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