Classification of processes involved in sharing individual participant data from clinical trials

Ohmann, Christian; Canham, Steve; Banzi, Rita; Kuchinke, Wolfgang; Battaglia, Serena

doi:10.12688/f1000research.13789.1

Cited by 9 publications

(6 citation statements)

References 10 publications

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“…In essence, more mitigation measures would be imposed on requests of higher sensitivity (requests for data with higher potential for injury or from requester that are not highly trusted). Such mitigations could manifest as a reduction in the granularity of the data and/or as restrictions on when and how a user can access the data [ 104 , 105 ]. Implementations of risk-based systems are found in [ 106 , 107 ].…”

Section: Current Practicementioning

confidence: 99%

Informed Consent in Biomedical Research

Dankar

Gergely

Dankar³

2019

Computational and Structural Biotechnology Journal

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Informed consent is the result of tumultuous events in both the clinical and research arenas over the last 100 years. Throughout this time, the notion of informed consent has shifted tremendously, both due to advances in medicine, as well as the type of data being gathered. As such, informed consent has misaligned with the goals of medical research. It is becoming more and more vital to address this chasm, and begin building new frameworks to link this disconnect. Thus, we address three goals in this paper. First, we discuss the history of informed consent and unify the varying definitions of the term. Second, we evaluate the current research on the topic, classify them into themes, and attend to the problems therein. Lastly, we employ these themes of informed consent research mentioned previously to provide guidance and insight for future research in the arena.

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Section: Current Practicementioning

confidence: 99%

Informed Consent in Biomedical Research

Dankar

Gergely

Dankar³

2019

Computational and Structural Biotechnology Journal

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“…Over recent years, the importance of sharing data from clinical trials has substantially grown and several major organizations and institutions have developed policies and recommendations to promote the development of data sharing . However, data sharing is a very complex enterprise, both legally and logistically . One of the main challenges in data sharing is obtaining consent of trial participants for future unspecified use of generated data, which is related to the necessity to ensure the compliance with the current legal data privacy protection standards .…”

Section: Introductionmentioning

confidence: 99%

“…This problem becomes even more complicated in view of differences in legal regulations relevant to data sharing adopted in different countries. In addition, a major logistical problems associated with data sharing is a lack of complete infrastructure to suport sharing data on a global scale …”

Section: Introductionmentioning

confidence: 99%

Legal regulations, ethical guidelines and recent policies to increase transparency of clinical trials

Borysowski

Wnukiewicz-Kozłowska

Górski

2020

Brit J Clinical Pharma

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Timely and accurate dissemination of outcomes is essential to accomplish main benefits of scientific research including clinical trials. Clinical trial results can be disseminated in two main ways: by publication in a peer‐reviewed journal and by posting on a publicly available clinical trial register. The credibility of the literature on clinical trials is significantly diminished because a high percentage of trials is not published. While current legal regulations both in the European Union (EU) and the USA impose a duty to submit summary results of clinical trials to a respective register (EU Clinical Trial Register and http://ClinicalTrials.gov, respectively), the compliance with this requirement has been generally inadequate. Trial outcomes can be also made accessible by data sharing. However, in spite of the wide promotion of this idea, the access of investigators to participant‐level datasets remains limited. The main objective of this review is to discuss current legal regulations, international standards, ethical guidelines and recent policies pertaining to dissemination of clinical trial results.

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“…An alternative to these robust anonymization techniques appears to be reinforced minimization, which consists of removing the main identifiers and semi-identifiers (list of HIPAA items in the USA), replacing all the dates by timeframes and generalizing certain variables when possible. A database prepared using this technique should be able to be shared with the scientific community through a third-party platform that guarantees data access and security using processes such as those described by Ohmann et al[3,14].In order to make transparency requirements compatible with personal data protection requirements, in addition to introducing sharing tools, codes of conduct should be put in place to help share health data for scientific research, in accordance with recitals 26, 33 and 50, and pursuant to Articles 14.5, 40 and 89 of the GDPR.…”

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confidence: 99%

How the new European data protection regulation affects clinical research and recommendations?

et al. 2019

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Clinical research on human subjects or their data is confronted with conflicting requirements with, on the one hand, the principle of open science (transparency and data sharing), the possibilities offered by big data and the reuse of healthcare or research data, and on the other, changes to the regulatory and legislative framework, including the general data protection regulation (GDPR).A roundtable was organized in Giens, France in October 2018 to identify problem areas, the need for clarification and streamlining, and to make recommendations to promote clinical research while ensuring a high level of patient protection. After details were given of these developments, the roundtable participants were able to propose recommendations, primarily 1) to clarify: what is considered anonymized data, and what is "public interest" within the meaning of the GDPR; 2) for the French data protection authority (CNIL) to continue preparing reference methodologies to simplify the approval system; 3) to promote the secondary use of data by making it easier to inform patients and obtain broad patient consent, by specifying the circumstances under which their withdrawal and opposition rights apply, so as to limit the risk of bias; 4) to facilitate access to data warehouses by providing technological and methodological aids. The roundtable also recommends increasing discussions between authorities in Europe on research topics, encouraging French authorities to contribute to the preparation of codes of conduct and setting up a voluntary harmonization procedure to coordinate the opinions of data protection authorities, while ensuring that key documents are available in English.

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Classification of processes involved in sharing individual participant data from clinical trials

Cited by 9 publications

References 10 publications

Informed Consent in Biomedical Research

Informed Consent in Biomedical Research

Legal regulations, ethical guidelines and recent policies to increase transparency of clinical trials

How the new European data protection regulation affects clinical research and recommendations?

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