Dataset Information

Development of a consent resource for genomic data sharing in the clinical setting.

ABSTRACT: PURPOSE:Data sharing between clinicians, laboratories, and patients is essential for improvements in genomic medicine, but obtaining consent for individual-level data sharing is often hindered by a lack of time and resources. To address this issue, the Clinical Genome Resource (ClinGen) developed tools to facilitate consent, including a one-page consent form and online supplemental video with information on key topics, such as risks and benefits of data sharing. METHODS:To determine whether the consent form and video accurately conveyed key data sharing concepts, we surveyed 5,162 members of the general public. We measured comprehension at baseline, after reading the form and watching the video. Additionally, we assessed participants' attitudes toward genomic data sharing. RESULTS:Participants' performance on comprehension questions significantly improved over baseline after reading the form and continued to improve after watching the video. CONCLUSION:Results suggest reading the form alone provided participants with important knowledge regarding broad data sharing, and watching the video allowed for broader comprehension. These materials are now available at http://www.clinicalgenome.org/share . These resources will provide patients a straightforward way to share their genetic and health information, and improve the scientific community's access to data generated through routine healthcare.

SUBMITTER: Riggs ER

PROVIDER: S-EPMC6292744 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Development of a consent resource for genomic data sharing in the clinical setting.

Riggs Erin Rooney ER Azzariti Danielle R DR Niehaus Annie A Goehringer Scott R SR Ramos Erin M EM Rodriguez Laura Lyman LL Knoppers Bartha B Rehm Heidi L HL Martin Christa Lese CL

Genetics in medicine : official journal of the American College of Medical Genetics 20180613 1

<h4>Purpose</h4>Data sharing between clinicians, laboratories, and patients is essential for improvements in genomic medicine, but obtaining consent for individual-level data sharing is often hindered by a lack of time and resources. To address this issue, the Clinical Genome Resource (ClinGen) developed tools to facilitate consent, including a one-page consent form and online supplemental video with information on key topics, such as risks and benefits of data sharing.<h4>Methods</h4>To determi ...[more]

PMID: 29899502

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Project description:BackgroundIn clinical genomics, sharing of rare genetic disease information between genetic databases and laboratories is essential to determine the pathogenic significance of variants to enable the diagnosis of rare genetic diseases. Significant concerns regarding data governance and security have reduced this sharing in practice. Blockchain could provide a secure method for sharing genomic data between involved parties and thus help overcome some of these issues.ObjectiveThis study aims to contribute to the growing knowledge of the potential role of blockchain technology in supporting the sharing of clinical genomic data by describing blockchain-based dynamic consent architecture to support clinical genomic data sharing and provide a proof-of-concept implementation, called ConsentChain, for the architecture to explore its performance.MethodsThe ConsentChain requirements were captured from a patient forum to identify security and consent concerns. The ConsentChain was developed on the Ethereum platform, in which smart contracts were used to model the actions of patients, who may provide or withdraw consent to share their data; the data creator, who collects and stores patient data; and the data requester, who needs to query and access the patient data. A detailed analysis was undertaken of the ConsentChain performance as a function of the number of transactions processed by the system.ResultsWe describe ConsentChain, a blockchain-based system that provides a web portal interface to support clinical genomic sharing. ConsentChain allows patients to grant or withdraw data requester access and allows data requesters to query and submit access to data stored in a secure off-chain database. We also developed an ontology model to represent patient consent elements into machine-readable codes to automate the consent and data access processes.ConclusionsBlockchains and smart contracts can provide an efficient and scalable mechanism to support dynamic consent functionality and address some of the barriers that inhibit genomic data sharing. However, they are not a complete answer, and a number of issues still need to be addressed before such systems can be deployed in practice, particularly in relation to verifying user credentials.

Project description:BACKGROUND:There has been considerable investment and strategic planning to introduce genomic testing into Australia's public health system. As more patients' genomic data is being held by the public health system, there will be increased requests from researchers to access this data. It is important that public policy reflects public expectations for how genomic data that is generated from clinical tests is used. To inform public policy and discussions around genomic data sharing, we sought public opinions on using genomic data contained in medical records for research purposes in the Australian state of Queensland. METHODS:A total of 1494 participants completed an online questionnaire between February and May 2019. Participants were adults living in Australia. The questionnaire explored participant preferences for sharing genomic data or biological samples with researchers, and concerns about genomic data sharing. RESULTS:Most participants wanted to be given the choice to have their genomic data from medical records used in research. Their expectations on whether and how often they needed to be approached for permission on using their genomic data, depended on whether the data was identifiable or anonymous. Their willingness to sharing data for research purposes depended on the type of information being shared, what type of research would be undertaken and who would be doing the research. Participants were most concerned with genomics data sharing that could lead to discrimination (insurance and employment), data being used for marketing, data security, or commercial use. CONCLUSIONS:Most participants were willing to share their genomic data from medical records with researchers, as long as permission for use was sought. However, the existing policies related to this process in Queensland do not reflect participant expectations for how this is achieved, particularly with anonymous genomics data. This inconsistency may be addressed by process changes, such as inclusion of research in addition to clinical consent or general research data consent programs.

Project description:BackgroundMandates abound to share publicly-funded research data for reuse, while data platforms continue to emerge to facilitate such reuse. Birth cohorts (BC) involve longitudinal designs, significant sample sizes and rich and deep datasets. Data sharing benefits include more analyses, greater research complexity, increased opportunities for collaboration, amplification of public contributions, and reduced respondent burdens. Sharing BC data involves significant challenges including consent, privacy, access policies, communication, and vulnerability of the child. Research on these issues is available for biological data, but these findings may not extend to BC data. We lack consensus on how best to approach these challenges in consent, privacy, communication and autonomy when sharing BC data. We require more stakeholder engagement to understand perspectives and generate consensus.MethodsParents participating in longitudinal birth cohorts completed a web-based survey investigating consent preferences for sharing their, and their child's, non-biological research data. Results from a previous qualitative inquiry informed survey development, and cognitive interviewing methods (n?=?9) were used to improve the question quality and comprehension. Recruitment was via personalized email, with email and phone reminders during the 14-day window for survey completion.ResultsThree hundred and forty-six of 569 parents completed the survey in September 2014 (60.8%). Participants preferred consent processes for data sharing in future independent research that were less-active (i.e. no consent or opt-out). Parents' consent preferences are associated with their communication preferences. Twenty percent (20.2%) of parents generally agreed that their child should provide consent to continue participating in research at age 12, while 25.6% felt decision-making on sharing non-biological research data should begin at age 18.ConclusionsThese finding reflect the parenting population's preference for less project-specific permission when research data is non-biological and de-identified and when governance practices are highly detailed and rigourous. Parents recognize that children should become involved in consent for secondary data use, but there is variability regarding when and how involvement occurs. These findings emphasize governance processes and participant notification rather than project-specific consent for secondary use of de-identified, non-biological data. Ultimately, parents prefer general consent processes for sharing de-identified, non-biological research data with ultimate involvement of the child.

Project description:BackgroundInformed consent in medical practice is essential and a global standard that should be sought at all the times doctors interact with patients. Its intensity would vary depending on the invasiveness and risks associated with the anticipated treatment. To our knowledge there has not been any systematic review of consent practices to document best practices and identify areas that need improvement in our setting. The objective of the study was to evaluate the informed consent practices of surgeons at University teaching Hospitals in a low resource setting.MethodsA cross-sectional study conducted at three university teaching hospitals in Uganda. Self-guided questionnaires were left at a central location in each of the surgical departments after verbally communicating to the surgeons of the intention of the study. Filled questionnaires were returned at the same location by the respondents for collection by the research team. In addition, 20 in-depth interviews were held with surgeons and a review of 384 patients' record files for informed consent documentation was done.ResultsA total of 132 (62.1%) out of 214 questionnaires were completed and returned. Respondents were intern doctors, residents and specialists from General surgery, Orthopedic surgery, Ear, Nose and Throat, Ophthalmology, Dentistry, Obstetrics and Gynaecology departments. The average working experience of respondents was 4.8 years (SD 4.454, range 0-39 years). 48.8% of the respondents said they obtained consent all the time surgery is done while 51.2% did not obtain consent all the time. Many of the respondents indicated that informed consent was not obtained by the surgeon who operated the patient but was obtained either at admission or by nurses in the surgical units. The consent forms used in the hospitals were found to be inadequate and many times signed at admission before diagnosing the patient's disease.ConclusionsInformed consent administration and documentation for surgical health care is still inadequate at University teaching hospitals in Uganda.

Dataset Information

Development of a consent resource for genomic data sharing in the clinical setting.

Publications

Development of a consent resource for genomic data sharing in the clinical setting.

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