scholarly journals NIH policy supports broader sharing of genomic data, strengthens informed-consent rules

2014 ◽  
Vol 167 (1) ◽  
pp. viii-ix ◽  
Keyword(s):  
Informed Consent ◽  
Genomic Data ◽  
Nih Policy

Researcher Knowledge, Attitudes, and Communication Practices for Genomic Data Sharing

2020 ◽  
pp. 155626462096930
Author(s):  
Heather P. Nick ◽  
Kelsey Kehoe ◽  
Amanda Gammon ◽  
Jorge L. Contreras ◽  
Kimberly A. Kaphingst
Keyword(s):  
Data Sharing ◽  
Pediatric Patients ◽  
Genomic Data ◽  
Basic Knowledge ◽  
Structured Interviews ◽  
Principal Investigators ◽  
Qualitative Thematic Analysis ◽  
Communication Practices ◽  
Nih Policy ◽  
Cancer Studies

This study examines knowledge, attitudes, and communication practices toward genomic data sharing among principal investigators and research coordinators engaged in cancer and non-cancer studies. We conducted 25 individual semi-structured interviews and conducted a qualitative thematic analysis. Most interviewees had basic knowledge of data sharing requirements, but lacked specific details of recent changes to NIH policy. Principal investigators perceived more risks to participants for data sharing than the research coordinators who generally obtained consent. Interviewees perceived a trend toward providing fewer data sharing options to participants in the consent process, and had observed that parents of pediatric patients asked more questions than adult patients. Our findings highlight potential areas for improvement related to data sharing during consent processes.

scholarly journals User-focused data sharing agreements: a foundation for the genomic future

JAMIA Open ◽  
2019 ◽  
Vol 2 (4) ◽  
pp. 402-406
Author(s):  
Carolyn Petersen
Keyword(s):  
Informed Consent ◽  
Cultural Differences ◽  
Data Sharing ◽  
Genomic Data ◽  
Barriers To Success ◽  
Potential Barriers ◽  
User Interests ◽  
Dynamic Consent ◽  
Environmental Considerations ◽  
Fundamental Values

Abstract Data sharing agreements that clearly describe what individuals are agreeing to and what responsibilities data stewards will undertake are crucial for the establishment, maintenance, and flourishing of genomic datasets. To optimize genomic data resources, researchers, care professionals, and informaticians must regard system design, user objectives, and environmental considerations through users’ eyes, identifying fundamental values on which to build and potential barriers to success that must be avoided. Design of agreements that promote desired data sharing and protect valuable data resources as necessary begins with a review of user interests and concerns. Nontraditional approaches for informed consent (eg, abbreviated informed consent, electronic informed consent, and dynamic consent) can facilitate achievement of data donors’ privacy-related goals while making data available to researchers. Transparency in individual-researcher interactions, recognition and accommodation of cultural differences, and identification of shared needs and goals create a foundation for data sharing agreements that work over short and long terms.

scholarly journals Informed consent and ethical re-use of African genomic data

2014 ◽  
Vol 8 (1) ◽  
Author(s):  
Galen EB Wright ◽  
Adebowale A Adeyemo ◽  
Nicki Tiffin
Keyword(s):  
Informed Consent ◽  
Genomic Data

EU Laws on Privacy in Genomic Databases and Biobanking

2016 ◽  
Vol 44 (1) ◽  
pp. 128-142 ◽  
Author(s):  
David Townend
Keyword(s):  
European Union ◽  
Informed Consent ◽  
Personal Data ◽  
Genomic Data ◽  
The European Union ◽  
Right To Privacy ◽  
Council Of Europe ◽  
Genomic Databases ◽  
The Right To Privacy ◽  
The Right

Both the European Union and the Council of Europe have a bearing on privacy in genomic databases and biobanking. In terms of legislation, the processing of personal data as it relates to the right to privacy is currently largely regulated in Europe by Directive 95/46/EC, which requires that processing be “fair and lawful” and follow a set of principles, meaning that the data be processed only for stated purposes, be sufficient for the purposes of the processing, be kept only for so long as is necessary to achieve those purposes, and be kept securely and only in an identifiable state for such time as is necessary for the processing. The European privacy regime does not require the de-identification (anonymization) of personal data used in genomic databases or biobanks, and alongside this practice informed consent as well as governance and oversight mechanisms provide for the protection of genomic data.

scholarly journals Making community voices heard in a research–health service alliance, the evolving role of the Community Advisory Group: a case study from the members’ perspective

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Janet L. Wale ◽  
Louisa Di Pietro ◽  
Heather Renton ◽  
Margaret Sahhar ◽  
Christine Walker ◽  
...  
Keyword(s):  
Health Care ◽  
Informed Consent ◽  
Patient Care ◽  
Data Storage ◽  
Program Planning ◽  
Genomic Data ◽  
Advisory Group ◽  
Main Body ◽  
Full Spectrum ◽  
Community Advisory Group

Abstract Background The Melbourne Genomics Health Alliance (the Alliance) is a collaboration of leading hospitals, research and academic organisations, supported by its member organisations and the Victorian Government. The Alliance was set up by its members in 2013 to steer the translation of genomics, making it an integral part of health care in Victoria, Australia. The Community Advisory Group (CAG) was formed soon after, to give input and advice across the program. This was to ensure consideration of community values, perspectives and priorities, and knowledge translation for patient care. The CAG was charged with providing a strong community voice for the duration of the program. Appointed members were experienced consumer advocates with developed connections to the community. Main body The Alliance progressed from an initial Demonstration Project (2013–2015) to a multifaceted program (2016–2020). The CAG worked strategically to help address complex issues, for example, communication, privacy, informed consent, ethics, patient experience, measurement and evaluation standards and policies, data storage and re-use of genomic data. Many aspects of translating genomics into routine care have been tackled, such as communicating with patients invited to have genomic testing, or their caregivers, and obtaining informed consent, clinical questions across 16 areas of health care, training and education of health and laboratory professionals, genomic data management and data-sharing. Evidence generated around clinical utility and cost-effectiveness led to government funding of testing for complex genetic conditions in children. Conclusion The CAG activities, recorded in a CAG-inspired Activity register, span the full spectrum of information sharing and consultation to co-design and partnership. The CAG were involved at multiple levels of participation and in all tiers of activity including governance, development of policies and procedures, program planning and evaluation. Working relationships were built up and a level of trust instilled to advance the Alliance work program in ensuring an effective patient-care model of delivery of genomics. CAG input into project deliverables has been tangible. Less tangible contributions included presentations at external meetings and conferences, direct interactions at meetings with Alliance members, interactions with visitors and external experts, taking part in consultations with experts, state and federal government.

Tools and Resources: Web Sites of Interest

2001 ◽  
Vol 6 (2) ◽  
pp. 6-8
Author(s):  
Christopher R. Brigham
Keyword(s):  
Informed Consent ◽  
Physical Examination ◽  
Functional Status ◽  
Web Sites ◽  
Satisfaction Survey ◽  
High Quality ◽  
Diagnostic Studies ◽  
Physician Relationship ◽  
Complete History

Abstract The AMA Guides to the Evaluation of Permanent Impairment (AMA Guides), Fifth Edition, explains that independent medical evaluations (IMEs) are not the same as impairment evaluations, and the evaluation must be designed to provide the data to answer the questions asked by the requesting client. This article continues discussions from the September/October issue of The Guides Newsletter and examines what occurs after the examinee arrives in the physician's office. First are orientation and obtaining informed consent, and the examinee must understand that there is no patient–physician relationship and the physician will not provide treatment bur rather will send a report to the client who requested the IME. Many physicians ask the examinee to complete a questionnaire and a series of pain inventories before the interview. Typical elements of a complete history are shown in a table. An equally detailed physical examination follows a meticulous history, and standardized forms for reporting these findings are useful. Pain and functional status inventories may supplement the evaluation, and the examining physician examines radiographic and diagnostic studies. The physician informs the interviewee when the evaluation is complete and, without discussing the findings, asks the examinee to complete a satisfaction survey and reviews the latter to identify and rectify any issues before the examinee leaves. A future article will discuss high-quality IME reports.

FDA Reviews One Informed Consent Rule

2006 ◽  
Vol 5 (12) ◽  
pp. 62
Author(s):  
ELIZABETH MECHCATIE
Keyword(s):  
Informed Consent

Informed Consent

2011 ◽  
Author(s):  
Deborah Bowman ◽  
John Spicer ◽  
Rehana Iqbal
Keyword(s):  
Informed Consent
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