Informed Consent for Secondary Research Under the New NIH Data Sharing Policy

2021 ◽  
Author(s):  
Mark A. Rothstein
Keyword(s):  
Informed Consent ◽  
Data Sharing ◽  
Secondary Research

Informed Consent for Secondary Research under the New NIH Data Sharing Policy

2021 ◽  
Vol 49 (3) ◽  
pp. 489-494
Author(s):  
Mark A. Rothstein
Keyword(s):  
Informed Consent ◽  
Data Management ◽  
Data Sharing ◽  
Grant Application ◽  
Secondary Research

AbstractThe new NIH data sharing policy, effective January 2023, requires researchers to submit a data management and data sharing plan in their grant application. Expanded data sharing, encouraged by NIH to facilitate secondary research, will require informed consent documents to explain data sharing plans, limitations, and procedures.

Regulations and Norms for Reuse of Residual Clinical Biospecimens and Health Data

2021 ◽  
pp. 019394592110292
Author(s):  
Elizabeth E. Umberfield ◽  
Sharon L. R. Kardia ◽  
Yun Jiang ◽  
Andrea K. Thomer ◽  
Marcelline R. Harris
Keyword(s):  
Informed Consent ◽  
Scoping Review ◽  
Real World ◽  
Genetic Information ◽  
Final Analysis ◽  
Health Data ◽  
Federal Regulations ◽  
Secondary Research ◽  
Domain Experts ◽  
Key Issues

Nurse scientists are increasingly interested in conducting secondary research using real world collections of biospecimens and health data. The purposes of this scoping review are to (a) identify federal regulations and norms that bear authority or give guidance over reuse of residual clinical biospecimens and health data, (b) summarize domain experts’ interpretations of permissions of such reuse, and (c) summarize key issues for interpreting regulations and norms. Final analysis included 25 manuscripts and 23 regulations and norms. This review illustrates contextual complexity for reusing residual clinical biospecimens and health data, and explores issues such as privacy, confidentiality, and deriving genetic information from biospecimens. Inconsistencies make it difficult to interpret, which regulations or norms apply, or if applicable regulations or norms are congruent. Tools are necessary to support consistent, expert-informed consent processes and downstream reuse of residual clinical biospecimens and health data by nurse scientists.

Meta consent: a flexible and autonomous way of obtaining informed consent for secondary research

BMJ ◽  
2015 ◽  
Vol 350 (may07 31) ◽  
pp. h2146-h2146 ◽  
Author(s):  
T. Ploug ◽  
S. Holm
Keyword(s):  
Informed Consent ◽  
Secondary Research ◽  
Meta Consent

How cancer patients and oncologist assess data-sharing and the risk of re-identification in genomic research? Ethical implications for informed consent and governance.

2016 ◽  
Vol 34 (15_suppl) ◽  
pp. e18186-e18186
Author(s):  
Eva Caroline Winkler ◽  
Sebastian Schleidgen ◽  
Christoph Schickhardt ◽  
Christof V. Kalle ◽  
Dominik Ose ◽  
...  
Keyword(s):  
Informed Consent ◽  
Cancer Patients ◽  
Data Sharing ◽  
Genomic Research ◽  
Ethical Implications

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 Three More Reasons for Qualitative Psychologists to Share Human Data

2021 ◽  
Author(s):  
Veli-Matti Karhulahti
Keyword(s):  
Informed Consent ◽  
Data Sharing ◽  
Quantitative Data ◽  
Qualitative Data ◽  
Data Types ◽  
Shared Data ◽  
Human Data ◽  
Alternative Perspective ◽  
Special Means ◽  
Privacy Risks

Qualitative data sharing practices in psychology have not developed as rapidly as those in parallel quantitative domains. This is often explained by numerous epistemological, ethical, and pragmatic issues concerning qualitative data types. In this essay, I provide an alternative to the frequently expressed (often reasonable) concerns regarding the sharing of qualitative human data by highlighting three advantages of qualitative data sharing. I argue that sharing qualitative human data is not by default “less ethical,” “riskier,” and “impractical” compared to quantitative data sharing, but in some cases more ethical, less risky, and easier to manage for sharing because 1) informed consent can be discussed, negotiated, and validated, 2) the shared data can be curated by special means, and 3) the privacy risks are mainly local instead of global. I hope the provided alternative perspective further encourages qualitative psychologists to share their data when it is epistemologically, ethically, and pragmatically possible.

Abstract A04: Preferences for models of informed consent for secondary research uses of biospecimens among diverse women

2014 ◽  
Author(s):  
Katherine Brown ◽  
Bettina F. Drake ◽  
Sarah Gehlert ◽  
Leslie Wolf ◽  
James DuBois ◽  
...  
Keyword(s):  
Informed Consent ◽  
Secondary Research

Abstract A12: High rates of informed consent for biospecimen and data sharing among low-income Hispanic women: Results of a pilot randomized trial

2016 ◽  
Author(s):  
Jesse Nodora ◽  
Maria Elena Martinez ◽  
Richard Schwab ◽  
Kristen Wells ◽  
Hyeon-eui Kim ◽  
...  
Keyword(s):  
Informed Consent ◽  
Randomized Trial ◽  
Data Sharing ◽  
Low Income ◽  
Hispanic Women

scholarly journals Consent through the lens of semantics: State of the art survey and best practices

Semantic Web ◽  
2021 ◽  
pp. 1-27
Author(s):  
Anelia Kurteva ◽  
Tek Raj Chhetri ◽  
Harshvardhan J. Pandit ◽  
Anna Fensel
Keyword(s):  
Informed Consent ◽  
Best Practices ◽  
Data Processing ◽  
Data Sharing ◽  
State Of The Art ◽  
End Users ◽  
Literature Survey ◽  
Semantic Technology

The acceptance of the GDPR legislation in 2018 started a new technological shift towards achieving transparency. GDPR put focus on the concept of informed consent applicable for data processing, which led to an increase of the responsibilities regarding data sharing for both end users and companies. This paper presents a literature survey of existing solutions that use semantic technology for implementing consent. The main focus is on ontologies, how they are used for consent representation and for consent management in combination with other technologies such as blockchain. We also focus on visualisation solutions aimed at improving individuals’ consent comprehension. Finally, based on the overviewed state of the art we propose best practices for consent implementation.

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