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

2021 ◽  
Author(s):  
Mark A. Rothstein
2021 ◽  
Vol 49 (3) ◽  
pp. 489-494
Author(s):  
Mark A. Rothstein

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.


2021 ◽  
pp. 019394592110292
Author(s):  
Elizabeth E. Umberfield ◽  
Sharon L. R. Kardia ◽  
Yun Jiang ◽  
Andrea K. Thomer ◽  
Marcelline R. Harris

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.


BMJ ◽  
2015 ◽  
Vol 350 (may07 31) ◽  
pp. h2146-h2146 ◽  
Author(s):  
T. Ploug ◽  
S. Holm

2016 ◽  
Vol 34 (15_suppl) ◽  
pp. e18186-e18186
Author(s):  
Eva Caroline Winkler ◽  
Sebastian Schleidgen ◽  
Christoph Schickhardt ◽  
Christof V. Kalle ◽  
Dominik Ose ◽  
...  

JAMIA Open ◽  
2019 ◽  
Vol 2 (4) ◽  
pp. 402-406
Author(s):  
Carolyn Petersen

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.


2021 ◽  
Author(s):  
Veli-Matti Karhulahti

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.


2014 ◽  
Author(s):  
Katherine Brown ◽  
Bettina F. Drake ◽  
Sarah Gehlert ◽  
Leslie Wolf ◽  
James DuBois ◽  
...  

2016 ◽  
Author(s):  
Jesse Nodora ◽  
Maria Elena Martinez ◽  
Richard Schwab ◽  
Kristen Wells ◽  
Hyeon-eui Kim ◽  
...  

Semantic Web ◽  
2021 ◽  
pp. 1-27
Author(s):  
Anelia Kurteva ◽  
Tek Raj Chhetri ◽  
Harshvardhan J. Pandit ◽  
Anna Fensel

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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