Governing Secondary Research Use of Health Data and Specimens: The Inequitable Distribution of Regulatory Burden Between Federally-Funded and Industry Research

2021 ◽  
Author(s):  
Kayte Spector-Bagdady
Keyword(s):  
Health Data ◽  
Research Use ◽  
Federally Funded ◽  
Secondary Research ◽  
Regulatory Burden ◽  
Industry Research

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.

scholarly journals The Norwegian Twin Registry

2019 ◽  
Vol 22 (6) ◽  
pp. 647-650
Author(s):  
Thomas Nilsen ◽  
Ingunn Brandt ◽  
Jennifer R. Harris
Keyword(s):  
Record Linkage ◽  
Potential Benefit ◽  
Data Access ◽  
Health Data ◽  
Research Use ◽  
Twin Data ◽  
Physical And Mental Health ◽  
Twin Registry ◽  
Other Information ◽  
Data Collections

AbstractThe Norwegian Twin Registry (NTR) is maintained as a research resource that was compiled by merging several panels of twin data that were established for research into physical and mental health, wellbeing and development. NTR is a consent-based registry. Where possible, data that were collected in previous studies are curated for secondary research use. A particularly valuable potential benefit associated with the Norwegian twin data lies in the opportunities to expand and enhance the data through record linkage to nationwide registries that cover a wide array of health data and other information, including socioeconomic factors. This article provides a brief description of the current NTR sample and data collections, information about data access procedures and an overview of the national registries that can be linked to the NTR for research projects.

scholarly journals Secondary research use of personal medical data: attitudes from patient and population surveys in The Netherlands and Germany

2020 ◽  
Author(s):  
Gesine Richter ◽  
Christoph Borzikowsky ◽  
Wiebke Lesch ◽  
Sebastian C. Semler ◽  
Eline M. Bunnik ◽  
...  
Keyword(s):  
The Netherlands ◽  
Medical Data ◽  
Research Use ◽  
Population Surveys ◽  
Secondary Research

scholarly journals IRB practices and policies regarding the secondary research use of biospecimens

2015 ◽  
Vol 16 (1) ◽  
Author(s):  
Aaron J Goldenberg ◽  
Karen J Maschke ◽  
Steven Joffe ◽  
Jeffrey R Botkin ◽  
Erin Rothwell ◽  
...  
Keyword(s):  
Research Use ◽  
Secondary Research

scholarly journals Secondary research use of personal medical data: patient attitudes towards data donation

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Gesine Richter ◽  
Christoph Borzikowsky ◽  
Bimba Franziska Hoyer ◽  
Matthias Laudes ◽  
Michael Krawczak
Keyword(s):  
Medical Research ◽  
Data Access ◽  
Patient Data ◽  
Individual Autonomy ◽  
Research Use ◽  
Secondary Research ◽  
Opt Out ◽  
Legitimate Interests ◽  
Legal Entitlement ◽  
High Level

Abstract Background The SARS-CoV-2 pandemic has highlighted once more the great need for comprehensive access to, and uncomplicated use of, pre-existing patient data for medical research. Enabling secondary research-use of patient-data is a prerequisite for the efficient and sustainable promotion of translation and personalisation in medicine, and for the advancement of public-health. However, balancing the legitimate interests of scientists in broad and unrestricted data-access and the demand for individual autonomy, privacy and social justice is a great challenge for patient-based medical research. Methods We therefore conducted two questionnaire-based surveys among North-German outpatients (n = 650) to determine their attitude towards data-donation for medical research, implemented as an opt-out-process. Results We observed a high level of acceptance (75.0%), the most powerful predictor of a positive attitude towards data-donation was the conviction that every citizen has a duty to contribute to the improvement of medical research (> 80% of participants approving data-donation). Interestingly, patients distinguished sharply between research inside and outside the EU, despite a general awareness that universities and public research institutions cooperate with commercial companies, willingness to allow use of donated data by the latter was very low (7.1% to 29.1%, depending upon location of company). The most popular measures among interviewees to counteract reservations against commercial data-use were regulation by law (61.4%), stipulating in the process that data are not sold or resold (84.6%). A majority requested control of both the use (46.8%) and the protection (41.5%) of the data by independent bodies. Conclusions In conclusion, data-donation for medical research, implemented as a combination of legal entitlement and easy-to-exercise-right to opt-out, was found to be widely supported by German patients and therefore warrants further consideration for a transposition into national law.

scholarly journals Correction: Secondary research use of personal medical data: attitudes from patient and population surveys in The Netherlands and Germany

2021 ◽  
Author(s):  
Gesine Richter ◽  
Christoph Borzikowsky ◽  
Wiebke Lesch ◽  
Sebastian C. Semler ◽  
Eline M. Bunnik ◽  
...  
Keyword(s):  
The Netherlands ◽  
Medical Data ◽  
Research Use ◽  
Population Surveys ◽  
Secondary Research

scholarly journals Research use of linked health data - a best practice protocol

2002 ◽  
Vol 26 (3) ◽  
pp. 251-255 ◽  
Author(s):  
C.W. Kelman ◽  
A.J. Bass ◽  
C.D.J. Holman
Keyword(s):  
Best Practice ◽  
Health Data ◽  
Research Use

Instrumentation for Measurement of Lingual Strength

1968 ◽  
Vol 11 (1) ◽  
pp. 189-193 ◽  
Author(s):  
Lois Joan Sanders
Keyword(s):  
Single Channel ◽  
Displacement Transducer ◽  
Tongue Pressure ◽  
Maximum Pressure ◽  
Research Use ◽  
Direct Writing ◽  
Significant Difference ◽  
Pressure Unit ◽  
Force Displacement ◽  
Consistent Response

A tongue pressure unit for measurement of lingual strength and patterns of tongue pressure is described. It consists of a force displacement transducer, a single channel, direct writing recording system, and a specially designed tongue pressure disk, head stabilizer, and pressure unit holder. Calibration with known weights indicated an essentially linear and consistent response. An evaluation of subject reliability in which 17 young adults were tested on two occasions revealed no significant difference in maximum pressure exerted during the two test trials. Suggestions for clinical and research use of the instrumentation are noted.

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