Practical Barriers and Ethical Challenges in Genetic Data Sharing
by
Claire L. Simpson 1,*, Aaron J. Goldenberg 2, Rob Culverhouse 3, Denise Daley 4, Robert P. Igo, Jr. 5, Gail P. Jarvik 6, Diptasri M. Mandal 7, Deborah Mascalzoni 8, Courtney Gray Montgomery 9, Brandon L. Pierce 10, Rosemarie Plaetke 11,‡, Sanjay Shete 12, Katrina A. B. Goddard 13 and Catherine M. Stein 5
Claire L. Simpson 1,*, Aaron J. Goldenberg 2, Rob Culverhouse 3, Denise Daley 4, Robert P. Igo, Jr. 5, Gail P. Jarvik 6, Diptasri M. Mandal 7, Deborah Mascalzoni 8, Courtney Gray Montgomery 9, Brandon L. Pierce 10, Rosemarie Plaetke 11,‡, Sanjay Shete 12, Katrina A. B. Goddard 13 and Catherine M. Stein 5
1
Computational and Statistical Genomics Branch, National Human Genome Research Institute, Baltimore, MD 21224, USA
2
Department of Bioethics, Case Western Reserve University, Cleveland, OH 44106, USA
3
Department of Internal Medicine, Washington University in St. Louis, St. Louis, MO 63110, USA
4
Department of Medicine, University of British Columbia, Vancouver, BC V6Z 1Y6, Canada
5
Department of Epidemiology & Biostatistics, Case Western Reserve University, Cleveland, OH 44106, USA
6
Departments of Medicine (Medical Genetics) and Genome Sciences, University of Washington, Seattle, WA 98195, USA
7
Department of Genetics, Louisiana State University Health Sciences Center, New Orleans, LA 70112, USA
8
EURAC Institute of Genetic Medicine, Bolzano 39100, Italy
9
Oklahoma Medical Research Foundation, Oklahoma City, OK 73104, USA
10
Department of Health Studies, University of Chicago, Chicago, IL 60637, USA
11
Department for Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany
12
UT MD Anderson Cancer Center, Houston, TX 77030, USA
13
Center for Health Research, Kaiser Permanente Northwest, Portland, OR 97227, USA
*
Author to whom correspondence should be addressed.
‡
Currently at Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg D-20246, Germany;
Int. J. Environ. Res. Public Health 2014, 11(8), 8383-8398; https://doi.org/10.3390/ijerph110808383
Received: 1 August 2014 / Accepted: 12 August 2014 / Published: 15 August 2014
(This article belongs to the Special Issue Genetic Epidemiology)
The underlying ethos of dbGaP is that access to these data by secondary data analysts facilitates advancement of science. NIH has required that genome-wide association study data be deposited in the Database of Genotypes and Phenotypes (dbGaP) since 2003. In 2013, a proposed updated policy extended this requirement to next-generation sequencing data. However, recent literature and anecdotal reports suggest lingering logistical and ethical concerns about subject identifiability, informed consent, publication embargo enforcement, and difficulty in accessing dbGaP data. We surveyed the International Genetic Epidemiology Society (IGES) membership about their experiences. One hundred and seventy five (175) individuals completed the survey, a response rate of 27%. Of respondents who received data from dbGaP (43%), only 32% perceived the application process as easy but most (75%) received data within five months. Remaining challenges include difficulty in identifying an institutional signing official and an overlong application process. Only 24% of respondents had contributed data to dbGaP. Of these, 31% reported local IRB restrictions on data release; an additional 15% had to reconsent study participants before depositing data. The majority of respondents (56%) disagreed that the publication embargo period was sufficient. In response, we recommend longer embargo periods and use of varied data-sharing models rather than a one-size-fits-all approach.
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Keywords:
data sharing; identifiability; GWAS; ELSI; ethics; publication embargo; collaboration
This is an open access article distributed under the Creative Commons Attribution License
MDPI and ACS Style
Simpson, C.L.; Goldenberg, A.J.; Culverhouse, R.; Daley, D.; Igo, R.P., Jr.; Jarvik, G.P.; Mandal, D.M.; Mascalzoni, D.; Montgomery, C.G.; Pierce, B.L.; Plaetke, R.; Shete, S.; Goddard, K.A.B.; Stein, C.M. Practical Barriers and Ethical Challenges in Genetic Data Sharing. Int. J. Environ. Res. Public Health 2014, 11, 8383-8398.
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