Practical Barriers and Ethical Challenges in Genetic Data Sharing
Abstract
:1. Introduction
2. Experimental Section
2.1. Survey Design and Implementation
2.2. Data Analysis
3. Results and Discussion
Survey Respondents a | IGES Overall Membership a | |
---|---|---|
Students | 33 (18%) | 146 (23%) |
Regular | 147 (82%) | 497 (77%) |
Total | 175 | 643 |
Continent / region | ||
United States | 138 (74%) b | 428 (67%) |
Canada | 37 (6%) | |
Europe | 39 (21%) | 123 (19%) |
Australia, New Zealand, and Other | 9 (5%) | 55 (8%) |
Characteristic | N (%) |
---|---|
Type of organization | |
Academic or university | 129 (72%) |
Government agency | 17 (9%) |
Hospital | 11 (6%) |
Research Institute | 22 (12%) |
Industry | 1 (0.5%) |
Length of time in current position | |
< 3 years | 52 (29%) |
3 to 5 years | 37 (21%) |
6 to 10 years | 41 (23%) |
11 to 15 years | 15 (8%) |
> 15 years | 35 (19%) |
3.1. Data Access
Strongly Agree | Agree | Disagree | Strongly Disagree | Undecided / Don’t Know | Missing / No Response | |
---|---|---|---|---|---|---|
The process for requesting data from dbGaP was easy | 2 (3) | 23 (29) | 25 (31) | 14 (18) | 9 (11) | 7 (9) |
It was easy to find a signing official | 29 (36) | 23 (29) | 7 (9) | 7 (9) | 1 (1) | 13 (16) |
Response | N (%) a |
---|---|
Yes, I had to go through full-board review | 13 (16) |
Yes, I had to go through an expedited IRB (or equivalent) review | 30 (38) |
No, the IRB (or equivalent) waived the requirement for approval, or the study was considered exempt | 16 (20) |
No, my Institution does not require me to apply for IRB (or equivalent) approval to obtain and analyze data from dbGaP | 12 (15) |
Missing / no response | 9 (11) |
3.2. Data Contributors
Questions and Responses | N (%) a |
---|---|
For how many studies have you deposited data into dbGaP? | |
1 | 28 (62) |
2 | 12 (27) |
3 | 1 (2) |
5 | 2 (4) |
Missing / no response | 2 (4) |
For any of the studies that you contributed to dbGaP, did your IRB (or equivalent) put any restrictions on data release? | |
Yes | 14 (31) |
No | 21 (47) |
Not sure | 9 (20) |
Missing / no response | 1 (2) |
For any of the studies that you contributed to dbGaP, did you reconsent the research participants in order to deposit the data on dbGaP | |
Yes | 14 (31) |
No | 24 (53) |
Not sure | 6 (13) |
Missing / no response | 1 (2) |
When you reconsented individuals, did you inform individuals about the potential of being identified from their genotype or phenotype data?a | |
Yes | 6 (43) |
No | 3 (21) |
Not sure | 5 (36) |
How much do you agree with the following statement: The embargo period was sufficient to perform the analyses that I wanted to do? | |
Strongly agree | 1 (2) |
Agree | 9 (20) |
Disagree | 12 (27) |
Strongly disagree | 13 (29) |
Undecided | 6 (13) |
Too early to determine | 3 (7) |
Missing / no response | 1 (2) |
3.3. Alternatives to Depositing Data in dbGaP
Reason | N * |
---|---|
It would not be legally possible to deposit the data in dbGaP according to country’s (or institutional) requirements | 13 |
The procedure was too complicated | 3 |
The consent form would not allow broad data sharing | 16 |
Did not trust system of data sharing | 6 |
The data sharing policy is “not in agreement with my personal ethical opinions” | 1 |
Subjects deceased and cannot be reconsented | 1 |
Inability to require IRB approval by data requestors | 1 |
Vulnerable population | 1 |
Data collected from other countries | 1 |
Social responsibility | 1 |
3.4. Future Implications
4. Conclusions
4.1. Issues for dbGaP Access and Use
4.2. Ethical Implications for Access and Contribution
4.3. The Consortium Model
4.4. Implications for Future Studies
4.5. Limitations
Acknowledgments
Author Contributions
Conflicts of Interest
References
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Share and Cite
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.; et al. Practical Barriers and Ethical Challenges in Genetic Data Sharing. Int. J. Environ. Res. Public Health 2014, 11, 8383-8398. https://doi.org/10.3390/ijerph110808383
Simpson CL, Goldenberg AJ, Culverhouse R, Daley D, Igo RP Jr., Jarvik GP, Mandal DM, Mascalzoni D, Montgomery CG, Pierce BL, et al. Practical Barriers and Ethical Challenges in Genetic Data Sharing. International Journal of Environmental Research and Public Health. 2014; 11(8):8383-8398. https://doi.org/10.3390/ijerph110808383
Chicago/Turabian StyleSimpson, Claire L., Aaron J. Goldenberg, Rob Culverhouse, Denise Daley, Robert P. Igo, Jr., Gail P. Jarvik, Diptasri M. Mandal, Deborah Mascalzoni, Courtney Gray Montgomery, Brandon L. Pierce, and et al. 2014. "Practical Barriers and Ethical Challenges in Genetic Data Sharing" International Journal of Environmental Research and Public Health 11, no. 8: 8383-8398. https://doi.org/10.3390/ijerph110808383