Difference between revisions of "ELSI Issues in Citizen Science: Cancer and Health Research Using Mobile Devices"

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(Created page with "{{CV Event - Comprehensive |Date Updated=2016/02/03 |Event Section=Grants and Contracts |Event Start Date=2016/07/01 |Event End Date=2018/06/30 |Role/Degree=Co-Investigator |T...")
 
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{{CV Event - Comprehensive
 
{{CV Event - Comprehensive
|Date Updated=2016/02/03
+
|Date Updated=2016/08/11
 
|Event Section=Grants and Contracts
 
|Event Section=Grants and Contracts
|Event Start Date=2016/07/01
+
|Event Start Date=2017/04/01
|Event End Date=2018/06/30
+
|Event End Date=2020/03/31
 
|Role/Degree=Co-Investigator
 
|Role/Degree=Co-Investigator
|Title=ELSI Issues in Citizen Science: Cancer and Health Research Using Mobile Devices
+
|Title=Addressing ELSI Issues in Unregulated Health Research Using Mobile Devices
|Organization/Committee/Department/Journal Name=National Institutes of Health, National Human Genome Research Institute
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|Organization/Committee/Department/Journal Name=National Institutes of Health, National Cancer Institute
|CVDescription=Health research performed by "citizen scientists" and research using smartphones and other mobile medical devices are becoming more widely used. These new strategies have important implications for the ethical conduct of research. This proposed study will examine these methods in light of current research regulations and propose ways in which basic principles of research ethics can be met by this research. Citizen scientists who receive no federal funding are not subject to the Common Rule, the FDA research regulations, or the HIPAA Privacy Rule. Yet, citizen science health research using mobile devices poses a substantial challenge to recruitment, inclusion and exclusion criteria, informed consent, privacy, security, research with vulnerable populations, incidental findings, and data sharing. This project also conducts interviews of participants in the Share the Journey breast cancer study and other key stakeholders. The project has the following four aims.
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|CVDescription=Health research using mobile devices, such as smartphones and tablets, is becoming more common. New hardware and software can transform a mobile device into a sophisticated data collection and analytical platform. These technologies are fundamentally changing health research because the recruitment, data collection, and data sharing are conducted online without any face-to-face interaction between researchers and research participants.
Aim 1: Examine perspectives on ethical and regulatory challenges raised by mobile device-enabled citizen science by interviewing key stakeholders actively involved in this type of research. The investigators will attempt to learn the expectations of research participants and the views of app developers, researchers, and thought leaders in citizen science on the regulation of this new type of research.
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Aim 2: Apply research ethics to mobile device-enabled, citizen science health research. Leading experts will discuss the ethical issues raised by these new forms of research at three invitation-only meetings of the study's Working Group. The members of the group will develop consensus recommendations, and their papers will be published in a special symposium issue of the Journal of Law, Medicine & Ethics.
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Increasingly, this research also is being conducted by researchers who do not receive any federal funding and are not subject to the Common Rule, the FDA research regulations, and the HIPAA Privacy Rule. Yet, unregulated health research using mobile devices raises numerous important ethical issues including external review, recruitment, inclusion and exclusion criteria, informed consent, privacy and security, incidental findings, and data sharing.
Aim 3: Hold two app developers' workshops. Because of the central role of app developers in mobile health innovations, we will hold 2 workshops on the ethical issues in designing and using mobile apps for health research. Edited video highlights will be posted on the internet.
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Aim 4: Hold a conference on public policy issues. At the end of the project, we will hold a conference in Washington, DC, to focus on the policy issues raised by citizen science using mobile devices. The conference will be geared to the NIH, FDA, OHRP, Congressional staffs, state governments, professional organizations, patient groups, researchers, IRBs, and other stakeholders.
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This project has the following three aims:
 +
Aim 1: Conduct in-depth qualitative interviews to elicit thought leaders' perspectives on the risks and appropriate protections for participants in unregulated health research using mobile devices.
 +
Aim 2: Develop a detailed analysis of the ELSI issues through a series of 4 meetings by a diverse, expert working group, and use a consensus-building methodology to develop recommendations.
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Aim 3: Devise and implement educational programs and translation of the consensus recommendations.
 
|Grant Status=Pending
 
|Grant Status=Pending
 
|Grant PI=Mark Rothstein
 
|Grant PI=Mark Rothstein
|Grant Direct Costs=$974,242
+
|Grant Direct Costs=$1,809,556
|Grant Indirect Costs=$386,764
+
|Grant Indirect Costs=$520,237
|Grant Percent Effort=15
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|Grant Percent Effort=10
 +
|Invited Talk Boolean=No
 +
|Presenter Boolean=No
 +
|Organizer Boolean=No
 
}}
 
}}

Revision as of 10:59, 11 August 2016

Date Updated 2016/08/11
Event Section Grants and Contracts
Event Date
Event Start Date 2017/04/01
Event End Date 2020/03/31
Role/Degree Co-Investigator
Title Addressing ELSI Issues in Unregulated Health Research Using Mobile Devices
Organization/Committee/Department/Journal Name National Institutes of Health, National Cancer Institute
Institution/School/Hospital
City
State
Expiration Date
CVDescription Health research using mobile devices, such as smartphones and tablets, is becoming more common. New hardware and software can transform a mobile device into a sophisticated data collection and analytical platform. These technologies are fundamentally changing health research because the recruitment, data collection, and data sharing are conducted online without any face-to-face interaction between researchers and research participants.

Increasingly, this research also is being conducted by researchers who do not receive any federal funding and are not subject to the Common Rule, the FDA research regulations, and the HIPAA Privacy Rule. Yet, unregulated health research using mobile devices raises numerous important ethical issues including external review, recruitment, inclusion and exclusion criteria, informed consent, privacy and security, incidental findings, and data sharing.

This project has the following three aims: Aim 1: Conduct in-depth qualitative interviews to elicit thought leaders' perspectives on the risks and appropriate protections for participants in unregulated health research using mobile devices. Aim 2: Develop a detailed analysis of the ELSI issues through a series of 4 meetings by a diverse, expert working group, and use a consensus-building methodology to develop recommendations. Aim 3: Devise and implement educational programs and translation of the consensus recommendations.

Anticipated Year
Degree Abbreviation
Degree Honors
Major Area
Training Level
Certification Type
Sections
Scope
Service Type
Learner Type
Grant Status Pending
Funder Grant Number
UofL Office of Grants Management Number
Grant PI Mark Rothstein
Grant Direct Costs $1,809,556
Grant Indirect Costs $520,237
Grant Percent Effort 10
Grant Percent Collaboration
Invited Talk Boolean No
Conference Scope
Authors
Page Numbers
Author Role
JAMA Format Reference
Publication Type
Publication Status
PMID
Presentation Type
Presenter Boolean No
Organizer Boolean No
Also Published Location
Also Published Date
Volume Number
Issue Number