Regulation of Direct-to-Participant Genomic Research

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Date Updated 2018/04/12
Event Section Grants and Contracts
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Event Start Date 2018/03/01
Event End Date 2021/01/31
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Title Regulation of International Direct-to-Participant Genomic Research
Organization/Committee/Department/Journal Name National Institutes of Health, National Human Genome Research Institute
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CVDescription New techniques for genomic research are being developed to take advantage of the ability to contact research participants directly, without utilizing physicians, hospitals, or biobanks. Researchers are now able to use the internet to recruit and enroll research participants in genomic studies by using an online application and consent process. Participants send their health records electronically and ship a sample of blood or saliva to the researchers. Although this process has been approved by IRBs for domestic studies, it is unclear whether this process is lawful for international research because of the diverse laws and policies of the countries where the participants reside. This research will study the important, but complex, question of whether international direct-to- participant genomic research is lawful in a sample of 32 countries. It will also consider what steps are necessary to facilitate this efficient, diversity-enhancing research while still protecting the welfare of research participants.
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Grant Status Current
Funder Grant Number R01HG009914
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Grant PI Mark Rothstein
Grant Direct Costs $446,548
Grant Indirect Costs $137,803
Grant Percent Effort 5
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