Coronary Artery Disease Clinical Trial
Official title:
Informed Consent for Whole Genome Sequencing: Civic Ideals and Social Norms Referenced by Early Participants
Verified date | January 31, 2014 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Since 2007, the cost of sequencing a diploid human genome has fallen dramatically, from
approximately $70 million to $20,000. As affordable sequencing platforms become more widely
available, the advancement of biomedical science will draw increasingly on whole genome
sequencing research requiring large cohorts of diverse populations. Key policy, ethical and
legal implications of these developments will need to be understood in order to promote the
efficacy and effectiveness of genomic research going forward.
An overall aim of this project is to obtain feedback on the informed consent process from
some of the earliest particpants in studies using whole genome sequencing. A more specific
goal is to characterize the salient personal and public references accessed by participants
around the time of the informed consent process. By highlighting trends in participants views
about study participation around the time of the initial informed consent process, we aim to
advance the development of an ethically and socially relevant vocabulary with which to
negotiate future terms of use for personal sequence data in genomic research.
Participants will be asked to complete a one-time, semi-structured telephone interview
lasting approximately 45 minutes in the period 2-8 weeks following their initial informed
consent session at the NIH. They will be recruited from two NIH protocols employing whole
genome sequencing for distinct purposes. They The ClinSeqTM Study is a large-scale medical
sequencing project investigating the causal role of genetics in cardiovascular disease
enrolling both symptomatic and healthy individuals. The Whole Genome Medical Sequencing for
Gene Discovery Study (WGMS) enrolls children and adults for full sequencing with the aim of
discovering the genetic etiology of rare conditions.
Status | Completed |
Enrollment | 30 |
Est. completion date | January 31, 2014 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
- INCLUSION CRITERIA: - Adult over 18 years of age - English-speaking - Individuals consented to participate in either the NIH's ClinSeq or Whole Genome Medical Sequencing for Gene Discovery protocols EXCLUSION CRITERIA: - Children under 18 years of age - Non-English speakers - Individuals consented to participate in either the NIH's ClinSeq or Whole Genome Medical Sequencing for Gene Discovery protocols more than 8 weeks prior to their recruitment for this study. |
Country | Name | City | State |
---|---|---|---|
United States | National Human Genome Research Institute (NHGRI), 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Human Genome Research Institute (NHGRI) |
United States,
Affleck G, Tennen H, Pfeiffer C, Fifield J. Appraisals of control and predictability in adapting to a chronic disease. J Pers Soc Psychol. 1987 Aug;53(2):273-9. — View Citation
Angrist M. Only connect: personal genomics and the future of American medicine. Mol Diagn Ther. 2010 Apr 1;14(2):67-72. doi: 10.2165/11534710-000000000-00000. — View Citation
Annas GJ, Roche P, Green RC. GINA, genism, and civil rights. Bioethics. 2008 Aug;22(7):ii-iv. doi: 10.1111/j.1467-8519.2008.00693.x. — View Citation
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