Clinical trial · Observational
Informed Consent for Whole Genome Sequencing: Ideals and Norms Referenced by Early Participants
Informed Consent for Whole Genome Sequencing: Civic Ideals and Social Norms Referenced by Early Participants
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Coffin - Sins Syndrome | — | UNRESOLVED | — |
| Coronary Artery Disease | — | UNRESOLVED | — |
| Dubouitz Syndrome | — | UNRESOLVED | — |
| Familial Isolated Hyperparathyroidism | — | UNRESOLVED | — |
| Proteus Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Qualitative Description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
* 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.
References
Publications (3)
- BACKGROUNDAffleck 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. doi: 10.1037//0022-3514.53.2.273. PMID 3625467
- BACKGROUNDAngrist 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. PMID 20359249
- BACKGROUNDAnnas 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. No abstract available. PMID 18786085