- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00767702
Use of Population Descriptors in Human Genetic Research
Exploring the Use of Population Descriptors in Human Genetic Research
This study will explore scientists opinions and practices regarding the use of population descriptors (e.g., race, ethnicity, ancestry, geography and nationality) to describe a research study population. It will collect genetic researchers opinions, understandings and experiences studying human genetics and genetic variation.
Scientists who are a principal investigator or co-principal investigator n a human genetic or genomic study of a common disease with at least preliminary data that uses population descriptors may be eligible for the study.
Participants are asked to think about their study populations and how they are described in their research. They participate in two audio-taped semi-structured interviews that last from about 90 to 120 minutes. They may also participate in one or both of the following optional study components:
- A third semi-structured interview that explores implementing a new method of describing study populations in data analysis.
- 2 to 3 days of lab observation, in which a member of the study research team meets the lab members, observes daily activities and attends lab meetings.
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Human Genome Research Institute (NHGRI), 9000 Rockville Pike
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION CRITERIA:
The study population is comprised of intramural and extramural principal investigators:
- Conducting human genetic or genomic research on common disease
- Conducting a project in which they use population descriptors to describe their study sample
- Have collected, at a minimum, preliminary data that allows them to complete an exploratory exercise re-conceptualizing their use of population descriptors in this project.
Participation is limited to researchers who have collected data that gives them sufficient background and context to meaningfully complete this exercise. Insight gathered from our study population on alternatives to existing methods of population classification and description used in human genetic research is especially useful not only because of their professional expertise, but because they are the group that would need to implement alternatives.
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Publications and helpful links
General Publications
- Burchard EG, Ziv E, Coyle N, Gomez SL, Tang H, Karter AJ, Mountain JL, Perez-Stable EJ, Sheppard D, Risch N. The importance of race and ethnic background in biomedical research and clinical practice. N Engl J Med. 2003 Mar 20;348(12):1170-5. doi: 10.1056/NEJMsb025007. No abstract available.
- Tang H, Quertermous T, Rodriguez B, Kardia SL, Zhu X, Brown A, Pankow JS, Province MA, Hunt SC, Boerwinkle E, Schork NJ, Risch NJ. Genetic structure, self-identified race/ethnicity, and confounding in case-control association studies. Am J Hum Genet. 2005 Feb;76(2):268-75. doi: 10.1086/427888. Epub 2004 Dec 29.
- Pennisi E. Breakthrough of the year. Human genetic variation. Science. 2007 Dec 21;318(5858):1842-3. doi: 10.1126/science.318.5858.1842.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 999908217
- 08-HG-N217
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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