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Exploring the Use of Population Descriptors in Human Genetic Research
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), September 2008
Sponsored by: National Human Genome Research Institute (NHGRI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00767702
  Purpose

The usefulness of social and political population labels, including those based on race, ethnicity, geographic location, ancestry, and nationality, in science and medicine is a topic of heated debate. The discussion is significant not only for defining rigorous scientific study designs, but for influencing how scientists and the broader society conceptualize, discuss, and react to human difference. Misuse of population descriptors in genetic and genomic research has the potential to perpetuate misinformation, stigmatize certain groups and simplify the complex relationships between individual identity, genetics, and health. With such potential harms in mind, National Institutes of Health guidelines to use the Office of Management and Budget categories of race and ethnicity to monitor inclusion in clinical trials and evaluate potential differences in the safety and efficacy of interventions have been questioned. As increasing attention is given to the implications of human genetic variation on disease and health, actively engaging with scientists may help to identify a lexicon for discussing human genetic variation that is scientifically sound and socially and politically meaningful. We aim to conduct a pilot qualitative study of genetic researchers, exploring their use of population descriptors in human genetic research, including an experiment in which they have the opportunity to describe and group their study populations in a new way. We use qualitative methods to capture researcher's opinions and practices as they think critically about the use of population labels in their studies. Understanding individual scientists' opinions about the strengths and weaknesses of different classifications in various contexts will provide important data to help define and facilitate appropriate use of population descriptors in human genetic research.


Condition
Population Groups
Genetics, Medical
Ethnology
Disease
Qualitative Research

U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Exploring the Use of Population Descriptors in Human Genetic Research

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 120
Study Start Date: September 2008
Detailed Description:

The usefulness of social and political population labels, including those based on race, ethnicity, geographic location, ancestry, and nationality, in science and medicine is a topic of heated debate. The discussion is significant not only for defining rigorous scientific study designs, but for influencing how scientists and the broader society conceptualize, discuss, and react to human difference. Misuse of population descriptors in genetic and genomic research has the potential to perpetuate misinformation, stigmatize certain groups and simplify the complex relationships between individual identity, genetics, and health. With such potential harms in mind, National Institutes of Health guidelines to use the Office of Management and Budget categories of race and ethnicity to monitor inclusion in clinical trials and evaluate potential differences in the safety and efficacy of interventions have been questioned. As increasing attention is given to the implications of human genetic variation on disease and health, actively engaging with scientists may help to identify a lexicon for discussing human genetic variation that is scientifically sound and socially and politically meaningful. We aim to conduct a pilot qualitative study of genetic researchers, exploring their use of population descriptors in human genetic research, including an experiment in which they have the opportunity to describe and group their study populations in a new way. We use qualitative methods to capture researchers' opinions and practices as they think critically about the use of population labels in their studies. Understanding individual scientists' opinions about the strengths and weaknesses of different classifications in various contexts will provide important data to help define and facilitate appropriate use of population descriptors in human genetic research.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00767702

Contacts
Contact: Vence L. Bonham, J.D. (301) 594-3973 bonhamv@nhgri.nih.gov

Locations
United States, Maryland
National Human Genome Research Institute (NHGRI), 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
Study ID Numbers: 999908217, 08-HG-N217
Study First Received: October 6, 2008
Last Updated: November 11, 2008
ClinicalTrials.gov Identifier: NCT00767702  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Genetic/Genomic Researchers
Human Genetic Variation
Interviews
Research Design
Race/Ethnicity
Interview
Human Genetic Variation

ClinicalTrials.gov processed this record on January 30, 2009