Population GroupsNCT00767702
Use of Population Descriptors in Human Genetic Research
An observational study of Population Groups and Genetics, Medical, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Population Groups, Genetics, Medical, Ethnology
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2008to 8 Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Human Genome Research Institute (NHGRI), 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Population Groups, Genetics, Medical, Ethnology, Disease, Qualitative Research
- Keywords
- Genetic/Genomic Researchers, Human Genetic Variation, Interviews, Research Design, Race/Ethnicity, Interview
- Medical subject headings
- Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2008 (estimated)
- Study start18 Sep 2008
- Study completion8 Aug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Population GroupsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Vence L Bonham, J.D., Principal investigator, National Human Genome Research Institute (NHGRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00767702
- Sponsor's protocol ID
- 999908217
- Other IDs
- 08-HG-N217
- Status last verified
- 8 Aug 2012
- First submitted
- 6 Oct 2008
- Last updated
- 6 Nov 2019
- Results posted
- No
Publications
Pennisi E. Breakthrough of the year. Human genetic variation. Science. 2007 Dec 21;318(5858):1842-3. doi: 10.1126/science.318.5858.1842.
PubMed 18096770Burchard 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.
PubMed 12646676Tang 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.
PubMed 15625622
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Use of Population Descriptors in Human Genetic Research
- ClinicalTrials.gov ID
- NCT00767702
- Acronym / sponsor ID
- 999908217
- Conditions
- Population Groups, Genetics, Medical, Ethnology, Disease, Qualitative Research
- Keywords
- Genetic/Genomic Researchers, Human Genetic Variation, Interviews, Research Design, Race/Ethnicity, Interview
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 18 Sep 2008
- Study completion
- 8 Aug 2012
- First posted
- 7 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
- Background: PubMed 18096770Pennisi E. Breakthrough of the year. Human genetic variation. Science. 2007 Dec 21;318(5858):1842-3. doi: 10.1126/science.318.5858.1842.
- Background: PubMed 12646676Burchard 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.
- Background: PubMed 15625622Tang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vence L Bonham, J.D. principal investigator
National Human Genome Research Institute (NHGRI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Population Groups and Genetics, Medical, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00767702, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2019; AzTrials last refreshed its copy on 7 Nov 2026.