Cultural DiversityNCT00767858
Cultural Congruence in International Genetics Research
An observational study of Cultural Diversity, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial summary
This study will explore how cultural differences influence genetics research in developing countries. Human genetics research is becoming more common in developing countries. However, when research is conducted with people living in developing countries, there is a chance that culture differences can lead to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cultural Diversity
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2008to 24 Feb 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will include genetics researchers who have had direct contact with participants in human genetic research in developing countries. A researcher may be defined as any project staff, faculty, or investigator involved in carrying out a genetics research protocol in a developing country. Project staff are included as potential participants so that whoever has most contact with genetic research participants is able to participate in the proposed study.
- Researchers will be able to decide whether the country that they are working in is defined as a developing country, as opposed to dictating a fixed list of countries that qualify. This will be assessed by participant report during the screening process.
Who cannot join
- Researchers who do research in developing countries but do not have direct contact with human participants.
- Participants who are non-English-speaking or under the age of 18.
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: Cultural Congruence in International Genetics Research: Perceptions of Opportunities and Challenges Among Researchers
This study will explore how cultural differences influence genetics research in developing countries. Human genetics research is becoming more common in developing countries. However, when research is conducted with people living in developing countries, there is a chance that culture differences can lead to misunderstandings between investigators and participants, resulting in ineffective research. This study will explore challenges facing investigators conducting genetics research in developing countries and opportunities to improve this kind of research.
Scientists who have conducted genetics research in a developing country may be eligible to participate in this study. Participants are interviewed by telephone. The interview, which lasts about an hour, includes questions about the researchers decision to conduct the study they have done, the times they noticed that culture played a role in the research and the times that were more challenging and less challenging.
The interviews are recorded, transcribed and analyzed for themes related to cultural congruence and specific challenges and opportunities with regard to cultural congruence.
Read the detailed description
The objective of the proposed study is to describe cultural congruence, including diversity, awareness, sensitivity, and competence in people conducting human genetics research in developing countries, as well as to explore challenges and opportunities to improve cultural congruence. Human genetics research is becoming more common in developing countries, as researchers take advantage of differences in environment and population diversity. However, when research is conducted with individuals living in developing countries, there is a chance that culture will lead to misunderstandings between investigators and participants and consequently ineffective research. The proposed study uses a cross-sectional semi-structured qualitative interview design. Thirty to forty-five participants will be recruited. Participants will be researchers with experience in conducting genetics research in developing countries, who will have had direct contact with the participants in their research studies. These researchers will be recruited from professional organizations, through identification of lead authors in literature searches, and through snowball recruitment. Interviews will be conducted by telephone, recorded, transcribed, and analyzed for themes related to cultural congruence and specific challenges and opportunities with regard to cultural congruence.
- Conditions
- Cultural Diversity
- Keywords
- Genetic, Genetic Literacy, Human Genetic Research, Cultural Congruence, Interview
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 start24 Sep 2008
- Study completion24 Feb 2016
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 Cultural DiversityStudies 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Barbara B Biesecker, Principal investigator, National Human Genome Research Institute (NHGRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00767858
- Sponsor's protocol ID
- 999908225
- Other IDs
- 08-HG-N225
- Status last verified
- 24 Feb 2016
- First submitted
- 6 Oct 2008
- Last updated
- 5 Apr 2018
- Results posted
- No
Publications
Betancourt JR, Green AR, Carrillo JE, Ananeh-Firempong O 2nd. Defining cultural competence: a practical framework for addressing racial/ethnic disparities in health and health care. Public Health Rep. 2003 Jul-Aug;118(4):293-302. doi: 10.1093/phr/118.4.293.
PubMed 12815076Ezeome ER, Marshall PA. Informed consent practices in Nigeria. Dev World Bioeth. 2009 Dec;9(3):138-48. doi: 10.1111/j.1471-8847.2008.00234.x. Epub 2008 Apr 29.
PubMed 18452553Chokshi DA, Thera MA, Parker M, Diakite M, Makani J, Kwiatkowski DP, Doumbo OK. Valid consent for genomic epidemiology in developing countries. PLoS Med. 2007 Apr;4(4):e95. doi: 10.1371/journal.pmed.0040095.
PubMed 17455985
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cultural Congruence in International Genetics Research: Perceptions of Opportunities and Challenges Among Researchers
- ClinicalTrials.gov ID
- NCT00767858
- Acronym / sponsor ID
- 999908225
- Conditions
- Cultural Diversity
- Keywords
- Genetic, Genetic Literacy, Human Genetic Research, Cultural Congruence, Interview
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 9 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 24 Sep 2008
- Study completion
- 24 Feb 2016
- 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 how cultural differences influence genetics research in developing countries. Human genetics research is becoming more common in developing countries. However, when research is conducted with people living in developing countries, there is a chance that culture differences can lead to misunderstandings between investigators and participants, resulting in ineffective research. This study will explore challenges facing investigators conducting genetics research in developing countries and opportunities to improve this kind of research.
Scientists who have conducted genetics research in a developing country may be eligible to participate in this study. Participants are interviewed by telephone. The interview, which lasts about an hour, includes questions about the researchers decision to conduct the study they have done, the times they noticed that culture played a role in the research and the times that were more challenging and less challenging.
The interviews are recorded, transcribed and analyzed for themes related to cultural congruence and specific challenges and opportunities with regard to cultural congruence.
Detailed description
The objective of the proposed study is to describe cultural congruence, including diversity, awareness, sensitivity, and competence in people conducting human genetics research in developing countries, as well as to explore challenges and opportunities to improve cultural congruence. Human genetics research is becoming more common in developing countries, as researchers take advantage of differences in environment and population diversity. However, when research is conducted with individuals living in developing countries, there is a chance that culture will lead to misunderstandings between investigators and participants and consequently ineffective research. The proposed study uses a cross-sectional semi-structured qualitative interview design. Thirty to forty-five participants will be recruited. Participants will be researchers with experience in conducting genetics research in developing countries, who will have had direct contact with the participants in their research studies. These researchers will be recruited from professional organizations, through identification of lead authors in literature searches, and through snowball recruitment. Interviews will be conducted by telephone, recorded, transcribed, and analyzed for themes related to cultural congruence and specific challenges and opportunities with regard to cultural congruence.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants will include genetics researchers who have had direct contact with participants in human genetic research in developing countries. A researcher may be defined as any project staff, faculty, or investigator involved in carrying out a genetics research protocol in a developing country. Project staff are included as potential participants so that whoever has most contact with genetic research participants is able to participate in the proposed study.
- Researchers will be able to decide whether the country that they are working in is defined as a developing country, as opposed to dictating a fixed list of countries that qualify. This will be assessed by participant report during the screening process.
Key exclusion criteria (2 listed)
- Researchers who do research in developing countries but do not have direct contact with human participants.
- Participants who are non-English-speaking or under the age of 18.
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 was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Background: PubMed 12815076Betancourt JR, Green AR, Carrillo JE, Ananeh-Firempong O 2nd. Defining cultural competence: a practical framework for addressing racial/ethnic disparities in health and health care. Public Health Rep. 2003 Jul-Aug;118(4):293-302. doi: 10.1093/phr/118.4.293.
- Background: PubMed 18452553Ezeome ER, Marshall PA. Informed consent practices in Nigeria. Dev World Bioeth. 2009 Dec;9(3):138-48. doi: 10.1111/j.1471-8847.2008.00234.x. Epub 2008 Apr 29.
- Background: PubMed 17455985Chokshi DA, Thera MA, Parker M, Diakite M, Makani J, Kwiatkowski DP, Doumbo OK. Valid consent for genomic epidemiology in developing countries. PLoS Med. 2007 Apr;4(4):e95. doi: 10.1371/journal.pmed.0040095.
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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.
Barbara B Biesecker 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 Cultural Diversity, 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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 5 Apr 2018. 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 was stopped early. Results are not available in the source record.
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 NCT00767858, 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 5 Apr 2018.