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NCT03983863 · ClinicalTrials.gov registry record
Mapping Institutional Identities and the Production of Ethics
A clinical trial, sponsored by National Human Genome Research Institute (NHGRI).
- Completed
- Registry status
- 61
- Enrollment target
NCT03983863: Completed study, sponsored by National Human Genome Research Institute (NHGRI).
NCT03983863 is a clinical trial that has completed, run by National Human Genome Research Institute (NHGRI). The registered enrollment target is 61 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03983863 has completed, sponsored by National Human Genome Research Institute (NHGRI).
- COMPLETED
- Registry status
- 61 participants
- Enrollment target
Study Summary
Background: Researchers want to learn how members of IRB committees interact with each other. They want to see how this affects the decision-making process. They want to learn how members see their role and the roles of their fellow members. They want to see if these views are actualized during meetings. To do this, researchers will sit in on IRB meetings and interview committee members. Objective: To explore the dynamics between IRB members. To explore how these dynamics affect the IRB process of decision making. Eligibility: NIH IRB staff or members Design: In Phase I, an investigator (AI) will sit in on IRB meetings for 6 months. The AI will take notes on the dynamics of the committees. The AI s will focus will be on the dialogue and the behavior of both the group and each member. The AI will also focus on the factors that form the decision-making process. The AI will audio-record the meetings to help take detailed notes. These recordings will be destroyed after 3 months. If the AI does not hear from members before the IRB meetings, the AI will assume that the member is agreeing to take part in Phase I. In Phase II, the AI will contact some members about taking part in a 60-minute interview. The interview will be semi-structured. It will be on site and in person. It will explore how the members see their role and the roles of others on the committee. Contact information will be collected only for members who take part in Phase II. Data will be de-identified. Withdrawing from the study will not affect any member s role on the IRB.
Primary Outcome
The primary objective is to explore what dynamics exist within IRB committees, how members in each role interact with each other, and how these interactions affect participation in the deliberation/decision-making process. This will be explored through direct observation of IRB committee meetings.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2019-05-30 |
| Est. Completion | 2021-04-30 |
What the finished NCT03983863 record still lists
NCT03983863 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 61 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT03983863 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03983863 about?
NCT03983863 is a clinical study titled "Mapping Institutional Identities and the Production of Ethics". Background: Researchers want to learn how members of IRB committees interact with each other. They want to see how this affects the decision-making process. They want to learn how members see their role and the roles of their fellow members. They want to see if these views are actualized during mee...
What is the current status of trial NCT03983863?
This trial is currently completed. The enrollment target is 61 participants. The study started on 2019-05-30. Estimated completion is 2021-04-30.
Who is sponsoring clinical trial NCT03983863?
This trial is sponsored by National Human Genome Research Institute (NHGRI), which has 185 total clinical trials registered on ClinicalTrials.gov.
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