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Mapping Institutional Identities and the Production of Ethics

NCT03983863 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 61

Last updated 2024-09-04

No results posted yet for this 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.

Conditions

  • IRB Decision Making

Sponsors & Collaborators

  • National Human Genome Research Institute (NHGRI)

    lead NIH

Principal Investigators

  • Sara C Hull, Ph.D. · National Human Genome Research Institute (NHGRI)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-30
Primary Completion
2019-06-30
Completion
2021-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03983863 on ClinicalTrials.gov