IRB Decision MakingNCT03983863
Mapping Institutional Identities and the Production of Ethics
An observational study of IRB Decision Making, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IRB Decision Making
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2019to 30 Apr 2021
- 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
Study population: All members/staff of NIH IRBs and IRB panels that fall under the NIH Intramural Federal Wide Assurance (FWA).@@@
- ELIGIBILITY CRITERIA:
All members/staff of NIH IRBs and IRB panels that fall under the NIH Intramural Federal Wide Assurance (FWA).
Trial locations and contacts
1 site in 1 country.
United States1 site
National Human Genome Research Institute (NHGRI)
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the detailed description
Objective: The study has two objectives. 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.
The secondary objective of this research is to explore what each member/staff perceives his/her role and the roles of other committee members to be and whether these perceptions are congruent with how roles are actualized during meetings.
Study Population: Our target population consists of all members/staff of NIH IRBs and IRB panels that fall under the NIH Intramural Federal Wide Assurance (FWA).
Design: The project will involve two phases: direct observation and semi-structured interviews. Phase I (direct-observations) will involve an associate investigator, Hina Walajahi, sitting in on regularly scheduled IRB meetings at the NIH and taking observational notes on committee dialogue, individual and group behavior, and factors that contribute to the decision-making process. Meetings will be audio-recorded in order to validate the observation notes. The observational data will be used to select appropriate committee members/staff and guide questions for the semi-structured interviews.
For Phase II (semi-structured interviews), the same associate investigator will conduct in-person, semi-structured interviews with contacted IRB members/staff regarding role perception respective to other members and the committee as a whole. Interviews will last approximately 60 minutes. They will be audio-recorded and transcribed.
Outcome Measures: A qualitative codebook will be created from observational and interview data, focusing on themes including, but not limited to: member interactions, member participation in discussion, committee deliberation processes and voting behavior.
- Conditions
- IRB Decision Making
- Keywords
- NIH, Panel, Member/Staff, Natural History
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IRB | Our target study population consists of all members/staff of NIH IRBs and IRB panels that fall under the NIH Intramural Federal Wide Assurance (FWA). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamics
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.
Measured: Enrollment
Secondary outcomes (1)
Perception
The secondary objective of this research is to explore what each member/staff perceives his/her role and the roles of other committee members to be and whether these perceptions are congruent with how roles are actualized during meetings. This will be explored through semi-structured interviews with select IRB committee members/staff.
Measured: Single follow-up session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start30 May 2019
- Primary completion30 Jun 2019
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IRB Decision MakingStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Sara C Hull, Ph.D., Principal investigator, National Human Genome Research Institute (NHGRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03983863
- Sponsor's protocol ID
- 999919106
- Other IDs
- 19-HG-N106
- Status last verified
- Sep 2024
- First submitted
- 7 Jun 2019
- Last updated
- 4 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping Institutional Identities and the Production of Ethics
- ClinicalTrials.gov ID
- NCT03983863
- Acronym / sponsor ID
- 999919106
- Conditions
- IRB Decision Making
- Keywords
- NIH, Panel, Member/Staff, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 30 May 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 12 Jun 2019 (actual)
- 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.
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.
Detailed description
Objective: The study has two objectives. 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.
The secondary objective of this research is to explore what each member/staff perceives his/her role and the roles of other committee members to be and whether these perceptions are congruent with how roles are actualized during meetings.
Study Population: Our target population consists of all members/staff of NIH IRBs and IRB panels that fall under the NIH Intramural Federal Wide Assurance (FWA).
Design: The project will involve two phases: direct observation and semi-structured interviews. Phase I (direct-observations) will involve an associate investigator, Hina Walajahi, sitting in on regularly scheduled IRB meetings at the NIH and taking observational notes on committee dialogue, individual and group behavior, and factors that contribute to the decision-making process. Meetings will be audio-recorded in order to validate the observation notes. The observational data will be used to select appropriate committee members/staff and guide questions for the semi-structured interviews.
For Phase II (semi-structured interviews), the same associate investigator will conduct in-person, semi-structured interviews with contacted IRB members/staff regarding role perception respective to other members and the committee as a whole. Interviews will last approximately 60 minutes. They will be audio-recorded and transcribed.
Outcome Measures: A qualitative codebook will be created from observational and interview data, focusing on themes including, but not limited to: member interactions, member participation in discussion, committee deliberation processes and voting behavior.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IRB | – | –Our target study population consists of all members/staff of NIH IRBs and IRB panels that fall under the NIH Intramural Federal Wide Assurance (FWA). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All members/staff of NIH IRBs and IRB panels that fall under the NIH Intramural Federal Wide Assurance (FWA).@@@
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
Dynamics
Time frame: Enrollment
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.
1 secondary outcome
Perception
Time frame: Single follow-up session
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 4 Sep 2024.
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.
Sara C Hull, Ph.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 IRB Decision Making, 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?
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 4 Sep 2024. 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.
What does the primary outcome measure?
Dynamics (time frame: Enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2024.