- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04263506
A Vignette-based Randomized Controlled Trial to Evaluate the Impact of Supervisor's Role on Research Practices of Doctoral Students
A Vignette-based Randomized Controlled Trial to Evaluate the Impact of Supervisor's Role on Research Practices of Doctoral Students Facing Dilemma Situations
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PhD students are the next generation of researchers and will present the field in the future. However, several environmental factors might influence their research practice. In this study, we will evaluate the influence of supervisors on PhD students' research practice (an environment where there is a lack of opposition to detrimental research practice from the supervisor).
Objective: To evaluate the influence of supervisors on PhD students' research practice
Design: A randomized controlled trial
- Intervention: Participants will be shown two case vignettes describing dilemma situations in research reported with and without the role of the supervisor.
- Participants: The participants will be PhD students in all biomedical disciplines.
- Sample size will be 300 participants
- Primary outcome: In each vignette, participants will have to indicate which solution they prefer on a semantic differential scale, rated from - 5 to -1 (preference for solution A) and from 1 to 5 (preference for solution B). Participants will be forced to make a choice between the 2 solutions. The primary outcome will be the mean preference score.
- This study is approved by ethics review regulations by INSERM (CEEI-IRB): IRB00003888
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- PhD students in biomedical sciences
Exclusion Criteria:
- NA
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Vignette with supervisor's opinion
Participants in this arm will receive vignettes with an additional sentence describing supervisor's opinion (i.e.
supervisor does not oppose to detrimental research practice)
|
A vignette describing a dilemma situation for a researcher (e.g.
adding an honorary author) with or without the description of supervisor's advice that does not oppose to detrimental research practice (i.e. the supervisor is fine with whatever the PhD student decides in the dilemma).
|
|
Active Comparator: Vignette without supervisor's opinion
Participants in this arm will receive vignettes without an additional sentence describing supervisor's opinion.
|
A vignette describing a dilemma situation for a researcher (e.g.
adding an honorary author) with or without the description of supervisor's advice that does not oppose to detrimental research practice (i.e. the supervisor is fine with whatever the PhD student decides in the dilemma).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean preference score
Time Frame: Immediate assessment
|
In each vignette, we will ask participants, what would you do if you are in the place of the character in the vignette?
Participants will have to indicate which solution they prefer on a semantic differential scale, rated from - 5 to -1 (preference for solution A) and from 1 to 5 (preference for solution B).
We will calculate the mean preference score
|
Immediate assessment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of students who chose the detrimental research practice
Time Frame: Immediate assessment
|
Proportion of students who made choices rated from -5 to -1
|
Immediate assessment
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ISB-014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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