A Vignette-based Randomized Controlled Trial to Evaluate the Impact of Research Climate on Research Practices of Doctoral Students

A Vignette-based Randomized Controlled Trial to Evaluate the Impact of Research Climate on Research Practices of Doctoral Students Facing Dilemma Situations

This study aims to evaluate the impact of research climate on PhD students' research practice (i.e., an environment where their peer (i.e., a post-doc researcher) had detrimental practice in a similar situation)

Study Overview

• Status: Unknown
• Conditions: The Study Focus on no Specific Condition
• Intervention / Treatment: Other: Vignette with emphasis on research climate

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, the investigators will evaluate the impact of research climate on PhD students' research practice (exposure to an environment where their peers commit a detrimental practice).

Objective: To evaluate the impact of research climate on PhD students' research practice

Design: A randomized controlled trial

1. Intervention: Participants will be shown two case vignettes describing dilemma situations in research reported with and without research climate factor.
2. Participants: The participants will be PhD students in all biomedical disciplines.
3. Sample size will be 300 participants
4. 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.
5. This study is approved by ethics review regulations by INSERM (CEEI-IRB): IRB00003888

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris Cedex 04, France, 75181
    • Centre d'Epidémiologie Clinique, hôpital Hôtel Dieu, Assistance Publique-Hôpitaux de Paris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• PhD students in biomedical disciplines

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)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vignette with research climate; Participants in this arm will receive vignettes describing a dilemma situation in research (e.g adding honorary author) with additional sentence describing research climate (i.e. an environment where their peer had detrimental practice in a similar situation)	Other: Vignette with emphasis on research climate; A vignette describing a dilemma situation for a researcher (e.g. adding an honorary author) with or without a research environment factor (i.e. an environment where other researchers commit detrimental research practice)
Active Comparator: Vignette without research climate; Participants in this arm will receive vignettes describing a dilemma situation in research without the additional sentence describing research climate	Other: Vignette with emphasis on research climate; A vignette describing a dilemma situation for a researcher (e.g. adding an honorary author) with or without a research environment factor (i.e. an environment where other researchers commit detrimental research practice)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean preference score	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).	Immediate assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
proportion of students who chose the detrimental research practice (DRP)	Proportion of students rated from -5 to -1 for the DRP.	Immediate assessment

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2020
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: February 7, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: ISB-013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No