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

The Study Focus on no Specific Condition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04263805
• Other study ID #: ISB-013
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Isabelle BOUTRON, Pr
• Phone: +33 (0)1.42.34.78.33
• Email: isabelle.boutron[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• PhD students in biomedical disciplines

Exclusion Criteria:

• NA

Related Conditions & MeSH terms

• The Study Focus on no Specific Condition

Intervention

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)

Locations

Country	Name	City	State
France	Centre d'Epidémiologie Clinique, hôpital Hôtel Dieu, Assistance Publique-Hôpitaux de Paris	Paris Cedex 04

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	proportion of students who chose the detrimental research practice (DRP)	Proportion of students rated from -5 to -1 for the DRP.	Immediate assessment