Thank you for being willing to consider participating in this research project. Please review the Participant Information Sheet for more information.
Study MMZ-001– Semi-Structured Interviews with Subject Matter Experts; Preparation for a Research Project to Update, Enhance, and Evaluate a Medicine Development and Regulatory Review Process Simulation Game, MeduMaZe®, as a Pedagogical Tool
SREC reference and committee: Cardiff University School of Pharmacy and Pharmaceutical Sciences Research Ethics Committee reference 2425-01
Name of lead researcher: Alison Bowers
Name of supervisor: Dr Louise Hughes
Tick the boxes below to indicate your consent to each study element.
1. I confirm that I have read the information sheet dated 22 April 2025 version 1.4 for the above research project.*
2. I confirm that I have understood the information sheet dated 22 April 2025 version 1.4 for the above research project and that I have had the opportunity to ask questions and that these have been answered satisfactorily.*
3. I understand that my participation is voluntary and I am free to withdraw at any time before the de-identified, transcript-based Interview Report is finalised without giving a reason and without any adverse consequences.*
4. I understand that data collected during the research project may be looked at by individuals from Cardiff University, where it is strictly necessary and/or relevant to evaluation of the output of the research project.*
5. I understand that my personal information (name, contact details, subject matter area of expertise, and current job title or seniority) will be collected for the purposes explained to me, as set out in the Participant Information Sheet.*
6. I understand that my personal information will be held in accordance with all applicable data protection legislation & in strict confidence unless disclosure is required by law or professional obligation. I have been informed of my rights under data protection legislation & how I can raise any concerns.*
7. I understand who will have access to the personal information provided, how it will be managed, and what will happen to these data at the end of the research project.*
8. I consent to the interview being recorded. I can choose to have my camera on or off; the video will not be used. I understand that the audio stream recording will only be used for the purposes of assuring accurate transcription of my answers.
9. I understand how the information I provide will be used in the research. A summary based on the report of my interview, including de-identified excerpts and/or verbatim quotes, may be used as part of any future research publication or thesis.*
10. I understand that the interviewer will contact me again within 4 weeks of the original interview to clarify or confirm their interpretation of my answers by sending me a Draft Interview Report to review, based on a transcript, and I consent to this.*
11. I understand how the findings and results of the research project will be written up and published.*
12. I understand that MeduMaZe is not commercially available at present. Commercial opportunities for the game may be reassessed at some future date.*
13. I agree to take part in this research project.*
By typing your signature above, you agree that this consent may be signed electronically.
THANK YOU FOR PARTICIPATING IN OUR RESEARCH
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YOU WILL BE SENT AN ELECTRONIC COPY OF THIS CONSENT FORM TO KEEP.
