PARTICIPANT INFORMATION FOR QUT RESEARCH PROJECT

Survey in a lecture

Mock Randomised Controlled Trial

QUT Ethics Approval Number 1700000251

RESEARCH TEAM
Principal Researcher: Professor Philip Baker
Associate Researchers: Adjunct Associate Professor Daniel Francis
School of Public Health and Social Work, Faculty Health
Professor Abby Cathcart, QUT Business School
Queensland University of Technology (QUT)

DESCRIPTION
This project is being undertaken as part of teaching about randomized controlled trials.

The purpose of this project is to provide a fun and memorable experience for students and health
professionals to learn the operational fundamentals and epidemiological principles of a randomised
controlled trial (RCT). We also intend to use the data we collect for teaching and learning quality
assurance.

You are invited to participate in this lecture because you are studying evidence based practice,
epidemiology, or attending a professional development workshop and you meet predetermined
criteria, which might be biased.

PARTICIPATION
Participation will involve completing prompted questions using an electronic voting device during
the lecture or workshop. The questions are answered anonymously and will include questions such
as your gender, your level of happiness and learning experience. Combined with the lecture and
group discussion, the duration of the mock trial will be the scheduled lecture time, in most cases two
hours.

Questions will include:

How confident are you in identifying the key steps of a clinical trial?
Which picture best describes your present feeling?

You may also be asked to eat in a blinded manner about 4 to 5 grams of commercially prepared
candy. The colour you receive will be randomly allocated. You will learn about randomisation in the
lecture. You will be asked some of the questions before and after eating the candy.

Audience response technology is routinely used in the teaching and learning of epidemiology by
your instructors. Research has shown students benefit from engaged rather than passive learning.
Your participation in the candy eating part of the lecture is entirely voluntary. If you agree to
participate you do not have to complete any questions you are uncomfortable answering. Your
decision to participate or not participate will in no way impact upon your current or future
relationship with QUT (for example your grades).
If you do agree to participate you can withdraw from the project during your participation without
penalty. However as the voting is anonymous, once voting has been submitted it will not be possible
to withdraw. Withdrawals and drop-outs (attrition) will be discussed during the lecture.

All comments and responses will be treated confidentially. The names of individual persons are not
required in any of the responses; however a computer will record responses for each voting device
during the lecture.

EXPECTED BENEFITS
It is expected that this project will benefit you directly by learning about a RCT and critical appraisal.
However, it may also benefit fellow learners and also the future quality of teaching.

RISKS
There are no risks beyond normal day-to-day living associated with your participation in this project.
You should not participate if you are diabetic, have known food allergies, or otherwise not able to
consume about 4 to 5 g of commercially prepared chocolate candy, such as Smarties (Nestle
Australia).

This lecture asks learners to answer questions about their feelings.

PRIVACY AND CONFIDENTIALITY

All comments and responses are anonymous and will be treated confidentially unless required by
law. The names of individual persons are not required in any of the responses.

Any data collected as part of this project will be stored securely as per QUTs Management of
research data policy.

Please note that non-identifiable data from this project may be used as comparative data in future
projects or stored on an open access database for secondary analysis.

CONSENT TO PARTICIPATE
The use of the electronic voting system is accepted as an indication of your consent to participate in
this project.

QUESTIONS / FURTHER INFORMATION ABOUT THE PROJECT

If you have any questions or require further information please contact one of the listed researchers:

Philip Baker p2.baker@qut.edu.au 07 3138 5596

Abby Cathcart abby.cathcart@qut.edu.au 07 3138 7745

CONCERNS / COMPLAINTS REGARDING THE CONDUCT OF THE PROJECT

QUT is committed to research integrity and the ethical conduct of research projects. However, if you
do have any concerns or complaints about the ethical conduct of the project you may contact the
QUT Research Ethics Advisory Team on 07 3138 5123 or email humanethics@qut.edu.au. The QUT
Research Ethics Advisory Team is not connected with the research project and can facilitate a
resolution to your concern in an impartial manner.

THANK YOU FOR HELPING WITH THIS RESEARCH PROJECT.

PLEASE KEEP THIS SHEET FOR YOUR INFORMATION.