JAWATANKUASA ETIKA UNIVERSITI UNTUK PENYELIDIKAN

MELIBATKAN MANUSIA (JKEUPM)

UNIVERSITI PUTRA MALAYSIA, 43400 UPM SERDANG,
SELANGOR, MALAYSIA

FORM 2.4: RESPONDENT’S INFORMATION SHEET AND INFORMED CONSENT FORM

Please read the following information carefully and do not hesitate to discuss any questions you
may have with the researcher.

1. STUDY TITLE :

Establishing a new approach to clinical communication skills assessment for medical students using an
immersive virtual simulated patient.

2. INTRODUCTION:

Communication skill is one of the important components that should be taught for undergraduate medical
students. The ability to communicate with patients and their relatives is a crucial skill as a doctor,
unfortunately, a lot of medical students in that area thus leading to patients’ dissatisfaction in their
healthcare.

To overcome this kind of issue, real simulated patients (SPs) are being used for training and assessment
of the students’ competencies in this area. Despite its advantages, the usage of real SPs needs a lot of
resources such as cost, time, and training. As an alternative, several countries have been using virtual
simulated patient (vSP) to train their medical students to overcome the challenges of using the SPs.

In parallel with curriculum standards and education setting of medical schools in Malaysia, our cultures,
and language, a simple vSP prototype will be developed based on the data collected from the focus group
discussion. The prototype will be evaluated for its validity, reliability, feasibility, and resource implications.
The findings of this study will determine whether the vSP prototype is relevant, realistic, effective and a
valid tool to be used in our educational setting.

You are invited to participate voluntarily in this research. You will be required to provide your ideas or
opinions on the communication between doctors and patients/relatives, your understanding in doctor-
patient communication, the critical components in the communication, the quality of work required, and
the quality of feedback received from both sides.

If you agree to participate in this study, you will be given a copy of this ‘Respondent’s Information sheet
and Informed consent form’ to keep for yourself. Before participating in this study, you are required to
read and understand the information and ask if you have any doubts. You will be involved in a focus
group discussion (FGD)/semi-structured interview and for both methods will take about 40-60 minutes.
This study is estimated to include up to 120 participants from any hospitals or clinics in Malaysia (private
and government) and Faculty of Medicine and Health Sciences, Universiti Putra Malaysia (FMHS, UPM).

3. WHAT WILL YOU HAVE TO DO?

This study will involved two different method of data collections. First is focus group discussion (FGD) and
another one is semi-structured interview. FGD will be conducted to different group of participants: doctors
and medical students, while semi-structured interview will be conducted with different group of
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participants: patients and patients’ relatives. In FGD, the reseacher will become as a moderator,
meanwhile in semi-structured interview, the researcher will become an interviewer.

Participants that voluntarily take part in this study will be briefed about the purpose of the study,
background, methodology and ‘Respondent’s Information sheet and Informed consent form’. All
participants will be tagged with a number as an ID. All the participants will undergo some of the
discussion through the FGD or one-to-one interview through the semi-structured interview. The
participants need to answer the questions that will be asked by the moderator or interviewer. The
questions are open-ended, thus the participants are free to give their answers or opinions and they will be
audio-recorded for this study. Both FGD and semi-structured interview will be moderated in English. For
participants having difficulty in speaking English, you will be allowed to speak in the Malay language. The
focus group and semi-structured interview are estimated to span around 40-60 minutes for each
session.

4. WHO SHOULD NOT PARTICIPATE IN THE STUDY?

This study will include Malaysian doctors, medical students, patients and patients’ relatives from any
hospitals or clinics in Malaysia (private and government) and Faculty of Medicine and Health Sciences,
Universiti Putra Malaysia (FMHS, UPM). This study will not include Non-Malaysia doctors, medical
students, patients and patients’ relatives from any hospitals or clinics in Malaysia (private and
government) and Faculty of Medicine and Health Sciences, Universiti Putra Malaysia (FMHS, UPM).

Your participation is voluntary. You may refuse to take part or stop your participation in this study at any
time without penalty or loss of benefits to which you are entitled. Your participation may be halted by the
research team without your consent if you have violated the study eligibility criteria in any form. The
research team member will discuss it with you if the matter arises.

5. WHAT WILL BE THE BENEFITS OF THE STUDY:

(a) TO YOU AS THE SUBJECT?

You will receive a small honorarium/incentive as a token of appreciation to recognize the time spent and
your effort in participating in the study.

(b) TO THE INVESTIGATOR?

The findings from this study may develop a new immersive virtual simulated patient (vSP) prototype that
corresponds with the curriculum standards of medical schools in Malaysia for education purposes.

6. WHAT ARE THE POSSIBLE RISKS?

During the focus group discussion or semi-structured interview, a trained researcher who has no authority
will moderate the discussion or interview, therefore you will have the freedom to provide your consent and
be involved in the FGD or semi-structured interview without coercion. Furthermore, medical students’
input will not affect their grades. All data will be treated as anonymous and discussions will remain
confidential.

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7. WILL THE INFORMATION THAT YOU PROVIDE AND YOUR IDENTITY REMAIN CONFIDENTIAL?

The researchers that are involved in this study will keep all the information and identities provided by the
participants confidential throughout the study unless disclosure is required by law. Data obtained from this
study that does not identify you individually will be published for knowledge purposes.

By agreeing to participate in this study, you authorize the record review, information storage and data
processes. Your original records may be reviewed by the researchers, the Ethical Review Board for this
study, and regulatory authorities to verify the study procedures and/or data. Only research team members
are authorized to assess your information for educational purposes.

The report of the findings will be provided via email if you wish to know the results of your participation in
the study. If you agree, your email address will be requested in the Subject Formation and Consent Form.

8. WHO SHOULD YOU CONTACT IF YOU HAVE ADDITIONAL QUESTIONS DURING THE COURSE
OF THE RESEARCH?

If you have any question regarding this study, please contact

Nurul Ain Mohd Salim

Faculty of Medicine and Health Sciences
Universiti Putra Malaysia,
43400 UPM Serdang, Selangor, Malaysia.
Phone No: +6012 461 9701 (Email:nurulainmohdsalim89@gmail.com)

Dr. Siti Khadijah Adam

Medical Education Research and Innovation Unit (MERIU) & Pharmacology Unit,
Department of Human Anatomy,
Faculty of Medicine and Health Sciences,
Universiti Putra Malaysia,
43400 UPM Serdang, Selangor, Malaysia.
Phone No: +6012 611 7617 (E-mail: sk.adam@upm.edu.my)

If you have any question regarding the Ethical Approval or any issue related to this study, please contact

JKEUPM (Ethic Committee for Research Involving Human Subject)

Office of the Deputy Vice Chancellor (Research & Innovation)
Universiti Putra Malaysia,
43400 UPM Serdang, Selangor, Malaysia .
Tel. No: +6 03 9769 1002 (E-mail: tncpi@upm.edu.my)

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Please note your initials here if you have read and understood the contents of this page______

9. CONSENT

I MUHAMMAD MUSTAFFA BIN MOHAMED TAHA Identity Card No. 841110-14-5611 addres
NO.11,LORONG 9, TAMAN KIRANA, 21700 KUALA BERANG, TERENGGANU hereby voluntarily
agree to take part in the research stated above *(clinical /drug trial/video recording/focus group/interview-
based/questionnaire-based).

I have been informed about the nature of the research in terms of methodology, possible adverse
effects and complications (as written in the Respondent’s Information Sheet). I understand that I have
the right to withdraw from this research at any time without giving any reason whatsoever. I also
understand that this study is confidential and all information provided with regard to my identity will
remain private and confidential.

I* wish/do not wish to know the results related to my participation in the research

I* agree/do not agree that the images/photos/video recordings/voice recordings related to me be used in
any form of publication or presentation (if applicable)

* delete where necessary

Signature ……..………………………… Signature ……..………………………….

(Respondent) (Witness)

Date :………………………………….….. Name :………………………………….…..

I/C No. :………………………………….…..

I confirm that I have explained to the respondent the nature and purpose of the above-mentioned
research.

Date ……..………………………… Signature ……..………………………….

(Researcher)

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