Version <1.

0 (update as needed)>, dated <to state>

PARTICIPANT INFORMATION SHEET AND INFORMED CONSENT FORM

(for adult subjects)

1. Title of study: <insert study title>

2. Name of investigator and institution: <to list>

3. Name of sponsor: <State sponsor; if no sponsor/other source of funding, state: no external

funding>

4. Introduction:

It is important that you understand why the research is being done and what it will involve.
Please take your time to read through and consider this information carefully before you decide
if you are willing to participate. Ask the study staff if anything is unclear or if you would like
more information. After you are properly satisfied that you understand this study, and that you
wish to participate, you must sign this informed consent form.

Your participation in this study is voluntary. You do not have to be in this study if you do not
want to. You may also refuse to answer any questions you do not want to answer. If you
volunteer to be in this study, you may withdraw from it at any time. If you withdraw, any data
collected from you up to your withdrawal will still be used for the study. Your refusal to
participate or withdrawal will not affect any medical or health benefits to which you are
otherwise entitled.

This study has been approved by the Medical Research and Ethics Committee, Ministry of
Health Malaysia.

5. What is the purpose of the study?

The purpose of this study is to <insert study purpose in layperson terms>. This research is
necessary to improve the understanding of parents of children with Autism.

This research will be conducted for duration of xx month (dd/mm/yyyy till dd/mm/yyyy). The
expected number of participants is (to state number) individuals.

6. What are my responsibilities when taking part in this study?

It is important that you answer all of the questions asked by the study staff honestly and
completely which will take about (to state) minutes of your time. Study team will also access
your medical records for the following information. (to list)

For studies involving questionnaire/survey/interview:

You will be given a survey form to be answered / You will be interviewed by (to state
interviewer). This form contains (to state number) sections which will enquire about (to list
generally) topics

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7. What are the potential risks and side effects of being in this study?
Participation to this study will not affect your treatment, and the risk is minimal. You are free to
decline to answer any of the questions that you feel uncomfortable with.

8. What are the benefits of being in this study?

There may or may not be any benefits to you. Information obtained from this study will help
<for example, improve the treatment or management of disorder being studied>.

9. Who is funding the research?

This study is sponsored by <to list. Please note that if there is no university grant or outside funding,
you should state: This study does not receive any external funding>. You will not be paid for
participating in this study.

10. Will my medical information be kept private?

All your information obtained in this study will be kept and handled in a confidential manner, in
accordance with applicable laws and/or regulations. When publishing or presenting the study
results, your identity will not be revealed without your expressed consent. Individuals involved
in this study, qualified monitors and auditors, and governmental or regulatory authorities may
inspect the study data, where appropriate and necessary.

11. Who should I call if I have questions?

If you have any questions about the study or if you think you have a study related injury and
you want information about this study, please contact the study doctor, <to state> at telephone
number [to state].

If you have any questions about your rights as a participant in this study, please contact: The
Secretary, Medical Research & Ethics Committee, Ministry of Health Malaysia, at telephone
number 03-3362 8407/8205/8888.

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INFORMED CONSENT FORM

Title of Study: <insert title of study>

By signing below I confirm the following:

 I have been given oral and written information for the above study and have read and
understood the information given.
 I have had sufficient time to consider participation in the study and have had the opportunity
to ask questions and all my questions have been answered satisfactorily.
 I understand that my participation is voluntary and I can at anytime free withdraw from the
study without giving a reason and this will in no way affect my future treatment. I am not
taking part in any other research study at this time. I understand the risks and benefits, and I
freely give my informed consent to participate under the conditions stated. I understand that
I must follow the study doctor’s (investigator’s) instructions related to my participation in
the study.
 I understand that study staff, qualified monitors and auditors, the sponsor or its affiliates,
and governmental or regulatory authorities, have direct access to my medical record in order
to make sure that the study is conducted correctly and the data are recorded correctly. All
personal details will be treated as STRICTLY CONFIDENTIAL
 I will receive a copy of this subject information/informed consent form signed and dated to
bring home.
 I agree/disagree* for my family doctor to be informed of my participation in this study.
(*delete which is not applicable)

Subject:

Signature: I/C number:

Name: Date:

Investigator conducting informed consent:

Signature: I/C number:

Name: Date:

Impartial witness:

Signature: I/C number:

Name: Date:

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