AF 03 06 EN Participant Information Sheet and Consent Form

AF 03-06
Instructions and Template:
1.Use very simple language to understand easily,

precisely. Should not be more than 3-4 pages.
2.Do not copy content of research proposal/thesis
as information for participant. It should be adjusted
accordingly and rewrite.
3.Avoid technical terms. (If used, give explanation
in lay language).
4.Avoid using sensitive words to participants e.g. in
end-stage of cancer person
5.State what participants need to do (What, When
and time involved, Where, How, With whom)
6.For illiterate persons, state how to inform them,
Note:
 Research involving secondary data or anonymous
stored specimens and its owner cannot be traced or
re-identified, the researcher can request to waive
information sheet and consent form.
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 Research involving vulnerable group eg. drug abuses,

HIV subjects, persons infected with venereal
diseases, sex workers, illegal workers etc.,. if signing
the consent causes no participants or research using
questionnaires and without respondent name or
research by telephone interview or online. the
researcher can request to waive signing consent.
However, information for those research participants
must be provided.
 For researcher participants age 8-17 years old, must
co-sign consent with parent or guardian.
*Please delete “”instructions” before

submission*
Template: Research Participant Information Sheet

and Consent Form
Title of research project

………………………………………………………………………………………...
Principal researcher’s name …………………………………………….
Position ……………………
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Office address
………………………………………………………………………………..
…………………...……
Home address
…………………………………………………………………………..
…………………………...…
Telephone (office) ……………………..…….. Telephone (home)
……………………….……….
Cell phone ……………………………….. E-mail:
………………………………………………..………………
Example of introduction
You are being invited to take part in a research project.
Before you decide to participate it is important for you to
understand why the research is being done and what it will
involve. Please take time to read the following information
carefully and do not hesitate to ask if anything is unclear or
if you would like more information.
Example of contents
1. State in brief what this project involved and for what
purposes.
Do not copy content of research proposal/thesis as
information for participant. It should be adjusted
accordingly and rewrite.
2. State how to provide information by whom and how
to obtain consent
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 If potential participant is illiterate/cannot read and

write, state how the researcher will proceed with the
process of informed consent.
 In vulnerable group e.g. psychosis, prisoner, mental
retarded, person under eighteen years old, pregnant
woman, dementia, disabled, minority, conscription,
very sick person, refugee, etc., state how informed
consent is handled?
3. Details of participant.
 Number of participants needed in research project.
 Characteristics, including inclusion and exclusion
criteria
 How to approach potential participants.
 Group allocation and number of participants in
each group (if applicable).
4. Details of screening process of inclusion/exclusion
criteria or qualifications.
 State you need to pass the screening procedure
before enrolling into the project.
(If screening process is rather complicated, please
have a separate information sheet)
 State how to screen them, where, time used, any
risks. For persons who fail the screening, state how
you will do as an expression of your appreciation for
their time loss with you.
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 If any persons found to need any help/advice,

please state what will be done for that person.
 If medical records are needed, state you will ask
from authority for permission to use them.
 If participants are being treated, permission from
physician in charge should be acquired.
5. Procedure upon participants:
 Preparations for research activities (e.g. fasting
for blood collection, how to dress)
 Who, will do what, how, when, where, how
much time involved as indicated in the
research proposal. Please consider having
picture or diagram for better understanding.
 For research using questionnaires (self-
responding or interview) please indicate topics
and number of questions in each topics
including estimated time used.
 For small group discussion, please indicate
topic to be discussed, time, place and person
who will conduct the discussion.
 For complicated program/ activities, please
summarize in table for easily understand.
 For continuous activities, state how much time
(weeks/months) which participants have to
engage in the project.
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 If there is picture taken/tape recording/

observation of activities of research participants,
permission must be granted before performing.
 If asking participants to do any recording, please
consider if it’s possible, should not be a burden
and researcher must definitely use them.
 If using any specimens of participants, eg. urine
or blood , please indicate explicitly any fasting?,
how many times and what time, the amount
should be indicated in tea spoonful, where the
specimens are sent to, who will pay for the
cost. If the specimens have to be sent abroad,
please indicate you have “material transfer
agreement”.
6. Indicate risk/harm procedure which may cause ill

effect to physical, mental, social, economic, belief of
participants. State how the researcher has any
preventive/protective measures toward those
consequences. In case an ill effect occurs, state guideline
how to assist that participant.
7. For benefit of the project, state clearly; what/how to

individual/public/academy. Do not exaggerate benefit.
If study’s results proved beneficial, state what kind
of benefit(s) researcher will share with the control
group/community.
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8. Information will include “Information related directly

to you will be kept confidential and how”. Results of the
study will be reported as total picture. Any information
which could be able to identify you will not appear in the
report.
9. State what researcher will do with personal data

after research project is completed e.g. tape recorder will
be deleted, blood/urine will be destroyed. If it will be kept
for future studies, should be stated in the information sheet
and re-consent.
10. State explicitly whether there is any compensation

for time loss/inconveniences transportation fee etc. The
amount of money should be appropriate, not too high as if
to “induce” or not too low as to take advantage of
participants.
If researcher give any gift, please state what it is. It
must be usable for participants and do not mention the
price.
If nothing to give, state that there is nothing to give
participants but only heartfelt thanks
11. Information will include “participation to the study
is voluntary and participant has the right to deny and/or
withdraw from the study at any time, no need to give any
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reason, and there will be no bad impact upon that

participant.” (state explicitly e.g. still receive the same usual
services).
12. Information will include “if you have any question
or would like to obtain more information, the researcher
can be reached at all time. If the researcher has new
information regarding benefit on risk/harm, participants will
be informed as soon as possible.” This practice will provide
an opportunity for participants to decide whether to
stay/not stay with the project. (In case of one time
interview and unable to re-contact participants, no need to
state this underline sentence).
13. State “If researcher does not perform upon

participants as indicated in the participant information sheet
and consent form, participants can report the incident to
the Research Ethics Review Committee for Research
Involving Human Research Participants, Group I,
Chulalongkorn University (RECCU) Jamjuree 1 Bldg., 254
Phyathai Rd., Patumwan district, Bangkok 10330, Thailand,
Tel./Fax. 0-2218-3202, 0-2218-3049 E-mail:
[email protected]”
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Please see if it’s possible for e.g., vulnerable person,

marginal persons to complain ethical committee, please
I have been explained by researcher and understand all

the details provided. And I voluntarily signed my name to
enroll in this project and receive a copy of this document.
Sign................................................... Sign.........................................
consider complain to local authority.
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AF 03 06 EN Participant Information Sheet and Consent Form

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AF 03 06 EN Participant Information Sheet and Consent Form

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AF 03-06

Instructions and Template:

1.Use very simple language to understand easily,

 Research involving vulnerable group eg. drug abuses,

*Please delete “”instructions” before

Template: Research Participant Information Sheet

Title of research project

 If potential participant is illiterate/cannot read and

 If any persons found to need any help/advice,

 If there is picture taken/tape recording/

6. Indicate risk/harm procedure which may cause ill

7. For benefit of the project, state clearly; what/how to

8. Information will include “Information related directly

9. State what researcher will do with personal data

10. State explicitly whether there is any compensation

reason, and there will be no bad impact upon that

13. State “If researcher does not perform upon

Please see if it’s possible for e.g., vulnerable person,

I have been explained by researcher and understand all

consider complain to local authority.

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