University Ethics Review Committee

Center for Research and Development

900 San Marcelino Street, Manila
1000 Manila, Philippines
Office: (+632)- 524-2011 loc 153
uerc-secretariat@adamson.edu.ph

<Yr,- category= Program-

INFORMED CONSENT FORM Sequence> 2016-01-ARC-2

For ___________________________

I. PROTOCOL BASIC INFORMATION

Title:

Approval Date: Study Site:

Principal Investigator (PI):

Email: Mobile Number:
Sponsor: Contact Person:
Email: Mobile No.:

II. Information Sheet <All of the following elements should be considered in the writing of the ICF. However in the
actual ICF, it is not necessary that these elements would appear as headings>
a. Introduction <invitation to participate in the research with the provision for allowing the prospective
participants to ask questions about the research from whoever they feel comfortable with and the right to
stop and ask the Principal investigator or other researchers should there be words/ statements that are not
clear to them>
b. Purpose of the Study <explanation of the purpose of the study should be direct to the point and use simple
and easy-to-understand words more than scientific or professional jargon. State how the participation of the
subject could help>
c. Procedures <brief description on how the study would be conducted including the nature and process that
they would go through. It should explain every detail of their participation especially the sensitive aspects.
Interventions that would be carried out like taking of blood sample, interview etc. should be elaborated
well.>
d. Voluntary Participation <provides the criteria in the selection of participants and how they best fit. It should
be noted however the voluntary nature of their participation and more importantly their non-participation is
not detrimental to the current benefits they are enjoying, affiliation, job and relationships>
e. Duration <states how much time is asked from the participants for the whole duration of the study including
the follow-ups. It should describe exactly how much time is demanded from them for the whole duration and
each time they meet, how often including intervals, how to go about their participation including logistics and
the place to conduct the study>
f. Possible risks, discomforts and inconveniences<any risk, discomfort and inconvenience both
anticipated (expected) and not anticipated (unexpected) have to be mentioned and the participants are
given the option to refuse to participate without explanation.>
g. Possible Benefits < the benefits are the positive consequence/s if the research problem/s is/are answered.
Benefits can be for the individual, immediate community where the participants are and the society in
general.>

F-CRD-UERC Form No. 011 Informed Consent Form

Page 1 of 3
 University Ethics Review Committee
Center for Research and Development
900 San Marcelino Street, Manila
1000 Manila, Philippines
Office: (+632)- 524-2011 loc 153
uerc-secretariat@adamson.edu.ph

h. Compensation, reimbursements, alternative procedure or treatment <The giving of financial or material

gifts for their participation is not encouraged, however the participants should be
compensated/reimbursed/treated for any untoward incident/ cost/ injury or other similar cases that may
happen to them because of their participation>
i. Confidentiality/ Anonymity <as far as the investigators are concerned, the participants should be assured
that any information or data obtained from them be treated with respect and utmost confidentiality. Their
identity should likewise remain anonymous or free from any suggestion or clue that would lead others to
connect/ relate personal information with the actual person. Specimens should be treated with utmost care
and well defined access information including details about storage (duration, type of storage facility,
location)>
j. Sharing of Results <the plan of sharing the results of the study should be elaborated in details. If there’s a
plan to publish the results, such should be mentioned as well. The confidentiality and anonymity aspect of
this ICF should be reiterated. This part should likewise include the regulatory body, UERC, who can access
the obtained data including personal information if it is called for by the query for VERFICATION
PURPOSES only.>
k. Rights of the Participants
< right to withdraw from the study- the participants shall be informed of their right to discontinue or
withdraw from their participation at any stage of the study anytime without prejudice to the benefits they are
enjoying, job, relationships, affiliations, etc.
<right to just benefit or compensation or royalty- (if applicable) the participants have the right to demand
for any financial or material benefit if their particular contribution (specimen, idea etc) is planned to be
commercialized>
<right to refuse continues usage of personal information, specimen, personal contribution- (if
applicable) participants may withdraw anytime his/her contribution to the study or demand for the
discontinuation of usage, destruction or disposal of his/her contribution (specimen)
<right to access results of the study- the participants should be informed of the results of the study.

l. Contact <provide contact information of the person who can answer queries or anything untoward happens
like injury etc. It is important to mention that the study has been approved by the UERC and can be
contacted with the given contact information.>

F-CRD-UERC Form No. 011 Informed Consent Form

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 University Ethics Review Committee
Center for Research and Development
900 San Marcelino Street, Manila
1000 Manila, Philippines
Office: (+632)- 524-2011 loc 153
uerc-secretariat@adamson.edu.ph

III. Certificate of Consent

<I have read the foregoing information, or it has been read to me. I have had the opportunity to ask questions
about it and any questions I have been asked have been answered to my satisfaction. I consent voluntarily to be a
participant of this study>

_______ <Signature over printed name>___________

_ _/_ _/ _ _ _ _

F-CRD-UERC Form No. 011 Informed Consent Form

Page 3 of 3
 University Ethics Review Committee
Center for Research and Development
900 San Marcelino Street, Manila
1000 Manila, Philippines
Office: (+632)- 524-2011 loc 153
uerc-secretariat@adamson.edu.ph

F-CRD-UERC Form No. 011 Informed Consent Form

Page 4 of 3
 University Ethics Review Committee
Center for Research and Development
900 San Marcelino Street, Manila
1000 Manila, Philippines
Office: (+632)- 524-2011 loc 153
uerc-secretariat@adamson.edu.ph

F-CRD-UERC Form No. 011 Informed Consent Form

Page 5 of 3
 University Ethics Review Committee
Center for Research and Development
900 San Marcelino Street, Manila
1000 Manila, Philippines
Office: (+632)- 524-2011 loc 153
uerc-secretariat@adamson.edu.ph

F-CRD-UERC Form No. 011 Informed Consent Form

Page 6 of 3
 University Ethics Review Committee
Center for Research and Development
900 San Marcelino Street, Manila
1000 Manila, Philippines
Office: (+632)- 524-2011 loc 153
uerc-secretariat@adamson.edu.ph

F-CRD-UERC Form No. 011 Informed Consent Form

Page 7 of 3
 University Ethics Review Committee
Center for Research and Development
900 San Marcelino Street, Manila
1000 Manila, Philippines
Office: (+632)- 524-2011 loc 153
uerc-secretariat@adamson.edu.ph

F-CRD-UERC Form No. 011 Informed Consent Form

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