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

INFORMED CONSENT ASSESSMENT FORM

For ___________________________

I. PROTOCOL BASIC INFORMATION

Title:

Approval Date:

Principal Investigator (PI):

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

II. INFORMED CONSENT (Measure of Adequateness of provision with 10 as the maximum value. There
should be no value lower than 6 and a minimum of 84 cumulative points to be acceptable)
Basic Elements Page Max Reviewer’s Comments
No. 10
1. 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
2. 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
in the study.
3. Procedures
brief description on how the study
would be conducted including the
nature and process that they would go
F-CRD-UERC Form No. 012 Informed Consent Assessment 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

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
4. 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
5. 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
6. 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
7. Possible Benefits
the benefits are the positive
consequence/s if the research
problem/s is/are answered. Benefits
can be for the individual, immediate

F-CRD-UERC Form No. 012 Informed Consent Assessment 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

community where the participants are

and the society in general
8. Compensation, reimbursements,
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
9. 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) any sensitive
information may not be shared even
with the closest family member without
the consent of the participant.
10. 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,

F-CRD-UERC Form No. 012 Informed Consent Assessment 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

who can access the obtained data

including personal information if it is
called for by the query for
VERFICATION PURPOSES only.>
11. 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.
12. 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.>

TOTAL
F-CRD-UERC Form No. 012 Informed Consent Assessment Form
Page 4 of 4
 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. 012 Informed Consent Assessment Form

Page 5 of 4
 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. 012 Informed Consent Assessment Form

Page 6 of 4
 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. 012 Informed Consent Assessment Form

Page 7 of 4
 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. 012 Informed Consent Assessment Form

Page 8 of 4
 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. 012 Informed Consent Assessment Form

Page 9 of 4
 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. 012 Informed Consent Assessment Form

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