Research Ethics Committee

PROTOCOL REVIEW ASSESSMENT FORM

INSTRUCTIONS: Please submit 1 hard copy of this form, together with the appropriate supporting documentation.

TO THE PRINCIPAL INVESTIGATOR Please indicate in the space provided below whether or not the specified assessment point is
(PI): addressed by your study protocol. To facilitate the evaluation of the assessment point,
indicate the page and paragraph where this information can be found or “NA” if not
applicable.

TO THE PRIMARY REVIEWER: Please evaluate how the assessment points outlined below have been appropriately
addressed by the study protocol, as applicable by confirming the submitted information and
putting your comments in the space provided. Indicate your conclusions under
“RECOMMENDED ACTION” and sign on space provided.

SEC.
B STUDY PROTOCOL ASSESSMENT FORM FOR PROTOCOL NO. _________________
Page
where Reviewer: _________________________
ASSESSMENT POINTS found c/o
Project N Unable Explanation if no or unable to assess or
Leader Yes
o to assess indicate “NA” if not applicable
B1 1. SCIENTIFIC VALIDITY

1.1. Is/Are the main research p. 14 par 3

question(s) reasonable?
1.2. Are the study objectives specific,
measurable, attainable, and p. 14 par 3
reasonable based on the research
instrument(s) presented?
1.3. Is/Are the research
instrument(s)/data collection
tool(s) adopted from existing N/A

one(s) and has the developer’s

consent for its usage in the study?
1.4. Does the protocol present
sufficient background
information or results of previous p. 4
studies that merit the
involvement of human
participants?
B2 2. ETHICAL CONSIDERATIONS IN THE CONDUCT OF STUDY

2.1. In conducting this research, is

there a conflict of interest on the
part of the researchers and/or N/A
their Research
Adviser(s)/Supervisor(s)/Mentor(
s)?
2.2. For faculty-initiated research
only: Is there disclosure of
collaborative study terms of
reference (e.g. multi-country/ multi-
N/A
institutional studies, including
intellectual property rights, publication
rights, information and responsibility in
sharing, transparency and capacity
building) ?
2.3. Is/Are the researcher(s) N/A

sufficiently
knowledgeable/trained to conduct
the proposed study based on
his/her/their dated and signed
Talamban Campus, Nasipit, Talamban, Cebu City, Philippines 6000
Phone: +63 (32) 2300100 loc 204 and 2547742 Email: rec@usc.edu.ph Website: www.usc.edu.ph
 Research Ethics Committee

STUDY PROTOCOL ASSESSMENT FORM FOR

PROTOCOL NO. _________________
SEC.
B

Reviewer: _________________________
Page
ASSESSMENT POINTS where
found c/o

N Unable Explanation if no or unable to assess or

Project Yes
o to assess indicate “NA” if not applicable
Leader
CV?
2.4. Do(es) the Research
Adviser(s)/Supervisor(s)/Mentor(
s) has/have sufficient research N/A
experience based on his/her/their
dated and signed CV?
2.5. Is the research
environment/site/facility p. 17 para 1

appropriate?
2.6. Does the selection and
recruitment of participants p. 17 para 3
comply with the ethical demands
of equity?
2.7. Is the duration of human
participants’ involvement in the p. 18 par 1

study reasonable?
2.8. Does the study involve individuals
who are vulnerable, i.e. those
whose pertinent circumstances p. 19 par 3
will likely impair their capacity to
give free, prior and informed
consent?
2.9. Are appropriate mechanisms in
p. 19 para
place to protect the potential 3, Appendix
vulnerable participants, e.g. B
assent form for children?
2.10. Are probable risks/harm to
the human participants as result
of participation in the study p. 19 par 3,
Appendix B
clearly identified, i.e. physical,
psychological, social, economic,
legal?
2.11. In order to adequately
address the risk/benefit balance,
does the protocol provide p. 19 par 3,
means/mechanisms that Appendix B
sufficiently mitigate the
risks/probable harm to the
human participants?
2.12. Is the informed consent
procedure/form adequate and
culturally appropriate, e.g. p. 41

(back-)translation is appended?
Indicate “NA” if not applicable.
B3 3. DATA PROTECTION PLAN
3.1. Does the study involve
personal/sensitive data collection p. 19 par 2
and/or processing?

Talamban Campus, Nasipit, Talamban, Cebu City, Philippines 6000

Phone: +63 (32) 2300100 loc 204 and 2547742 Email: rec@usc.edu.ph Website: www.usc.edu.ph
 Research Ethics Committee

STUDY PROTOCOL ASSESSMENT FORM FOR

PROTOCOL NO. _________________
SEC.
B

Reviewer: _________________________
Page
ASSESSMENT POINTS where
found c/o

N Unable Explanation if no or unable to assess or

Project Yes
o to assess indicate “NA” if not applicable
Leader
3.2. Does the protocol provide
measures for personal/sensitive
information to be sufficiently p. 19 par 2

anonymized for adequate data

protection?
3.3. Is there legal permission to obtain
and process the data? Indicate N/A

“NA” if not applicable.

3.4. Does the study specify how long
will collected data be p. 19 par 2
used/processed?
3.5. Does the protocol provide
measures as to how data p. 19 par 2
transfer/sharing information will
be monitored?
3.6. Does the study discuss how and
where collected data will be
securely stored in terms of data
structure/format or encryption of p. 19 par 2
identifiable information and
separation from sensitive data
such as health data?
3.7. Does the study discuss how and
where collected data will be
securely stored in terms of p. 19 par 2
treating unforeseen data added
such as incidental findings
during the study?
3.8. Does the study discuss where
collected data will be securely
stored in terms of location and p. 19 par 2
hardware, e.g. avoids loss/easily
accessible media such as memory
sticks?
3.9. Does the protocol indicate how
collected data will be securely p. 19 par 2

accessed?
3.10. Does the study clearly state
how and when collected data will p. 19 par 2
be (ir)reversibly
disposed/destroyed?

RECOMMENDED ACTION:
EXEMPT FROM REVIEW
APPROVED
MINOR MODIFICATIONS REQUIRED
MAJOR MODIFICATIONS REQUIRED

Talamban Campus, Nasipit, Talamban, Cebu City, Philippines 6000

Phone: +63 (32) 2300100 loc 204 and 2547742 Email: rec@usc.edu.ph Website: www.usc.edu.ph
 Research Ethics Committee

DISAPPROVED

DEFER (CLARIFICATIONS REQUIRED BEFORE A DECISION CAN BE MADE)

JUSTIFICATION:

PRIMARY REVIEWER:
_________________________ ______________
Signature over printed name Date: <dd/mm/yyyy>

PANEL SECRETARY:
________________________ ______________
Signature over printed name Date: <dd/mm/yyyy>

PANEL CHAIR:
________________________ ______________
Signature over printed name Date: <dd/mm/yyyy>

Talamban Campus, Nasipit, Talamban, Cebu City, Philippines 6000

Phone: +63 (32) 2300100 loc 204 and 2547742 Email: rec@usc.edu.ph Website: www.usc.edu.ph