AF 01-v1/SOP004/v1

CNU-REC RESEARCH PROTOCOL APPLICATION FORM

CEBU NORMAL UNIVERSITY RESEARCH ETHICS COMMITTEE CNU-REC

INSTRUCTIONS: Please accomplish three (3) copies of this application form and attach them to the copies of the
proposal submitted for review.

SECTION A APPLICATION DETAILS

CNU-REC Code:
(To be filled up by assigned by the CNU-REC __ __ __/__ __ __ __-__ __ - _________
Secretariat)

A1 Project Title:
The Meaning of Learning to Students Amidst Pandemic: Modular Approach vs. Online
Learning
Date of Submission: Nov. 12, 2020 Proposed Start Date: November 16, 2020
Type of Study (Basic Research, Clinical Trial, Survey, etc.) Approximate Duration: 4 MONTHS
Educational Research (Survey)
Minimum 36.
Expected number of participants: Maximum of 50

A2 Principal Investigator/Lead Researcher

Please note that a student – undergraduate, postgraduate or research postgraduate cannot be the Principal
Investigator for Ethics purposes.
Full Name: Hermoso Margaritta Position Held: Lead Researcher

Address: (to receive Approval Certificate) Email: margarittahermoso3@gmail.com

Telephone/Cellphone No.: 09430579323
Fax: N/A

Declaration To be Signed by the Principal Investigator:

▪
I am aware of the ethical aspects of this research project.

▪
I undertake to commit and submit the ‘Continuing Review Approval Form’ on an annual basis to the
Cebu Normal University Ethics Review Committee (CNU-REC).

▪ I will ensure that changes in approved research protocols are reported promptly and are not initiated
without approval by the CNU-REC, except when necessary to eliminate apparent immediate hazards to the
participant.

▪
I will ensure that all adverse or unforeseen problems arising from the research project are reported in a timely fashion
to the CNU-REC.

▪ I will undertake to provide notification when the study is complete and if it fails to start or is abandoned.

SIGNATURE: DATE: November 12, 2020

FOR FURTHER INFORMATION:

CONTACT: cnuerc@cnu.edu.ph
CNU-REC SECRETARIAT
Cebu Normal University Research Payment Details
Date of Payment:
OR number:
 AF 02-v1/SOP004/v1

PROTOCOL REVIEW ASSESSMENT FORM

CEBU NORMAL UNIVERSITY RESEARCH ETHICS COMMITTEE CNU-REC

INSTRUCTIONS: Please submit 3 (1 original + 2 double sided copies) copies of your protocol assessment form,
together with the appropriate supporting documentation.

TO THE PRINCIPAL Please indicate in the space provided below whether or not the specified
INVESTIGATOR/LEAD assessment point is addressed by your study protocol. To facilitate the
RESEARCHER: evaluation of the assessment point, indicate the page and paragraph
where this information can be found.

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 under “REVIEWER COMMENTS.” Finalize your review by
indicating your conclusions under “RECOMMENDED ACTION” and signing
in space provided for the primary reviewer.

SECTION B STUDY PROTOCOL ASSESSMENT FORM

To be filled out by the PI

Indicate if Page and
the Paragraph
protocol where it is
ASSESSMENT POINTS contains Found REVIEWER COMMENTS
specified
assessment
point
Yes No

B1 1. SCIENTIFIC DESIGN
1.1. Objectives
Review of viability of expected output yes Page 6,
1.2. Literature review
Review of results of previous
animal/human studies showing Yes Page 4-5,
Paragraph
known risks and benefits of 3
intervention, including known
adverse drug effects, in case of drug
trials.
Page 7,
1.3. Research design Paragraph 2
Review of appropriateness of design yes
in view of objectives
1.4. Sampling design
Page 8-9,
Paragrap
Review of appropriateness of sample yes h1
Size
1.5. Sample size
Page 8-9,
Paragrap
h1
Review of computation of sample yes
size
1.6. Statistical analysis plan
Review of appropriateness of No
statistical methods used and how
 participant data will be summarized

1.7. Data analysis plan

Review of appropriateness of yes Page 11
statistical and non-statistical Paragraph 2
methods of data analysis
1.8. Inclusion criteria
Review of precision of criteria for No
both scientific merit and safety
concerns; and of equitable selection
1.9. Exclusion criteria
Review of criteria precision both for
scientific merit and safety concerns No
and of justified concerns
1.10. Withdrawal criteria
Review of criteria precision both for No
scientific merit and safety concerns
B2 2. CONDUCT OF STUDY
2.1. Specimen handling
Review of specimen storage, access, N/A
disposal and terms of use
2.2. PI qualifications
Review of CV and relevant
certifications to ascertain capability no
to manage study related risks
2.3. Suitability of site
Review of adequacy of qualified staff N/A
and infrastructures
2.4. Duration Page 11
Review of length/extent of human Paragraph 2
participant involvement in the study yes
B3 3. ETHICAL CONSIDERATIONS
3.1. Conflict of Interest
Review of management of conflict
arising from financial, familial or NO
proprietary considerations of the PI,
sponsor or the study site
3.2. Privacy and Confidentiality
Review of measures or guarantees to
protect privacy and confidentiality of Page 13
participant information as indicated yes Paragraph 3
by data collection methods including
data protection plans
3.3. Informed Consent Process
Review of application of the principle
of respect for persons, who may Page 13
solicit consent, how and when it will yes Paragraph 1
be done; who may give consent
especially in case of special
populations like minors and those
who are not legally competent to
give consent, or indigenous people
which require additional clearances
3.4. Vulnerability
Review of involvement of vulnerable
study populations and impact on
informed consent (see 3.3). Yes
Vulnerable groups include children, Page 13,
the elderly, ethnic and racial minority Paragraph
groups, the homeless, prisoners, 1
people with incurable disease, people
who are politically powerless or
junior members of a hierarchical
group
3.5. Recruitment
Review of manner of recruitment Page 9
including appropriateness of yes Paragraph 1
identified recruiting parties
3.6. Assent
Review of feasibility of obtaining
assent vis á vis incompetence to
consent; Review of applicability of
the assent age brackets in children:
0-under 7: No Assent N/A
7-under 12: Verbal Assent
12-under 15: Simplified Assent Form
15-under 18: Co-sign informed
Consent form with parents
3.7. Risks
Review of level of risk and measures
to mitigate these risks (including
physical, psychological, social,
economic), including plans for
adverse event management; Review No
of justification for allowable use of
placebo as detailed in the
Declaration of Helsinki (as
applicable)
3.8. Benefits
Review of potential direct benefit to
participants; the potential to yield
generalizable knowledge about the
participants’ condition/problem; non- No
material compensation to participant
(health education or other creative
benefits), where no clear, direct
benefit from the project will be
received by the participant
3.9. Incentives or compensation
Review of amount and method of No
compensations, financial incentives,
or reimbursement of study-related
 expenses

3.10. Collaborative study terms of

reference
Review of terms of collaborative
study especially in case of multi-
country/ multi-institutional studies,
including intellectual property rights, N/A
publication rights, information and
responsibility sharing, transparency
and capacity building

RECOMMENDED ACTION
APPROVAL
MINOR MODIFICATIONS
MAJOR MODIFICATIONS
DISAPPROVAL
JUSTIFICATION FOR RECOMMENDATION

PRIMARY REVIEWER:
___________________ ______________
Signature over printed name Date: <dd/mm/yyyy>
PANEL SECRETARY:
DR. RIVIKA C. ALDA ______________
Signature over printed name Date: <dd/mm/yyyy>
PANEL CHAIR:
DR. EMMANUEL V. HERNANI ______________
Signature over printed name Date: <dd/mm/yyyy>
 AF 03-v1/SOP004/v1

INFORMED CONSENT FORM (ICF) CHECKLIST

CEBU NORMAL UNIVERSITY RESEARCH ETHICS COMMITTEE CNU-REC

INSTRUCTIONS: Please submit 3 (1 original + 2 double sided copies) copies of your protocol assessment form,
together with the appropriate supporting documentation.

SECTION C INFORMED CONSENT ASSESSMENT FORM

TO THE PRINCIPAL
INVESTIGATOR/LEAD RESEARCHER:
TO THE PRIMARY REVIEWER:
Please indicate in the space provided below whether or not the specified
element is addressed by the Informed Consent Form (ICF). TO facilitate the
evaluation of the assessment point, indicate the page and paragraph where the
information can be found.
Please evaluate how the elements outlined below have been appropriately
addressed by the Informed Consent Form (ICF), as applicable by confirming the
submitted information and putting your comments in the space provided under
“REVIEWER COMMENTS.” In your comments, ensure that vulnerability,
recruitment process, and process of obtaining informed consent are always
assessed in the context of the study protocol and the participant. Finalize your
review by indicating your conclusions under “RECOMMENDED ACTION” and
signing in space provided for the primary reviewer.

To be filled out by the PI

Indicate if
C1 ESSENTIAL ELEMENTS the
Page and
protocol
(as applicable to the study) Paragraph
contains REVIEWER COMMENTS
where it is
specified
found
assessment
point
Yes No
Page 1-
2,
Paragra
1. Statement that the study involves research yes ph 4
Page 2,
Paragrap
2. Statement describing the purpose of the h3
study yes
Page 12,
Paragrap
3. Study-related treatments and probability h1
for random assignment yes
Page 10
Paragrap
h 4, and
page 11
Paragrap
4. Study procedures including all invasive h 2-3
procedures Yes
Page
13,
Paragra
5. Responsibilities of the participant yes ph 1-3
Page 9,
Paragrap
6. Expected duration of participation in the h1
 study yes
Page 8,
Paragrap
7. Approximate number of participants in the Yes h2
study
8. Study aspects that are experimental no
9. Foreseeable risks to
participant/embryo/fetus/ nursing infant;
including pain, discomfort, or
inconvenience associated with No
participation including risks to spouse or
partner; and integrating risks as detailed in
the investigator’s brochure
10. Risks from allowable use of placebo (as
applicable) no
11.Reasonably expected benefits; or Yes
absence of direct benefit to Page 3,
participants, as applicable Paragraph
1,2,3
12.Expected benefits to the community yes Page 3,
or to society, or contributions to Paragraph
scientific knowledge 1,2,3
13.Description of post-study access to no
the study product or intervention that
have been proven safe and effective
14.Alternative procedures or treatment no
available to participant
15.Compensation or insurance or no
treatment entitlements of the
participant in case of study-related
injury
16.Anticipated payment, if any, to the no
participant in the course of the study;
whether money or other forms of
material goods, and if so, the kind and
amount
17.Compensation (or no plans of no
compensation) for the participant or
the participant’s family or dependents
in case of disability or death resulting
from study-related injuries
18.Anticipated expenses, if any, to the no
participant in the course of the study
19.Statement that the participant is yes Page 13,
voluntary, and that participant may Paragraph 1-2
withdraw anytime without penalty or
loss of benefit to which the participant
is entitled
20.Statement that the study monitor(s), No
auditor(s), the CNU-ERC Ethics Review
Panel, and regulatory authorities will be
granted direct access to participant’s
medical record for purposes ONLY of
verification of clinical trial procedures
and data
21.Statement that the records yes Page 13,
identifying the participant will be kept Paragraph 3
confidential and will not be made
publicly available, to the extent
permitted by law; and that the identity
of the participant will remain
confidential in the event the study
results are published; including
limitations to the investigator’s ability
to guarantee confidentiality
22. Description of policy regarding the no
use of genetic tests and familial genetic
information, and the precautions in
place to prevent disclosure of results to
immediate family relative or to others
without consent of the participant.
23.Possible direct or secondary use of no
participant’s medical records and
biological specimens taken in the
course of clinical care or in the course
of this study
24.Plans to destroy collected biological no
specimen at the end of the study; if
not, details about storage (duration,
type of storage facility, location, access
information) and possible future use;
affirming participant’s right to refuse
future use, refuse storage, or have the
materials destroyed
25.Plans to develop commercial no
products from biological specimens and
whether the participant will receive
monetary or other benefit from such
development
26.Statement that the participant yes Page 13,
or participant’s legally acceptable Paragraph 1
representative will be informed in a
timely manner if information becomes
available that may be relevant to
willingness of the participant to
continue to participation

27.Statement describing access f No

participant to the result of the study

28.Statement describing extent of no

participant’s right to access his/her
records (or lack thereof vis à vis
pending request for approval of non or
partial disclosure)

29.Foreseeable circumstances and no

reasons under which participation in
the study may be terminated

30.Sponsor, institutional affiliation of No

the investigators, and nature and
sources of funds

31.Statement whether the investigator no

is serving only as an investigator or as
both investigator and the participant’s
healthcare provider

32.Person(s) to contact in the study yes Page 13,

team for further information regarding Paragraph 2
the study and whom to contact in the
event of study-related injury
33. Statement that the Ethics Review No
Committee Panel has approved the
study, and may be reached through
the following contact for
information regarding rights of study
participants, including grievances and
complaints:
 Name of CNU-ERC Panel Chair: EMMANUEL
HERNANI
Address: Psychology Dept.College of Arts and
Sciences
Email: emmanuelhernani@yahoo.com
34. Comprehensibility of language used No

35. Other comments not addressed by items No

1-34
RECOMMENDED ACTION
 Approve
 Minor Modifications
 Major Modifications 
 Disapprove
 Pending, if major clarifications are required before a decision can be made 
JUSTIFICATION FOR RECOMMENDED ACTION

PRIMARY REVIEWER Signature ______________________

Date: Name:
<dd/mm/yyyy> <Title, Name, Surname>
PANEL SECRETARY Signature ______________________
Date: Name: DR. RIVIKA C. ALDA
<dd/mm/yyyy>
PANEL CHAIR Signature ______________________
Date: Name: DR. EMMANUEL V. HERNANI
<dd/mm/yyyy>
 AF 04-v1/SOP004/v1

DETAILED BUDGET SHEET

CEBU NORMAL UNIVERSITY RESEARCH ETHICS COMMITTEE CNU-REC

SECTION D DETAILED BUDGET FOR THE PROPOSED STUDY

D1
Particulars Sources of Funds and Amount (PhP)
Source (A) Source (B) Source (C)

I. Personal Services (PS)

a. Salaries
b. Honoraria
Sub-total for PS

II. Maintenance and Other

Operating Expenses (MOOE)
a. Traveling expenses
b. Supplies and materials expenses
Sub-total for MOOE

III. Capital Outlay

Sub-total for Capital Outlay

GRAND TOTAL
 AF 05-v1/SOP004/v1

CNU-ERC PROTOCOL PACKAGE CHECKLIST

CEBU NORMAL UNIVERSITY RESEARCH ETHICS COMMITTEE CNU-REC

IMPORTANT: The purpose of this checklist is to provide support for CNU-ERC Secretariat conducting screening
of submission materials.
Item
No. Documents for Submission Yes No NA
BASIC REQUIREMENTS
1 CNU-REC processing fee
2 Cover Letter /
3
CNU-REC Research Protocol Application Form, duly filled and duly signed by the
Principal Investigator /
4 Protocol Review Assessment Form /
5 Compliance Checklist (approved and signed by the adviser and panel members) /
6 Informed Consent Form (ICF) Checklist /
7 Study Protocol - 3 hard copies (fastened in short paper folder) /
8 Study Protocol - soft copy sent by e-mail (cnuerc@cnu.edu.ph) /
9 Amendments to protocol, if any /
Participant Information Sheet & Informed Consent Form (ICFs) in English and dialect /
10
spoken and understood by research participants
11 Amendments to ICF, if any /
12 Research participants questionnaires (if applicable) /
13
Signed and dated brief current Curriculum Vitae (CV) of Principal Investigators and Co- /
Investigators
14 Document Receipt Form (one copy only) /
15 Gantt Chart (signed and endorsed by the adviser/technical review panel) /
SUPPLEMENTARY
16 Research participants recruitment procedures: advertisement, notices (if applicable) /
17 Translation of Informed Consent & Back Translation Certificate /
18 Case Record Form (for clinical research) /
19 Investigator Brochure (if applicable) /
20 Insurance Policy & Indemnity Letter (if applicable) /
21 Copy of Good Clinical Practice Training Certificate for all Investigators /
22 If ICFs is not applicable, is waiver applied for /
Clinical Trial Agreement for drug trial / Memorandum of Understanding / Copy of
23 clinical trial protocol Material Transfer Agreement (MTA), as applicable, for collaborator /
& government sponsored trials (draft if final not ready)
24 FDA marketing/manufacturing license for herbal formulations / nutraceutics /
a) Administrative sanction from the Head of the Institution in case of collaborat6ive
studies with other institutions / foreign agencies (one copy) or Memorandum of /
Understanding (as applicable)
25

b) Administrative sanction from the Head of the Institution for the samples to be sent /
to outside institution (one copy) or Material Transfer Agreement (as applicable)
26 Line Item Budget /
27 Detailed Budget Sheet /
28 Site profile /
29 Any other documents submitted
 DOCUMENT RECEIPT FORM
CEBU NORMAL UNIVERSITY RESEARCH ETHICS COMMITTEE CNU-REC

IMPORTANT: The purpose of this checklist is to provide support for CNU-REC Secretariat conducting screening of
submission materials.
CNU-REC
Code: __ __ __/__ __ __ __-__ __ - _______
Type of Submission:  Initial Review  Continuing Review of Approved Protocols
 Resubmission for re-review  Renewal
 Protocol Amendments  Protocol Termination
 Full
If an approved study, level of  Exempt
initial review:
 Expedited
Protocol Title:

Telephone Number: Fax:

Preferred
Email:  Phone  Fax  E-mail
contact
Institute:
Delivery route:  Post  E-submission  In-person
Documents submitted:  Complete  Incomplete, will submit on
______________________________
Checklist to assess the projects before they are submitted to CNU-REC REVIEW
Item
No. Documents for Submission Yes No NA

BASIC REQUIREMENTS
1. CNU-REC processing fee
2. Cover Letter
3. CNU-REC Research Protocol Application Form, duly filled and duly signed by the
Principal Investigator
4. Protocol Review Assessment Form
5. Compliance Checklist (approved and signed by the adviser and panel members)
6. Informed Consent Form (ICF) Checklist
7. Study Protocol - 3 hard copies (fastened in short paper folder)
8. Study Protocol - soft copy sent by e-mail (cnuerc@cnu.edu.ph)
9. Amendments to protocol, if any
10. Participant Information Sheet & Informed Consent Form (ICFs) in English and
dialect spoken and understood by research participants
11. Amendments to ICF, if any
12. Research participants questionnaires (if applicable)
13. Signed and dated brief current Curriculum Vitae (CV) of Principal Investigators and
Co-Investigators
14. Document Receipt Form (one copy only)
15. Gantt Chart (signed and endorsed by the adviser/technical review panel)

SUPPLEMENTARY
16. Research participants recruitment procedures: advertisement, notices (if
applicable)
 17. Translation of Informed Consent & Back Translation Certificate
18. Case Record Form (for clinical research)
19. Investigator Brochure (if applicable)
20. Insurance Policy & Indemnity Letter (if applicable)
21. Copy of Good Clinical Practice Training Certificate for all Investigators
22. If ICFs is not applicable, is waiver applied for
Clinical Trial Agreement for drug trial / Memorandum of Understanding / Copy of
23. clinical trial protocol Material Transfer Agreement (MTA), as applicable, for
collaborator & government sponsored trials (draft if final not ready)
24. FDA marketing/manufacturing license for herbal formulations / nutraceutics
c) Administrative sanction from the Head of the Institution in case of
collaborat6ive studies with other institutions / foreign agencies (one copy) or
Memorandum of Understanding (as applicable)
25.

d) Administrative sanction from the Head of the Institution for the samples to be
sent to outside institution (one copy) or Material Transfer Agreement (as
applicable)
26. Line Item Budget
27. Detailed Budget Sheet
28. Site profile
29. Any other documents submitted

------ - - - - - -TOBEFILLEDOUTBYTHERECSECRETARIAT

COMPLETENESS Complete

OF DOCUMENT Incomplete

REMARKS

DATE RECEIVED:
RECEIVED BY:

*NOTE: Please bring this receipt with you when you visit the Office of the CNU-REC.
 AF 07-v1/SOP004/v1

Informed Consent Form

Project Title: The Meaning of Learning to Students Amidst Pandemic: Modular Approach vs. Online Learning
Investigator: Dhafney Gonzaga, Jaime Erlano, Jamaica Fayette Lopez, Michael Clyde S. Lepasana, and Jane Lumen
Sponsor: N/A

We, the third year students who are currently enrolled in the Bachelor of Secondary
Education Major in Science of Cebu Normal University – Main Campus is currently on the
process of conducting our thesis as a requirement for our Educational Research subject. In
connection with this, we would like to ask for your written consent to be one of our respondents
for our research paper data gathering procedure.

PURPOSE OF THE STUDY

This study aims to identify the meaning of learning to the students in this trying time of
COVID19 pandemic: Modular versus Online mode of earning.

PROCEDURES
If you volunteer to participate in this study, you will be asked to engage in a one-on-one
interview with one of the researchers. This will be done via Google Meet, Messenger or any
other online platform of your choice. You will be answering the questions based on your
experiences and perspective. With your consent, the researcher will record the whole interview
session on an audio recording device. If you wish not to, the researcher will just take note by
hand. Feel free to tell the researcher if you are not comfortable, as well as the things that you
wish not to include in this study. The one-on-one interview will take 15-20 minutes at most or it
will be up to you.

Number of participants will be in this study

The study involves 13 participants, 26 of whom are students who opted modular mode of
learning, and another 50 students who chose online mode of learning.

ALLOTMENT TIME OF PARTICIPATION

The participation of your son or daughter will not exceed to 1 hour.

POTENTIAL RISKS AND DISCOMFORTS

In the event of psychological discomfort resulting from participation in this research, the
Cebu Normal University does not provide any medical treatment or hospitalization for
participants in this study nor provide compensation for any injury sustained as a result of
participation in this research study, except as required by law.

POTENTIAL BENEFITS TO SUBJECTS AND/OR TO SOCIETY

The researchers believe that as a prospective teacher and as a member of society and
academe, you will find our research useful as an effort to improve the instructional delivery of
lessons through online platform. This study will provide a baseline data on the implementation
of pure online instructional delivery for the development of a framework to teach courses
tailored fit for face-to-face courses into an online modality. Your full and voluntary participation
in the study will be compensated in a form of an Internet Load via GCash for the time and effort
you have rendered. If you have concerns that associating your name with any portion or all of
what you say could be detrimental, then simply request confidentiality before, during, or after
any interview or conversation, in part or completely. The findings could be used as references
for future researches. The researchers do not anticipate any risks of harm to you from
participation.

Costs
There is no cost at all, except for the time and effort required to participate in the data
gathering procedures.

CONFIDENTIALITY
We, the researcher will make sure that all records are keep confidential including your
name, your name, and response to the said study. The collected information/data will only be
available to the researcher who are responsible in conducting the study. If the result of this
study will published, the data will be released in table form and the name of the individual
participants will not be mentioned. The digitally recorded audio-video files will be stored in the
computer of the researcher with security password housed in her residence. Only the principal
investigator will have access to the file. The files will be deleted once the research paper will be
published in a journal.

PARTICIPATION AND WITHDRAWAL

You can choose whether or not to be in this study. For instances during the study you
encountered some unforeseen problem or discomfort, you have the right to terminate your
participation to the study. You may also refuse to answer any questions you do not want to
answer. There is no penalty if you withdraw from the study and you will not lose any benefits to
which you are otherwise entitled.

IDENTIFICATION OF INVESTIGATORS
If you have any query or concerns about this research, you may ask questions to this
contact information margarittahermoso3@gmail.com or you may reach the mobile number
09430579323.