5.

Management of Protocol
UNIVERSITY OF BAGUIO SOP No:
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Effective Date:

5. MANAGEMENT OF PROTOCOL SUBMISSIONS

APPLICATION FORM FOR PROTOCOL REVIEW (FORM 5.1)

REC Protocol Number: 02-20-21-007
Sponsor Protocol No: Submission Date:

Types of Submission: / Initial Review Continuing Review

Resubmission for re-review Protocol Termination
Protocol Amendments Final Report

Protocol Title: COCONUT HUSK (COCUS NUCIFERA) MASK AS AN

ALTERNATIVE FACE MASK

Principal Investigator: Gabriel D. Jamero

Telephone Number: 09305773212 Fax:

Email: [email protected] Preferred Contact: Phone

Fax
/ Email

Institute: University of Baguio Science High School

Sponsor:

Conflict of Interest Are you a regular employee of the sponsor? Yes No

Declaration (Relationship Did you do consultancy or part time work forthe sponsor? Yes No
withsponsor) In the past year, did you receive P250, 000 or more from the Yes No
sponsor?
Other ties with the sponsor
PI Signature

Document Submitted: Type of Research (Experimental

Descriptive, Social Science)
/ Protocol summary CVs
Patient information form Study budget Social Science/ Qualitative Research
Informed consent form Revised protocol
Research term list Revised consent form Study Duration:
Amendments _______________________________
Others
Received By:
_______________________________

Date:
_______________________________
 5. Management of Protocol
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5. MANAGEMENT OF PROTOCOL SUBMISSIONS

PROTOCOL SUMMARY SHEET (FORM 5.2)

REC Protocol No.: Title
COCONUT HUSK (COCUS NUCIFERA) MASK AS AN
ALTERNATIVE FACE MASK

Principal Investigator: Sponsor:

Gabriel D. Jamero

The purpose of the study is to see if a mask made of coconut husk (Cocos nucifera) could be an effective
and suitable substitute for surgical masks. The study will not only determine whether coconut husk (Cocos
nucifera) is a suitable substitute for making surgical masks, but it will also determine whether it can
compete with surgical masks. The study also aims to determine if a face mask made of coconut husk
(Cocus Nucifera) is effective at filtering dust and if it is breathable like a surgical face mask. The study will
Rationale also look into whether a face mask made from coconut husk (Cocus Nucifera) has a positive impact on the
environment. The study also aims to determine if a face mask made of coconut husk (Cocus Nucifera) is
more durable than a surgical mask. Finally, the study wants to know if a face mask made of coconut husk
(Cocus Nucifera) is less expensive than a surgical mask. This study will also help future researchers who
are planning or conducting studies similar to this study.

• To determine the effectiveness of filtering dust and breathability of the Coconut

husk mask compared to the surgical mask.

• To determine whether the coconut mask have a positive impact on the environment.
Objectives
• To assess the durability of the coconut husk mask.

• To deduce whether the coconut husk mask will cost less than the surgical mask.

The axial coding design will be used for the qualitative research because the researchers will be primarily
interested in the similar or connected variation characteristics of coconut husks. The variables will include
Study Design/ Methodology antibacterial, eco-friendly, durability, and usability properties, and the researchers will conduct a test to
determine which mask is more effective, the coconut husk mask or the surgical mask.

The study's target will include the grade 7, 8, 9, 10 students currently enrolled in UBSHS.
The study will also include both male and female students along with its researchers of the
Inclusion Criteria university

This includes the following; People who have breathing issues, people with past health
issues, people that are under any signs or symptoms of any sickness, people below the age
Exclusion Criteria of 12, and people that do not consent to the research or experiment.

The researchers will utilize the coding method with the research data gathered and collected
dividing the answers in various categories including the characteristics of how useful the
Data Analysis Plan coconut husk is and how can it be used in the project. after categorizing the answers an axial
coding method will be used to draw connections between the groups to see if there is a similar
or connected variation
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5. MANAGEMENT OF PROTOCOL SUBMISSIONS

Study Outcomes

PROTOCOL EVALUATION FORM (FORM 5.3)

REC Protocol No. Date (D/M/Y):

Protocol Title:

Principal Investigator: Gabriel D. Jamero

Department: Science High School Contact no./ Email: [email protected]

Rasheed Ayen Dunque [email protected]

David Gerardo Isidore Ongoco [email protected]
Co-investigator(s) Contact no./ Email:
Lorenzo Rodriguez [email protected]
Isaac Nathanael Ugay [email protected]

Total No. of Participants: Five (5) researchers from 10 No. of Study Sites: 1
Quantum Physicists

Sponsor: Contact no./ Email:

Duration of the Study: Status: New Amended

Type of Study: Intervention Epidemiology Observational Study

Document Review Individual based Genetic
Social Survey Others, specify:

Review Status: Full Committee Expedited Exempt

Description of the Study in brief: Mark whatever applies to the study.

Randomized Questionnaire Use of Genetic Materials
Observational Global Protocol Investigator Initiated
Diagnostic
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5. MANAGEMENT OF PROTOCOL SUBMISSIONS

A. PROTOCOL DOCUMENT REVIEW:

1. Objectives of the Study What should be improved?

clear unclear

2. Need for human participants Comment:

Yes No

3. Methodology What should be improved?

clear unclear

4. Background Information and Data Comment:

sufficient insufficient

5. Risks and Benefits Assessment Comment:

acceptable unacceptable

6. Inclusion Criteria Comment:

appropriate inappropriate

7. Exclusion Criteria Comment:

appropriate inappropriate

8. Withdrawal Criteria Comment:

appropriate inappropriate

9. Involvement of Vulnerable Participants Comment:

Yes No

10. Voluntary, Non-Coercive Recruitment of Comment:

Participants
Yes No
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11. Sufficient number of participants? Comment:
Yes No

12. Control Arms (placebo, if any) Comment:

Yes No

13. Are the qualifications and experience of the Comment:

participating investigators appropriate?
Yes No

14. Disclosure or Declaration of Potential Conflicts of Comment:

Interest
Yes No

15. Facilities and infrastructure of participating sites Comment:

appropriate inappropriate

16. Community Consultation Comment:

Yes No

17. Involvement of local researchers andcommunities Comment:

in the protocol preparation and implementation
Yes No

18. Contribution to local capacity building Comment:

Yes No

19. Benefit to local communities Comment:

Yes No

20. Sharing of study results Comment:

appropriate inappropriate

21. Are blood/tissue samples sent abroad? Comment:

Yes No

B. RECOMMENDATION:

Approval Minor Revision

Decision
Major Revision/ Resubmission Disapproval

Comments (Identify items

for revision):
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Reviewer’s Name: Date:

Signature: