SAINT MARY’S UNIVERSITY Document Code REB-FO-006

BAYOMBONG, NUEVA VIZCAYA Revision 001

Effectivity Date 2022/07/01

UNIVERSITY RESEARCH ETHICS BOARD
Page/s 1 of 6

PROTOCOL APPLICATION FORM

I. REFERENCE SECTION (To be filled by SMUREB Secretariat)

1. SMUREB Code:
2. Date of initial submission:
3. Date of official acceptance:
4. Classification of submitted protocol:

Instruction to the Researcher: Answer all items in this section. Indicate N/A when
not applicable on your proposed study. Incomplete
forms will not be accepted.
II. APPLICATION INFORMATION
1. Study Title

2. The Primary Investigator

Name:
Birth Date:
Address:
e-mail:
Mobile Number:
3. Other Investigators and their corresponding task description
*Add additional rows if necessary or attach additional file

4. Study Category  4.1. Research involving human participants

4.1.1. Number of Participants: ___________
 4.2. Others (indicate):

5. Category of  5.1. SMU Undergraduate Student

Investigator  5.2. SMU Graduate Student
 5.3. College/University Faculty Member
 5.4. Non-SMU Undergraduate Student
 5.5. Non-SMU Graduate Student
 5.6. Independent Researcher
 5.7 Others, please specify:
 SAINT MARY’S UNIVERSITY Document Code REB-FO-006

BAYOMBONG, NUEVA VIZCAYA Revision 001

Effectivity Date 2022/07/01

UNIVERSITY RESEARCH ETHICS BOARD
Page/s 2 of 6

6. Purpose of study  6.1 Academic requirement (Thesis, Dissertation,

Training Requirement)
 6.2 Independent research work
 6.3 Multi-institutional or multi-country
collaboration
 6.4 Others (indicate):

7. Study Protocol Synopsis

7.1. Technical Synopsis Please write synopsis of the study on the cell space
provided or attach another sheet based on the
specified components. If items are not applicable,
indicate by N/A.
Attach the full study protocol to this application.

7.1a. Objectives

7.1b. Literature review

rationalizing the design

7.1c. Research design

7.1d. Sampling design,

sample size

7.1e. Inclusion criteria,

exclusion criteria,
withdrawal criteria
7.1f. Data collection plan

7.1g. Specimen collection

and processing plan
(including plans for
specimen storage and
duration of storage)
7.1h. Data analysis plan
(including statistical basis
for design, as applicable)
 SAINT MARY’S UNIVERSITY Document Code REB-FO-006

BAYOMBONG, NUEVA VIZCAYA Revision 001

Effectivity Date 2022/07/01

UNIVERSITY RESEARCH ETHICS BOARD
Page/s 3 of 6

7.1i. Rationalization for

choice of study site
(including capacity of site
to address known risks of
study protocol, such as
availability of equipment
and facilities, as
applicable) (Cross
reference information
with statements provided
in the informed consent)
7.2. Ethical This should be stated in the proposal under
Considerations methodology whenever applicable. Please indicate the
Section specific section and page in the submitted proposal
where the following elements are found.
If items are not applicable, indicate by N/A.
7.2a. Protection of privacy and confidentiality of research
information including data protection plan
7.2b. Management of vulnerability of research participants
7.2c. Risks of the study (including social risks)

7.2d. Benefits of the study

7.2e. Compensations/reimbursements/entitlements of
participants
7.2f. Informed consent process and recruitment procedures
7.2g. Terms of reference of collaborative study (as
applicable, such as intellectual property agreements and
similar concerns)
7.2h. Terms of available study-related insurance
7.2i. Attached Informed Consent Form (ICF)
7.2j. Attached ICF translated to local language
7.2k. Disclosure of conflict of interest
 SAINT MARY’S UNIVERSITY Document Code REB-FO-006

BAYOMBONG, NUEVA VIZCAYA Revision 001

Effectivity Date 2022/07/01

UNIVERSITY RESEARCH ETHICS BOARD
Page/s 4 of 6

8. Use of special  8.1 Children (under 18)

populations or  8.2 Indigenous People
vulnerable groups  8.3 Elderly
 8.4 People on welfare/social assistance
 8.5 Poor and unemployed
 8.6 Patients in emergency care
 8.7 Homeless persons
 8.8 Refugees or displaced persons
 8.9 Patients with incurable diseases
 8.10 Others (indicate):
 8.11 Not applicable
9. Study Duration

10. Endorsing Unit  10.1 SMU-Junior High School

 10.2. SMU-Senior High School
 10.3. SMU-SAB
 10.4. SMU-SHNS
 10.4. SMU-SEAIT
 10.5. SMU-STEH
 10.6. SMU-School of Graduate Studies
 10.7. SMU-URC
 10.8. Other Institution (Please Specify)

11. Study site (Indicate where the study will be conducted)

12. Funding agency: (Indicate the name of funding agency)

13. Study Budget

14. Submitted by:

Study
designation
15. Signature of
Principal
Investigator
 SAINT MARY’S UNIVERSITY Document Code REB-FO-006

BAYOMBONG, NUEVA VIZCAYA Revision 001

Effectivity Date 2022/07/01

UNIVERSITY RESEARCH ETHICS BOARD
Page/s 5 of 6

III: SCIENTIFIC/TECHNICAL REVIEW APPROVAL ENDORSEMENT

This section should be signed by the Chair/Head of the Scientific/Technical Review
committee/office that reviewed the scientific soundness of the study and issued the
appropriate approval. Alternatively, results of Scientific/Technical Review
disposition may be appended to this application, instead of completing this section,
provided that the information required below had been appropriately addressed.
STUDY PROTOCOL
TITLE:
Principal
Investigator:
I confirm that the (NAME OF SCIENTIFIC/TECHNICAL REVIEW
COMMITTEE/OFFICE) has reviewed and approved the following study protocol-
related information: Objectives/Expected output supported by literature review;
overall research design; sampling design, sample size, Inclusion/exclusion/
withdrawal criteria; data collection plan and specimen collection, processing, and
storage as applicable; data analysis plan including statistical design/framework,
as applicable.
Issuing
committee/office:
Head of
committee/office:
Signature: Date of Signature:

IV. INSTITUTIONAL ENDORSEMENT

This section should be signed by the head of unit (administrative authority legally
empowered to sign on behalf the unit such as Dean, Director, and the like) of the
Principal Investigator. This section is required only for initial submission of
non-SMU investigator.
STUDY PROTOCOL
TITLE:

Principal
Investigator:
I confirm that I have read this Application and that the research will be
implemented under the oversight of this Department/Institution in accordance
with the conditions of approval by the SMU Research Ethics Board. I also confirm
that the Principal Investigator has a regular appointment in this institution.
Issuing unit/college/:
 SAINT MARY’S UNIVERSITY Document Code REB-FO-006

BAYOMBONG, NUEVA VIZCAYA Revision 001

Effectivity Date 2022/07/01

UNIVERSITY RESEARCH ETHICS BOARD
Page/s 6 of 6

Head of unit:
Signature: Date of Signature:

V. AUTHORIZATION AND ACKNOWLEDGEMENT OF REVIEW

This section should be signed by the head of unit (administrative authority legally
empowered to sign on behalf the unit such as Dean, Director, and the like) of the
Principal Investigator. This section is required only for initial submission of
non-SMU investigator.
STUDY PROTOCOL
TITLE:

Principal
Investigator:
This is to certify that the (Name of institution)
1) Has no local Institutional Review Board/ Ethics Review Committee; and
2) Authorizes and acknowledges the Saint Mary’s University Research Ethics
Board (SMUREB), located at Ponce Street, Don Mariano Marcos, Bayombong, Neva
Vizcaya to perform the ethical review of the abovementioned study protocol in
accordance with international ethical standards and national regulatory
requirements, and oversee the conduct of the research study which includes
progress monitoring, adverse event monitoring, and site visits.
Name of Research
Site
Address of Research
Site
Signatory Official
Position of Official
Signature Date of Signature: