Republic of the Philippines

UNIVERSITY OF SOUTHERN MINDANAO

Kabacan, Cotabato
[email protected]

OFFICE OF THE VICE PRESIDENT FOR

RESEARCH, DEVELOPMENT AND EXTENSION

MEMORANDUM No. 53
Series of 2024

TO : FACULTY, STAFF, AND STUDENTS

SUBJECT : RESEARCH ETHICS COMMITTEE (RECO) AND INSTITUTIONAL CARE
AND ANIMAL USE COMMITTEE (IACUC)

FROM : DEBBIE MARIE B. VERZOSA

DATE : June 25, 2024
====================================================================================

The University community is reminded that any and all research, including student theses involving:
• human participants are required to secure approval from the Research Ethics Committee (RECO),
and
• animals are required to secure approval from the Institutional Care and Animal Use Committee.

Approval must be secured prior to data collection. Please refer to Attachment A for application
procedures. Note that Department Research Coordinators, are responsible for facilitating the Ethics
Approval of research involving human participants for theses within their department (Procedure #6).

All forms are available in the University of Southern Mindanao Research, Development and Extension
(USM RDE) website (www.usm.edu.ph/rde). Alternatively, you may scan the QR code below.

For widest dissemination.

“UNITY IN DIVERSITY AND

SUSTAINABLE DEVELOPMENT IN
MINDANAO THROUGH QUALITY AND RELEVANT EDUCATION.”

USM-SYS-F71-Rev.2.2023.12.29
Attachment A.

Research Ethics Review Process

1. The University Ethics Review process is adopted from the National Ethical Guidelines for
Research Involving Human Participants by the Philippine Council for Health Research and
Development, 2022.
2. USM Research Ethics Committee (RECO) conducts the ethical review of research
proposals involving human participants and other relevant studies in the University based
on an assessment of the research activities outlined in the protocol.
3. USM faculty, staff, and student researchers are required to secure ethical approval from
the University RECO or any other research ethics committee accredited by the Philippine
Health Research Ethics Board (PHREB) for any research involving human participants
prior to any data collection. All research ethics forms are available in the USM RDE page
(https://www.usm.edu.ph/rde/).
4. Researchers whose research involves human participants shall complete REC Form 1.1
(Appendix 24: Application for Ethics Review of a New Protocol). For students, one printed
copy of REC Form 1.1 together with the attachments (Basic requirements and Supporting
Documents outlined in Section 3 of the form) shall be submitted to the DRC. For faculty
or RDE personnel, the application form shall be emailed directly to the RECO
([email protected]).
5. The Informed Consent Form (Appendix 24a), Assent Form (Appendix 24b), and Legally
Authorized Representative (LAR) Form (Appendix 24c) as specified in the Basic
Requirements in Section 3 of Appendix 24 shall follow the University template. The signed
Informed Consent Form is necessary evidence of voluntary participation for respondents
18 years old or above. For respondents below 18 years old, voluntary participation is
demonstrated by an Informed Consent form signed by their parent or guardian and an
Assent Form signed by the respondent. For respondents who are substantially unable to
sign a Consent Form due to being physically incapacitated, mentally challenged, illiterate,
a guardian or representative may give consent in their behalf through the LAR Form.
6. For student research, the DRC shall identify all research that involves human participants
and prepare a list of all ethics applications within their department and submit all printed
applications and attachments to the RECO. This list shall include the name of the
researcher, title of the research and if the research is exempted from review (i.e., no
human participants are involved). For research that involves human participants, the DRC
shall collect the application forms (Appendix 24), check if the forms are completely filled
out and if all attachments are complete. The DRC will then submit the printed copies of
the list and the application forms to the RECO. For external campuses, the DRC shall
upload to a Google Drive the list of research and the application forms, with folders
organized by program, and within each program, in folders named after the surname of
the researcher.
7. Researchers whose proposals are exempt from ethical review and wish to obtain ethical
clearance shall proceed directly to RECO and bring a copy of their outline/proposal
(approved by the technical committee).
8. Submissions to the RECO shall be from the 1st to 20th of the month, for inclusion in the
RECO monthly review. Submissions received by the RECO from the 21st to the end of
the month shall be considered in the subsequent month’s review.
9. The REC Secretariat, upon receipt of the submission, shall have the DRC or research sign
a logbook.
10. The REC Secretariat shall inform the applicant about the classification of their protocol
(full-board, expedited) through email. Applications may be approved, disapproved, or
recommended for revisions.
11. Results of the evaluations requiring full-board review as determined by the RECO shall
be emailed within 30 working days. Results of the evaluations of applications requiring
only expedited review shall be emailed within 14 working days.
12. Researchers whose application requires revisions shall submit REC Form 5.5 (Appendix
25: Resubmission Form) within 10 days to comply with the requirements set forth by the
Committee. If the researcher fails to comply within 10 days, any subsequent application
shall be treated as a new submission. Results of the resubmission shall be emailed within
14 working days after the resubmission.
13. Researchers whose ethics applications are approved shall receive a printed certificate to
conduct from the RECO. They shall sign in the logbook once they receive their printed
certificate.
14. Researchers shall receive their Ethical Clearance certificate after data collection, provided
that there have been no unapproved changes made to the submitted and approved
protocol during the study.
15. In case amendments to the approved protocol are required, researchers shall submit REC
Form 5.1 (Appendix 26: Application for Ethics Review of Amendments) to the RECO.
16. Researchers are expected to submit progress reports through REC Form 5.5 (Appendix
27: Application for Continuing Review) to the RECO. The reports should describe
compliance to the approved protocol as well as any problems encountered.
13. In case of any changes in the protocol, researchers shall inform RECO through email.
Their letter shall include deviations from the approved protocol and the justifications for
such. They shall receive a decision letter from the RECO within 7 working days.
14. In case of adverse/negative events that happened during conduct of the study (for
researchers and participants), the researchers must submit a report to the RECO through
email. The RECO shall conduct on-site visit to assess the risk and give recommendations
(to proceed/terminate).
15. The researcher shall obtain the voluntary informed consent of the prospective research
participant/respondent. In the case of an individual who is incapable of giving or who has
diminished capacity to give informed consent, the researcher must obtain their assent
together with the consent of a legally authorized representative, according to applicable
 laws. Hence, the informed consent shall consider essential information for participants,
documentation of consent, waiver of informed consent and renewing consent.
16. Ethical clearance is usually for a period of one year, which may be renewed if an
application for continuing review is submitted before the expiration of the earlier ethics
clearance. Renewal applications must be received by the USM REC at least 30 days before
the expiry of the current approval.

Institutional Animal Care and Use Committee (IACUC) Protocol Review

Workflow
Pursuant to Republic Act 8285, otherwise known as the Animal Welfare Act of 1998, all studies
involving live vertebrate animals are subject to the review of the Institutional Animal Care and
Use Committee (IACUC).

Before a scientific procedure can be carried out on animals, the procedure must first be approved
through the USM-IACUC's protocol review process.

1. For registration and documentation, the researcher shall first register online through this
link: https://bit.ly/3Q58ofe
2. The link can be accessed through the official Facebook page of USM IACUC
(https://www.facebook.com/usmiacuc2022).
3. The researcher shall submit two (2) hard copies (Letter size bond paper) of the accomplished
USM IACUC Form 1 (Appendix 24) together with a copy of the certificate of registration
enclosed in long brown envelope to the IACUC Office at least 3 months before the
commencement date of the study/procedures. Form 1 accessible through the USM FB page
and the USM RDE website.
4. The Chairperson of the IACUC shall assign the study/procedure under one of the following
categories (refer to DA AO 40, s.1999 for the description of the categories):
● Category 1: Procedures of Low or Mild Severity
● Category 2: Procedures of Medium or Moderate Severity
● Category 3: Procedures of High or Substantial Severity

*Category 1 procedures are for expedited review by the IACUC chairperson.

*Category 2 procedures are for expedited review by the IACUC chairperson, and 1 or 2
other members of the committee assigned by the chairperson
*Category 3 procedures are for full review by a quorum of the IACUC, but not by less
than 3 members.

5. The IACUC Chair assigns the reviewer of the protocol. The IACUC shall notify the researcher
the result of the evaluation, including summarized comments and recommendations. In case
of revisions, the researcher shall submit one (1) hard copy of the revised document to the
IACUC Office. No study/procedure can be conducted without prior approval.
6. Note that for Category 3 procedures, approval means approval of most of the quorum
present. No member may participate in the review or approval of a procedure in which the
member has a conflicting interest (e.g., direct involvement in the project) except to provide
information requested by the IACUC.
7. The proponent shall submit the final copy of the IACUC Form 1 signed by the adviser, for
the approval by the IACUC committee.
Appendix 1. Application for Ethics Review of a New Protocol

USM RDE Manual 2023 1

USM RDE Manual 2023 2
Appendix 2. Resubmission Form

USM RDE Manual 2023 3

Appendix 3. Application for Ethics Review of Amendments

USM RDE Manual 2023 4

Appendix 4. Application for Continuing Review

USM RDE Manual 2023 5

Appendix 5. USM IACUC Form 1

Republic of the Philippines

UNIVERSITY OF SOUTHERN MINDANAO
Kabacan, Cotabato

________________________________ __
Institutional Animal Care and Use Committee (IACUC) Form 1

ANIMAL CARE and USE STATEMENT IACUC Use Only

(Protocol Review Form)
Protocol #: ________
I. PROCEDURE(S) and/or TITLE OF RESEARCH STUDY:
Review Date: ______

Action: / / Approved
II. GENERAL PURPOSE/OBJECTIVES: / / Approved
/ / Approved
/ / Approved
III. DURATION or TIME FRAME:

IV. RESPONSIBLE PERSON/S:

1. Name/s (underline the leader):

1. Contact number/Email:

2. Qualifications (Provide the degree/s and/or training experience; for undergraduates, write course):

3. Affiliation/Address:

4. Research Adviser:

V. BACKGROUND and SIGNIFICANCE OF THE PROCEDURE or RESEARCH:

(Include a description of biomedical characteristics of the animals which are essential to the proposed
procedure/research and indicate evidence of experiences with the proposed animal model)

VI. DESCRIPTION of METHODOLOGIES/EXPERIMENTAL DESIGN:

This section should establish that the proposed procedures/research is well designed scientifically and ethically.
The following should be indicated or described:

A. Type of animal to be used (species and strain/breed):

USM RDE Manual 2023 6

 B. Source of animals (complete name and address of source/facility):

C. Reason/basis for selecting the animal species (give the reason/s for the use of the animals):

D. Sex, age, and number of animals (justify the number of animals that will be used):

E. Quarantine and acclimation or conditioning process (cite reference):

F. Animal care procedures

i. Cage type (give the type, material, and dimensions of the cage that will house the
animals):
ii. Number of animals per sex per cage:

iii. Identification (indicate how each individual animal will be identified from one another):
iv. Cage cleaning method:
v. Living conditions (include where the animals will be housed, the room temperature,
humidity, ventilation, and lighting):
vi. Animal diet, feeding, and watering methods:
G. Experimental or animal manipulation method:
i. Description of animal or treatment groups (give a description of the methods of
animal manipulation that will be used including the method of conditioning):

ii. Restraint or handling of animals per technical procedure/s to be conducted:

iii. Dosing method(s) to be performed in animals (include the frequency, volume of

experimental dose(s), route, method of restraint and expected outcome or effects):

iv. Biological sample collection (specify the type of biological agent, whether blood, urine,
feces, etc., and identify its collection method/route, frequency, volume, and method of
restraint used):

v. Animal examination procedures and frequency of examinations (including

restraining methods):

vi. Anesthesia of animals (including drug, dosage, and frequency):

vii. Pre-emptive medications that will be given to animals prior to surgery or technical
procedure/s to be performed in animals:

USM RDE Manual 2023 7

 viii. Surgical procedures, type, and purpose (if any):

1. Where will surgery be performed?

2. Description of supportive care and monitoring procedures during and after

surgery:

3. Description measures for possible post-surgical complications:

4. Name(s) of surgeon(s) and qualifications.

ix. Humane endpoints (Describe the plan for monitoring pain, discomfort, or distress
during and after the procedure. If animals will be euthanized, include the method that
will be used).

B. Potential hazards (Include any potential hazards for the animals and the personnel involved
as well as preventive measures to avoid hazards.)

C. Indicate and describe euthanasia method (if any):

D. Organ sample collection after euthanasia:

E. Is there a non-animal model applicable for the procedure/study? If so, please provide
the reason for not using it:

F. Indicate the name(s) and qualification(s) of all personnel who will be responsible for
conducting the procedures (An additional list can be attached; indicate if student).

G. Waste disposal (Describe how animal carcasses and other wastes generated by the
procedure will be disposed of.)

H. List of References (please attach list):

II. DECLARATION BY THE RESPONSIBLE PERSON:

I ACCEPT THE RESPONSIBILITIES FOR ASSURING THAT THE PROCEDURES/STUDY WILL BE

CONDUCTED IN ACCORDANCE WITH THE APPROVED PROTOCOL.

USM RDE Manual 2023 8

 I ASSURE THAT ALL PERSONNEL WHO WILL USE THIS PROTOCOL AND WORK WITH
ANIMALS HAS RECEIVED APPROPRIATE TRAINING/INSTRUCTIONS IN PROCEDURAL AND
HANDLING TECHNIQUES, AND ON ANIMAL WELFARE CONSIDERATIONS.

I AGREE TO OBTAIN WRITTEN APPROVAL FROM THE INSTITUTIONAL ANIMAL CARE AND
USE COMMITTEE (IACUC) PRIOR TO MAKING ANY CHANGES AFFECTING MY PROTOCOL.

I ALSO AGREE TO PROMPTLY NOTIFY THE IACUC IN WRITING OF ANY

EMERGENT PROBLEMS THAT MAY ARISE IN THE COURSE OF THIS STUDY, INCLUDING THE
OCCURRENCE OF ADVERSE SIDE EFFECTS.

____________________________________ _______________

Principal Investigator (Signature over Printed Name) Date Accomplished

__________________________________ ________________

Research Adviser (Signature over Printed Name) Date Accomplished

Noted by:

_______________ Date: ____________

Chair, USM IACUC

USM RDE Manual 2023 9