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University Ethics Review Committee

Center for Research and Development


900 San Marcelino Street, Manila
1000 Manila, Philippines
Office: (+632)- 524-2011 loc 153
uerc-secretariat@adamson.edu.ph

PROTOCOL ASSESSMENT AND APPROVAL FORM

Title: Level of Client’s Satisfaction in the Services Rendered in a Selected Health Center

I. Protocol’s 5 point Research Agenda Category: The study has to be aligned to at least one of the agenda to be
accepted for review. (Kindly check the appropriate box/es)
□ Productivity and Competitiveness in Business and Education
□ Advancement of Science and Technology
□ Integrative Development Approaches in Social Science, Humanities and Communication
□ Community Health and the Effective Delivery of Health Care
□ Environmental Conservation and Preservation
II. Evaluation of the Elements of Research
PAGE *Technical Panel **UERC
Nos.
1.0 Design of the Study MAX Reviewer’s Comments Reviewer’s Comments
10
(UERC) (Optional)
1.1 Objectives:
Review of the clarity and viability of the
expected output.
1.2 Literature Review:
Review of relevance of sources to
support the study being conducted.
Likewise it reviews risks and adverse
effects encountered in studies involving
animal and human subjects and the
benefits of any related interventions.
1.3 Framework:
Review of the correctness of the
theoretical/ conceptual framework in
identifying the key variables and in
showing their relationships.
1.3 Research Design
Review of appropriateness of design in
view of objectives
1.4 Sampling Design and
Determination of
participants/informants
Review of appropriateness of sampling
methods and techniques, and
correctness of sample size computation
1.5 Inclusion Criteria
/exclusion criteria:
Review of precision of criteria for
scientific merit and safety concerns.
1.6 Data Analysis Plan/
Narrative Analysis/
synthesis Plan:
Review of the appropriateness of
statistical and narrative methods of
data/information analysis.
1.7 Withdrawal Criteria:
Review of precision of criteria for
scientific merit and safety concerns

TOTAL

F-CRD-UERC Form No. 007 Protocol Assessment and Approval Form


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University Ethics Review Committee
Center for Research and Development
900 San Marcelino Street, Manila
1000 Manila, Philippines
Office: (+632)- 524-2011 loc 153
uerc-secretariat@adamson.edu.ph
2.0 CONDUCT OF STUDY: Page Reviewer’s Comments MAX Reviewer’s Comments
No. 10
(Technical Panel) (Optional)
2.1 Specimen handling/
Plan of Approach to human
participants
Review of specimen storage, access,
disposal and terms of use/ Review of
how the human participants will be
engaged in the study.

2.2 Primary Investigator


Qualifications
Review of CV and relevant certifications
to ascertain capability to manage the
study and its related risks

2.3 Suitability of Site


Review of adequacy of qualified staff
and infrastructures.

2.4 Duration
Review of length/extent of human
participants in the study
3.0 ETHICAL
CONSIDERATIONS
3.1 Conflict of interest 47
Review of management of conflict
arising from financial, familiar or
proprietary considerations of the Primary
Investigator, sponsor and the study site
3.2 Privacy and 47
Confidentiality
Review of measures or guarantees to
protect privacy and confidentiality of
participant information as indicated by
data collection methods including data
protection plans
3.3 Informed Consent 48
Process
Review of application of the principle of
respect for persons, who may solicit
consent, how and when it will 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 48
Review of involvement of vulnerable
study populations and impact on
informed consent;
Vulnerable groups include children, the
elderly, ethnic and racial minority
groups, the homeless, prisoners, people
with incurable disease, people who are
politically powerless, or junior members
of a hierarchical group
3.5 Recruitment 48
Review of manner of recruitment
including appropriateness of identified
recruiting parties
3.6 Assent 49
Review of feasibility of obtaining assent
vis a vis incompetence to consent:
Review of applicability of the assent age
brackets in children:
0 and under 7: no assent
7 and under 12: verbal assent
12 and under 15 simplified assent form
15 and under 18 co-sign informed
consent form with parents

F-CRD-UERC Form No. 007 Protocol Assessment and Approval Form


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University Ethics Review Committee
Center for Research and Development
900 San Marcelino Street, Manila
1000 Manila, Philippines
Office: (+632)- 524-2011 loc 153
uerc-secretariat@adamson.edu.ph

Page Reviewer’s Comments MAX Reviewer’s Comments


No. 10
(Technical Panel) (Optional)
3.7 Risks 49
Review of level of risk and measures to
mitigate these risks (including physical,
psychological social and economic)
including plans for adverse event
management:
Review of justification for allowable use
of placebo (Helsinki Declaration)
3.8 Benefits 49
Review of potential direct benefit to
participants; the potential to yield
generalizable knowledge about the
participants condition/ problem; non-
material compensation to participant
(health education or other creative
benefits) where no clear, direct benefit
from the project
3.9 Incentives or 49
compensation
Review of amount and method of
compensations, financial incentives, or
reimbursement of study-related
expenses
3.10 Community 50
Considerations
Review of impact of the research on the
community where the research occurs
and/or to whom findings can be linked;
including issues like stigma or draining of
local capacity: sensitivity to cultural
traditions, and involvement of the
community in decisions about the
conduct of study
3.11 Collaborative Study 50
terms of reference
Review of terms of collaborative study
especially in case of multi-country/ multi-
institutional studies, including intellectual
property rights, publication rights,
information and responsibility sharing,
transparency and capacity building.

F-CRD-UERC Form No. 007 Protocol Assessment and Approval Form


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University Ethics Review Committee
Center for Research and Development
900 San Marcelino Street, Manila
1000 Manila, Philippines
Office: (+632)- 524-2011 loc 153
uerc-secretariat@adamson.edu.ph

III. Instruction: For the paper to be approved it has to garner ≥ 30/50 points and a favorable decision by the
UERC

Criteria for Approval of Research Proposal Max Remarks


10
A For the Technical Panel
1 The design, methodology and research framework are appropriate
for the study.
*Please refer to II. Evaluation of the Elements of Research under
Technical Panel
0-30 - (not acceptable)
30-38 - 5 points
39-46- - 6 points
47-56- - 7 points
57-65- - 8 points
66-74- - 9 points
75-80 -10 points

2 Has great impact and contribution to


a. Growth of knowledge/Potential for Intellectual Property
Registration/ Patent registration:
1. Novelty (newness)
2. Usefulness
3. Non-obvious (not public knowledge)
b. Welfare of the community and/ or nations/ Commercialization
of inventions:
1. Practical utility
2. Repeatability and transferability
3. Technological/ theoretical Soundness (Efficiency and
Effectiveness)
c. Empowerment of the socially disadvantaged:
1. Addresses fundamental human concerns (eg. basic
needs, promotion of human dignity, integrity of creation,
promotion of peace and justice etc.)
2. Promotes self-sufficiency and self-determination among
the socially disadvantaged
3. Fosters access to and increase participation in literacy,
numeracy, health, technology, religion, social and
cultural endeavors.
3 Has potential for Refereed Journal Publication:
1. Scientific soundness
2. Relevance and impact on knowledge advancement
TOTAL POINTS

Decision:

Approved:
Comments:

Disapproved:
Reasons:

F-CRD-UERC Form No. 007 Protocol Assessment and Approval Form


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University Ethics Review Committee
Center for Research and Development
900 San Marcelino Street, Manila
1000 Manila, Philippines
Office: (+632)- 524-2011 loc 153
uerc-secretariat@adamson.edu.ph

B For the UERC Justification for the Decision.

Has been approved by the University Ethics Review Committee


(applicable to study protocols with human subjects/participants)
**Please refer to II. Elements of Research under UERC

Approved conditionally, subject to amendments


(any item with 8 points)
Approved conditionally, subject to clarification
(any item with 7 points)
Approved conditionally, subject to submission of further
documentation
(any number with 6 points)
Decision deferred
(any item with 5 points)
Not approved (any item below five)

Technical Reviewer: UERC Reviewer

Name and Signature Name and Signature

Date: Date:

F-CRD-UERC Form No. 007 Protocol Assessment and Approval Form


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University Ethics Review Committee
Center for Research and Development
900 San Marcelino Street, Manila
1000 Manila, Philippines
Office: (+632)- 524-2011 loc 153
uerc-secretariat@adamson.edu.ph

F-CRD-UERC Form No. 007 Protocol Assessment and Approval Form


Page 6 of 5
University Ethics Review Committee
Center for Research and Development
900 San Marcelino Street, Manila
1000 Manila, Philippines
Office: (+632)- 524-2011 loc 153
uerc-secretariat@adamson.edu.ph

F-CRD-UERC Form No. 007 Protocol Assessment and Approval Form


Page 7 of 5
University Ethics Review Committee
Center for Research and Development
900 San Marcelino Street, Manila
1000 Manila, Philippines
Office: (+632)- 524-2011 loc 153
uerc-secretariat@adamson.edu.ph

F-CRD-UERC Form No. 007 Protocol Assessment and Approval Form


Page 8 of 5
University Ethics Review Committee
Center for Research and Development
900 San Marcelino Street, Manila
1000 Manila, Philippines
Office: (+632)- 524-2011 loc 153
uerc-secretariat@adamson.edu.ph

F-CRD-UERC Form No. 007 Protocol Assessment and Approval Form


Page 9 of 5
University Ethics Review Committee
Center for Research and Development
900 San Marcelino Street, Manila
1000 Manila, Philippines
Office: (+632)- 524-2011 loc 153
uerc-secretariat@adamson.edu.ph

F-CRD-UERC Form No. 007 Protocol Assessment and Approval Form


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