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: EFFECTIVENESS AND ACUTE DERMAL IRRITATION OF PREFORMULATED PEDICULICIDE SHAMPOO

OF ANNONA SQUAMOSA AND AZADIRACHTA INDICA

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 boxes)
□ 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
PAG
E *Technical Panel **UERC
Nos.
1.0 Design of the Study MAX Reviewer’s Comments Reviewer’s Comments
10
(UERC) (Optional)
1.1 Objectives: 1
Review of the clarity and viability of the
expected output.
1.2 Literature Review: 1-9
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: 10
Review of the correctness of the
theoretical/ conceptual framework in
identifying the key variables and in
showing their relationships.
1.3 Research Design 10-14
Review of appropriateness of design in
view of objectives
1.4 Sampling Design and 14
Determination of
participants/informants
Review of appropriateness of sampling
methods and techniques, and
correctness of sample size computation
1.5 Inclusion Criteria 14
/exclusion criteria:
Review of precision of criteria for
scientific merit and safety concerns.
1.6 Data Analysis Plan/ 14
Narrative Analysis/
 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

10
No. (Technical Panel)(Optional)
2.1 Specimen handling/ 14
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 15-23

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

2.3 Suitability of Site 24

Review of adequacy of qualified staff
and infrastructures.

2.4 Duration 24
Review of length/extent of human
participants in the study
3.0 ETHICAL
CONSIDERATIONS
3.1 Conflict of interest 9
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 24
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 24
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 24
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 24
Review of manner of recruitment
including appropriateness of identified
recruiting parties
 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

10
No. (Technical Panel)(Optional)
3.7 Risks 24
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 25
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 25
compensation
Review of amount and method of
compensations, financial incentives, or
reimbursement of study-related
expenses
3.10 Community 25
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 25
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.
 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
appropriatefor 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--8points
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
culturalendeavors.
3 Has potential for Refereed Journal Publication:
1. Scientific soundness
2. Relevance and impact on knowledge advancement
TOTAL POINTS

Decision:

Approved:
Comments:
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
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
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
 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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