Uvirb Form Iic1 Research Protocol Quantitative-Must Use2

UVIRB FORM II(C1) 2015: RESEARCH PROTOCOL ASSESSMENT FORM QUANTITATIVE STUDY
09/28/2015
University of the Visayas

INSTITUTIONAL REVIEW BOARD
Corner Colon & Jakosalem Streets, Cebu City 6000, Philippines
Telephone: +63 (32) 416.7990; Email: uvirb2015@gmail.com
RESEARCH PROTOCOL ASSESSMENT FORM

QUANTITATIVE STUDY
Instructions:
To the Principal Investigator: Please indicate in the space provided below whether or not the specified assessment point is addressed by your
study protocol to facilitate the evaluation of the assessment point. Indicate the page and paragraph where this information can be found.
To the Reviewer: Kindly evaluate how the assessment points outlined below have been appropriately addressed by the researcher protocol as
applicable. Please confirm the submitted information by putting your comments in the space provided under REVIEWER COMMENTS. Finalize
your review by indicating your conclusions under RECOMMENDED ACTION and sign the space provided by the reviewer.
Reference Number 2016 - _______
Protocol Title : ____________________________________________________________________
Authors:_________________________________________________________________________
Adviser: ___________________________________________________________________________
Panel Members: _____________________________________________________________________
RESEARCH PROTOCOL EVALUATION TO BE FILLED-OUT BY THE TO BE FILLED-OUT BY THE REVIEWER
1
09/28/2015


QUANTITATIVE STUDY
PRINCIPAL INVESTIGATOR
OR PROPONENT
Indicate if the Page
protocol contains &paragraph
where it is
ASSESSMENT POINTS the specified found REVIEWER COMMENTS
point
YES NO N/A
PRE CHAPTER REQUIREMENTS
TITLE:
Is the title a good one, succinctly suggesting key
variables and the study population?
INTRODUCTION
Rationale:
Does the introduction present a clear exposition of
the topic?
Is the introduction supported by scholarly evidences?
Does the introduction reveal what is unknown?
Is the gap addressed?
CONCEPTUAL OR THEORETICAL FRAMEWORK
Are the key concept adequately defined
conceptually?
Is there a conceptual or theoretical framework,
rationale, and/or map, and (if so) is it appropriate? If
not, is the absence of one justified?
2
09/28/2015


QUANTITATIVE STUDY
STATEMENT OF THE PROBLEM
Is the problem stated unambiguously, and is it easy to
identify?
Does the problem statement build a cogent,
persuasive argument for the new study?
HYPOTHESES OR RESEARCH QUESTIONS
Are research questions and/or hypotheses explicitly
stated? If not, is their absence justified?
Are questions and hypotheses appropriately worded,
with clear specification of key variables and the study
population?
Is there a good match between the specific research
questions and methods used?
Is a quantitative approach appropriate?
SIGNIFICANCE OF THE STUDY AND COMMUNITY
CONSIDERATION
Does the problem have significance to the
profession?
Is there a review of the impact of the research on the
community where the research occurs?
Is there a clear statement to which findings are
linked?
Is there discussion on issues like stigma or drainage of
local capacity?
Is there discussion on sensitivity to cultural
traditions?
Is there involvement of the community in decision
about the conduct of the study?
3
09/28/2015


QUANTITATIVE STUDY
OR PROPONENT
where it is
point
YES NO N/A
REVIEW OF RELATED LITERATURE AND STUDIES
Does the literature review observe the Evidence
hierarchy of Designs for cause-probing questions
(lower designs must be integrated as part of the
review of literature)?
Is the literature review up to date and based mainly
on primary sources?
Does the review provide a state-of-the-art
synthesis of evidence on the problem?
Does literature review provide a sound basis for the
new study?
METHODOLOGY
Research Design
Is the most rigorous possible design used, given the
study purpose?
Are appropriate strategies made to enhance
interpretability of the findings?
Is the number of data collection points appropriate?
4
09/28/2015


QUANTITATIVE STUDY
OR PROPONENT
where it is
point
YES NO N/A
Will the design minimize biases and threats to the
internal, construct, and external validity of the study
(e.g., was blinding used, was attrition minimized)?
POPULATION AND SAMPLE
Is the population described?
Is the sample described in sufficient detail?
Is the best possible sampling design used to enhance
the samples representativeness?
Are measures to minimize sampling biases identified?
Is the planned sample size adequate?
Was a power analysis used to estimate sample size
needs? If not, is the reason justifiable?
Is there an Inclusion criterion? Are the inclusion
criteria precise both for scientific merit and safety
concerns?
Is there equitable Selection?
Is there an Exclusion Criteria?
Are the exclusion Criteria precise both for scientific
merit and safety concerns?
Is there justifiable exclusion?
5
09/28/2015


QUANTITATIVE STUDY
OR PROPONENT
ASSESSMENT POINTS the specified point where
found
it is
REVIEWER COMMENTS
YES NO N/A
Is there withdrawal criteria?
Are the withdrawal criteria precise both for scientific
merit and safety concerns?
DATA COLLECTION AND MEASUREMENT
Are the operational and conceptual definitions
congruent? (Please see Chapter 1)
Are key variables operationalized using the best possible
method and with adequate justification?
Are specific instruments adequately described and were
they good choices, given the study purpose, variables
being studied, and the study population?
Is there evidence that the data collection methods will
yield data that are reliable and valid?
Are there suitable and qualified staff?
Is there suitable infrastructure?
Was there discussion on the length/extent of human
involvement in the study?
For specimen studies:
Is there specimen storage?
-Is there access protocol?
-Is there disposal protocol?
-Is there terms of use?
6
09/28/2015


QUANTITATIVE STUDY
OR PROPONENT
found
it is
REVIEWER COMMENTS
YES NO N/A
Procedures:
Are the procedures adequately described?
Are the planned activities rigorously developed?
DATA ANALYSIS
Were analyses designed to address each research
question or test each hypothesis?
Were appropriate statistical methods designed, given the
level of measurement of the variables, number of groups
being compared, and assumptions of the tests?
Will it utilize the most powerful analytic method (e.g.,
will the analysis help to control for confounding
variables)?
Will Type I and Type II errors avoided or minimized?
In intervention studies, will the intention-to-treat analysis
performed? Will it evaluate problems of missing values?
PI, ADVISER OR CONSULTANT QUALIFICATION
Is the PI Qualified?
If not, are there qualified advisers or consultant?
7
09/28/2015


QUANTITATIVE STUDY
OR PROPONENT
found
it is
REVIEWER COMMENTS
YES NO N/A
COLLABORATIVE STUDY TERMS OF REFERENCE
Is there a discussion of terms of collaboration?
- IP rights
- Publication rights
- Information
- Responsibility sharing or Terms of
Reference
- Transparency
- Capacity Building
8
09/28/2015


QUANTITATIVE STUDY
RECOMMENDED ACTION:
EXEMPTED APPROVE
EXPEDITED MINOR MODIFICATIONS
FULL BOARD MAJOR MODIFICATIONS
DISAPPROVE
PENDING, IF MAJOR CLARIFICATION ARE REQUIRED BEFORE A DECISION CAN BE
MADE
JUSTIFICATION FOR RECOMMENDED ACTION:
PRIMARY REVIEWER: RESEARCH ADVISER: RESEARCH INSTRUCTOR:
_____________________________________ ___________________________________ ____________________________________

(Print Name& Signature) (Print Name& Signature) (Print Name& Signature)

Uvirb Form Iic1 Research Protocol Quantitative-Must Use2

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UVIRB FORM II(C1) 2015: RESEARCH PROTOCOL ASSESSMENT FORM QUANTITATIVE STUDY

University of the Visayas

RESEARCH PROTOCOL ASSESSMENT FORM

Reference Number 2016 - _______

Protocol Title : ____________________________________________________________________

RESEARCH PROTOCOL EVALUATION TO BE FILLED-OUT BY THE TO BE FILLED-OUT BY THE REVIEWER

University of the Visayas

RESEARCH PROTOCOL ASSESSMENT FORM

University of the Visayas

RESEARCH PROTOCOL ASSESSMENT FORM

University of the Visayas

RESEARCH PROTOCOL ASSESSMENT FORM

University of the Visayas

RESEARCH PROTOCOL ASSESSMENT FORM

University of the Visayas

RESEARCH PROTOCOL ASSESSMENT FORM

University of the Visayas

RESEARCH PROTOCOL ASSESSMENT FORM

University of the Visayas

RESEARCH PROTOCOL ASSESSMENT FORM

University of the Visayas

RESEARCH PROTOCOL ASSESSMENT FORM

JUSTIFICATION FOR RECOMMENDED ACTION:

PRIMARY REVIEWER: RESEARCH ADVISER: RESEARCH INSTRUCTOR:

_____________________________________ ___________________________________ ____________________________________

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