REC - FO - 0024 - Ethics Study Protocol Assessment Form and Minutes-4

University of the Immaculate Conception
REC_FO_0024
Research Ethics Committee (REC)
Control No.: _________
Bonifacio Street, Davao City, Philippines
Ethics Study Protocol Assessment Form and Minutes
Protocol Submission Date _______________________________________________

Study Protocol Title _______________________________________________
UIC-REC Reference Number: Protocol Code _____________________________ ______
Principal Investigator _______________________________________________
Type of Review _______________________________________________
(full board or expedited)
Primary Reviewers _______________________________________________
Secondary Reviewers (Members) _______________________________________________
Telephone No. (082) 227-82-86 (loc. 211) ● Email Address: rpic@uic.edu.ph Page 1 of 17
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Sponsor _______________________________________________
Quorum Status _______________________________________________
Conflict of Interest _______________________________________________
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 Primary Reviewer: Please evaluate how the assessment points outlined below have
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been appropriately addressed by the study protocol, as applicable,

by confirming the submitted information and putting your comments
in the space provided under “REVIEWER COMMENTS.” Finalize your
review by indicating your conclusions under “RECOMMENDED
ACTION” and signing in space provided for the primary reviewer.
To be filled out by the PIs

Indicate if Page and
the study paragraph
protocol where it is
ASSESSMENT POINTS contains the found REVIEWER
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specified COMMENTS
assessment
point
1. SCIENTIFIC DESIGN YES N/A PAGE #
1.1 Objectives
Review of viability of expected output
1.2 Literature Review
Review of results of previous animal/ human
studies showing known risks and benefits
1.3 Research Design
Review of appropriateness of design in view of
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objectives
1.4 Sampling Design
Review of appropriateness of sampling methods
and techniques
1.5 Sample Size
Review of justification of sample size
1.6 Data Analysis Plan
Review of appropriateness of statistical and non-
statistical methods of data analysis
1.7 Inclusion Criteria
Review of precision of criteria both for scientific
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merit and safety concerns; and of equitable

selection
1.8 Exclusion Criteria
Review of criteria precision both for scientific
merit and safety concerns; and of justified
exclusion
1.9 Withdrawal Criteria
Review of criteria precision both for scientific
merit and safety concerns
2. CONDUCT OF STUDY YES N/A PAGE #
2.1 Specimen handling
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Review of specimen for storage, access, disposal,

and terms of use
2.2 PI Qualifications
Review of CV and relevant certifications to
ascertain capability to manage study related risks
2.3 Duration
Review of length/ extent of the study
3. ETHICAL CONSIDERATIONS YES N/A PAGE #
3.1 Voluntary Participations
Willingness of human participants to be involved
in the investigation after fully knowing the
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purpose of the study

3.2 Privacy and Confidentiality
Review of measures or guarantees to protect
privacy and confidentiality of participant
information
3.3 Informed Consent Process
Review of application of the principle of respect
for persons, who may solicit consent, how and
when it will be done
3.4 Recruitment
Appropriateness of identified recruiting parties
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3.5 Risks
Review of level of risks and measures to mitigate
these risks (including physical, psychological,
social economic), including plans for adverse
event management
3.6 Benefits
The potential to yield generalizable knowledge
about the participants’ condition/ problem;
non0material compensation to participant (health
education or other creative benefits)
3.7 Biosafety
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Sample collection, processing and proper disposal

of infectious and or any biological hazards
4. OTHER ETHICAL ISSUES YES N/A PAGE #
4.1 Plagiarism
No trace/evidence of misrepresentation of
someone else’s work as his/her own (the
investigator). Use of Grammarly or Turnitin
software and/ or Plagiarism Detector is in place.
4.2 Fabrication
No trace/evidence of intentional
misrepresentation of what has been done. No
making up of data and/or results, or purposefully
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putting forward conclusions that are not

accurate. No inconsistency with the existing
literature among the information included in
manuscript.
4.3 Falsification
No trace of purposefully misrepresenting the
work to fit a model or theoretical expectation. No
evidence of over claiming or exaggerations.
4.4 Conflict of Interest (COI)
No trace of COI, i.e. Disclosure of COI ( COI is a
set of conditions in which a professional
judgment concerning primary interest such as
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the participants’ welfare or the validity of the

research tends to be influenced by a secondary
interest such as financial or academic gains or
recognitions.
4.5 Focus Group Participant
Identification
Addressing the fact that the information
discovered within the group becomes common
knowledge among those in attendance; thus,
there must be a provision in the consent form
reminding participants to keep the information
discussed confidential.
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4.6 Deceit
Evidence that the benefit of misleading the
respondents outweigh any potential harm to
them.
4.7 Observation
Provisions to address an ethical issue when
observing people in public or quasipublic place,
e.g. to have notices placed at the entrance of the
store indicating that the researchers will be
operating in this area at specific times.
4.8 Permission from
Organizational/Location
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Has expressed getting a written permission from

the organization in which the research is being
undertaken or the location in which the data are
being collected. When getting written
permission, the person to talk to must have the
authority to give the permission sought and that
the activities are organized well in advance.
4.9 Technology Issues

Provisions as to the use of online panels,
collection of data online, and how does one view
the information being communicated in an online
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environment, are put in place and are made

understandable to the participants.
4.10 Authorship
Provisions on authorship must be made clear,
e.g. authorship qualifications, i.e. authorship
credit should be based only on substantial
contributions to conception and design, or
acquisition of data, or analysis and interpretation
of data; drafting the article or revising it critically
for important intellectual content; and final
approval of the version to be published.
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RECOMMENDED ACTION:
□ APPROVED
□ MINOR MODIFICATIONS MUST BE IMPLEMENTED (PENDING APPROVAL A)
□ MAJOR MODIFICATIONS MUST BE IMPLEMENTED (PENDING APPROVAL B)
□ DISAPPROVED
*If in GROUP, be sure all members affix their names and signature, too.
Prepared by
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__________________________________
(Signature over Printed Name)
__________________________________

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University of the Immaculate Conception

Ethics Study Protocol Assessment Form and Minutes

Protocol Submission Date _______________________________________________

been appropriately addressed by the study protocol, as applicable,

To be filled out by the PIs

merit and safety concerns; and of equitable

Review of specimen for storage, access, disposal,

purpose of the study

Sample collection, processing and proper disposal

putting forward conclusions that are not

the participants’ welfare or the validity of the

Has expressed getting a written permission from

4.9 Technology Issues

environment, are put in place and are made

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