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RPIC - FO - 0024 - Ethics Study Protocol Assessment Form and Minutes-4
RPIC - FO - 0024 - Ethics Study Protocol Assessment Form and Minutes-4
REC_FO_0024
Research Ethics Committee (REC)
Bonifacio Street, Davao City, Philippines Control No.: _________
Sponsor _______________________________________________
Quorum Status _______________________________________________
Conflict of Interest None___________________________________________
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
been appropriately addressed by the study protocol, as applicable,
Telephone No. (082) 227-82-86 (loc. 211) ● Email Address: rpic@uic.edu.ph Page 2 of 20
University of the Immaculate Conception
REC_FO_0024
Research Ethics Committee (REC)
Bonifacio Street, Davao City, Philippines Control No.: _________
Telephone No. (082) 227-82-86 (loc. 211) ● Email Address: rpic@uic.edu.ph Page 3 of 20
University of the Immaculate Conception
REC_FO_0024
Research Ethics Committee (REC)
Bonifacio Street, Davao City, Philippines Control No.: _________
assessment
point
1. SCIENTIFIC DESIGN YES N/A PAGE #
1.1 Objectives / 02
Review of viability of expected output
1.2 Literature Review / 05-06
Review of results of previous animal/ human
studies showing known risks and benefits
1.3 Research Design / 08
Review of appropriateness of design in view of
objectives
Telephone No. (082) 227-82-86 (loc. 211) ● Email Address: rpic@uic.edu.ph Page 4 of 20
University of the Immaculate Conception
REC_FO_0024
Research Ethics Committee (REC)
Bonifacio Street, Davao City, Philippines Control No.: _________
Telephone No. (082) 227-82-86 (loc. 211) ● Email Address: rpic@uic.edu.ph Page 5 of 20
University of the Immaculate Conception
REC_FO_0024
Research Ethics Committee (REC)
Bonifacio Street, Davao City, Philippines Control No.: _________
Telephone No. (082) 227-82-86 (loc. 211) ● Email Address: rpic@uic.edu.ph Page 6 of 20
University of the Immaculate Conception
REC_FO_0024
Research Ethics Committee (REC)
Bonifacio Street, Davao City, Philippines Control No.: _________
2.2 PI Qualifications / 24
Review of CV and relevant certifications to
ascertain capability to manage study related risks
2.3 Duration / MOA
Review of length/ extent of the study
3. ETHICAL CONSIDERATIONS YES N/A PAGE #
3.1 Voluntary Participations / 14
Willingness of human participants to be involved
in the investigation after fully knowing the
purpose of the study
3.2 Privacy and Confidentiality / 15
Telephone No. (082) 227-82-86 (loc. 211) ● Email Address: rpic@uic.edu.ph Page 7 of 20
University of the Immaculate Conception
REC_FO_0024
Research Ethics Committee (REC)
Bonifacio Street, Davao City, Philippines Control No.: _________
Telephone No. (082) 227-82-86 (loc. 211) ● Email Address: rpic@uic.edu.ph Page 8 of 20
University of the Immaculate Conception
REC_FO_0024
Research Ethics Committee (REC)
Bonifacio Street, Davao City, Philippines Control No.: _________
3.6 Benefits / 14
The potential to yield generalizable knowledge
about the participants’ condition/ problem;
non0material compensation to participant (health
education or other creative benefits)
3.7 Biosafety / -
Sample collection, processing and proper disposal
of infectious and or any biological hazards
4. OTHER ETHICAL ISSUES YES N/A PAGE #
Telephone No. (082) 227-82-86 (loc. 211) ● Email Address: rpic@uic.edu.ph Page 9 of 20
University of the Immaculate Conception
REC_FO_0024
Research Ethics Committee (REC)
Bonifacio Street, Davao City, Philippines Control No.: _________
4.1 Plagiarism / 16
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 / 16
No trace/evidence of intentional
misrepresentation of what has been done. No
making up of data and/or results, or purposefully
putting forward conclusions that are not
accurate. No inconsistency with the existing
literature among the information included in
Telephone No. (082) 227-82-86 (loc. 211) ● Email Address: rpic@uic.edu.ph Page 10 of 20
University of the Immaculate Conception
REC_FO_0024
Research Ethics Committee (REC)
Bonifacio Street, Davao City, Philippines Control No.: _________
manuscript.
4.3 Falsification / 16
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) / 16
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
the participants’ welfare or the validity of the
research tends to be influenced by a secondary
interest such as financial or academic gains or
Telephone No. (082) 227-82-86 (loc. 211) ● Email Address: rpic@uic.edu.ph Page 11 of 20
University of the Immaculate Conception
REC_FO_0024
Research Ethics Committee (REC)
Bonifacio Street, Davao City, Philippines Control No.: _________
recognitions.
4.5 Focus Group Participant / 15
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.
4.6 Deceit / 16
Evidence that the benefit of misleading the
respondents outweigh any potential harm to
Telephone No. (082) 227-82-86 (loc. 211) ● Email Address: rpic@uic.edu.ph Page 12 of 20
University of the Immaculate Conception
REC_FO_0024
Research Ethics Committee (REC)
Bonifacio Street, Davao City, Philippines Control No.: _________
them.
4.7 Observation / 17
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 / 10
Organizational/Location
Has expressed getting a written permission from
the organization in which the research is being
undertaken or the location in which the data are
Telephone No. (082) 227-82-86 (loc. 211) ● Email Address: rpic@uic.edu.ph Page 13 of 20
University of the Immaculate Conception
REC_FO_0024
Research Ethics Committee (REC)
Bonifacio Street, Davao City, Philippines Control No.: _________
Telephone No. (082) 227-82-86 (loc. 211) ● Email Address: rpic@uic.edu.ph Page 14 of 20
University of the Immaculate Conception
REC_FO_0024
Research Ethics Committee (REC)
Bonifacio Street, Davao City, Philippines Control No.: _________
RECOMMENDED ACTION:
Telephone No. (082) 227-82-86 (loc. 211) ● Email Address: rpic@uic.edu.ph Page 15 of 20
University of the Immaculate Conception
REC_FO_0024
Research Ethics Committee (REC)
Bonifacio Street, Davao City, Philippines Control No.: _________
□ 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.
Telephone No. (082) 227-82-86 (loc. 211) ● Email Address: rpic@uic.edu.ph Page 16 of 20
University of the Immaculate Conception
REC_FO_0024
Research Ethics Committee (REC)
Bonifacio Street, Davao City, Philippines Control No.: _________
Prepared by
Telephone No. (082) 227-82-86 (loc. 211) ● Email Address: rpic@uic.edu.ph Page 17 of 20
University of the Immaculate Conception
REC_FO_0024
Research Ethics Committee (REC)
Bonifacio Street, Davao City, Philippines Control No.: _________
Telephone No. (082) 227-82-86 (loc. 211) ● Email Address: rpic@uic.edu.ph Page 18 of 20
University of the Immaculate Conception
REC_FO_0024
Research Ethics Committee (REC)
Bonifacio Street, Davao City, Philippines Control No.: _________
Ulong, Mogrimen R.
Signature over Printed Name
Telephone No. (082) 227-82-86 (loc. 211) ● Email Address: rpic@uic.edu.ph Page 19 of 20
University of the Immaculate Conception
REC_FO_0024
Research Ethics Committee (REC)
Bonifacio Street, Davao City, Philippines Control No.: _________
Telephone No. (082) 227-82-86 (loc. 211) ● Email Address: rpic@uic.edu.ph Page 20 of 20