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Brokenshire College: Form A. Study Protocol Assessment Form and Minutes

This document is a study protocol assessment form from the Brokenshire College Research Ethics Committee. It provides a framework for evaluating the scientific design, conduct, ethical considerations, and other aspects of a proposed study on the preparedness and competencies of nursing students on standard health precautions in handling infectious diseases. The assessment covers objectives, literature review, research design, sampling methods, data analysis plan, inclusion/exclusion criteria, specimen handling, investigator qualifications, risks and benefits to participants, informed consent process, and other ethical issues like conflicts of interest, deception, and permission from organizations. Reviewers are asked to evaluate how the protocol addresses each point and provide comments.

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137 views

Brokenshire College: Form A. Study Protocol Assessment Form and Minutes

This document is a study protocol assessment form from the Brokenshire College Research Ethics Committee. It provides a framework for evaluating the scientific design, conduct, ethical considerations, and other aspects of a proposed study on the preparedness and competencies of nursing students on standard health precautions in handling infectious diseases. The assessment covers objectives, literature review, research design, sampling methods, data analysis plan, inclusion/exclusion criteria, specimen handling, investigator qualifications, risks and benefits to participants, informed consent process, and other ethical issues like conflicts of interest, deception, and permission from organizations. Reviewers are asked to evaluate how the protocol addresses each point and provide comments.

Uploaded by

geng geng
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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BCREC - 01

Brokenshire College Rev. 01 / November 6, 2017


Approved by:
Madapo Hills, Davao City, 8000, Philippines
Tel No.(082) 227-2105 local 154/ Fax No. (082) 227-2105
Control No.: _______________

Form A. Study Protocol Assessment Form and Minutes

Brokenshire College Research Ethics Committee


Madapo Hills, Davao City

Protocol Submission Date _______________________________________________


Study Protocol Title Preparedness and Competencies of Nursing Students on
Standard Health Precautions in Handling Infectious Diseases
UIC-REC Reference Number:

Principal Investigator Custodio , Nicomedes III Legaspi, Mei Kaiza


Deliña, Merry Joy Abulag, Sharmine
Martel, Christine Cadayona, Exil

Type of Review _______________________________________________


(full board or expedited)
Primary Reviewers _______________________________________________
Secondary Reviewers (Members) _______________________________________________
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
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
specified COMMENTS
assessment
point
1. SCIENTIFIC DESIGN YES N/A PAGE #
1.1 Objectives
Review of viability of expected output
1.2 Literature Review
BCREC - 01
Brokenshire College Rev. 01 / November 6, 2017
Approved by:
Madapo Hills, Davao City, 8000, Philippines
Tel No.(082) 227-2105 local 154/ Fax No. (082) 227-2105
Control No.: _______________
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
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
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
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
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
3.5 Risks
Review of level of risks and measures to mitigate
these risks (including physical, psychological,
BCREC - 01
Brokenshire College Rev. 01 / November 6, 2017
Approved by:
Madapo Hills, Davao City, 8000, Philippines
Tel No.(082) 227-2105 local 154/ Fax No. (082) 227-2105
Control No.: _______________
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
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
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
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.
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,
BCREC - 01
Brokenshire College Rev. 01 / November 6, 2017
Approved by:
Madapo Hills, Davao City, 8000, Philippines
Tel No.(082) 227-2105 local 154/ Fax No. (082) 227-2105
Control No.: _______________
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
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
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.

RECOMMENDED ACTION:

□ APPROVED
□ MINOR MODIFICATIONS MUST BE IMPLEMENTED (PENDING APPROVAL A)
□ MAJOR MODIFICATIONS MUST BE IMPLEMENTED (PENDING APPROVAL B)
□ DISAPPROVED

Prepared by:

Custodio, Nicomedes III Legaspi, Mei Kaiza


Deliña, Merry Joy Abulag, Sharmine
Martel, Christine Cadayona, Exil

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