LICEO DE CAGAYAN UNIVERSITY LDCU_REB

RESEARCH ETHICS BOARD Form 2(C)

Rodolfo N. Pelaez Blvd., Kauswagan, Cagayan de Oro City
Effective Date:
STUDY PROTOCOL ASSESSMENT FORM August 15, 2021

LDCU-REB Document No.

 2022-07-0344-CON

Project Title KNOWLEDGE AND ADHERENCE TO SAFETYPROTOCOLS OF NURSING STUDENTS DURING THE C
Study PANDEMIC

Date received July 7, 2022

INSTRUCTIONS:
To the principal investigator: Please indicate in the space provided below whether or not the specified assessment
addressed by your study protocol. To facilitate the evaluation of the assessment poin
the page and paragraph where this information can be found.

To the reviewer: Please evaluate how the assessment points outlined below have been appropriately addressed by
protocol, as applicable, and by confirming the submitted information and putting your comments
space provided under “Comments.” Finalize your review by indicating your decision and recomme
and signing in the space provided for the reviewer.

ASSESSMENT POINTS To be filled out by the principal To be filled out by the r

Investigator
Indicate if the Page and
study protocol paragraph
contains the where it is found
specified
assessment
point
COMMENTS
1. Scientific design YES N/A
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 of intervention,
including known adverse drug effects, in
case of drug trials
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 to be used
and how participant data will be
summarized
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

LICEO DE CAGAYAN UNIVERSITY LDCU_REB

RESEARCH ETHICS BOARD Form 2(C)

Rodolfo N. Pelaez Blvd., Kauswagan, Cagayan de Oro City Effective Date:

STUDY PROTOCOL ASSESSMENT FORM August 15, 2021

2. Conduct of Study
2.1. Data collection plan /
Review of appropriateness of data
collection, including description of
personal data to be collected.
For studies involving use of database,
review of database management and
role of personal data collector, as well
as authority of investigator to access
database. (NEGHHR 2017)
2.2. Specimen handling
Review of specimen storage,
access, disposal, and terms of use,
including appropriateness of
biobank custodian and adherence
to institutional guidelines for
biobanking, including provision for
sample and data removal and
destruction for biobanked
samples (NEGHHR 2017)
2.3. Principal investigator
qualifications
Review of CV and relevant certifications
to ascertain capability to manage study
related risks
2.4. Suitability of site
Review of adequacy of qualified staff
and infrastructures
2.5. Duration of participant
involvement
Review of length/extent of human
participant involvement in the study
3. Ethical Consideration
3.1. Transparency and Conflict of
interest
Review of management of conflict
arising from financial, familial, or
proprietary considerations of the PI,
sponsor, or the study site (NEGHHR
2017)
3.2. Privacy, confidentiality, and
data protection plan
Review of measures or guarantees to
protect privacy and confidentiality of
participant information and in
compliance with the Data Privacy Act of
2012 as indicated by data collection
methods including data protection plans
including the steps to be taken so that
all who have access to the data and the
identities of the respondents can
safeguard privacy and confidentiality
(ex. providing adequate instructions to
research assistants, transcribers, or
translators) (NEGHHR 2017);

Review of appropriateness of processing

personal data, storage of data, access,
disposal, and terms of use (NEGHHR
2017; Data Privacy Act of 2012)
 LICEO DE CAGAYAN UNIVERSITY LDCU_REB

RESEARCH ETHICS BOARD Form 2(C)

Rodolfo N. Pelaez Blvd., Kauswagan, Cagayan de Oro City Effective Date:
August 15, 2021
STUDY PROTOCOL ASSESSMENT FORM
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;
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
(NEGHHR 2017)
3.4. Waiver of informed consent
Review of justification for waiver
of informed consent or waiver of
documentation of consent with
considerations to potential risk to
participants, collection of data, and
mechanisms to ensure confidentiality
and anonymity (NEGHHR 2017)
3.5. Justification for the
involvement of vulnerable
groups
Review of involvement of vulnerable
study populations and impact on
informed consent (see 3.3). Vulnerable
groups include 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.
Involvement of vulnerable groups must
always be assessed in the context of the
protocol and the participants (NEGHHR
2017)
3.6. Justification for involving
minors (less than 18 years old)
Review of involvement of minors and
impact on informed consent (see 3.3).
Research involving minors must always
be assessed in the context of the
protocol and the participants
3.7. Assent
Review of feasibility of obtaining assent
vis à vis incompetence to consent;

Review of applicability of the assent age

brackets in children:
0-under 7: No assent
7-under 12: Verbal Assent
12-under15: Simplified Assent Form
15-under18: Co-sign informed consent
form with parents
(NEGHHR 2017)
3.8. Consent for continued
participation
For research involving children and
adolescents, review of process for
obtaining consent if the participant
reaches legal age during the research.
(CIOMS 2016)
3.9. Recruitment
Review of manner of recruitment
including appropriateness of identified
recruiting parties
3.10. Risks
Review of level of risk and measures to
mitigate these risks (including
physical, psychological, social,
 LICEO DE CAGAYAN UNIVERSITY LDCU_REB

RESEARCH ETHICS BOARD Form 2(C)

Rodolfo N. Pelaez Blvd., Kauswagan, Cagayan de Oro City Effective Date:

STUDY PROTOCOL ASSESSMENT FORM August 15, 2021

economic), including plans for adverse

event management;

Review of justification for allowable

use of placebo as detailed in the
Declaration of Helsinki (as applicable);

Review of course of action in case of

breach of data (as applicable)
3.11. Benefits
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 will be
received by the participant
3.12. Safety monitoring plan
Review of appropriateness of measures
to assess risk and burdens to the
participants and precautions taken to
minimize negative impact of the study
on the well-being of the participants
(NEGHHR 2017)
3.13. Post-trial access
Review of provision of clinical trials
for post-trial access
3.14. Incentives or compensation
Review of amount and method of
compensations, financial incentives, or
reimbursement of study-related
expenses
3.15. Compensation for study
related injuries
Review of amount and method of
compensations for study-related
injuries, including treatment
entitlements, or certificate of
insurance for clinical trials.
3.16. Community considerations
Review of impact of the research
on the community where the
research occurs and/or to whom
findings can be inked; 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
3.17. Collaborative study 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
 LICEO DE CAGAYAN UNIVERSITY LDCU_REB

RESEARCH ETHICS BOARD Form 2(C)

Rodolfo N. Pelaez Blvd., Kauswagan, Cagayan de Oro City Effective Date:

STUDY PROTOCOL ASSESSMENT FORM August 15, 2021

3.18. Dissemination / data sharing

plan/ statement
Review of appropriateness in sharing
research results which may have
significant implications on the well
being of the participants and the
community and in relation to achieving
social value (NEGHHR 2017)
3.19. Other issues
Review of issues not subsumed in the
issues covered by items 3.1 to
3.11

RECOMMENDED ACTION: (this portion for LREB)

 APPROVE (the application is satisfactory and needs no amendment or correction)
 MINOR MODIFICATIONS (the application is essentially ethically sound; however, the principal invest
needs to make some minor amendments before it can be approved)
 MAJOR MODIFICATIONS (the application is essentially ethically sound; however, the principal invest
needs to make some minor revisions before it can be approved)
 DISAPPROVE (the application is unethical and does not comply with the ethical requirement for res
proposals)
 PENDING, IF MAJOR CLARIFICATIONS
 ARE REQUIRED BEFORE A DECISION

Justification for recommendation

Primary Reviewer Signature

Date Name