This section explains the ethical
dimension of the study. The following are the subsections of this part:
1. Justify
your competence and credibility as a principal investigator. Also, justify the
competence of other members in the team.
2. Identification
of vulnerability of population (if applicable).
a. Declare
which population is vulnerable.
b. Explain
why these research participants can be considered vulnerable.
c. Protective
measures to be undertaken by the research team to address vulnerability.
d. Properly
cite sources for your claims.
3. Identification
of risks
a. Identify
the risks to participants involved (one risk = one paragraph).
b. Categorize
whether the risks involved is physical, psychological, social or economic.
c. Categorize
whether the risks are minimal, moderate or high.
d. Categorize
whether the risks have low or high probability.
e. Explain
in detail how the research will address these risks to offer utmost protection
for the participants.
f. Properly
cite sources for your claims.
4. Identification
of benefits: what will each individual participant, his/her community or
organization, and society get from my research?
5. Autonomy
(prior, free, informed consent process).
a. Explain
briefly the informed consent process (parental consent and child’s assent for
subjects that are minors).
b. Indicate
how you will ensure full disclosure, full comprehension and voluntariness in
securing consent.
c. For
community based research, also explain the full process of acquiring social
license to participate (entrée).
d. Explain
the general parts of your informed consent form (indicate appendix where the
ICF can be found). Also, indicate whether there are multiple versions and
language for the ICF.
e. Explain
your intentions to do covert observations and withholding of full consent and
justify the scientific merits of these process. Also, justify that there will
be no risk in withholding information or consent.
f. Properly
cite sources for your claims.
6. Data
protection plan
a. Explain
the procedures that you will undertake in order to maintain the privacy of the
participant.
b. Explain
in detail how you will keep information de-identified (anonymized) and
confidential.
c. Explain
where, how and how long you will store your data.
d. Explain
security measures and identify the personnel who will have access to the data.
e. Explain
how you will encrypt and protect digital data.
f. Explain
data destruction process.
g. Properly
cite sources for your claims.
7. Justice
a. Explain
how equitable treatment for each participant will be achieved.
b. Explain
the specific details of compensation (cash or kind) to be received by the
participant.
8. Declaration
of conflict(s) of interest, affiliations and financial interests of any
research team member to the study.
..