Ethical Considerations

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.

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