Salazar, Ferdinand
Angeles, Jason
Sy, Ava Kristy
Inobaya, Marianette T.
Aguila, Ariza
Toner, Tom
Bangs, Michael J.
Thomsen, Edward
Paul, Richard E. http://orcid.org/0000-0002-0665-5089
Funding for this research was provided by:
Agence Française de Développement (ECOMORE2)
Article History
Received: 31 January 2019
Accepted: 19 April 2019
First Online: 14 May 2019
Ethics approval and consent to participate
: This trial protocol (version 2, 21 May 2018) was approved by the Research Institute for Tropical Medicine Institutional Review Board (Reference No. 2018–09, 1 June 2018) and the Institut Pasteur Institutional Review Board (Reference No. 2018–03, 14 June 2018). Any follow-on protocol amendments will be reviewed and approved by these committees.The ISRCTN trial registry is pending a number assignment and will also be informed in a timely manner of any amendments. All subjects will be engaged in a process of documented informed consent, and assent where appropriate, before participating in any study activities (Additional file InternalRef removed). For the consent process, the objective, procedures, risks, and benefits of the study will be explained to the participant and he/she will be encouraged to ask questions for clarifications. The participant will also be advised that he/she may choose not to participate in the research study and may withdraw their participation at any time without prejudice. This would not adversely affect him/her or their family. The participant will also be informed that his/her identification shall be kept strictly confidential and shall be known only to designated research staff. Information and consent forms will be translated into Tagalog and cross-checked for accuracy. In addition to the written information sheet, there will be a comic strip, available from the DoH, featuring images of what dengue is, how it is transmitted, what this study proposes to do, what the potential implication will be, and what the study hopes to achieve. All parents/guardians (legal tutors) will be informed of the study and consent will be obtained from at least one of the parents or guardians for children enrolled. In addition, verbal assent will be obtained from children 7 years and older. For individuals (parents, guardians, children > 7 years old) unable to read sufficiently, BHWs will act as an independent witness and countersign the consent form. Participants and their immediate co-residing family members will be informed of any new information pertinent to the study arising during the study period.<b><i>Regulatory framework of the study:</i></b> Typology: interventional research with minimal risks on human volunteers (health-related study involving humans) with collection of personal data on a population of 4600 children aged 6 to 16 years in Lipa City. This trial is considered of minimal risk to study participants and therefore there are no provisions for ancillary or post-trial care or for compensation to those who suffer harms from trial participation, beyond the existing Philippines social security system. Regulatory framework: research will fully respect and adhere to the Philippine regulatory framework, international recommendations (Revised Declaration of Helsinki, 2013, CIOMS International Guidelines for Health-Related Human Behavioral Research, 2016), and French regulations on data protection (Act N° 78–17 relating to the protection of individuals with regard to the processing of personal data, 2016).
: Not applicable.
: The authors declare that they have no competing interests.
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