Auditing Preparedness for Vector Control Field Studies

Abstract

The value of baseline entomological data to any future area-wide release campaign relies on the application of consistent methods to produce results comparable across different times and places in a stepwise progression to larger releases. Traditionally, standard operating procedures (SOPs) and operational plans support this consistency and, thus, the validity of emergent data. When release plans include transgenic mosquitoes for vector control or other novel beneficial insects, additional factors come into play such as biosafety permits, stakeholder acceptance, and ethics approval, which require even greater coordination and thoroughness. An audit approach was developed to verify the correct use of SOPs and appropriate performance of tasks during mosquito mark, release, recapture (MRR) studies. Audit questions matched SOPs, permit terms and conditions, and other key criteria, and can be used to support subsequent "spot check" verification by field teams. An external team of auditors, however, was found to be effective for initial checks in this example before the use of a transgenic strain of laboratory mosquitoes. We recommend similar approaches for field studies using release of novel beneficial insects, to ensure useful and valid data as an outcome and to support confidence in the rigor of the step-wise process. Similar objectives of regulatory compliance, enduring record keeping, and utility of studies were described for studies in containment facilities, 25 and an internal audit process was used to evaluate readiness for proceeding with key steps such as applications for import of novel organisms. 26

Small-scale release of non-gene drive mosquitoes in Burkina Faso: from engagement implementation to assessment, a learning journey

“…The engagement audit methodology was developed in parallel to the assessment of the field entomology readiness [29] and was preceded by a similar process for community readiness to the importation and contained use of non-gene drive sterile male mosquitoes. The first step was establishment of an internal audit checklist.…”

“…Decisions regarding project activities would therefore proceed based on the milestone set, if deemed appropriate, while the new learning feeds into engagement for the next phase or other sites. This criterion was considered an internal pre-requisite, similar to the regulatory permits and the scientific activities and teams [29]. This internal high standard in terms of engagement and community acceptance is a direct response to the project's values of excellence, evidence-based decision, co-development and accountability [11]; as well as a management measure for project risk related to the first release of a genetically-modified mosquito in an African country.…”

“…As a result, the project considers that engagement is one of its pillars, together with science and regulatory compliance. Hence, the decision to proceed with the small-scale release of non-gene drive sterile male mosquitoes-is based on the project's preparedness on those three aspects: scientific readiness [28,29], regulatory approvals and communities' readiness. This preparedness is assessed internally through a systematic and rigorous process specific to each one of these components.…”

Preparing an Insectary in Burkina Faso to Support Research in Genetic Technologies for Malaria Control

“…This is in addition to official audits. These unofficial audits are based on extensive checklists and records of compliance, as well as observation of operations (similar to that described for field audits by Collins and Quinlan 2020 ).…”