Considerations for the use of human participants in vector biology research: a tool for investigators and regulators.

Nicole L Achee,Stephanie James,Michael J Bangs,Laura Youngblood,James V Lavery

doi:10.1089/vbz.2014.1628

Abstract

A thorough search of the existing literature has revealed that there are currently no published recommendations or guidelines for the interpretation of US regulations on the use of human participants in vector biology research (VBR). An informal survey of vector biologists has indicated that issues related to human participation in vector research have been largely debated by academic, national, and local Institutional Review Boards (IRBs) in the countries where the research is being conducted, and that interpretations and subsequent requirements made by these IRBs have varied widely. This document is intended to provide investigators and corresponding scientific and ethical review committee members an introduction to VBR methods involving human participation and the legal and ethical framework in which such studies are conducted with a focus on US Federal Regulations. It is also intended to provide a common perspective for guiding researchers, IRB members, and other interested parties (i.e., public health officials conducting routine entomological surveillance) in the interpretation of human subjects regulations pertaining to VBR.

Highlights

Many diseases of public health importance, both within the United States and internationally, are transmitted to humans by an arthropod vector
Research to understand the vector as well as its interaction with humans and the environment aims to identify better ways to prevent the spread of such diseases and is a widely recognized field of biomedical research
An informal survey of vector biologists has indicated that issues related to human use in vector research have been largely debated by academic, national, and local Institutional Review Boards (IRBs) in the countries where the research is being conducted and that interpretations and subsequent requirements made by these IRBs have varied widely

Summary

Introduction

Many diseases of public health importance, both within the United States and internationally, are transmitted to humans by an arthropod vector. The current document focuses on the human-landing catch (HLC) technique, a method commonly used in routine surveillance (monitoring) and intervention evaluations for mosquito vectors This comprises the first of a more comprehensive set of considerations related to additional VBR techniques (i.e., release of vectors in the field, human blood feeds for colony production). Front-line malaria control interventions, including the use of long-lasting insecticide-treated nets (LLINs) and indoor residual spray (IRS) of insecticides, are among the most widely used and effective methods of arthropod-borne disease prevention They have been shown to reduce disease burden dramatically when implemented properly (Roberts et al 2000, Mabaso et al 2004, Townson et al 2005, Bhattarai et al 2007, Fegan et al 2007, Sharp et al 2007, ChizemaKawesha et al 2010). With the expanding global distribution of arboviruses (Weaver and Reisen 2010) and renewed calls for the elimination and eradication of malaria, it is inevitable that new tools and innovative strategies will be required to improve the impact of vector control programs (Alonso et al 2010, World Health Organization 2010)

Vector biology research

Key criteria defining human subject research

Obtaining identifiable private information

Findings

Techniques in VBR Involving Humans