Challenges researchers need to consider when dealing with regulators

Abstract

Australia's gene technology regulation will be used to illustrate some key challenges researchers should consider in the interface between research and regulation. These challenges result from the variety of legal obligations as well as from the different viewpoints, motivations and assumptions of researchers and regulators. Australia's gene technology regulation is based on a framework comprising both Commonwealth and corresponding State and Territory legislation designed to manage risks posed by genetically modified organisms (GMOs). While the Gene Technology Regulator is an essential decision maker, researchers may also need to interact with other regulators when developing products for various uses, such as those tasked with food safety, agricultural and veterinary chemicals, therapeutics and biosecurity. Each one of those regulators must satisfy their relevant legislation and may, therefore, require different information from the researcher. The legislation under which each regulator is required to operate is often prescriptive with regard to the processes that must be followed and the considerations that must be taken into account. Amendments to the legislation are possible but may be slow compared with the fast-paced and adaptive nature of scientific research. Other challenges may include: the desire of researchers to protect intellectual property versus the public expectation of transparency from regulators; or the notion in researchers that genetically modified organisms are simply organisms versus the regulator's legislation and risk oriented view. Challenges arising from differences in focus and expectations can be overcome by improving dialogue and engagement between regulators and researchers. This will also lead to a more robust regulatory system. © 2014 The Author(s).