Novel platforms for genetic analysis: an assessment of rapid, portable diagnostic devices.

• Author: Mehta, Michael D.

Pioneered simultaneously in Denmark and the United States in the early 1990s, consensus conferencing is a relatively new tool for consulting the public on a wide range of issues. A consensus conference involves members of the lay public and gives them the central role in assessing a problem area. Participants rarely have subject expertise that is directly relevant to the topic being explored and contribute by making their views known in the form of concerns, values, and everyday experiences. The underlying purpose of a consensus conference is to provide a means by which ordinary (lay) members of society can be involved in a purposeful way in making their views known to regulators, industrial actors, scientists, and politicians.

Consensus conferencing often involves an examination of science and technology issues and is seen as a way to reinvigorate democratic decision making by including the public "upstream" in the development of science and technology, rather than after-the-fact. Additionally, it is a tool for building trust and for creating a more open and transparent dialogue.

In Canada, consensus conferencing has been used previously to explore topics like genetically modified foods, plant molecular farming, and blood safety. Other countries have used consensus conferencing on topics like nanotechnology (USA), telecommunications and teleworking (USA and Denmark), national electricity policy (Switzerland), and radioactive waste management (UK). Consensus conferencing is about building consensus. Since consensus refers to "general agreement," the results of a consensus conference are a record of group decisions, and represent positions and recommendations that participants can "live with." It is therefore fundamental to the success of a consensus conference that the process for getting to a certain degree of general agreement occurs in an environment which promotes inclusivity, participation, cooperation, egalitarianism, and a willingness to be solution oriented.

The purpose of a consensus conference is to produce an informed debate on a limited subject and to produce statements and recommendations that reflect the nature of the deliberations. As such, this document reflects the views of 22 adult Canadians from coast-to-coast, and across all age ranges. Participants were selected in one of three ways: (1) responses from a series of advertisements in the Globe and Mail newspaper, (2) random digit telephone recruitment using quota sampling, and (3) "snowball" sampling to fill in demographic gaps. In general, participants were non-specialists who were motivated to understand the importance of the issues, and were not meant to reflect a perfectly random assortment of Canadians.

The topic of this consensus conference was the development of rapid, portable, low-cost diagnostic devices. Such devices are being developed in many parts of the world, and utilize micro-fluidics, electrical fields, micro-scale pumps, and fluorescence technologies to analyze biological samples including blood, urine, water, etc. Such devices have been called various names including "micro-fluidic platform technology" and "lab-on-chip technology." These devices, and the glass and silicon chips that are used with them, will provide "point of care" and "point of concern" testing that may usher in a new age of testing and monitoring.

This technology brings the functionality of a large-scale laboratory down to the size of a hand-held unit which can perform diagnostic testing, meter, measure and mix samples, move mixtures to temperature-controlled chambers, and separate and analyze results. By taking advantage of favourable scaling properties and a small footprint, this technology promises to improve the availability of diagnostic and genetic testing, environmental monitoring, and several other clinical and non-clinical applications. Clearly, such technology has many risks and benefits associated with its use, and also raise a range of socio-economic and ethical issues.

Based on a New Emerging Team grant provided by the Canadian Institutes of Health Research (CIHR) entitled "Novel Platforms for Genetic Analysis," and led by Dr. Linda Pilarski from the Cross Cancer Institute and the University of Alberta, a team of researchers is developing a "made in Canada" version of this technology. Dr. Michael Mehta of the University of Winnipeg has conducted a series of public engagement exercises since 2003, with this consensus conference being the final stage.

The following report includes the recommendations and observations of participants in this consensus conference regarding this technology. The report is divided into two sections: (1) clinical applications, and (2) non-clinical applications.

It is expected that the report will form the basis for future public engagement on this topic, and it is hoped that policy makers, politicians, regulators, scientists and others will consider these carefully thought out recommendations. There is much richness and reflection in them, and they represent the product of a consensus process that could act as a model for future deliberations on the development of new scientific innovations in general.

CLINICAL GROUP

Recommendations 1

We recommend that the Government of Canada support this technology for the "public good," and that all reasonable efforts should be made to develop and deploy this technology in the developing world.

The group had lively debate on the risks and benefits of this technology. Opinions were strong and sometimes anchored in personal experiences. Eventually a general consensus was formed based on the need to maximize the benefits of this technology while minimizing risks. Several questions were raised, such as:

* Who defines "public good"? Which "public" is being referred to?

* How far should Canada commit to developing this technology domestically?

* How far should Canada commit to supporting this technology in developing countries?

* Which Government of Canada departments should take the lead?

Recommendations 2

We recommend that the general public be educated on this technology, and that they be consulted on specific applications of this technology.

The group reached consensus that the general public should be consulted on specific applications of this technology. The group felt that the public would need to be educated (e.g., on terminology, the technology itself, applications, and various social, ethical and economic issues) in order to maximize their engagement and contributions to the consultation process. It was clear from the discussion that participants felt that members of the general public should not be marginalized from such discussions since the public has a vested interest in this technology and its applications. Participants felt that the consultation process needs to be ongoing as the technology evolves. Participants also felt that Canadians would be ready, willing and able to participate in the public consultation process. In short, they believed that the public has a right to be heard and that Canadians have a duty and obligation to contribute to determining how to implement this technology.

Recommendation 3

We recommend ongoing review in a systematic way of the social considerations of applications of this technology.

The group reached consensus that the technology was going to continue to evolve and...