Nanotechnology and the Ethical Conduct of Research Involving Human subjects.

• Author: Sheremeta, Lorraine

1. Introduction

   The purpose of Canada's Tri-Council Policy Statement on the Ethical Conduct for Research Involving Humans (1) is to promote only research that is conducted according to the highest ethical standards. As a condition of federal funding, researchers who are granted federal funding or who work within institutions that receive federal funding must comply with the ethical principles espoused in the articles of the TCPS. The TCPS is not law nor is it a set of rigid rules. Rather, it is an ethical framework that is intended to provide guidance to researchers and the research ethics boards charged with ethical review of human subject research. "[T]he key is sensitive and thoughtful implementation of the spirit and requirements of the document," (2) not blind adherence to rules. From the outset, it was recognized that "considerations around the ethical conduct of human subjects are complex and continually evolving" and that ethical principles must be re-evaluated and adapted to the context in which they are applied. As the scope of nanotechnology has inevitably grown to include human subject research, this paper is intended to initiate discussion about the potential impact that it may have on human subject research and to determine whether or how this impact might best be reflected in the TCPS.

   Respect for human dignity demands that research be done with a view to morally acceptable ends and that morally acceptable means be used to achieve those ends. Importantly, to be considered ethical, research must also have scientific merit. (3) It is clear that the welfare and integrity of the individual is the paramount consideration in research that is ethical from the perspective of the TCPS. Steps must therefore be taken to ensure that individual research subjects are not instrumentalized either during research or as a result of human subject research.

   Additionally, a number of trans-disciplinary guiding ethical principles have emerged that express common standards, values and aspirations of researchers. These principles include:

   * Respect for free and informed consent

   * Respect for vulnerable persons

   * Respect for privacy and confidentiality

   * Respect for justice and inclusiveness

   * Balancing harms and benefits

   * Minimizing harm

   * Maximizing benefit

   In light of these principles, it is important to consider whether there is anything unique about nanotechnology that will impact the application of these ethical principles. To answer this question and to understand the emerging issues it is important to first define what nanotechnology is and, second, to identify specific areas of research where we can reasonably expect nanotechnology to be used in human subjects.

2. Technology Overview

   What is Nanotechnology and how will it be used in Human Subject Research?

   Nanoscale science and engineering is a dynamic domain of science and technology at the confluence of the physics, chemistry, biology, information technology, biotechnology and medicine. "Nanoscience" is the study of the first level of organization of matter (either biological or man-made) that determines its fundamental characteristics and function. It has been described as "the builder's final frontier." (4)

   Within the nano domain, fundamental characteristics of materials that we typically presume immutable--including electrical conductivity, colour, strength, and melting point can all change. By understanding the altered characteristics of materials at the nanoscale and by tailoring the structure of materials in specific ways it is possible to engineer novel materials with characteristics that are unanticipated from macro-scale observation and measurement. By studying the common features of nanoscale entities like nanocrystals and nanotubes scientists are gaining new insight into natural processes that occur in living systems and in the environment.

   "Nanotechnology" is inherently hard to define. The term represents a series of technologies used independently or in combination to make products, perform tasks and to gain a better understanding of science. Canada's National Research Council describes nanotechnology as:

   [M]anufacturing at the molecular level--building things from molecular or nano-scale components. A nanometer is one billionth of a metre (3-4 atoms wide). Nanotechnology proposes the construction of novel nano-scale devices possessing extraordinary properties. Through the development of such instruments and techniques it is becoming possible to study and manipulate individual atoms. This ability is almost in the grasp of humankind. (5) Through this newfound control over the natural world, nanoscience and the technologies derived from it are expected to have profound societal effects--both positive and negative. It is predicted that:

   Few industries will escape the influence of nanotechnology. Faster computers, advanced pharmaceuticals, controlled drug delivery, biocompatible materials, nerve and tissue repair, surface coatings, better skin care and protection, catalysts, sensors, telecommunications, magnetic materials and devices--these are just some areas where nanotechnology will have a major impact. Indeed, there is a growing appreciation that it is difficult to find areas of manufacturing and industry where nanoscience and nanotechnology will not have an impact. (6) It has been postulated that "[n]anotechnology today is arguably at about the same stage that information technology occupied in the early 1960s, or biotechnology at the beginning of the 1980s." (7)

   Society appears poised to engage a deeply polarized debate over the benefits and risks of nanotechnology. (8) The ETC Group (an action group on Erosion, Technology and Concentration--formerly RAFI), for example, has recommended an immediate moratorium on commercial production of new nanomaterials and the creation of a global process to evaluate the economic, health and environmental implications of nanotechnology. (9) It recommends strict adherence to the precautionary principle, which they advocate as being "a commonsense approach to Atomtechnology". Oddly, and simultaneously, they recognize that the precautionary principle is neither uniformly defined nor embraced. (10)

   Greenpeace takes a less radical approach than the ETC Group. (11) It recognizes that the impact of nanotechnology will be gradual and limited in the short term and argues that a moratorium would likely be both impractical and harmful. It strongly advises industry players to take the issue of public acceptance of nanotechnology seriously. Failure to do so, they warn, may result in a self-imposed moratorium. Commitment to developing sound environmental practices and in performing relevant research to evaluate human safety is urged. This is particularly salient in light of an increasing number of reports in the academic literature and in the popular press that nanoparticles may pose health risks to animals and humans. (12) It has been predicted that failure, by government and industry, to acknowledge the concerns raised by the critics of nanotechnology may lead to a backlash, similar to that experienced in the context of agricultural biotechnology. (13) Early recognition of the political realities, societal concerns, underlying environmental and human safety issues and their potential relevance to human subject research is essential.

   Despite the emerging concerns, Canada, like virtually all other developed countries, is committed to building national capacity in the area of nanotechnology. (14) The National Research Council, the province of Alberta and the University of Alberta are combining resources to build a national institute at the University of Alberta. (15) The National Institute for Nanotechnology, though physically located in Alberta, aspires to attract researchers from across Canada and around the world and catapult Canada onto the international nanotechnology stage.

   Though nanotechnology is expected to impact most sectors of the economy, it is expected to have a profound impact on health and health related technologies. Given that health and healthcare provision are among Canada's foremost priorities (16), the government is eager to find and to adopt more cost effective methods of healthcare delivery. (17) To the extent that nanotechnology is perceived able to provide solutions to current healthcare problems, it will inevitably receive high priority from research funding agencies, including the CIHR. (18) In the medical context, nanoscience is expected to facilitate the development of, among other things:

   ...