David Koepsell

Human research ethics has developed in both theory and practice mostly from experiences in medical research. Human participants, however, are used in a much broader range of research than ethics committees oversee, including both basic and applied research at technical universities. Although mandated in the United States, the United Kingdom, Canada, and Australia, non-medical research involving humans need not receive ethics review in much of Europe, Asia, Latin America, and Africa. Our survey of the top 50 technical universities in the world shows that, where not specifically mandated by law, most technical universities do not employ ethics committees to review human studies. As the domains of basic and applied sciences expand, ethics committees are increasingly needed to guide and oversee all such research regardless of legal requirements. We offer as examples, from our experience as an ethics committee in a major European technical university, ways in which such a committee provides needed services and can help ensure more ethical studies involving humans outside the standard medical context. We provide some arguments for creating such committees, and in our supplemental article, we provide specific examples of cases and concerns that may confront technical, engineering, and design research, as well as outline the general framework we have used in creating our committee.

John R. Searle’s 1995 publication The Construction of Social Reality is the foundation of this collection of scholarly papers examining Searle's philosophical theories. Searle’s book sets out to reconstruct the ontology of the social sciences through an analysis of linguistic practices in the context of his celebrated work on intentionality. His book provided a stimulating account of institutional facts such as money and marriage and how they are created and replicated in everyday social life. The authors in this collection provide a critical appraisal of these and other ideas presented in Searle’s original publication. The editors' introduction clearly outlines the main issues in the debate and provides a useful introduction to Searle's contributions to social science.

For the past half-century, issues relating to the ethical conduct of human research have focused largely on the domain of medical, and more recently social–psychological research. The modern regime of applied ethics, emerging as it has from the Nuremberg trials and certain other historical antecedents, applies the key principles of: autonomy, respect for persons, beneficence, non-maleficence, and justice to human beings who enter trials of experimental drugs and devices :168–175, 2001). Institutions such as Institutional Review Boards and Ethics Committees oversee most governmentally-funded medical research around the world, in more than a hundred nations that are signers of the Declaration of Helsinki. Increasingly, research outside of medicine has been recognized to pose potential risks to human subjects of experiments. Ethics committees now operate in the US, Canada, the U.K. and Australia to oversee all governmental-funded research, and in other jurisdictions, the range of research covered by such committees is expanding. Social science, anthropology, and other fields are falling under more clear directives to conduct a formal ethical review for basic research involving human participants. The legal and institutional response for protecting human subjects in the course of developing non-medical technologies, engineering, and design is currently vague, but some universities are establishing ethics committees to oversee their human subjects research even where the experiments involved are non-medical and not technically covered by the Declaration of Helsinki. In The Netherlands, as in most of Europe, Asia, Latin America, or Africa, no laws mandate an ethical review of non-medical research. Yet, nearly 2 years ago we launched a pilot ethics committee at our technical university and began soliciting our colleagues to submit their studies for review. In the past year, we have become officially recognized as a human subjects ethics committee for our university and we are beginning the process of requiring all studies using human subjects to apply for our approval. In this article, we consider some of the special problems relating to protecting human participants in a technology context, and discuss some of our experiences and insights about reviewing human subjects research at a technical university, concluding: that not less than in medical studies, human participants used in technology research benefit from ethical committees’ reviews, practical requirements for publications, grants, and avoiding legal liability are also served by such committees, and ethics committees in such contexts have many similarities to, but certain other special foci than medical ethics committees. We believe that this experience, and these observations, are helpful for those seeking to establish such committees in technology research contexts, and for framing the particular issues that may arise in such contexts for the benefit of researchers, and nascent committees seeking to establish their own procedures.

Currently, under the law of intellectual property, IP owners may exclude from use or production substances and processes that we would ordinarily consider to be products of nature. This has helped companies monopolize disease genes, and thus diagnostic testing for those diseases, and “biosimilar” products, pharmaceutical materials that mimic biological materials. Extending the current paradigm to the world of synthetic biology and nanotechnology will create further injustices in the delivery of health care to billions of people around the world. As such, I advocate heading this trend off at the pass. Scientists ought to conduct basic research into the building blocks of biology and matter in the open, publishing their results, releasing knowledge into the public domain upstream so that beneficial innovation can be produced without fear of downstream litigation, and so that what ought to remain in the public domain as a matter of right (products of nature) does not become unjustly monopolized.

Much of the discussion regarding nanotechnology centers around perceived and prosphesied harms and risks. While there are real risks that could emerge from futuristic nanotechnology, there are other current risks involved with its development, not involving physical harms, that could prevent its full promise from being realized. Transitional forms of the technology, involving “microfab,” or localized, sometimes desk-top, manufacture, pose a good opportunity for case study. How can we develop legal and regulatory institutions, specifically centered around the problems of intellectual property, that both stimulate innovation, and make the best possible use of what will eventually be a market in “types” rather than “tokens”? This paper argues that this is the most critical, current issues facing nanotechnology, and suggests a manner to approach it.