Institutional review boards and investigators are used to talking about risks of harm. Both low risks of great harm and high risks of small harm must be disclosed to prospective subjects and should be explained and categorized in ways that help potential subjects to understand and weigh them appropriately. Everyone on an IRB has probably spent time at meetings arguing over whether a three-page bulleted list of risk description is helpful or overkill for prospective subjects. Yet only a small fraction (...) of all the time and attention lavished on risk disclosure has been devoted to discussing whether and when potential benefit to subjects can reasonably be claimed and, if so, how it should be described in the consent form and process.Traditionally, IRBs and regulators have worked to ensure that clear lines can be drawn between research that, by definition, carries no potential for direct benefit — because it uses healthy volunteers or because it is not foreseeably focused on the development of treatments — and research that does have the development of effective treatments as its goal. (shrink)

University of North Carolina at Greensboro Most approaches to the philosophy of the natural and social sciences are basedon completed scientific investigations. However, there are many importantcases in science in which testing is incomplete. These cases are termed suspendedtrials and are particularly significant in biomedical and allied health fields. Initially,the authors' interest in suspended trials was piqued by a controversialmethod for assisting autistic children known as facilitated communication. Thisarticle examines facilitated communication and other examples of suspendedtrials from the perspective of (...) an economics of science and game theory. Themodel is consistent with recent evolutionary approaches to the philosophy ofthe natural and social sciences and with recent contributions to an economicunderstanding of science. Key Words: clinical trials • innovative therapies • economics of science • suspended trials • facilitated communication • economics of clinical research. (shrink)

Dual-track assessment directs research ethics committees to assess the risks of research interventions based on the unclear distinction between therapeutic and non-therapeutic interventions. The net risks test, in contrast, relies on the clinically familiar method of assessing the risks and benefits of interventions in comparison to the available alternatives and also focuses attention of the RECs on the central challenge of protecting research participants.Research guidelines around the world recognise that clinical research is ethical only when the risks to participants are (...) reasonable.1 Appropriate implementation of this requirement is vital to protecting research participants and allowing research to proceed when it poses acceptable risks. Unfortunately, as the US National Bioethics Advisory Commission notes: “current regulations do not further elaborate how risks and potential benefits are to be assessed, and little additional guidance is available to IRBs.”1The NBAC, as well as numerous commentators, recommend that research ethics committees , ethics review committees and institutional review boards should adopt what may be called dual-track risk assessment.2–5 Yet, dual-track assessment unnecessarily divides research interventions into two different categories before assessing their risks and relies on the unclear distinction between therapeutic and non-therapeutic interventions. As a result, dual-track assessment provides RECs with confusing guidance and has the potential to block valuable research that poses acceptable risks. This paper describes one alternative, the net risks test, and argues that this approach offers a better method for assessing research risks, one that puts RECs in a position to protect participants without blocking appropriate research studies.BACKGROUNDClinical research exposes participants to interventions and procedures to gather systematic data that may be used to improve overall health and well-being. To ensure that research is ethical, RECs must ensure that the risks and burdens to participants are not excessive and that …. (shrink)

A medical profession which did not seek improved means to conquer disease would be condemned for dereliction of its duty, Members of the public will not accept the current state of the medical arts as finite but feel justified in expecting the development of more effective therapies for illness, and the promotion of improved means of preventive care.With this assertion, the distinguished academic, Bernard Dickens, places research firmly in the domain of the public interest. Foster agrees, saying that, “[t]o improve (...) medical care as much as we can, if not to perfect it, means that we have to accept the need for research.” Giesen adds a further emphasis to the search for medical advancements, saying that “freedom of research and scientific inquiry is, in itself, an important aspect of open societies.“. (shrink)

A medical profession which did not seek improved means to conquer disease would be condemned for dereliction of its duty, Members of the public will not accept the current state of the medical arts as finite but feel justified in expecting the development of more effective therapies for illness, and the promotion of improved means of preventive care.With this assertion, the distinguished academic, Bernard Dickens, places research firmly in the domain of the public interest. Foster agrees, saying that, “[t]o improve (...) medical care as much as we can, if not to perfect it, means that we have to accept the need for research.” Giesen adds a further emphasis to the search for medical advancements, saying that “freedom of research and scientific inquiry is, in itself, an important aspect of open societies.“. (shrink)