Social Media, like Facebook and Twitter, are having a profound effect on the way that human subjects research is being conducted. In light of the changes proposed in ANPRM, in this article I argue that traditional research ethics and regulations may not easily translate to the use of social media in human subjects research. Using the conceptual model of apomediation, which describes the peer-to-peer way in which health information is shared via social media, I suggest that we may need to (...) think again about the suitability of current regulations to deal with social media research. (shrink)

Social media, meaning digital technologies and platforms such as blogs, wikis, forums, content aggregators, sharing sites, and social networks like Facebook and Twitter, have profoundly changed the way that information can be shared online. Now, almost anyone with a broadband internet connection or a smart phone can share ideas, data, and opinions with just about anyone else on the planet. This change has serious implications for the way in which human subjects research can be conducted and, concomitantly, for the ways (...) in which such research may be regulated. This article explores some of these issues. (shrink)

Autonomy has been hailed as the foremost principle of bioethics, and yet patients’ decisions and research subjects’ voluntary participation are being subjected to frequent restrictions. It has been argued that patient care is best served by a limited form of paternalism because the doctor is better qualified to take critical decisions than the patient, who is distracted by illness. The revival of paternalism is unwarranted on two grounds: firstly, because prejudging that the sick are not fully autonomous is a biased (...) and unsubstantial view; secondly, because the technical knowledge of healthcare professionals does not include the ethical qualifications and prerogative to decide for others.Clinical research settings are even more prone to erode subjects’ autonomy than clinical settings because of the tendency and temptation to resort to such practices as shading the truth when consent to participation is sought, or waiving consent altogether when research is done in emergency settings.Instead of supporting such dubious practices with unconvincing arguments, it would seem to be the task of bioethics to insist on reinforcing autonomy. (shrink)

There is near universal recognition that human participant protection is both morally and practically essential for all forms of research involving humans. Yet most of the discourse around human participant protection has focussed on norms—rules, regulations and governance arrangements—rather than on the actual effectiveness of these norms in achieving their ends—protecting participants from undue risk and ensuring respectful treatment as well as advancing the generation of useful knowledge. In recent years there has been increasing advocacy for evidence-based human participant protection (...) that would be grounded on the careful investigation of the effects of research on human participants. We offer an analysis of evidence-based protection and then focus on Canadian examples of research on evidence-based protection. We consider the prospects for such research being put into practice in Canada. Finally we connect our remarks to the theme of “the changing landscape of human participant protection.”. (shrink)

In emergency research, obtaining informed consent can be problematic. Research to develop and improve treatments for patients admitted to hospital with life-threatening and debilitating conditions is much needed yet the issue of research without consent (RWC) raises concerns about unethical practices and the loss of individual autonomy. Consistent with the policy and practice turn towards greater patient and public involvement in health care decisions, in the US, Canada and EU, guidelines and legislation implemented to protect patients and facilitate acute research (...) with adults who are unable to give consent have been developed with little involvement of the lay public. This paper reviews research examining public opinion regarding RWC for research in emergency situations, and whether the rules and regulations permitting research of this kind are in accordance with the views of those who ultimately may be the most affected. (shrink)

ABSTRACT In this paper, I support the claim that placing certain restrictions on public access to possible new treatments is morally problematic under some exceptional circumstances. Very ill patients may find that all available standard treatments are unacceptable, either because they are ineffective or have serious adverse effects, and these patients may understandably be desperate to try something new even if this means stepping into the unknown. Faced with certain death, it is rational to want to try something new and (...) to chance a dire outcome. Restricting possible new treatments to research trials may put these treatments scientifically, geographically or economically out of reach of these patients. For those who can get access, research restrictions could weaken, though not necessarily eliminate, the value of consent participants of such trials are able to give. Some participants may therefore be exploited for scientific purposes in the name of public interest. There are nonetheless compelling reasons for keeping some restrictive regulation in this area. (shrink)