A number of unique problems plague human research protection efforts at United States State and Territorial Departments of Health. The first problem is related to the number of Institutional Review Boards operated by and Federalwide Assurances held by DOHs. The lack of these two essential regulatory human research protection program mechanisms points to a possible inadequacy of infrastructure at DOHs for protecting human subjects. The second and third problems are related to the use and interpretation of research protection laws and (...) regulations at DOHs. Parsing public health activities into research or practice can be vexing and likely produces variability in how individual DOHs make the determination between research and practice and the outcomes of such decisions for the same or similar projects. A related problem is that DOH or Institutional Review Board officials might misclassify public health practice activities as research, which can have costly, adverse consequences. (shrink)

Abstract:Bioethicists are sometimes thought to have heightened obligations by virtue of the fact that their professional role addresses ethics or morals. For this reason it has been argued that bioethicists ought to “whistleblow”—that is, publicly expose the wrongful or potentially harmful activities of their employer—more often than do other kinds of employees. This article argues that bioethicists do indeed have a heightened obligation to whistleblow, but not because bioethicists have heightened moral obligations in general. Rather, the special duties of bioethicists (...) to act as whistleblowers are best understood by examining the nature of the ethical dilemma typically encountered by private employees and showing why bioethicists do not encounter this dilemma in the same way. Whistleblowing is usually understood as a moral dilemma involving conflicting duties to two parties: the public and a private employer. However, this article argues that this way of understanding whistleblowing has the implication that professions whose members identify their employer as the public—such as government employees or public servants—cannot consider whistleblowing a moral dilemma, because obligations are ultimately owed to only one party: the public. The article contends that bioethicists—even when privately employed—are similar to government employees in the sense that they do not have obligations to defer to the judgments of those with private interests. Consequently, bioethicists may be considered to have a special duty to whistleblow, although for different reasons than those usually cited. (shrink)

A number of unique problems plague human research protection efforts at United States (U.S.) State and Territorial Departments of Health (DOHs) problems which might be ameliorated through a consolidated national or regional, independent, not-for-profit Institutional Review Board (IRB).

All Canadian bioethicists need to reflect on the meaning and value of their work, to see more clearly how the ethics of bioethics is being undermined from within. In the case involving Dr Olivieri, the Hospital for Sick Children, the University of Toronto, and Apotex Inc, there were countless opportunities for bioethical heroism. And yet, no bioethics heroes emerged from this case. Much has been written about the hospital’s and the university’s failures in this case. But what about the deafening (...) silence from the Canadian bioethics community? Given the duty of bioethicists to “speak truth to power”, this silence is troubling. To date, nothing has been written about the silence. This article is intended as a partial remedy. As well, the article pays tribute to heretofore unsung heroes among Dr Olivieri’s research colleagues. (shrink)

In this pilot qualitative study 13 clinical bioethicists from across Canada were interviewed about their experiences of conflicts of interest and/or conflicting interests in their professional roles. The interviews generated five composite cases. Participants reported being significantly impacted by these experiences both personally and professionally.