The protection of unrepresented patients in emergency care research

In emergency care research, it may be the case that neither informed consent nor surrogate consent is possible. In order to nonetheless allow for such research, codes and regulations of research ethics have increasingly incorporated provisions regarding this specific situation. The protection that those provisions offer need to be better understood. This article addresses in what ways they protect individuals, and especially the extent to which the suggested protection compensates for the loss of surrogate consent. The Declaration of Helsinki, the Additional Protocol to the Convention on Human Rights and Biomedicine, and the EU Clinical Trials Regulation serve as the main illustrations.     

Best Practice to Order Authors in Multi/Interdisciplinary Health Sciences Research Publications

Misunderstanding and disputes about authorship are commonplace among members of multi/interdisciplinary health research teams. If left unmanaged and unresolved, these conflicts can undermine knowledge sharing and collaboration, obscure accountability for research, and contribute to the incorrect attribution of credit. To mitigate these issues, certain researchers suggest quantitative authorship distributions schemes (e.g., point systems), while others wish to replace or minimize the importance of authorship by using “contributorship”—a system based on authors’ self-reporting contributions. While both methods have advantages, we argue that authorship and contributorship will most likely continue to coexist for multiple ethical and practical reasons. In this article, we develop a five-step “best practice” that incorporates the distribution of both contributorship and authorship for multi/interdisciplinary research. This procedure involves continuous dialogue and the use of a detailed contributorship taxonomy ending with a declaration explaining contributorship, which is used to justify authorship order. Institutions can introduce this approach in responsible conduct of research training as it promotes greater fairness, trust, and collegiality among team members and ultimately reduces confusion and facilitates resolution of time-consuming disagreements.     

Person-oriented research ethics: integrating relational and everyday ethics in research

Research ethics is often understood by researchers primarily through the regulatory framework reflected in the research ethics review process. This regulatory understanding does not encompass the range of ethical considerations in research, notably those associated with the relational and everyday aspects of human subject research. In order to support researchers in their effort to adopt a broader lens, this article presents a “person-oriented research ethics” approach. Five practical guideposts of person-oriented research ethics are identified, as follows: (1) respect for holistic personhood; (2) acknowledgement of lived world; (3) individualization; (4) focus on researcher-participant relationships; and (5) empowerment in decision-making. These guideposts are defined and illustrated with respect to different aspects of the research process (e.g., research design, recruitment, data collection). The person-oriented research ethics approach provides a toolkit to individual researchers, research groups, and research institutions in both biomedical and social science research wishing to expand their commitment to ethics in research.     

Who Cares about Consent Requirements for Sourcing Human Embryonic Stem Cells? Are Errors In the Past Really Errors Of the Past?

Through an Access to Information Act request, we have obtained the consent forms used by the providers of every human embryonic stem cell (hESC) line approved for use by the Canadian Institutes of Health Research (CIHR), and examined them to verify whether or not they meet the consent requirements established by Canadian law and regulations. Our findings show that at least seven out of ten consent forms studied did not satisfy these minimum requirements. We then outline various options for responding to this situation in terms of: (i) remedial measures for dealing with executive problems with regulatory oversight procedures; and (ii) remedial measures for dealing with the impugned lines.