Introduction: Variation across research ethics boards in conditions placed on access to medical records for research purposes raises concerns around negative impacts on research quality and on human subject protection, including privacy.Aim: To study variation in REB consent requirements for retrospective chart review and who may have access to the medical record for data abstraction.Methods: Thirty 90-min face-to-face interviews were conducted with REB chairs and administrators affiliated with faculties of medicine in Canadian universities, using structured questions around a case study (...) with open-ended responses. Interviews were recorded, transcribed and coded manually.Results: Fourteen sites required individual patient consent for the study to proceed as proposed. Three indicated that their response would depend on how potentially identifying variables would be managed. Eleven sites did not require consent. Two suggested a notification and opt-out process. Most stated that consent would be required if identifiable information was being abstracted from the record. Among those not requiring consent, there was substantial variation in recognising that the abstracted information could potentially indirectly re-identify individuals. Concern over access to medical records by an outside individual was also associated with requirement for consent. Eighteen sites required full committee review. Sixteen allowed an external research assistant to abstract information from the health record.Conclusions: Large variation was found across sites in the requirement for consent for research involving access to medical records. REBs need training in best practices for protecting privacy and confidentiality in health research. A forum for REB chairs to confidentially share concerns and decisions about specific studies could also reduce variation in decisions. (shrink)
BackgroundThe amount of research utilizing health information has increased dramatically over the last ten years. Many institutions have extensive biobank holdings collected over a number of years for clinical and teaching purposes, but are uncertain as to the proper circumstances in which to permit research uses of these samples. Research Ethics Boards (REBs) in Canada and elsewhere in the world are grappling with these issues, but lack clear guidance regarding their role in the creation of and access to registries and (...) biobanks.MethodsChairs of 34 REBS and/or REB Administrators affiliated with Faculties of Medicine in Canadian universities were interviewed. Interviews consisted of structured questions dealing with diabetes-related scenarios, with open-ended responses and probing for rationales. The two scenarios involved the development of a diabetes registry using clinical encounter data across several physicians' practices, and the addition of biological samples to the registry to create a biobank.ResultsThere was a wide range of responses given for the questions raised in the scenarios, indicating a lack of clarity about the role of REBs in registries and biobanks. With respect to the creation of a registry, a minority of sites felt that consent was not required for the information to be entered into the registry. Whether patient consent was required for information to be entered into the registry and the duration for which the consent would be operative differed across sites. With respect to the creation of a biobank linked to the registry, a majority of sites viewed biobank information as qualitatively different from other types of personal health information. All respondents agreed that patient consent was needed for blood samples to be placed in the biobank but the duration of consent again varied.ConclusionParticipants were more attuned to issues surrounding biobanks as compared to registries and demonstrated a higher level of concern regarding biobanks. As registries and biobanks expand, there is a need for critical analysis of suitable roles for REBs and subsequent guidance on these topics. The authors conclude by recommending REB participation in the creation of registries and biobanks and the eventual drafting of comprehensive legislation. (shrink)
Using 94 published empirical articles in academic journals as a data base, this paper provides a critical review of the methodology employed in the study of ethical beliefs and behavior of organizational members. The review revealed that full methodological detail was provided in less than one half of the articles. Further, the majority of empirical research articles expressed no concern for the reliability or validity of measures, were characterized by low response rates, used convenience samples, and did not offer a (...) theoretic framework, hypotheses, or a definition of ethics. Several recommendations, including a reviewer rating form addressing methodological decisions and inclusion of methodologists on the review panel, are offered to improve methodological rigor in published ethics research. (shrink)
We give a historical overview of the development of almost 50 years of empirical research on the affordances in the past and in the present. Defined by James Jerome Gibson in the early development of the Ecological Approach to Perception and Action as the prime of perception and action, affordances have become a rich topic of investigation in the fields of human movement science and experimental psychology. The methodological origins of the empirical research performed on affordances can be traced (...) back to the mid 1980’s and the works of Warren and Michaels. Most of the research in Ecological Psychology performed since has focused on the actualization of discretely defined actions, the perception of action boundaries, the calculation of pi-numbers, and the measurement of response times. The research efforts have resulted in advancements in the understanding of the dynamic nature of affordances, affordances in a social context and the importance of calibration for perception of affordances. Although affordances are seen as an instrumental part of the control of action most studies investigating affordances do not pay attention to the control of the action. We conclude that affordances are still primarily treated as a utility to select behaviour, which creates a conceptual barrier that hinders deeper understanding of affordances. A focus on action-boundaries has largely prevented advancement in other aspects of affordances, most notably an integrative understanding of the role of affordances in the control of action. (shrink)
Moreau sketches here with enthusiasm the large features of Aquinas’s epistemology. He is not, as he makes clear, a Thomist either by training or by avowal. The book is not, then, a specialist’s monograph or dogmatic treatise. It is Moreau’s attempt to hear what Aquinas will say to the great questions. The attempt is largely successful in attending to Aquinas’s remarks, though it does not catch their ambiguities.
This monograph presents itself as an account of the various roles played by notions of participation in Aquinas’s Summa contra Gentiles. Lazzaro intends that the study be one of a series which will track these notions through the whole of the Thomist corpus. To judge by his repeated references, Lazzaro seems also to conceive this project as a confirmation and amplification of the accounts already given by Cornelio Fabro. It is not entirely clear what Lazzaro intends to add to Fabro—perhaps (...) further "documentation," perhaps a few nuances of interpretation. (shrink)