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Research in human subjects is at the core of achieving improvements in health outcomes. For clinical trials, in addition to the peer review of the results before publication, it is equally important to consider whether the trial will be conducted in a manner that generates data of the highest quality and provides a measure of safety for the participating subjects. In Canada, there is no definitive legislation that governs the conduct of research involving human subjects, but a network of regulations at different levels does provide a framework for both principal investigators and sponsors. In this paper, we provide an overview of the federal, provincial and institutional legislation, guidelines and policies that will inform readers about the requirements for clinical trial research. This includes a review of the role of the Food and Drug Regulations under the Food and Drugs Act and the Tri-Council Policy Statement (TCPS2), an overview of provincial legislation across the country, and a focus on selected policies from institutional research ethics boards and public health agencies. Many researchers may find navigation through regulations frustrating, and there is a paucity of information that explains the interrelationship between the different regulatory agencies in Canada. Better understanding the process, we feel, will facilitate investigators interested in clinical trials and also enhance the long-term health of Canadians.

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BACKGROUND: With emphasis on evidence-based medical care, 'evidence' is often the result of literature reviews. Hence, the critical question, "are literature reviews comprehensive?" AIM: This study compares the literature generated by a researcher and a health sciences librarian (HSL). METHODS: The Research Associate and the HSL conducted a parallel, segregated literature search on 'patient-centered care'. RESULTS: The Research Associate identified 215 manuscripts, and the HSL 129 manuscripts. Overlap was only 55 manuscripts. Differences in process and blind spots are discussed. CONCLUSION: To improve the quality of research outcomes, it seems prudent and ethical to have a synergistic collaboration between researchers and HSLs. Given that this is just one case study that has looked into the issue, further research is strongly encouraged.

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Resource allocation decisions have become increasingly necessary as the cost of health care habitually increases. Bilateral (second side) adult cochlear implantation (CI) is an example of a novel technology with accruing evidence of benefit, yet expense has limited universal employ. Currently at our centers, bilateral implantation is only provided under research protocol. In this article, we discuss the need for a principled approach concerning the distribution of a second device, both during this period of investigation and if ultimately an insured service. Allocation strategies, while extensively addressed in some arenas, have yet to be developed for second-side sequential adult CI. We advocate that physicians must assume an explicit role when both caring for individual patients as well as administering health care programs. We review social justice theories that inform resource allocation macrodecisions, and include a defence of age-based considerations. Our approach to patient selection for adult second-side CI sequentially considers clinical criteria (directly addressed in the article), a willingness to participate in rigorous research, and a 65 year cut-off. Ultimately, we employ random blinded selection for allocating bilateral CI among the remaining similarly situated individuals. This approach functions impartially and in a manner that is transparent for both patient and physician.

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The objective of this study was to conduct a broad-based systematic review of social, ethical, and legal considerations associated with genetic cancer risk assessment technologies (CaRATs). This paper focuses on psychosocial and ethical issues. Search results were limited to papers published in English, French, or German from January, 1990, to May, 2003. A quality assessment tool was developed and applied to retrieved papers. Application of the quality assessment tool resulted in 77 of 247 qualitative and quantitative primary research papers being reviewed and synthesized. A broad range of issues were addressed and grouped into content areas. Despite a large literature addressing psychosocial and ethical issues associated with CaRATs, many existing studies are not adequate to inform decision-makers and stakeholders. Careful policy analysis, as in some of the economic analyses reviewed here, is important to bridge this gap.

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It is common for drug trials to exclude older people, usually over 65 or 70. Many of the drugs which are successfully tested are then registered and become available either on prescription or over the counter. Healthcare professionals are left in a bind: either they do not prescribe the medications to those in the excluded age groups because of the lack of age-relevant data, or they prescribe, off-label, despite the lack of systematic collection of age-relevant data. Alternatively, if the pharmaceutical is available without prescription, older people may be buying without any inkling or warning that the drug was never tried on people of their own age. Either way, our older fellow citizens are not getting the same ethical treatment as younger adults. Compounding the questionable ethics involved is the fact that as age increases, the ratio of women to men increases. Amplified by the fact that women consume more pharmaceuticals than do men, the discrimination takes on a distinctively sexist slant as well as an ageist one. Two other groups often excluded from trials are (a) minors and (b) pregnant or lactating women. But the rationale for their exclusion is different from that for the exclusion of seniors. A major reason for these two groups' exclusion is the legal incapacity of the young to consent and the concomitant flow-on liability for injuries and damages to the youngsters. The potential exposure to later legal claims may be a strong motivating force for pharmaceutical companies to exclude from their trials people without legal capacity to consent. But the third group of people, seniors, is excluded by reference to their seniority not their inability to give informed consent. While the other two exclusions can be explained in terms of moral, social and legal conventions, seniority alone is based on two practical concerns: firstly, whether seniors are likely to die before the end of the trial, and secondly, the compounding effects of the so-called diseases of old age. Together, these concerns are thought to justify seniority exclusion in the interests of clean science. This paper examines some of the ethical issues, the implicit ageism and sexism in the exclusion of seniors. The discussion considers the ethical consequences of the exclusion, where seniors are either taking drugs in the absence of evidence-based trials on their age groups, or are denied drugs because they are untried on the age groups.

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