What makes public health studies ethical? Dissolving the boundary between research and practice.

BACKGROUND: The generation of evidence is integral to the work of public health and health service providers. Traditionally, ethics has been addressed differently in research projects, compared with other forms of evidence generation, such as quality improvement, program evaluation, and surveillance, with review of non-research activities falling outside the purview of the research ethics board. However, the boundaries between research and these other evaluative activities are not distinct. Efforts to delineate a boundary - whether on grounds of primary purpose, temporality, underlying legal authority, departure from usual practice, or direct benefits to participants - have been unsatisfactory.Public Health Ontario has eschewed this distinction between research and other evaluative activities, choosing to adopt a common framework and process to guide ethical reflection on all public health evaluative projects throughout their lifecycle - from initial planning through to knowledge exchange. DISCUSSION: The Public Health Ontario framework was developed by a working group of public health and ethics professionals and scholars, in consultation with individuals representing a wide range of public health roles. The first part of the framework interprets the existing Canadian research ethics policy statement (commonly known as the TCPS 2) through a public health lens. The second part consists of ten questions that guide the investigator in the application of the core ethical principles to public health initiatives.The framework is intended for use by those designing and executing public health evaluations, as well as those charged with ethics review of projects. The goal is to move toward a culture of ethical integrity among investigators, reviewers and decision-makers, rather than mere compliance with rules. The framework is consonant with the perspective of the learning organization and is generalizable to other public health organizations, to health services organizations, and beyond. SUMMARY: Public Health Ontario has developed an ethics framework that is applicable to any evidence-generating activity, regardless of whether it is labelled research. While developed in a public health context, it is readily adaptable to other health services organizations and beyond.

Informed consent, capitation, and conflicts of interest in clinical trials: views from the field.

BACKGROUND: The beliefs of research team members about informed consent practices are not well studied, especially in regard to financial aspects of research such as capitation fees. Sponsors of research offer capitation fees for the enrollment of subjects, and although this money is intended to cover the costs of the research it can sometimes be used in other ways. There is no clear consensus about whether this financial aspect of trials should be part of the informed consent process or whether it represents a potential conflict of interest. METHODS: We presented several hypothetical cases to members of the American College of Surgeons Oncology Group (ACOSOG) at a semi-annual meeting. ACOSOG is a federally funded clinical trials group evaluating surgical and adjuvant methods of cancer treatment. The meeting included surgeons, nurses, case managers, and others involved in clinical surgical trials. RESULTS: We found that most respondents believed that it would be a violation of the protocol to enroll a subject who showed lack of recall about the study. Most respondents also favored disclosure of capitation fees, especially if those fees went into discretionary accounts, but there was some disagreement about the benefit of that disclosure to potential participants. CONCLUSIONS: This study shows the need for greater work in ensuring that research team members share common understandings about informed consent. It also shows that most of these research team participants are prepared to make more disclosure about financial aspects of research than current standards in fact require.

Resource development in otolaryngology-head and neck surgery: an analysis on patient education resource development.

BACKGROUND: There is a need for educational tools in the consenting process of otolaryngology-head and neck procedures. A development strategy for the creation of educational tools in otolaryngology-head and neck surgery, particularly pamphlets on the peri-operative period in an adenotonsillectomy, is described. METHODS: A participatory design approach, which engages key stakeholders in the development of an educational tool, is used. Pamphlets were created through a review of traditional and grey literature and then reviewed by a community expert in the field. The pamphlets were then reviewed by an interdisciplinary team including educational experts, and finally by less vulnerable members of the target population. Questionnaires evaluating the pamphlets' content, layout, style, and general qualitative features were included. RESULTS: The pamphlets yielded high ratings across all domains regardless of patient population. General feedback was provided by a non-vulnerable patient population and final pamphlets were drafted. CONCLUSIONS: By using a participatory design model, the pamphlets are written at an appropriate educational level to incorporate a broad audience. Furthermore, this methodology can be used in future resource development of educational tools.

Introducing student nurses to operating department nursing.

The shortage of nurses is a major problem faced by the National Health Service. This also impacts on the shortage of theatre nurses where lack of recruitment and retention are threatening their existence (Montgomery 1997). Recruitment has not previously posed a problem in the operating department where the author works, due to pre-registration diploma nurses (PRDN) being allocated to the department as part of their critical care placement. Many of these students have been appointed to work in the operating theatre once qualified. However, due to changes in nurse education, students are now able to choose their placement.

The uncertainty of radio frequency treatment of renal cell carcinoma: findings at immediate and delayed nephrectomy.

PURPOSE: Radio frequency thermal therapy for the ablation of renal cell carcinoma has been reported. Outcomes are usually measured by imaging alone. We have performed ex vivo and in vivo experiments using radio frequency in porcine models in our laboratory. We now report our early experience in the treatment of renal cell carcinoma in patients who underwent post-radio frequency radical or partial nephrectomy. MATERIALS AND METHODS: We treated 10 patients diagnosed with small renal masses with radio frequency. All masses were biopsied before treatment. In 4 patients 5 renal cell carcinomas were treated with radio frequency after surgical exposure of the tumor followed immediately by partial or radical nephrectomy (acute group). Six other patients were treated percutaneously with ultrasound or computerized tomography guided radio frequency under local anesthesia and intravenous sedation 7 days before partial or radical nephrectomy (delayed group). A median of 2 radio frequency cycles was applied. Mean total heating time was 17 minutes 15 seconds. Specimens were analyzed grossly and histologically. Triphasic contrast-enhanced computerized tomography and/or magnetic resonance imaging was performed before and 7 days after radio frequency treatment in the delayed group. RESULTS: Mean radiological largest diameter of all 11 masses was 2.4 cm. and mean gross diameter was 2.2 cm. Pathological examination demonstrated residual viable tumor in approximately 5% of the volume in 4 of the 5 tumors in the acute group and in 3 of the 6 masses of the delayed group. In 1 delayed case the viable tumor appeared to be in contact with the renal vein. No significant complications were observed in 9 of the 10 patients. In 1 delayed case, a subcapsular hepatic hematoma, biliary fistula and pneumonia developed and resolved. CONCLUSIONS: Based on our experience, we continue to consider percutaneous radio frequency for the treatment of small renal cell carcinomas as a potentially curative therapy. However, complete tumor cell death appears to be difficult to achieve with our current treatment protocol. More phase II testing is indicated to ensure that this technique is an effective and reproducible treatment alternative.