Medical problems and physiologic responses during supervised inpatient cardiac rehabilitation: the patient after coronary artery bypass grafting.
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Biomedical subjects
Publications and source records attributed to C Foster.
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Research ethics committees have to ensure that research projects are asking sensible questions and are designed so that the questions will be answered, that the research subjects who are involved will not come to unnecessary harm, and that the autonomy of the research subjects will be respected. Where research proposals cannot fulfill all these criteria, research ethics committees have to perform a delicate balancing act amongst competing moral claims. These arise when, for example, the research is non-therapeutic or the research subjects are incompetent to give consent. Given that the balance of conclusions is so sensitive, it is hardly surprising that different committees sometimes disagree with each other.
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A prospective multi-center study was conducted to assess the use of a catheter anchoring device. Fifty-nine patients with catheters ranging in size from 8 to 30 French used 164 devices. The device was easy to apply and remove, facilitated catheter repositioning, prevented tension at the insertion site, and did not cause skin problems in the majority of patients. Compared to previous methods used, the mean wear-time for all catheters increased by 2 days when the anchoring device was used. When wear-time was correlated to catheter diameter, type, and location it was seen that patients with non-urinary catheters of less than 20 Fr diameters benefitted most from this device. Patients with foley catheters had the shortest wear-times.
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OBJECTIVE: To generate baseline data about the standards of practice of local research ethics committees (LRECs) in order to describe accurately the situation of ethical review procedures prior to the establishment of multi-centre research ethics committees (MRECs). DESIGN: The LERECs in the South Thames NHS Region were asked to describe their current practices, and to send us a copy of their application forms and guidance notes for researchers. RESULTS: All of the 27 LRECs approached for the survey responded. The results indicate that there are generally high standards of practice, and that most LRECs work in accordance with published guidelines. CONCLUSION: The problems that researchers face in seeking to obtain ethical approval for multi-centre research (pages 242-5) do not seem to have been caused by substandard LRECs. Hence the new system needs to sustain the high standards of practice whilst confronting the difficulties.
OBJECTIVE: To generate baseline data about the experiences of researchers applying to five or more local research ethics committees (LRECs) for ethical review. The new multi-centre review system will be compared with these data. DESIGN: Ninety-seven researchers, whose status as multicentre researchers was unclear, were identified from various sources in the South Thames Region. They were each sent a questionnaire asking for their views on the substance of ethical review and their experiences of the process of ethical review. RESULTS: Of the completed questionnaires, 24 fitted the multicentre criteria of applying to five or more LRECs. Responses showed dissatisfaction with LRECs' treatment of the scientific aspects of research, but satisfaction with aspects relating to consent and protection of patients' welfare. Respondents experienced great difficulty in the administration of the process of ethical review. CONCLUSIONS: The need for a new system of ethical review for multi-centre research is beyond doubt. It remains to be seen whether it will be an improvement.