Improving protection for research subjects in France: analysis of regional ethics committees.

OBJECTIVE: The aim of this study was to analyze the functioning of the French committees for the protection of people in biomedical research (CCPPRB). DESIGN: An independent evaluator visited all of the committees and analyzed their functioning by assessing the annual activity reports, filling data grids and observing the committees in session. RESULTS: We observed that the representation of a range of professions, which is required by law, was not always respected. This was partly because the administrative authority had accumulated delays in nominating members. Another explanation could be the absence of remuneration for the work and attendance of the members. There was considerable inter-committee variation concerning the way documents were distributed to the members during sessions and the extent of investigator and promoter involvement. Finally, large differences in the number of dossiers handled between committees led us to investigate the fairness of dossier distribution, as the number of dossiers dealt with has consequences, particularly for the finality of the opinions of the committees. CONCLUSIONS: This evaluation of the committees playing a crucial role in protecting participants in research trials provides new information that could be helpful for improving the way in which these committees function in the context of the European Directive.

[Ethics and handicap]. / Ethique et handicap.

The deprivation of numerous possibilities suffered by the severely-handicapped on account of their somato-psychic deficiency extends to many areas: mobility, relationships, autonomy in their everyday life, dependency, psychological or even mental consequences. The most elementary ethics would require to take all these deprivations into account, not just in the choice of accommodation structures but also in the behaviour of relatives and friends, or of qualified members of staff, in their approach to the handicapped. The range of application of these ethical rules must therefore extend from the quality of life and assistance, and the concern for efficiency of interventions, to the problems of security and securization, the assessment and the prevention of risks deriving from the handicap or its consequences, through the information of the patients regarding their elementary or specific rights, the introduction of the most favourable basis in order to make sure that they enjoy the dignity due to any human being, whatever his condition. Such a vast program requires a great many means of action, which all imply the recourse to the appropriate material and human assistance.

[Fluoride osteosis of hydro-telluric origin in a female patient with renal insufficiency. Apropos of a case with histomorphometric analysis]. / Ostéose fluorée d'origine hydro-tellurique chez une insuffisante rénale. A propos d'une observation avec analyse histomorphométrique.

We report a case of fluorosis due to high water and soil contents in a 23-year-old Algerian woman. The condition, which is infrequent at this age, was promoted by chronic renal failure due to a congenital renal malformation. Roentgenograms showing osteosis with increased bone density were suggestive of fluorosis rather than renal osteodystrophy. Bone tissue fluoride assay confirmed fluorosis. Histomorphometric analysis of bone biopsy specimens showed mixed lesions: major osteocondensation due to bone fluorosis and morphologic and dynamic osteomalacia related to the chronic renal failure.

[Anaphylactic reactions during hemodialysis: responsibility of the dialysis membrane (cuprophane)]. / Réactions anaphylactiques au cours de l'hémodialyse: responsabilité de la membrane de dialyse (cuprophane).

Iterative hemodialysis causes only exceptionally anaphylactic reactions. In those cases it has been possible to incriminate sterilizing agents (ethylene oxide, formaldehyde) and in a few cases the membrane. We report the case of one patient suffering from a chronic renal failure who had been undergoing hemodialysis treatment for more than six years in whom we noticed anaphylactic reactions at the beginning of each dialysis session carried on with cuprophan. We were able to use three different types of dialysis membranes: cuprophan, polyacrylonitrile and cellulose acetate, and two means of sterilization: ethylene oxide and gamma rays. The disorders we observed do not seem to be related to the phenomena usually observed during hemodialysis. The clinical signs linked with hypereosinophilia (13,000/mm3), hyperbasophilia (140/mm3) and an increase in total serum IgE disappeared when cuprophan membrane was replaced by cellulose acetate. One year later, hypereosinophilia had disappeared, hyperbasophilia had subsided, total IgE remained high. We conclude that IgE dependent anaphylaxis might be due to one component of the cuprophan membrane.

[Practical value of the determination of urinary fibrin degradation products in the early management of renal transplants]. / Intérêt pratique du dosage des produits de dégradation de la fibrine urinaire dans la surveillance précoce des transplantés rénaux.

We studied daily urinary excretion of fibrin degradation products (UFDP) during the first month following renal transplantation in 31 patients using the Merskey technique. After the 48 first hours a rise of UFDP was observed in 3 circumstances: 1) acute rejection: twenty-four acute rejections were observed in twenty-two patients. The increase of UFDP was constant. It preceeded the clinical diagnosis of rejection in 63 p. 100 of the patients. It has a predictive value in all cases. 2) Severe urinary infection. In 5 patients with urologic complications UFDP rose markedly. 3) Macroscopic hematuria. In 2 patients with gross hematuria very high rates of excretion were observed.

[Practical interest of the determination of urinary fibrin degradation products in the early monitoring of kidney transplants]. / Intérêt pratique du dosage des produits de dégradation de la fibrine urinaire dans la surveillance précoce des transplantés rénaux.

We studied daily urinary excretion of fibrin degradation products (UFDP) during the first month following renal transplantation in 31 patients using the Merskey technique. Passed the 48 first hours a rise of UFDP was observed in 3 circumstances: 1) acute rejection: twenty four acute rejections were observed in twenty two patients. The increase of UFDP was constant. It preceded the clinical diagnosis of rejection in 63 p. 100 of the patients. It has a predictive value in all cases. 2) Severe urinary infection. In 5 patients with urologic complications UFDP rose markedly. 3) Macroscopic hematuria. In 2 patients with gross hematuria very high rates of excretion were observed.

[Value of the assay of bone aluminum by pulse polarography]. / Intérêt du dosage de l'aluminium osseux par polarographie impulsionnelle.

Pulse polarography has been applied to the determination of aluminium in bone. The sensitivity, selectivity and reproducibility of the method are described. The results of bone aluminium concentrations in controls and in haemodialysed patients treated with aluminium compounds are discussed. Pulse polarography permits very precise measurements of aluminium impregnating bone.

[Measurement of aluminium in bone by pulse polarography (author's transl)]. / Intérêy du dosage de l'aluminium osseux par polarographie impulsionnelle.

Pulse polarography has been applied to the determination of aluminium in bone. The sensitivity, selectivity and reproducibility of the method are described. The results of bone aluminium concentrations in controls and in haemodialysed patients treated with aluminium compounds are discuted. Pulse polarography permits very precise measurements of aluminium impregnating bone.

[Importance of bone scanning with Tc 99m in the supervision of hemodialysis patients with chronic renal failure (author's transl)]. / Intérêt de la scinitgraphie osseuse au Tc 99 m dans la surveillance de l'insuffisant rénal chronique hémodialysé.

Bone uptake of 99 m Tc diphosphonate may allow early diagnosis of renal osteodystrophy. Our study deals with 53 patients treated by repeated hemodialysis and reveals scanning abnormalities in 75% of them. Bone scanning provides information which are not visualized radiologically, especially scattered or located pulmonary calcifications (15% in our series). It is valuable in the follow-up of bone changes and is part of the necessary investigations before carrying out parathyroidectomy.