Ética em pesquisa na dinâmica do campo científico: desafios na construção de diretrizes para ciências humanas e sociais / Research ethics in the dynamic of scientific field: challenges in the building of guidelines for social sciences and humanities

ResumoA elaboração de diretrizes para a apreciação ética de pesquisas em ciências humanas e sociais (CHS) se efetiva no campo científico, espaço marcado por disputas voltadas ao estabelecimento do padrão hegemônico de cientificidade. No Brasil, cabe ao Conselho Nacional de Saúde aprovar essas diretrizes, o que envolve certas especificidades. Com base na vivência das autoras no Grupo de Trabalho CHS da Comissão Nacional de Ética em Pesquisa (GT CHS/CONEP), este manuscrito apresenta o processo de elaboração de uma resolução para CHS e alguns dos seus desafios: a distância entre a garantia legal e a efetivação de diretrizes; a hegemonia biomédica e a posição marginal das CHS no Sistema CEP/CONEP; a inadequação da atual resolução ante as características da pesquisa em CHS; e o emprego do conceito de risco, em diretrizes voltadas a CHS no espaço da saúde. Discutem-se ainda interfaces e tensões no debate entre mérito científico e avaliação ética. A análise evidencia importantes impasses e dificuldades concernentes ao diálogo interparadigmático na pesquisa em saúde, consideradas as características das distintas tradições, a ancoragem da CONEP na perspectiva positivista e a defesa da hegemonia dessa tradição.

AbstractThe development of guidelines on research ethics for social science and humanities (SSH) takes place in the scientific field, marked by disputes aimed at the establishment of hegemonic scientific standard. In Brazil, the National Health Council is responsible for approving these guidelines, which involve certain specificities. Based on the authors' experience in the SSH Working Group of the National Commission on Research Ethics (GT CHS / CONEP), this article presents the process of development of guidelines for SSH, and some its challenges: the distance between the statutory guarantee and the effective execution of guidelines; the biomedical hegemony and the marginal position of the SSH in the CEP / CONEP system; the inadequacy of the current resolution facing the research features in CHS; the use of the concept of risk in guidelines aimed at SSH in the health area. Some interfaces and tensions in the debate between scientific merit and ethical evaluation are also discussed. The analysis highlights important impasses and difficulties regarding inter-paradigmatic dialogue in health research, considered the characteristics of the different traditions, the CONEP's heavily relying on the positivist perspective and the defense of that paradigm hegemony.

Supplemental feeding with ready-to-use therapeutic food in Malawian children at risk of malnutrition.

The study was a controlled, comparative clinical effectiveness trial of two supplementary feeding regimens in children at risk of malnutrition from seven centres in rural Malawi. Being at risk of malnutrition was defined as weight-for-height <85%, but >80% of the international standard. A stepped-wedge design with systematic allocation was used for assigning children to receive either ready-to-use therapeutic food (RUTF) (n=331) or micronutrient-fortified corn/soy-blend (n=41) for up to eight weeks. The primary outcomes were recovery, defined as weight-for-height >90%, and the rate of weight gain. Children receiving RUTF were more likely to recover (58% vs 22%; difference 36%; 95% confidence interval [CI] 20-52) and had greater rates of weight gain (3.1 g/kg.d vs 1.4 g/kg x d; difference 1.7; 95% CI 0.8-2.6) than children receiving corn/soy-blend. The results of this preliminary work suggest that supplementary feeding with RUTF promotes better growth in children at risk of malnutrition than the standard fortified cereal/legume-blended food.

Spinal tuberculosis with neurological deficits.

Two hundred patients suffering from tuberculosis (TB) of the spine with neurological complications were the subjects of this review. They were graded according to the Frankel system into--A: complete neurological deficit; B: sparing of some sensation; C: sparing of sensation but no useful motor function; D: sparing of sensation and useful motor function; and E: no deficits. Investigations carried out included detailed neurological assessment, radiography, contrast myelography and, in the later stages of the study, spinal computerized tomography (CT) scan. The authors believe that contrast myelography provides the best indication of spinal compression in TB spine. Treatment was by surgical decompression followed by chemotherapy. The surgical approach for thoracic spine disease was by the anterior transthoracic route. Cervical lesions were also approached by the anterior route, lateral to the carotid vessels. Unexpected findings during operation included lymphoma, plasmacytoma, non-tuberculous granulation tissue, salmonella osteomyelitis and tumour metastasis. Ten patients died during the postoperative period, all of whom had extensive systemic TB. When indicated, antituberculous drugs were administered postoperatively for two years and immobilization was done in a plaster cast for 3 months. Only 30 patients showed partial recovery. Improvement was found to be related to the grade of deficit; thoracic lesions with severe neurological deficits showed the least improvement while lumbar disease had the best outcome. The study recommended a combination of surgery and chemotherapy for all cases of TB spine with neurological deficits after a short delay during which respiratory function should be improved. The surgery should aim at decompression of the cord by removal of pus, granulation tissue and sequestra, with internal splintage with bone grafts to reduce the hospital stay. Conservative treatment is unwise because it is not always possible to distinguish between TB and neoplastic lesions.

Epidemiological aspects of relapses in leprosy.

Life table methods in which the cumulative probability of relapse in successive periods is calculated are preferable to the presentation of overall relapse rates. Their use facilitates the comparison of relapse rates and trends from different studies independent of duration of follow-up. Results from various studies including data from Malawi indicate that, (1) unlike after dapsone monotherapy, the cumulative probability of relapse in multibacillary patients is near to zero after WHO/MDT if strict definitions of relapse are used and, (2) the cumulative probability of relapse may approach 5% in paucibacillary patients 10 years after completion of WHO/MDT. On the whole, the epidemiological relevance of relapses is insignificant and future treatment regimens should be evaluated concerning their efficacy in preventing disabilities rather than relapses.