Silvana Ferreira Bento

Exclusive breastfeeding among working women with free daycare available at workplace

OBJETIVO: Investigar os fatores relacionados a decisao das mulheres em amamentar e a duracao planejada e, de fato observada, do aleitamento exclusivo entre trabalhadoras que dispoem de creche na empresa. METODOS: Estudo qualitativo no qual se comparou um grupo de 15 trabalhadoras cujos bebes estavam sendo alimentados apenas com leite materno quando comecaram a frequentar a creche da empresa com outro similar que incluia mulheres cujos bebes que, ao ingressar, ja estavam recebendo, alem do leite materno, outros alimentos. Foram realizadas entrevistas semi-estruturadas e grupos focais. RESULTADOS: Evidenciaram-se como fatores relacionados a decisao de iniciar a amamentacao e mante-la ao retornar ao trabalho: o desejo de amamentar, embasado no valor que as mulheres dos dois grupos atribuiam ao aleitamento materno, bem como seus maridos e outras pessoas significativas (por exemplo: mae, irma, amigas). A duracao do aleitamento exclusivo relacionou-se principalmente a orientacao do pediatra que cuidava do bebe, que foi distinta em cada um dos grupos estudados. CONCLUSAO: A existencia da creche no local de trabalho aparece como elemento relevante para a manutencao do aleitamento apos a licenca de maternidade, especialmente o materno exclusivo. A decisao sobre quanto tempo amamentar de forma exclusiva esteve relacionada as informacoes recebidas acerca do assunto antes e durante a gestacao, e no pos-parto. A diferenca entre os dois grupos estudados foi que as mulheres que mantiveram o aleitamento exclusivo por quase seis meses acreditavam que quanto mais tempo dessem somente o leite materno, mais beneficios o bebe teria, enquanto as mulheres do outro grupo acreditavam que tres meses de aleitamento exclusivo eram suficientes.

Esterilização cirúrgica voluntária na Região Metropolitana de Campinas, São Paulo, Brasil, antes e após sua regulamentação

This cross-sectional study compared the provision of surgical sterilization in public health services in Greater Metropolitan Campinas, São Paulo State, Brazil, and the characteristics of women and men who underwent sterilization before and after its legal regulation. Structured and pre-tested questionnaires were applied to 398 women, 15 directors of municipal family planning programs, and 15 coordinators of basic health units. Eight municipalities in Greater Metropolitan Campinas provided tubal ligation and nine performed vasectomy. Approximately half reported following the guidelines of the prevailing family planning legislation. There were no significant differences before or after legal regulation in terms of the characteristics of women and men sterilized or the waiting time for surgery. Most tubal ligations were still performed in combination with cesarean sections (the additional payment for sterilization had decreased, but the difference was not significant). There is strong evidence that in Greater Metropolitan Campinas the changes expected from legal regulation of surgical sterilization did not materialize. Although progress has been made, several distortions still need to be corrected.

Comitês de Ética em Pesquisa: adequação à Resolução 196/96

PURPOSE: This article intends to evaluate the structure, functioning and performance of 17 Institutional Review Boards (IRB), from the viewpoint of their presidents, in relation to the instructions of Resolution 196/96 of the National Council of Health, Ministry of Health, Brazil. METHODS: Presidents of 33 IRBs, that evaluated proposals for research on fertility control, were indicated by the professionals responsible for the area of gynecology in 46 Brazilian medical schools and by the directors of four research centers on human reproduction . A letter with a questionnaire were sent to the presidents, asking them to volunteer for the study. RESULTS: Seventeen presidents completed the questionnaire. Results disclosed a series of violations of Resolution 196/96. Three IRBs did not include representatives of the community among their members; four took over a month to release the Boards decision on proposals and 13 did not follow-up the studies. Composition and filing of the research proposals were in agreement with the Resolution. However, in eight IRBs time of mandate differed from that set forth in the Resolution. Almost all presidents (about 14 of the 17) thought that the composition and activities of their IRBs were adequate. Eleven considered the Resolution appropriate but difficult to comply with. CONCLUSION: These results suggest that an extensive debate on the operational viability of the Resolution would be timely. This endeavor could bring forth valuable suggestions for the improvement and applicability of the Resolution contributing to the improvement of the scientific and ethical quality of research.

Provision of voluntary surgical sterilization in the Campinas Metropolitan Area, São Paulo State, Brazil: perceptions of public health services managers and professionals

This study describes the perceptions of public health services managers and professionals concerning provision of voluntary surgical sterilization in the Campinas Metropolitan Area, São Paulo State, Brazil. The study adopted a qualitative approach in four municipalities (counties), where semi-structured interviews were conducted with 26 health professionals and health services managers involved in the provision of surgical sterilization. The interviewees identified difficulties in scheduling visits at Outpatient Family Clinics or Reference Centers (APF/CR), and the number of available surgeries in the accredited hospitals was insufficient. They emphasized the lack of physical infrastructure and human resources for conducting family planning activities in the primary health units as well as in the APF/CR.They also criticized the legal criteria for authorizing surgical sterilization, and mentioned adaptations to make them more appropriate to the each municipalitys situation. According to the health services managers and professionals, despite the efforts, meeting the demand for surgical sterilization in the Campinas Metropolitan Area was jeopardized by its centralization in the APF/CR, which in practice had to cover the gap in family planning activities in each municipalitys primary care units.

PROCESS FOR OBTAINING INFORMED CONSENT: WOMEN’S OPINIONS

UNLABELLED In Brazil, every study involving human beings is required to produce an informed consent form that must be signed by study participants: this is stated in Resolution 196/96.(1) Consent must be obtained through a specific structured process. OBJECTIVE To present the opinions of women regarding how the process of obtaining informed consent should be conducted when women are invited to participate in studies on contraceptive methods. SUBJECTS AND METHODS Eight focus groups were conducted, involving a total of 51 women living in the metropolitan region of Campinas. The women involved in the study were either participating in a clinical trial in the area of womens health or had participated in such a trial in the previous 12 months. A thematic guide was used to conduct the focus group discussions; the discussions were recorded, transcribed and a thematic analysis performed. RESULTS In general, the person who invites a woman to participate in a study should be a member of the research team but not the principal investigator. Information relating to the study should be given orally and in writing, both individually and in the group setting. Study volunteers should be informed about, among other things, the risks, possible side effects and discomforts, including long-term effects. The use of audiovisual aids to provide information was suggested. CONCLUSION The process for obtaining informed consent was seen as a means of establishing a relationship between the volunteers and the investigator/research team. The information that the study participants expected to be given coincides with the requirements established under Resolution 196/96. The use of audiovisual aids would improve understanding of the information provided.

Consentimento Informado Normatizado pela Resolução 196/96: Conhecimento e Opinião de Pesquisadores Brasileiros

Introduction: the Resolution 196/96 of the Conselho Nacional de Saude (National Council of Health/Ministry of Health) presents the main Brazilian guidelines on research involving human subjects, including the content of written informed consent. Purpose: to present the knowledge and opinion of Brazilian researchers on the contents of Resolution 196/96, specifically related to the informed consent form. Subjects and methods: forty-six doctors responsible for the area of gynecology at Brazilian universities, four directors of research centers and 31 researchers who participated in a study related to fertility regulation during the 12 months preceding September, 2000. Subjects completed a self-reporting questionnaire. Data were analyzed by the c2 test. Results: most subjects declared that they knew the Resolution 196/96 and considered it adequate, although difficult to comply with; they considered that all studies should have an informed consent form, and knew that its content should guarantee confidentiality. More researchers than those responsible for gynecology department/directors knew that the informed consent form should be prepared by the principal investigator. Significantly more responsible for gynecology department/directors than researchers declared that subjects must always sign (or put their thumb print if they do not know how to write) on the informed consent form. Subjects declared that payment of expenses resulting from participation in a study must always be explained in the informed consent form. Conclusion: despite the wide dissemination of the Resolution 196/96, it was not known by all the researchers nor by all those responsible for gynecology departament/directors. The majority agreed with the contents required by the Resolution for the informed consent form.

Adolescentes como voluntários de pesquisa e consentimento livre e esclarecido: conhecimento e opinião de pesquisadores e jovens

This article presents the results of a study that evaluated the knowledge and opinions of researchers and adolescents that served as their research subjects on the legal norms that regulate the participation of the latter as research subjects, the capacity of adolescents to make autonomous decisions regarding participation, and the adolescent experience after agreeing to take part in a study. This was a qualitative study with a convenience sample, the size of which was defined by the criteria of informational redundancy. Interviews were conducted with three researchers who had used adolescents as research subjects and nine of these subjects. This number of interviews was sufficient to reach informational redundancy. Data was collected through recorded semi-structured interviews, with open questions. All the researchers were familiar with some legal document related to the participation of adolescents as subjects of research. On the other hand, the adolescents were surprised because they were not aware of the existence of such documents. However, they considered them necessary for their own protection. In general, researchers and adolescents believe that adolescents have the capacity to decide autonomously to participate as research subjects. The adolescents affirmed that they had decided to volunteer conscientiously.

Consentimento livre e esclarecido: experiência de pesquisadores brasileiros na área da regulação da fecundidade

O objetivo deste estudo foi avaliar a experiencia de pesquisadores com a apreciacao do protocolo por um Comite de Etica em Pesquisa (CEP); com a elaboracao do Termo de Consentimento Livre e Esclarecido (TCLE) e com a obtencao do consentimento, e verificar se o conteudo do TCLE estava de acordo com as exigencias da Resolucao 196/96. Trinta e quatro pesquisadores completaram um questionario auto-respondido, enviado por correio eletronico. Quase todos os participantes (91%) relataram que o protocolo desse estudo havia sido avaliado por um CEP. Mais da metade deles referiram que o TCLE utilizado havia sido recebido pronto; que o consentimento do possivel sujeito havia sido obtido pelo pesquisador responsavel, e que os sujeitos haviam recebido uma copia do Termo assinada. Cerca da metade dos participantes afirmaram que a forma de ressarcimento das despesas dos sujeitos, decorrentes da participacao na pesquisa, e 44% disseram que as formas de indenizacao, no caso de eventuais danos, constavam no Termo. De acordo com o relato dos participantes, em geral as exigencias da Resolucao avaliadas haviam sido cumpridas.O objetivo deste estudo foi avaliar a experiencia de pesquisadores com a apreciacao do protocolo por um Comite de Etica em Pesquisa (CEP); com a elaboracao do Termo de Consentimento Livre e Esclarecido (TCLE) e com a obtencao do consentimento, e verificar se o conteudo do TCLE estava de acordo com as exigencias da Resolucao 196/96. Trinta e quatro pesquisadores completaram um questionario auto-respondido, enviado por correio eletronico. Quase todos os participantes (91%) relataram que o protocolo desse estudo havia sido avaliado por um CEP. Mais da metade deles referiram que o TCLE utilizado havia sido recebido pronto; que o consentimento do possivel sujeito havia sido obtido pelo pesquisador responsavel, e que os sujeitos haviam recebido uma copia do Termo assinada. Cerca da metade dos participantes afirmaram que a forma de ressarcimento das despesas dos sujeitos, decorrentes da participacao na pesquisa, e 44% disseram que as formas de indenizacao, no caso de eventuais danos, constavam no Termo. De acordo com o relato dos participantes, em geral as exigencias da Resolucao avaliadas haviam sido cumpridas.This study aimed to evaluate the experience of Brazilian researchers in relation to: assessment of the research protocol by a research ethics committee with the elaboration of a free informed term of consent (FITC) and the process of obtaining consent, as well as to verify whether the content and wording of the term of consent complies with Federal Ruling 196/96. Thirty-four researchers filled out a questionnaire and returned it by electronic mail. The vast majority of the respondents (91%) reported that the respective study protocol had been evaluated by a research ethics committee. More than half reported that they had received a previously prepared FITC; that consent from potential study subjects had been obtained by the researcher in charge; and that the subjects had received a copy of their signed FITC. Approximately one half of participants stated that the form of reimbursement of subjects was specified in the FITC, and 44% reported the same in relation to occasional damages resulting from the study. According to participants, in general the provisions of Ruling 196/96 had been met.

Consentimento Informado na Pesquisa Clínica: Teoria e Prática

Purpose: to evaluate the agreement between the theory about informed consent, represented by Resolution 01/88, and the practice according to the report of researchers and of women who were subjects of their research. Methods: eleven researchers from three centers of excellence in research related to fertility regulation in Brazil and 18 women, subjects of their research. Information was obtained through in-depth interviews and content analysis was carried out. Results: the report of the researchers agreed with the requirements of the Resolution; however, the womens report showed that most of the required items were not referred to when they were invited to participate in the research. Conclusion: a disagreement was observed between theory and practice in obtaining informed consent. This may be explained by difficulties in complying with the requirements of the Resolution in force at the time. On the other hand, it is also possible to imagine difficulties experienced by researchers when approaching the women and/or that the women also forgot the received information. Finally, a bias may have resulted from the researchers and women who had to give consent to participate in this study.

Filling out the compulsory notification in health services that care for women who suffer from sexual violence

OBJECTIVE To evaluate the proportion of health services that fill out the compulsory notification and what the main difficulties to fill it out are. METHODS A study was carried out with two different approaches. For the quantitative approach, a cross sectional study was performed, with telephone data collection. In the state of São Paulo, 291 health services that had reported providing care to women who suffer from sexual violence were identified. The sample was composed of 172 services that reported providing emergency care to women. In the qualitative approach, case studies were conducted. Six cities were chosen by intention and convenience. For each of them, professionals from two health services were invited to participate. Forty-five semi-structured interviews were conducted. For quantitative data, a descriptive analysis was carried out. For qualitative data, a thematic analysis of content was performed. RESULTS The proportion of health services which reported always filling out the notification in cases of sexual violence was 79.1%. More than half (53.5%) reported difficulties concerning the assisted women, one third reported reasons related to the form, and 29.7%, to the professionals. In the qualitative approach, the main difficulties were the size of the form, the problems to obtain the information about the woman and the difficulty for the professional to obtain this information. CONCLUSION Although most health services claimed to fill out the compulsory notification, they also mentioned several difficulties to do so, especially with regard to the workload of professionals and the misunderstanding about the importance of the notification in the context of comprehensive care to women who suffer from sexual violence. OBJECTIVE To evaluate the proportion of health services that fill out the compulsory notification and what the main difficulties to fill it out are. METHODS A study was carried out with two different approaches. For the quantitative approach, a cross sectional study was performed, with telephone data collection. In the state of São Paulo, 291 health services that had reported providing care to women who suffer from sexual violence were identified. The sample was composed of 172 services that reported providing emergency care to women. In the qualitative approach, case studies were conducted. Six cities were chosen by intention and convenience. For each of them, professionals from two health services were invited to participate. Forty-five semi-structured interviews were conducted. For quantitative data, a descriptive analysis was carried out. For qualitative data, a thematic analysis of content was performed. RESULTS The proportion of health services which reported always filling out the notification in cases of sexual violence was 79.1%. More than half (53.5%) reported difficulties concerning the assisted women, one third reported reasons related to the form, and 29.7%, to the professionals. In the qualitative approach, the main difficulties were the size of the form, the problems to obtain the information about the woman and the difficulty for the professional to obtain this information. CONCLUSION Although most health services claimed to fill out the compulsory notification, they also mentioned several difficulties to do so, especially with regard to the workload of professionals and the misunderstanding about the importance of the notification in the context of comprehensive care to women who suffer from sexual violence.