Alternatives of informed consent for storage and use of human biological material for research purposes: Brazilian regulation.

Informed consent is recognized as a primary ethical requirement to conduct research involving humans. In the investigations with the use of human biological material, informed consent (IC) assumes a differentiated condition on account of the many future possibilities. This work presents suitable alternatives for IC regarding the storage and use of human biological material in research, according to new Brazilian regulations. Both norms - Resolution 441/11 of the National Health Council, approved on 12 May 2011, and Ordinance 2.201 (NATIONAL GUIDELINES FOR BIOREPOSITORIES AND BIOBANKS OF HUMAN BIOLOGICAL MATERIAL FOR RESEARCH PURPOSE) of the Brazil Ministry of Health, approved on 14 September 2011 - state that the consent of subjects for the collection, storage and use of samples stored in Biobanks is necessarily established by means of a Free and Informed Consent Form (ICF). In order to obtain individual and formal statements, this form should contain the following two mutually exclusive options: an explanation about the use of the stored material in each research study, and the need for new consent or the waiver thereof when the material is used for a new study. On the other hand, ICF suitable for Biorepositories must be exclusive and related to specific research. Although Brazilian and international regulations identify the main aspects to be included in the IC, efforts are still necessary to improve the consent process, so that the document will become a bond of trust between subject and researcher.

Banco de encéfalos humanos: uma ferramenta importante para o estudo do envelhecimento cerebral / Banco de encéfalos humanos: una herramienta importante para el estudio del envejecimiento del cerebro / Bank of human encephala: an important tool for the study of brain aging

Para o melhor entendimento dos processos relacionados a senescência e à senilidade cerebral, o estudo do tecido cerebral é mandatório, tanto nos seus aspectos macroscópicos quanto microscópicos, sobretudo quando os dados encontrados na análise anátomo– patológica podem ser correlacionados com as condições clínico – funcionais dos indivíduos. De modo a propiciar ferramentas para o estudo do envelhecimento cerebral, foi criado o Banco de Encéfalos Humanos do Grupo de Estudos em Envelhecimento Cerebral da FMUSP (BEHGEEC), em 2003. O presente estudo tem como objetivo descrever a experiência do GEEC na criação e implementação de um banco deencéfalos humanos com fins de ensino e pesquisa e para tanto, relata a experiência do GEEC desde sua criação até seu funcionamento, apontando os procedimentos de coleta e processamento dos casos incluídos e suas rotinas de estudo, ensino e pesquisa. Palavras-chave: Encéfalo. Bancos de tecidos. Envelhecimento.

For a better understanding of processes related to senescence and to brain senility, the study of brain tissue is mandatory, regarding both the microscopic and the macroscopic aspects, over all when data found in anatomopathological analysis may be correlated to clinical-functional conditions of individuals. In order to make available tools for the study of brain aging, the Bank of HumanEncephala of the Group of Studies in Brain Aging of FMUSP was created (BEHGEEC) in 2003. The present study aims to describe the experience of GEEC in the creation and implementation of a bank of human encephala with purposes of teaching and research and for this it narrates the experience of GEEC since its creation until its functioning, pointing to procedures of collection and processing of cases and its routines of study, teaching and research. Keywords: Brain. Tissue banks. Aging.

Para una mejor comprensión de los procesos relacionados con la senectud y con la senilidad del cerebro, el estudio del tejido del cerebro es obligatorio, respecto a los aspectos microscópicos y a los macroscópicos, sobre todo cuando los datos encontrados en el análisis anatomopatológica se pueden correlacionar a las condiciones clínico-funcionales de los individuos. Para hacer las herramientas disponibles para el estudio del envejecimiento del cerebro, el banco de encéfalos humanos del grupo de estudios en el envejecimientodel cerebro de FMUSP (BEHGEEC) fue creado en 2003. Este estudio intenta describir la experiencia de GEEC en la creación y puesta en práctica de un banco de encéfalos humanos con propósitos de enseñanza y de investigación y para esto narra la experiencia de GEEC desde su creación hasta su funcionamiento, señalando a los procedimientos de la colección y del procesamiento de casos y a sus rutinasde estudio, enseñanza y investigación.Palabras llave: Encéfalo. Bancos de tejidos. Envejecimiento.

The impact of the International Atomic Energy Agency (IAEA) program on radiation and tissue banking in Cuba.

The first multi-tissue bank was founded at Havana in 1958. At that time, freeze-drying was used at the bank as a method of preserving, as well as Cobalt 60 irradiation to sterilise bone tissue, heart valves and others. The impact of the IAEA program in tissue banking activities in Cuba can be summarised as follows: (a) Increase in the production of sterilised tissues using ionising radiation (bone, pig skin and amnion) for medical treatment in the tissue bank of the Hospital Frank Pais; (b) increase of the quality of the productions of bone tissues, pig skin and amnion; (c) reduction in the import of tissues by increasing the local production of tissues; (d) sustainability in the number of donors through the implementation of a public and professional awareness campaign; (e) training of six persons in the Regional Training Centre of Buenos Aires; (f) qualification of one person in the administration of a tissue bank and in the implementation of a Quality System. The amount of tissues produced and sterilised using the ionising radiation techniques in the established banks was 25,510 units. The amount of patients treated with sterilised tissues produced by the established banks was 2,448.

The impact of the International Atomic Energy Agency (IAEA) program on radiation and tissue banking in Argentina.

Tissue banking activities in Argentina started in 1993. The regulatory and controlling national authority on organ, tissue and cells for transplantation activity is the National Unique Coordinating Central Institute for Ablation and Implant (INCUCAI). Three tissue banks were established under the IAEA program and nine other banks participated actively in the implementation of this program. As result of the implementation of the IAEA program in Argentina and the work done by the established tissue banks, more and more hospitals are now using, in a routine manner, radiation sterilised tissues processed by these banks. During the period 1992-2005, more than 21 016 tissues were produced and irradiated in the tissue banks participating in the IAEA program. Within the framework of the training component of the IAEA program, Argentina has been selected to host the Regional Training Centre for Latin American. In this centre, tissue bank operators and medical personal from Latin American countries were trained. Since 1999, Argentina has organised four regular regional training courses and two virtual regional training courses. More than twenty (20) tissue bank operators and medical personnel from Argentina were trained under the IAEA program in the six courses organised in the country. In general, ninety (96) tissue bank operators and medical personnel from eight Latin-American countries were trained in the Buenos Aires regional training centre. From Argentina 16 students graduated in these courses.

The impact of the International Atomic Energy Agency (IAEA) program on radiation and tissue banking in Chile.

The Tissue Banking Project in Chile started as an idea in 1996. Before 1996 in Chile there were only a few small bone banks working with their own standards of quality. The first tissue bank (LPTR) was established in 1998, with the technical and financial support of the IAEA. Since 2001, the laboratory began to produce tissues for clinical use, starting with the processing of 6 amniotic membranes, 2 femoral heads and 19 batches of pig skin. In 2002, the laboratory began the processing of human skin. Five students from Chile have graduated from training courses carried out in Singapore and in Buenos Aires under the IAEA training program since 1998. The amount of tissues produced and sterilized using ionizing radiation by the LPTR in the last years was 320,000 cm(2) of human skin, 553,600 cm(2) of pig skin, 5,400 cm(2) of amniotic membrane, 49 femoral heads, 3 large bones and 300 g of bovine bone. The patients treated with sterilized tissues produced by the LPTR were 200 deep burns treated with human skin and pig skin, 40 bone transplants from femoral heads, 77 ophthalmologic patients treated with amniotic membrane and 150 bovine bone transplants for dental treatments.

The impact of the International Atomic Energy Agency (IAEA) program on radiation and tissue banking in Mexico.

Tissue banking started in Mexico in 1948-1949, when two bone banks were established, one at the Infantile Hospital of Mexico and other at the Central Military Hospital. Mexico has benefited for the implementation of the IAEA program since through it has been able to settle down and to consolidate the Tissue Bank at the Instituto Nacional de Investigaciones Nucleares ININ (National Institute for Nuclear Research). This is the only bank in Latin America that has a Quality Management System in force, certified under ISO 9001:2000 since August 1, 2003. The first tissue processed was amnion. The main products of the BTR are amnion and pig skin. Both are biological tissues which their main use is as a wound dressing in patients with burns, scars, diabetic ulcers, epidermolysis bullosa, damaged ocular surface, etc. The General Health Law, published in 1984 and reformed in June 19, 2007, describes the procedure for the disposal of organs, tissues and human cadavers in its fourteenth title and in the Regulation for Sanitary Control. During the period 2001-2005, the ININ Tissue Bank produced 292 sterilised tissues (amnion, 86,668 cm(2), and frozen pig skin, 164,220 cm(2), at an estimated cost of 1,012,668 Mexican pesos. Until 2006, one hundred eighty five (185) patients have been treated with the use of sterilised tissues produced by the ININ Tissue Bank. The radiation source used for sterilisation of tissues is an industrial Cobalt-60 irradiator model JS-6500 AECL, which belongs to ININ. This equipment is located in other building, close to the BTR, in the Centro Nuclear de México "Dr. Nabor Carrillo Flores" (Nuclear Center of Mexico). Until 2006, six hospitals use in a routine way the sterilised tissues produced by the ININ Tissue Bank, for the treatment of burns originated by diverse agents like flame, electricity, liquids in boil, chemical reagents, as well as for the reconstruction of the ocular surface. Two of these hospitals treat patients of very low economic incomes, mainly needy individuals, who cannot afford to pay this type of treatments in other hospitals due to their high cost. The results obtained up to now are highly promising.

The impact of the International Atomic Energy Agency (IAEA) program on radiation and tissue banking in Peru.

The tissue bank "Rosa Guerzoni Chambergo" (RGCTB) located at the Child's Health Institute was inaugurated in 1996, with the financial and technical support of the IAEA program on radiation and tissue banking. Since 1998, the biological bandage of fresh and lyophilised pigskin, amnion and bone tissue is processed routinely in this bank. In all cases, the tissue is sterilised with the use of Cobalt-60 radiation, process carried out at the Laboratories of Irradiation of the Peruvian Institute of Nuclear Energy (IPEN). The tissue bank in the Child's Health Institute helped to save lives in an accident occurred in Lima, when a New Year's fireworks celebration ran out of control in January 2002. Nearly 300 people died in the tragic blaze and hundreds more were seriously burned and injured. Eight Lima hospitals and clinics suddenly were faced with saving the lives of severely burned men, women and children. Fortunately, authorities were ready to respond to the emergency. More than 1,600 dressings were sterilised and supplied to Lima surgeons. The efforts helped save the lives of patients who otherwise might not have survived the Lima fire. Between 1998 and September 2007, 35,012 tissue grafts were produced and irradiated. Radiation sterilised tissues are used by 20 national medical institutions as well as 17 private health institutions. The tissue bank established in Peru with the support of the IAEA is now producing the following tissues: pigskin dressings, fresh and freeze-dried; bone allografts, chips, wedges and powdered, and amnion dressings air-dried. It is also now leading the elaboration of national standards, assignment being entrusted by ONDT (Organización Nacional de Donación y Transplantes; National Organisation on Donation and Transplant). This among other will permit the accreditation of the tissue bank. In this task is also participating IPEN.

The impact of the International Atomic Energy Agency (IAEA) program on radiation and tissue banking in Brazil.

Until 2000, efforts into organising tissue banks in Brazil had not progressed far beyond small "in house" tissue storage repositories, usually annexed to Orthopaedic Surgery Services. Despite the professional entrepreneurship of those working as part time tissue bankers in such operations, best practices in tissue banking were not always followed due to the lack of regulatory standards, specialised training, adequate facilities and dedicated personnel. The Skin Bank of the Plastic Surgery Department of the Hospital das Clinicas of Sao Paulo, the single skin bank in Brazil, was not an exception. Since 1956, restricted and unpredictable amounts of skin allografts were stored under refrigeration for short periods under very limited quality controls. As in most "tissue banks" at that time in Brazil, medical and nursing staff worked on a volunteer and informal basis undergoing no specific training. IAEA supported the implementation of the tissue banking program in Brazil through the regional project RLA/7/009 "Quality system for the production of irradiated sterilised grafts" (1998-2000) and through two interregional projects INT/6/049 "Interregional Centre of Excellence in Tissue Banking", during the period 2002-2004 and INT/6/052 "Improving the Quality of Production and Uses of Radiation Sterilised Tissue Grafts", during the period 2002-2004. In 2001-2002, the first two years of operation of the HC-Tissue Bank, 53 skin transplants were carried out instead of the previous 4-5 a year. During this period, 75 individuals donated skin tissue, generating approximately 90,000 cm(2) of skin graft. The IAEA program were of great benefit to Brazilian tissue banking which has evolved from scattered make shift small operations to a well-established, high quality tissue banking scenario.

Protocolo de um banco de tecidos neoplásicos / Protocol for a tumor tissue bank

Um banco de tumores com organização sistematizada das informações permite a elaboração de pesquisas em câncer com conclusões sólidas e científicas. Assim, há a necessidade de um protocolo específico, cuja principal vantagem seria a de agregar informações qualificadas sobre o doador às amostras tumorais utilizadas para a pesquisa. O objetivo deste trabalho foi desenvolver um protocolo de procedimentos simples, confiável e reproduzível, para adquirir e armazenar amostras de tumores do sistema músculo-esquelético. O planejamento deste protocolo tem como base os dados da literatura relacionada a bancos de tecidos neoplásicos, no período de 1969 a 2005. Descreve a captação, armazenamento das amostras e o histórico do doador. O banco de tumores com um protocolo eficiente permite armazenar amostras de tecido normal e neoplásico, além de registrar dados referentes a pacientes com lesões neoplásicas. Além disso, possibilita o fornecimento, aos pesquisadores em câncer, de amostras de tecido em condições ideais para a pesquisa.

A Tumor Bank with systematic organization of data allows for the carrying out of cancer research with sound and scientific conclusions. The need thus arises for a specific protocol whose main advantage would be that of adding qualified donor information to tumor samples used in research. The purpose of this study was to develop a simple, reliable, and replicable procedures protocol to acquire and store samples of musculoskeletal tumors. The basis for the planning of this protocol comprises the information gathered in the literature relating to tumor tissue banks from 1969 to 2005. The paper describes the capture, storage, and donor background. The tumor bank with an efficient protocol allows to store both healthy and neoplastic tissue, and to record information relating to patients with neoplastic lesions. Furthermore, it enables supplying tissue samples in ideal research conditions.