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On-line version ISSN 1806-907X
Rev. Bras. Anestesiol. vol.58 no.2 Campinas Mar./Apr. 2008
Ethics Committee, conflict of interest, and registry of clinical assays
The resolution 196/96 of the National Health Board (CNS Conselho Nacional de Saúde) on Directives and Principles of Research on Humans) was instituted more than ten years ago, and incorporated four basic bioethical principles: autonomy, nonmaleficence, beneficence, and justice.
Some of those directives should be emphasized because, occasionally, they might be unknown by those dedicated to research in humans 1.
Informed Consent: indicates that the individual and/or his/her legal guardian agrees to participate in the study, without vice (simulation, fraud, or mistake), addiction, subordination, or intimidation, after complete and detailed explanation of the nature of the study, its objectives, methods, foreseen benefits, potential risks, and discomfort that it may cause, formulated in the terms of a consent agreeing to his/her voluntary enrollment.
Ethics Committees on Research (ECR) (Institutional Review Board IRB) interdisciplinary and independent council with an advisory, deliberative, and educational role, created to defend the interests of individuals participating in studies, their integrity and dignity, therefore guaranteeing that the studies remain within ethical standards.
Institutions involved in research in humans should institute one or more than one Ethics Committees on Research ECR, according to their needs.
If an ECR cannot be instituted, the institution or the researcher in charge should submit the study to the appreciation of the ECR of another institution, preferably one of those indicated by the National Committee of Ethics on Research (Comissão Nacional de Ética em Pesquisa CONEP/MS).
The ECR should have at least seven members, with health care professionals, and representatives of exact, social, and human sciences, including, for example, lawyers, theologians, sociologists, philosophers, bioethicists, and at least one member of society, representing those who use the institution. The ECR should be registered in the CONEP/MS.
The researcher should: a) present a study protocol to the ECR and await its ruling before starting the study; b) implement the study according to the protocol; c) present the data requested by the ECR at any time; d) keep the study data, along with all the documents recommended by the ECR, for 5 years; and e) submit the data for publication, giving credit to associate researchers and technical personnel; justify to the ECR the interruption of the study or non-publication of the results.
Research promotion agencies and the editorial board of scientific journals should request the ECR and/or CONEP documents approving the project.
Another important aspect of clinical studies, which is not included in the directives of the 196/96 resolution, is the concept of conflict of interest, which can be financial (direct or indirect) and non-financial. Conflict of interest can be defined as a clash between personal interests and the obligations of an individual in a position of trust 2. Conflict of interest arises when one or more than one of those involved with the project may it be researchers, or editor and/or reviewer of the journal in which the work will be published is connected to institutions or interests that might hinder the fairness of the study or restrict the competence or impartiality of his/her evaluation 3.
The direct or indirect relationship of the author, through the institution promoting the study, with companies that might eventually benefit from the results of the study is considered as a potential conflict of interest. The following types of relationships are considered as potentially conflicting and should be stated:
If in the prior two years one of the authors received consulting fees, was paid for conferences, writing texts, or provided any other paid services to the manufacturer of the product. If the researcher received any aid from the manufacturer of the product (research funds, equipment, drugs, labor workers) related to the current study or other study involving the same product. If the researcher received financial aid from the manufacturer of the product to participate in meetings. If the researcher owned stocks of the manufacturer. The manufacturer was involved in gathering, analysis, interpretation, or writing of the data. If the researcher is an employee of a company that might benefit, directly or indirectly, from the results of the study 4.
In general, there is a tendency to identify conflict of interest only as situations involving financial aspects. Other important aspects should be remembered, such as: personal, scientific, supportive, educational, religious, and social interests.
Editors might publish or not the information on conflict of interest submitted by the researchers according to their evaluation of whether the existing relationship might effectively influence the final result.
Finally, the Registry of Clinical Trials should also be mentioned. In 2004, the International Committee of Medical Journal Editors (ICMJE), a group that represents 11 renowned medical journals, stated that they would request the registry of clinical trials as a prerequisite for evaluating the work for publication 5. The accepted definition of a clinical trial was that of a project with prospective recruiting of subjects to study the cause-effect relationship between an intervention and the clinical outcome. In July 2005, the World Association of Medical Editors announced its support to the policy of requiring the registry of clinical trials. In 2006, the World Health Organization (WHO) announced the new standards for registry of clinical studies in humans, encouraging such registries.
In 2007, the ICMJE adopted the definition of clinical trials of the WHO, which includes preliminary trials (phase I): any study with prospective recruiting of subjects to undergo any health-related intervention (drugs, surgical procedures, equipment, behavioral therapies, changes in health care) to evaluate the effects on clinical outcomes (any biomedical or health-related parameter, including pharmacokinetic measurements and adverse reactions).
In 2007, BIREME recommended that all journals in the LILACS and SciELO database included the orientation for registry of randomized trials and clinical studies and that the identification number should be present after the summary.
To register a study, it is necessary to follow the steps proposed by the WHO, which developed a platform for the management of the addresses responsible for such registries (www.who.int/ictrp/en) 6. There are three portal groups to implement the registries.
The primary register that fulfill the standards of the WHO platform and of the ICMJE include:
Australian New Zealand Clinical Trials Registry
Chinese Clinical Trial Register (ChiCTR)
Clinical Trials Registry India (CTRI)
The data submitted by the ClinicalTrials.gov are included in the WHO search site, although it is not considered a primary register.
Another two groups are associated and potential registers, which are adapting themselves to the standards or requesting their inclusion, respectively.
The Latin American Clinical Trials Register (LatinRec) is included in the last group, and should be the preferential channel of researchers in Latin America and Caribe once it is approved.
All those steps, which apparently imprint a bureaucratic form to the primary impulse of the researcher to ask a question , are aimed at guaranteeing the safety of clinical trials, ensure to the study subjects that the information obtained from their altruism will be of public domain, and subsidize evidence-based medicine.
Key Words: BIOETHICS; MEDICAL ETHICS
Dr. Judymara Lauzi
Editor-in-Chief of the Brazilian Anesthesiology Journal
01. Conselho Nacional de Saúde Resolução 196/96 Diretrizes e Normas Regulamentadoras de Pesquisas Envolvendo Seres Humanos. Disponível em: <http://www.ufrgs.br/bioetica/res19696.htm>. Acesso em: 02 jan. 2008. [ Links ]
02. Houaiss A, Villar MS Dicionário Houaiss da Língua Portuguesa. Rio de Janeiro, Objetiva, 2001. [ Links ]
03. Alves EMO, Tubino P Conflito de interesses em pesquisa clínica. Acta Cir Bras, 2007;22: 412-415. [ Links ]
04. Normas de Vancouver Requisitos uniformes para originais submetidos a revistas biomédicas. Disponível em: <http://www.abem-educmed.org.br/rbem/normasdevancouver.htm>. Acesso em: 02 jan. 2008. [ Links ]
05. Guimarães CA Registro de ensaios clínicos. Rev Col Bras Cir 2007; 34:201- 204. [ Links ]