Assuntos
DEET , Mordeduras e Picadas de Insetos/prevenção & controle , Administração Cutânea , Animais , Criança , Culicidae/efeitos dos fármacos , DEET/administração & dosagem , DEET/efeitos adversos , Dermatite de Contato/etiologia , Fármacos Dermatológicos/administração & dosagem , Fármacos Dermatológicos/efeitos adversos , Feminino , Humanos , Lactente , Masculino , Absorção CutâneaRESUMO
BACKGROUND: Research carries a small but definite risk of injury to participants. However, there is no unanimity amongst the stakeholders regarding the nature and extent of compensation to be provided to an injured participant. AIMS: To determine the extent to which issues related to the provision of free treatment and compensation for research-related injury are addressed in the protocols submitted to Ethics Committees (ECs). SETTING AND DESIGN: Retrospective review of protocols submitted to two ECs in India. MATERIAL AND METHODS: Initial protocols submitted to two ECs during the calendar years 2007 and 2008 were reviewed. Statements related to treatment and compensations for study-related injury were studied for adequacy regarding provisions for free emergency treatment, and free treatment and compensation for research-related injury. Presence of special conditions, exclusions, and caveats, if any, were noted. STATISTICAL ANALYSIS USED: The proportion of protocols providing free treatment and compensation for research-related injury was presented as a percentage. RESULTS: The Informed Consent Documents (ICD) of 138 protocols were accessed. These included 115 (83.33%) industry-sponsored, 20 (14.49%) government-sponsored and three (2.17%) investigator-initiated projects. Forty-six (33.33%) intended to provide free treatment for a trial-related injury. Forty-two (30.43%) projects did not have any policy about providing treatment for a trial-related injury, whereas several others included statements that intended to provide treatment, but with certain restrictions. Thirty-three (23.91%) ICDs had statements indicating that there was no provision for compensation and 65(47.10%) ICDs stated nothing on the issue. CONCLUSION: ICDs submitted for initial review are not in conformity with the provisions for treatment of and compensation for research-related injuries enunciated in national guidelines and draft guidelines.
Assuntos
Compensação e Reparação/legislação & jurisprudência , Ética em Pesquisa , Consentimento Livre e Esclarecido/legislação & jurisprudência , Responsabilidade Legal/economia , Sujeitos da Pesquisa/economia , Humanos , Índia , Consentimento Livre e Esclarecido/estatística & dados numéricos , Sujeitos da Pesquisa/legislação & jurisprudência , Estudos Retrospectivos , Fatores de RiscoRESUMO
India is considered as a preferred site for conducting global clinical trials. Existence of a large treatment-naïve population, availability of English-speaking, skilled doctors, plenty of clinical material, and cost-savings are obvious advantages for carrying out clinical research in India. However, challenges exist at various levels. Lack of formal training in bioethics and research methodology, heavy burden of clinical duties and sub-optimal administrative support restrict investigators. Absence of oversight of functioning of ethics committees (ECs) and lack of mechanisms for ensuring quality of ethics review heighten societal concerns about safety of participants. Conducting research on issues not relevant to local needs and failure to ensure post-trial access further enhance society's cynicism. These issues need to be tackled through capacity building, training of investigators and EC members, strengthening of EC functioning and encouraging greater community participation.