title: [Registration of observational studies: it is time to comply with the Declaration of Helsinki requirement].
abstract: Publication bias is a serious deficiency in the current system of disseminating the results of human research studies. Clinical investigators know that, from an ethical standpoint, they should prospectively register clinical trials in a public registry before starting them. In addition, it is believed that this approach will help to reduce publication bias. However, most studies conducted in humans are observational rather than experimental. It is estimated that less than 2% out of 2 million concluded or ongoing observational studies have been registered. The 2013 revision of the Declaration of Helsinki requires registration of any type of research study involving humans or identifiable samples or data. It is proposed that funding agencies, such as the Fondo de Investigaciones Sanitarias, as well as private companies, require preregistration of observational studies before providing funding. It is also proposed that Research Ethics Committees which, following Spanish regulation, have been using the Declaration as the framework for assessing the ethics of clinical trials with medicines since 1990, should follow the same provisions for the assessment of health-related observational studies: therefore, they should require prospective registration of studies before granting their final approval. This would allow observational study investigators to be educated in complying with an ethical requirement recently introduced in the most important ethical code for research involving humans.
authors.affiliation: Investigación Clínica, Programa BUC (Biociencias UAM+CSIC), Centro de Excelencia Internacional, Universidad Autónoma de Madrid, Madrid, España. Electronic address: Rafael.dalre@fuam.uam.es.
authors.forename: Rafael
authors.initials: R
authors.lastname: Dal-Ré
authors.affiliation: Departamento de Ciencias de la Salud, Universidad de Jaén, Jaén, España; CIBER de Epidemiología y Salud Pública (CIBERESP), España.
authors.forename: Miguel
authors.initials: M
authors.lastname: Delgado
authors.affiliation: CIBER de Epidemiología y Salud Pública (CIBERESP), España; Unidad de Salud Pública, Universidad de Alcalá, Madrid, España.
authors.forename: Francisco
authors.initials: F
authors.lastname: Bolumar
mesh_terms: D028744:Ethics Committees, Research; D006381:Helsinki Declaration; D006805:Human Experimentation; D006801:Humans; D064887:Observational Studies as Topic / Q000592:standards; D017594:Publication Bias; D012042:Registries; D012109:Research Support as Topic
keywords: Biopharmaceutical industry; Chemical industry; Clinicaltrials.gov; Comité de ética de la investigación; Declaración de Helsinki; Declaration of Helsinki; Estudios observacionales; Financiadores; Funders; Industria biofarmacéutica; Industria química; Observational studies; Registro; Registry; Research ethics committee