Patient information sheet and consent form (original) (raw)
Related papers
Clinical study dossier (Clinical study protocol, Informed Consent Form)
Zenodo (CERN European Organization for Nuclear Research), 2022
Anonymisation the process by which personal data is irreversibly altered/anonymised in such a way that a data subject can no longer be identified directly or indirectly, either by the data controller alone or in collaboration with any other party. Biometric data personal data resulting from specific technical processing relating to the physical, physiological or behavioural characteristics of a natural person, which allow or confirm the unique identification of that natural person (The European Parliament and the Council of the European Union. General Data Protection Regulation-article 4). Consent means any freely given, specific, informed and unambiguous indication of the data subject's wishes by which he or she, by a statement or by a clear affirmative action, signifies agreement to the processing of personal data relating to him or her (The European Parliament and the Council of the European Union. General Data Protection Regulationarticle 4). CANTAB computerised neuropsychological testing (Cambridge Neuropsychological Test Automated Battery). Genetic data personal data relating to the inherited or acquired genetic characteristics of a natural person providing unique information about the physiology or the health of that natural person and which result, in particular, from an analysis of a biological sample from the natural person in question (The European Parliament and the Council of the European Union. General Data Protection Regulation-article 4). Personal Data any information relating to an identified or identifiable natural person ('data subject'); an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person (The European Parliament and the Council of the European Union. General Data Protection Regulationarticle 4). Processing any operation or set of operations which is performed on personal data or on sets of personal data, whether or not by automated means, such as collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction (The European Parliament and the Council of the European Union. General Data Protection Regulation-article 4). Processor a natural or legal person, public authority, agency, or other body which processes personal data on behalf of the controller (The European Parliament and the Council of the European Union. General Data Protection Regulation-article 4). Profiling any form of automated processing of personal data consisting of the use of personal data to evaluate certain personal aspects relating to a natural person, in particular to analyse or Project No. 964220 Title Clinical study dossier (Clinical study protocol, Informed Consent Form) Deliverable No. D5.1 Version 1 Project No. 964220 Title Clinical study dossier (Clinical study protocol, Informed Consent Form) Deliverable No. D5.1 Version 1
2022
The documents contains the informed consent forms provided to the participantes in the distinct phases of the clinical trial: 1) interview and EEG assessment, and 2) tDCS + cognitive training intervention phase.
Thérapie, 2009
Subjects taking part in biomedical research must be provided with legible and intelligible information enabling them to freely give their informed consent. At present, sponsors tend to provide many different types of information, not all of which is directly connected with or indeed really informative about studies for those taking part. As a result of this observation, a round table was convened during the Clinical Pharmacology meetings to deliberate on the creation of a charter concerning the drafting of information documents for biomedical research participants as well as a code of good practice for the preparation of such documents.
Thérapie, 2009
Subjects taking part in biomedical research must be provided with legible and intelligible information enabling them to freely give their informed consent. At present, sponsors tend to provide many different types of information, not all of which is directly connected with or indeed really informative about studies for those taking part. As a result of this observation, a round table was convened during the Clinical Pharmacology meetings to deliberate on the creation of a charter concerning the drafting of information documents for biomedical research participants as well as a code of good practice for the preparation of such documents.
Guidelines for Tailoring the Informed Consent Process in Clinical Studies
2021
These guidelines have been designed to provide information and evidence to assist with the development, or review of the consent process for use in clinical studies with human participants. These guidelines do not deal with issues related to informed consent in clinical practice. The guidelines have been developed by the i-CONSENT consortium. i-CONSENT (H2020, Grant Agreement number 741856) is a European Union H2020 funded program that aims to improve the information that individuals receive when deciding whether or not to take part in clinical studies.
Informed Consent: A Mandatory Step in Clinical Trials
Voluntary written consent given by potential subjects to participate in a clinical trial is known an informed consent. The informed consent process is designed keeping in mind the safety, benefits and rights of the research participants. Participants should sign the informed consent form only after they have thoroughly read and understood the content given in informed consent form and they should be able to utilize all the benefits and rights mentioned in the form. Research team should make an attempt to clarify the potential subjects about the difference between Clinical trial and Pharmacotherapeutics. This article contains the history, key elements, basic requirements, influential factors and obstacles of informed consent process.
Informed consent process in clinical trials: development of a patient-reported questionnaire
Farmacia hospitalaria : organo oficial de expresion cientifica de la Sociedad Espanola de Farmacia Hospitalaria, 2020
OBJECTIVE To develop a Spanish-language questionnaire aimed at evaluating patients' perception of the way they are briefed and their consent is obtained prior to participating in clinical trials. The tool was conceived to evaluate the following aspects: patients' personal experience, the way the informed consent process was implemented in practice, patients' level of satisfaction with the process, and their level of understanding of the study itself. METHOD This study looked into the development, adaptation and validation of a self-administered questionnaire intended to evaluate the informed consent process on the basis of information provided by respondents. The steps followed included: literature review, generation of an items pool, drawing up of the questionnaire, expert review, piloting, and reading ease optimization and analysis. A commonly-used English- language questionnaire was evaluated, translated into Spanish and adapted so as to determine the exten...
Comprehension of informed consent in clinical research
Revista Bioética, 2016
The informed consent form (ICF) is a document which explicitly confirms the consent of a participant in a research project, and should contain all necessary information clarifying the study in which the subject intends to participate. This study evaluates the level of comprehension of an ICF signed by 146 volunteers using a self-administered instrument. The average age of the sample was 47.29 years, and there was a prevalence of women (67.2%), incomplete primary education (53.4%) and no private health care (93.2%). The mean score of correct answers of 146 respondents was 53.1%. There was no association between the percentage of correct answers and the variables of gender, age, education and time of response. There was a significant association between taking the ICF home and the percentage of correct answers. The average value of correct answers found was not acceptable and educational measures must be implemented, seeking an increase in comprehension and the safety of participants.
Informed Consent: A Real Challenge in Clinical Trials
Informed consent is an agreement to do something or to allow something to happen only after all the relevant facts are known. It has a long history starting from early 1947 to till now with recent amendments. Informed consent play a major role in the clinical trials and is crucial factor on which the success of any clinical trials is dependent. It is classified in several types like parental consent, Assent, Verbal and short form among which to get a informed consent in assent type is a real challenge. Assent is a child’s (7-17yrs of age) affirmative agreement to participate in research and must be written at the appropriate reading level of the youngest subject in the age range using simplest terminologies. This review article discusses about the basic elements of informed consent and the process to be followed while obtaining informed consent.