Request an Ethical Approval
SUBMISSION FORM FOR RESEARCH PROJECT OR STUDY
Note on the use of this form
This form is intended as a support tool for the preparation and submission of research projects/studies to the Ethics Committee: Technology, Social Sciences and Humanities (CETCH-UCP), to clarify the minimum elements to be submitted. It does not replace the presentation of the research protocol, as a document that should describe the justification, objectives, design, methodology, monitoring, organization and conduct of a study, and on which the specific assessment of this Committee will focus.
As a complement to the research project/study, and as described in this form, the instructional elements that must instruct the request for assessment and opinion by the CETCH-UCP, in addition to the protocol, as complete as possible, are the following documents, when applicable:
- Forms, scales, surveys or other data collection documents, with reference to the previous validation of the instrument and authorization for its use;
- Timetable for the study/research project
- Model of informed consent to be applied;
- Model of the written information to be provided to the participants;
- Favorable opinion or authorization from the person(s) responsible in the entity(ies) where the study or research project will be developed, if applicable;
- Data protection impact assessment, and if applicable, the result of the prior consultation, or, if you consider that it is not necessary to conduct an impact assessment, justification as to why it is not necessary;
- Declaration of the researcher on the conditions of confidentiality of the data obtained in the strict context of the project/study, on access to them and the terms of their elimination;
- Declaration of conflict of interest (e.g., when existing, declaration of any connection, academic, professional or other, of the investigators to the entity sponsoring their funding);
- When applicable, declaration of the study supervisor(s);
- CV of the principal investigator and, where applicable, CV synopsis of all members of the research team (these documents must be signed and dated less than one year ago);
- Other documentation or information considered pertinent by the investigator or that the CETCH-UCP considers necessary, namely that related to the elements mentioned in article 16 no. 6 and 7 of the Clinical Research Law (Law no. 21/2014 of April 16).
It is advisable to read the Free and Informed Consent Model, approved by CETCH-UCP.
Processing of personal data regarding researchers
All personal data provided by the researchers (hereinafter "Holders") will be processed exclusively for the purpose of evaluation of the projects or studies submitted, as well as for the management of the research process, by CETCH-UCP, as the entity responsible for the data processing based on the relationship established with the researchers.
- CETCH-UCP may be contacted regarding any questions related to the data processing carried out in this context and for these purposes [firstname.lastname@example.org].
- The personal data of the Holders will be kept [for the period of time necessary to evaluate the project], except in cases where another period is required by applicable law.
- The CETCH-UCP guarantees to the Holders the exercise of their rights in relation to their data, such as the right of access, rectification, erasure, objection, limitation of processing and portability, in accordance with the applicable legislation.
- CETCH-UCP implements all the necessary and adequate security measures to protect the personal data of the Holders, whether the data is processed directly by CETCH-UCP or when the data is processed by partner entities.
- Holders may lodge a complaint with their DPO (Data Protection Officer - email@example.com), who will forward it to the National Commission for Data Protection (CNPD), if they consider that there is a breach of the legal provisions regarding data protection by CETCH-UCP.
Note: Upon completion of the research, the principal investigator should send CETCH-UCP a summary of the results obtained.