• In order to carry out an opinion survey work, is the approval of The Committee of Ethics and Human Research necessary?

The approval of the Committee of Ethics is not necessary if you are going to carry out an opinion survey about a topic or issue, professional status or satisfaction with certain matters, etc.

However, it is necessary to include a preamble in the survey stating whether it belongs to a research project, what is it about and what the purpose is, the benefits this information may provide, the willingness of the participation, the anonymous treatment of data and, in any way, reference to the processing of information according to the applicable Data Protection Law. In addition, it must include a contact person to ask for information. Finally, a paragraph must be included in which the survey respondent voluntarily accepts participation in the research and gives consent tacitly when responding to the survey.

A preamble model is attached.

Your authorisation is requested in order to participate in the research project titled: .................. The purpose of which is ............... It consists in:.............................. The expected benefits of this research will consist in ……………………………………………… The research will take place from .................(date).............until..................(date).... Participation in this research is completely voluntary, if you do not wish to participate in it, there will not be negative consequences for you. You may withdraw from the research at any moment without consequences. Answers are completely anonymous, so there will not be any information that may identify you. In any case, information will be used according to the Organic Law 15/1999 of December 13 on Protection of Personal Data (LOPD). Any questions regarding this research project may be asked to the Researcher at any moment: ………………………… whose e-mail is:………..

If you answer to the proposed questions, it is tacitly presumed that you have understood the purpose of the present research, that you have been able to ask and clarify your initial doubts and you have accepted to take part in it.

The researchers appreciate your valuable participation in the present research.

• What kind of works require the approval of the Committee of Ethics and Human Research?

Generally, authorisation is required for works in which information related to health, clinical data, supplementary examinations, analytical and radiological data, treatments, etc. is involved. Having the informed consent of the diagnostic tests and the therapeutic procedures received is not sufficient. It is also necessary to include an informed consent signed by the patient or their legal representative in order to use the data, whether it is an observational or experimental research, and in any case it must be positively evaluated by the Committee of Ethics and Human Research.

The informed consent must contain information about the research, the objectives, the methodology, the period of time the research will take place in, the benefits that may be obtained, the willingness to participate, the person responsible for the research, the right to withdraw from the research or withdraw the authorisation of the use and management of data and information according to the applicable Data Protection Law. You may find useful models in the webpage.

The request for a report to the Ethics Committee must be submitted at the beginning of the investigation. The Ethics Committee does not rule on investigations already carried out.

• What do I need to bring in order to ask for the approval of the Committee of Ethics and Human Research?

First, you must fill the first part of the application in which information about the researchers is required. The main researcher is presumed to be the person responsible for the project. In the case of a degree final dissertation, a master’s degree final dissertation or doctoral thesis, the tutor or supervisor of the project must be listed as the main researcher, and the student and other collaborators, if any, as part of the team. Researchers must include their institutional email addresses instead of their private ones, especially the main researcher. 

It must also include, in the space reserved for this purpose or in an attached file, a brief outline of the project, with an introduction and a justification, objectives and methodology, data collection procedure, information source, data management, type and selection of samples, etc. If the project is going to be submitted to a competitive call or is being financially supported by any company or entity, the researchers must bring the filled document approved by the call.

Only the projects whose main researcher belongs to the Universitat de València will be sent to the Committee of Ethics of the Universitat de València. In the case of multicentre projects, one authorisation by the Committee of Ethics of one of the participating centres is sufficient. For example, for collaborative works between the Universitat de València and public hospitals, or any other public institution, if the project has been approved by the committee of the hospital or institution it will not be necessary to bring it to the Committee of Ethics of the Universitat de València. Generally, the Committee of Ethics of the centre in which the research is taking place must be the one in charge of the approval. For example, if the research involves patients treated in a hospital, the committee of the hospital will take care of the approval.

Another mandatory document is the informed consent for the patients, with the specific information it must include: information about the study, the objectives, the methodology, the period of time the research will take place in, the benefits that may be obtained, the willingness to participate, the person responsible for the research, the right to withdraw from the research or withdraw the authorisation of the use and management of data and information according to the applicable Data Protection Law. You may find useful models in the webpage.