What types of projects does the Human Research Ethics Committee evaluate?

The Human Research Ethics Committee of the Experimental Research Ethics Committee of the Universitat de València is the body in charge of evaluating the methodological, ethical and legal aspects of scientific research activities carried out at the Universitat de València that involve:

•     Interventions on human beings.
•     Use of biological samples of human origin.
•     Use of personal data.

It also evaluates research projects involving human subjects in which the principal investigator is a researcher with a contractual relationship with the Universitat de València.

What types of projects are NOT evaluated by the Ethics and Human Research Committee?

•     Opinion surveys: If an opinion survey is to be conducted on any topic or issue, professional situation, satisfaction with certain issues, etc., as long as it does not include psychological or health information, authorization from the Ethics Committee is not required.
•     Those carried out in a publicly managed hospital or health center.
•     Those performed with genetically modified organisms (GMOs) and/or biological agents.
•     Those carried out with animals.
•     Final projects or doctoral theses not linked to degrees and doctoral programs of the Universitat de València.

What happens if I have had to start the field work before requesting the evaluation of the Human Research and Ethics Committee?

The Human Research Ethics Committee (CEIH) will not evaluate research projects in which the intervention on the participants has started before submitting the application (Law 14/2007 of July 3, 2007 on Biomedical Research).

Requests for a report to the CEIH must be submitted at least two months prior to the start of the research in order to obtain approval before the study is carried out.

In research projects with minors, what should I present?

Informed consent, according to the model provided on the website of the Human Research Ethics Committee of the University of Valencia. The following considerations must be taken into account:

•     Participants in a research must give their informed consent expressly to participate in the research and for the processing of personal data.
•     Consent for the processing of their personal data: will be given by the parents (signed by both parents whenever possible) or by the legal guardian of the minor if he/she is under 14 years of age. From this age onwards, the minor will give it by himself/herself.
•     Consent to participate in research:
  •  If the minor is over 16 years of age or an emancipated minor, the informed consent must be given by the minor him/herself unless they have judicially modified capacity (Law 41/2002). In this case, the consent will be given by the legal representative, after having heard their opinion.
  •  In research involving minors under 16 years of age, the informed consent must be signed by both parents whenever possible or by their legal guardian.
  •  All minors have the right to be informed and, from the age of 12, the minor has the right to be heard and listened to, with due consideration of his/her opinions (Law 41/2002).
  • In projects whose participants are persons with disabilities, consent shall be given in clear, simple and accessible language, in a way that takes into account their personal characteristics and needs, making use of means such as easy reading (Law 8/2021).

Negative certificate of previous sexual offenses of the researchers or, if applicable, of those persons who will be in contact with the minors or their personal data.

What regulations should be applied in studies carried out outside Spain?

The Human Research Ethics Committee is not responsible for verifying compliance with the legal requirements established in non-Spanish legislation for carrying out research.

The principal investigator must include in the documentation submitted a reference to the fact that he/she “assumes full responsibility for compliance with the legislation in force in the law of the country where the research is carried out”.

Studies with recordings, what should I take into account before a research study that records images or voice?

•     Participants should be informed that a recording will be made and of what type (voice, image or both).
•     The specific model for authorizing the taking and use of images published on the website of the Human Research Ethics Committee must be provided.
•     Restrict as much as possible the number of investigators who will have access to the recordings and specify who will have access to the image and/or voice data.
•     Images and recordings should be destroyed when the data necessary for the research and the fulfillment of the study's purposes (preparation of doctoral theses, scientific publications, etc.) have been obtained.
•     Images cannot be transferred.
•     Whenever it is not necessary to obtain research data (analysis of gestures, tone of voice, etc.), image or voice distortion systems must be used to prevent the identification of participants.