Growing Healthy (GrowHe)

Informed consent

The document families accept before taking part in the project.

Project title

Growing Healthy (GrowHe). A digital repository of children's psychological information to promote mental health

Principal investigators

Dr Maria Balle Cabot and Dr Jordi Llabrés Bordoy (UIB)

Contact

If you have any questions about this project, you can contact the people in charge by calling +34 663 989 899 or writing to info@batlab.cat

Funding

This study is funded by the Spanish Ministry of Science and Innovation under the R&D&I Projects programme of the State Research Agency.

What is the aim of this study?

We want to promote mental health, and to do so we need to focus on childhood, when disorders have not yet begun or become chronic. But mental health research with children poses important challenges. The most significant is the lack of data on “normal” behaviour, which would make it easier to tell what is not. Paediatricians, for example, have population and longitudinal data on weight and height, which makes it easier to detect problems when a child does not match what is expected for their age. Mental health professionals do not have this kind of data.

We want to create a digital repository of psychological information on the entire population aged 6 to 12 in the Balearic Islands. The data on these children will come from you, their family. We will collect it through a secure digital platform that complies with all personal data protection rules.

What will you have to do?

If you agree to take part in this study and give your approval to this consent, you will receive instructions for accessing the platform, from where you can start taking part and answering the questions.

Specifically, you will be able to take part in the following studies:

  1. Prospective longitudinal study. You will answer questionnaires on child behaviour, temperament, emotion regulation, your sociodemographic background and adversity when you start taking part, then after one year and finally after two years.
  2. Ecological momentary assessment study. You will answer short questionnaires on emotion regulation strategies several times a day over periods of a week.
  3. Study with wearable digital devices. We will give your son or daughter a device that measures heart activity, to wear during the week.

Of course, you can always leave questions unanswered and even leave any of the studies without giving any explanation.

Who will be able to see the data?

No one except the members of our research team will be able to access your children's data. However, since the aim is to support mental health research, the data will be shared on an open data portal after being anonymised (this means that it will be impossible, even for us, to know whom the data belongs to). To anonymise the data we will follow the recommendations of the Spanish Data Protection Agency and the most advanced technical systems, so that we can guarantee that, once the data has been anonymised and made available to the scientific community for analysis, no one will be able to identify any participant.

Is there any compensation for taking part?

As participants in the study you will have access, as a “reward”, to the private area of this web portal, which will include evidence-based information on children's psychological problems, training activities specially designed to promote children's mental health, reports on the project's data, and more. The content of this section will be defined by a committee with representatives of parents' associations. This committee will also review the questions that are asked and, in general, oversee the ethical aspects of the project.

Risks and benefits of the project

Taking part in the project involves no risk and, on the other hand, can bring many benefits for the health of our society. One in four health problems in the world is a mental health problem. Contributing your data to the repository will make a significant contribution to improving the mental health of the population.

I understand that

  • My participation is voluntary at the start and throughout the study, so I can withdraw at any time without having to give any explanation.
  • I am also aware that the confidentiality of my data is guaranteed.
  • This data will be processed confidentially and in accordance with current data protection legislation.
  • I have all the legal rights over this data that are detailed and specified at the foot of this consent.
  • This data will only be used by the team in charge for scientific purposes and will never be passed on to third parties except where required by law, and it will be kept for the time strictly necessary (public research funding calls may set different periods).
  • The legal basis of the project is the collection of data with informed consent (art. 6.1.a of the General Data Protection Regulation, GDPR), and processing the data as described is the only way to meet the objectives of the research project (art. 6.1.e of the GDPR).

I declare that

  • I have read this information document and have had the opportunity to ask the questions I needed in order to consider myself sufficiently informed about the objectives and methodology of the project.
  • I understand the characteristics and the aim of the study, as well as its possible benefits and risks.
  • I agree that the data collected may be used in the research project for research purposes, as well as for educational purposes.
  • I understand that the confidentiality of the data I provide will be maintained.
  • I give my consent voluntarily and I know that I am free to withdraw from the study at any time, for any reason, without giving further explanations or stating my reasons and without any negative consequences for me.
  • For all these reasons, by sending this form, I state my agreement to take part in this study.

In compliance with Organic Law 3/2018, of 5 December, on the Protection of Personal Data and the Guarantee of Digital Rights, we inform you that the data collected will be included in one or more files managed by the UIB in the record of processing activities set up for this purpose, whose aim is to carry out the research in progress. The data requested is necessary to achieve this purpose and, therefore, failing to obtain it prevents it from being achieved.

The UIB is the controller of the data and, as such, guarantees your rights of access, rectification, objection, erasure, portability, restriction of processing and not to be subject to automated individual decisions regarding the data provided and processed. To exercise these rights you must write to: Universitat de les Illes Balears, Secretaria General, for the attention of the Data Protection Officer, Ctra. de Valldemossa, km 7.5, 07122 Palma (Balearic Islands, Spain), or to the email address dpo@uib.es. You also have the right to lodge a complaint with the supervisory authority at https://www.aepd.es. Likewise, the UIB undertakes to respect the confidentiality of your data and to use it in accordance with the purpose for which it was collected.