The study is in line with the principles established by national and international regulations, including the Declaration of Helsinki (64th WMA General Assembly, Fortaleza, Brasil, Oct 2013) and the Code of Ethics. The project will start upon approval by the independent PSMAR Clinical Research Ethics Committee (PSMAR-CEIm). Recruitment in collaborating institutions will be initiated only after project approval by its corresponding ethics committee, whenever additional approval is required.
All personal data will be handled following Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, and the national Organic Law 3/2018, of December 5. All participants will provide explicit informed consent. When participants access the link to the online questionnaire platform, the participant’s information form specific for the subpopulation they belong to will appear in the first screen, which will be written in understandable language, and will describe in clear language the aims, methods, and implications of the research. At the end of the information about the study, the different points of the informed consent will be presented in the form of check options that will have to be clicked. Access to the questionnaire will only be allowed if all check options have been activated.
The answers to the different consent questions will be stored in the database, together with the other responses, and may be used as evidence that the participant did, indeed, consent. Exemption from obtaining a signed informed consent has been requested, given the observational, online data collection nature of the study and given the fact that, to be able to access the questionnaire, respondents will have to actively check all consent questions
The Qualtrics survey platform (web-based surveys; qualtrics.com) will be used for data collection in subpopulations of cases and close contacts (1) and healthcare center workers (2). This platform has three of the most important security certifications: FedRAMP, ISO 27001 and HITRUST Common Security Framework (CSF), to meet the security requirements of the most regulated industries and organizations and those of the RGPD (European General Data Protection Regulation). In addition, the platform has additional technology that allows the user to also comply with this regulation (GDPR OneTouch Data Deletion). The data collected through the platform is stored in servers located in the EU. All data stored in the EU data center is encrypted via the AES256 cypher standard. All data transmitted to the Qualtrics platform is encrypted via the industry standard protocol TLS 1.2 and higher. The only personal information that will be requested to participants in the study are contact details with the solely objective to be able to invite participants to the follow up surveys and to send reminders within the framework of the project. This personal data will be collected within the questionnaire, once the participant has given his or her consent to participate in the study. The data will be pseudo-anonymized and neither the study investigators nor the persons in charge of the analysis will have access to the personal data. Only the data manager designated for the study will be able to relate the personal data of the participants to the questionnaire responses. All data will be collected in a research file under the responsibility of the institution, will be considered confidential and will only be used by researchers for the purposes of the project. A Data Protection Officer involved in all stages of data processing has been appointed, DPO: email@example.com).
With regard to the Adult General Population sample (subpopulation 3), the external company IPSOS survey company (web-based surveys; ipsos.com), will be in charge of selecting the sample, inviting participants to the study and carrying out the interviews. A verbal informed consent to participate will be obtained: at the beginning of the contact call, a presentation text with information on the study will be read, and explicit consent will be asked to the participant to respond a questionnaire in two different occasions, baseline and after 6 months. This part of the call where explicit informed consent is requested will be recorded and stored. . At the end of the 6-month follow-up interview, participants will be asked again for verbal recorded consent asking permission for the company to provide contact details of the participant to the study investigators, so that investigators can recontact them for eventual subsequent follow up assessments of the study. IPSOS will ensure that personal data of the participants will be treated with the maximum confidentiality measures according to the current regulations in force (Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, and the national Organic Law 3/2018, of December 5), and that personal data will be exclusively used within the framework of this study. IPSOS data protection policy is detailed in the following link:
Physical security measures include strict control of access to data centers, firewalls, antivirus procedures, data retention/destruction policies, or disaster recovery plans.
Given the observational approach of the study, without therapeutic intervention, it is considered that it will pose minimum risk to the respondents. Participants with psychological distress will be provided with a list of effective care resources at the end of the questionnaire, including coordinates to nearby emergency care in case of suicidal symptoms.