The informed consent as legal and ethical basis of research data production

data protection, personal data, legal framework, social sciences

The trend toward and the obligation for sharing and long-term preservation of research data is in conflict with increasingly restrictive data protection legislation and practices on personal data in Europe, such as the General Data Protection Regulation (GDPR). Quali-tative research data, in particular, often cannot be completely de-identified without compromising the usability of the data. In consequence, the informed consent plays a crucial role in forming the basis of ethical and legal research to allow for the processing (collecting, storing, re-use) of data collected at considerable expense. This guide is con-cerned with the definition of the concept, the legislation governing it, and the best practices for drafting and obtaining informed consent from a social science perspective.

• The adequate informing of participants in research data production and their consent to participation and the further use of the data lays the groundwork for legal and ethical research.
• As the Swiss data protection legislations are currently being revised and the European General Data Protection Regulation (GDPR, art. 3, Territorial scope) extends by the rule of extraterritoriality to certain cases of Swiss research, if in doubt, chose the stricter standard, which is the GDPR.
• The consent form should contain or be preceded by a procedure of informing the potential respondent of the aim of the research and the risk and benefits of a potential participation.
• There is a wide range of forms that informed consent can take: The sensitivity of the data collected, the disclosure risk and confidentiality, the anonymisation potential, and the respondent population determine the degree of formality of the informed consent procedure and the elaborateness of the information divulged to respondents. As a general rule: The more sensitive the data and the higher the risk of disclosure, the more extended and/or formal the consent and information procedure should be.
• It is good practice to draft consent forms that allow for future scientific use of the data beyond the primary research team. If applicable, use the broad or unspecified consent approach, which allows for long-term preservation in a in a secure environment such as the repository of FORS and unspecified scientific re-use of data in keeping with the recognised ethical standards for scientific research.
• Include in the consent form the procedure followed to protect the identity, confidentiality and the personal data of the participant (anonymization/ pseudonymisation, access conditions, user contract, embargo, etc.). Avoid the termino-logies of “fully anonymised” or “strictly confidential”, since these features are hard to achieve in practice.
• Avoid setting an expiration date of the consent, and avoid committing to the destruction of the data after use by the primary research team.
• Best practice consent is sought before and after the data collection.
• Consent can also be sought retrospectively, and in some well-specified cases certain data can be released without consent form.
• The following features constitute the minimal content of information provided to the participant either on the consent form or on a separate information sheet (Universität Zürich, n.d.):
  a) Research project title, key features and link to project website;
  b) Names of researchers, affiliated institutions and contact information;
  c) Short, comprehensive summary of the project aims and purposes
  d) Benefits, potential risks and disadvantages arising from participation;
  e) Funding sources, if applicable;
  f) Implications of participation, e.g. duration of interview;
  g) Confirmation that the participation is voluntary, that the participant has read and understood the information given and had been given the occasion to ask questions;
  h) The fact that that the participant has a right to see and correct the personal data;
  i) Specifications regarding data protection measures (anonymisation, pseudonymisation, etc.) and procedures to secure the confidentiality and protect the personal data of the participant;
  j) If necessary, the future use of the data, e.g. storing in a secure environment and access for scientific researchers for secondary analysis, conditions of use and access;
  k) Confirmation that the participant can withdraw from the participation or consent at all times without stating the reasons (best outline these procedures of withdrawal);
  l) Confirmation that the participant will receive a copy of the consent form;
  m) Date and signature of both participant and researcher/interviewer.