Informed consent for data sharing

A guide to best practices in informed consent for enabling the sharing of research data beyond the purposes for which your data was collected.  

 

1. Introduction

In present days, not only participation in the research project has to be consented, but also the archiving and sharing of the data. This will result in reproducible research and data with long term value. If appropriate, consent forms should address the possibility of sharing data, future data publication (including storage in a repository) or long-term retention of data for reproducibility.

When you talk about ‘future use’ of the data this can mean different things. In order of increased reuse possibilities these could be:

  • Specific use
    Limited to the specific project under consideration; 
  • Extended use
    Future research projects that are either an extension of the original project or that are in the same general area of research (for example, genealogical, ethnographical, epidemiological, or chronic illness research);
  • Unspecified use
    Any future research. Specific future uses will, of course, be unknown, but participants can be informed of the conditions of potential reuse. For example, reuse could be limited to non-commercial use or anonymised data only.

Sharing of research data that relates to people can often be achieved using a combination of obtaining consent, anonymising data and regulating data access.
2. Do's and don'ts

Do's

  • Information sheets and consent forms should address the possibility of sharing data, future data publication (including storage in a repository) or long-term retention of data for verification. In this way informed consent from research participants can be obtained. 
  • State the conditions under which access to the data may be granted to others. E.g. sensitive data can be safely shared through mediated/controlled access, specific user agreements, de-identification and custom approval by the original research team. In some cases, it may also be appropriate to provide an opportunity for participants to select whom they agree to share their data with (and with whom they don't);
  • Statements about data publication and sharing in participant consent forms should:
    • explain that you as a researcher have an obligation to protect your subject's confidentiality and that you will only share the study data with the broad scientific community by retaining this confidentiality;
    • indicate how data will be de-identified in practice (e.g. by removing all personal information that could directly identify an individual);
    • state when the retention of personally identifiable information expires;
  • Consent should be documented with the collected data so subsequent users of the data are aware of the conditions agreed upon with participants;
  • If statements only mention the current study, sharing is not explicitly possible. You should add a sentence to make it clear to participants that the data could be used for further research, de-identified where possible, or identifiable with enough safeguards and security measures. 

Don'ts

Try to avoid putting this in your consent form:

  • Terms such as 'fully anonymous' or 'strictly confidential' as they are often impossible to achieve;
  • Promises to destroy data;
  • The mention of an expiration time period for the consent;
  • Promises that the data will only be seen or accessed by the research team.

3. How sharing is possible without consent

Sensitive data can legally be shared without explicit consent if the information given to participants prior to their consent for data collection indicated future use of the data, or if ALL of the following are applicable:

  • The opportunity to gain consent no longer exists or is not practical;
  • The data have been de-identified;
  • There is no risk that publishing or sharing the data will cause harm or contribute to discrimination towards the research participants or subjects;
  • Information sheets and consent forms from the original data collection did not preclude sharing.

4. Example sentences to add to your informed consent
  • “Any personal information that could reasonably identify you will be removed or changed before files are shared with other researchers or results are made public."
  • "If you decide to be in this study, the study researchers will get information that identifies you and your personal health information. This may include information that might directly identify you, such as your name and address. This information will be kept for the length of the study and a fixed period afterwards (x-years). After that time it will be destroyed or de-identified, meaning we will replace your identifying information with a code that does not directly identify you.”
  • “The principal investigator will keep a link that identifies you to your coded information, but this link will be kept secure and available only to the principal investigator or selected members of the research team. Any information that can identify you will remain confidential.”
  • “The information in this study will only be used in ways that will not reveal who you are. You will not be identified in any publication from this study or in any data files shared with other researchers. Your participation in this study is confidential.”
  • “Other genuine researchers [may] have access to this data only if they agree to preserve the confidentiality of the information as requested in this form.”
  • “Other genuine researchers may request access to de-identified data in the future. Access will only be granted if they agree to preserve the confidentiality of the information as requested in this form. Their access will also require approval from the original research team."
  • “If you withdraw from the study, you do not have to state why. Please do inform the researcher about your decision. All data already collected up until that moment will be used for the current and future research.”

When using tick boxes:

  • “I agree that research data gathered for the study may be published or made available provided my name or other identifying information is not used.”
  • “I understand that the research data, without any personal information that could identify me (not linked to me) may be shared with others.”

5. Sources and further reading

This guide was set up by RDM Support of Utrecht University (UU) with input from the UU Faculty Ethics Review Board (FERB) of the Faculty of Social and Behavioural Science.