BootcampSD: Consent from research participants

Consent from research participants
Section 6 of 10

consent form

One of the most important considerations when planning for the sharing of sensitive data is appropriate consent from research participants. This is essential even if data is to be anonymised before publication, as some risk of re-identification may still remain.

Gaining informed consent for data publication from research participants before data is collected is best practice. It also avoids the expense, delay and loss of use of data involved in attempting to obtain consent later in the research process. Concerns that participants will refuse to participate in research if consent for data sharing is requested are likely to be unfounded as long as the participants are fully informed and have confidence that no identifying data will be shared.

Statements about data publication and sharing in participant information sheets and consent forms should:

  • Avoid precluding data anonymisation and subsequent sharing
  • State the possibility of future data publication (including storage in a repository) and sharing of anonymised data
  • State any conditions under which access to the data may be granted to others

Once a study is complete, a copy of the ethically approved participant information sheet and a blank copy of the consent form should always accompany the data. This is so repository managers and any subsequent users are aware of the conditions agreed to by research participants. For existing data, when re-contact with research participants is no longer possible or practical, the possibility of sharing data may still exist. Check to see if the ethically approved information given to the research participants prior to their consent indicated the possibility of future use or sharing of the data:

  • If the information sheets or consent forms used specifically precluded data sharing, data publication will not be possible
  • If the information sheets or consent forms did not mention data re-use/sharing (after anonymisation) then after data have been properly anonymised, it may be possible to share data with selected researchers, under strict access controls

Question: which of the following clauses in a participant information sheet would enable the researcher to openly publish data?

1. I understand that the information collected about me will be used by the research group for the purpose of this study and may also be used by them as part of future projects.

2. I understand that only health professionals and members of the research team will have access to my personal data and that the overall anonymous data from the study may be seen and used by other researchers, for ethically approved research projects, on the understanding that confidentiality will be maintained.

3. I understand that after the study, anonymised data may be made publicly available and may be used for purposes not related to this study. However, it will not be possible to identify me from these data.