A sattelite

Informed consent

How do I manage informed consent for participation and data reuse?

  • Information presented here must be read in conjunction with LSE Informed Consent Guidance [PDF]
  • Never infer consent is given. The final decision always rests with the participant.
  • Consent should acknowledge potential future re-use of the data
  • Approaches can vary, but inform participants as to the purpose of the research:
    • what will happen to their contribution - including archiving and data sharing,
    • indicate the steps taken to safeguard the confidentiality and anonymity of participants,
    • outline the right to withdraw from the research.

Obtaining consent from research participants is essential. Consent should be competent, informed, and voluntary.

If your funding body or institution has a data archiving and reuse policy, and even after seeking advice, you have serious concerns about consent for reuse and archiving compromising data collection, there is an expectation you make a case for an exemption from data sharing rather than simply ignoring or prohibiting consent for archiving and reuse.

Do not unnecessarily prohibit data reuse through restrictive language on consent forms, for example, by stating that the data will only be shared by the research team or only used in publications.

The ESRC's expectation [PDF] is "when gaining informed consent, include consent for data sharing" (p.4). It is expected participants will always be asked if they consent to share their contribution. Therefore, a decision to share data still, and always, rests with participants. Provide information about data reuse as part of the information process and any subsequent conversations should discuss the benefits and risks of sharing.

The process of obtaining consent should acknowledge potential future uses of the data. Participants should be aware of what happens to their contribution, how it and they will be protected, and of their right to withdraw from the research. Specific future uses will, of course, be unknown, but participants can be informed as to the parameters of potential reuse - for example, non-commercial use, anonymised data only, no attempts to re-contact or identify participants permitted.

Researchers can be flexible in approaching consent. It can be negotiated and discussed at different points in the research -- although obtaining retrospective consent is often time consuming and inconvenient for both researcher and participant -- and where obtaining written consent is problematic, the option of verbal or recorded consent is available.

Likewise, consent can be considered as either a "one-off" or an ongoing "process".

 Type

 Pros

 Cons

One-off consent

  • Simple, practical, non-burdensome
  • Suitable for research where no sensitive of confidential information is gathered
  • Emphasis on ticking boxes.
  • Might not be suitable for exploratory research or repeated, longitudinal research

Ongoing “Process” consent

  • Suitable for research based on more than one point of contact with a participant
  • Risk loss of contact with participant before consent is completed.
  • Can be burdensome for researcher and participant with repeated requests.

Source: Corti, et al. (2014) Managing and Sharing Research Data: A Guide to Good Practice (London: Sage) p.117

Examples of consent forms and support on appropriate wording and approaches

UK Data Service Consent for Data Sharing

ICPSR Recommended Informed Consent Language for Data Sharing

Health Research Authority (UK) Consent and Participant Information Sheet Preparation Guidance

Further reading

Nuremburg Code 1947 "Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10", Vol. 2, pp. 181-182. Washington, D.C.: U.S. Government Printing Office, 1949.

World Medical Association (2013) Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects

Rose Wiles, Sue Heath, Graham Crow, Vikki Charles (2005) "Informed Consent in Social Research: A Literature Review" NCRM Methods Review Papers NCRM/001 ESRC National Centre for Research Methods [PDF]

Libby Bishop (2009) "Ethical Sharing and Re-Use of Qualitative Data" Australian Journal of Social Issues 44:3 pp.255-72 [PDF]

Alex Broom, Lynda Cheshire, Michael Emmison (2009) "Qualitative Researchers' Understandings of Their Practice and the Implications for Data Archiving and Sharing" Sociology 43:6 pp. 1163-1180