CREATE & MANAGE DATA
CONSENT & ETHICS
ETHICAL / LEGAL / GUIDANCE FOR RECS
In research with people there may be a perceived tension between data sharing and data protection. Research Ethics Committees (RECs) can play a role in advising researchers how their data can be shared while upholding data protection and research ethics' principles.
The role of RECs is to protect the safety, rights and well-being of research participants and to promote ethically sound research. Among other duties, this involves ensuring that research complies with the Data Protection Act 1998 regarding the use of personal information collected in research. At the same time, RECs need to be aware of conditions placed upon research grants to share data outputs.
RECs can play a mediating role in reconciling data sharing and data protection by advising researchers that:
- many funders recommend or require data sharing or data management planning
- most research data obtained from participants can be successfully shared without breaching confidentiality
- it is important to distinguish between personal data collected and research data in general (see definitions of personal, sensitive or confidential information)
- data protection laws only apply to personal data where consent has not been given to disclose, but they do not apply to anonymised data
- identifiable information may be excluded from data sharing
- even personal sensitive data can be shared if suitable procedures and precautions are taken, as is done at major data centres
- a combination of gaining consent for data sharing, anonymising data and controlling access to data can enable the ethical and legal sharing of data.
Ideally, participants should have an opportunity to make an informed decision about whether or not their data can be shared. Survey and qualitative data held at the UK Data Archive are typically anonymised, unless specific consent has been given for personal information to be included. They are not in the public domain and their use is regulated for specific purposes after user registration. Users sign an End User Licence in which they agree to conditions such as not attempting to identify any individuals from the data and not sharing data with unregistered users. For confidential or sensitive data stricter access controls may be imposed.
RECs can play a critical role by providing information to researchers, at the consent and planning stages, on how to share data ethically. An increasing number of University RECs are addressing data sharing in their guidelines or in ethical review procedures.
- King's College London, in its Research Ethics Guidelines,
highlights a researcher's responsibility to archive anonymised data
and make them available for re-use. It provides a template to
obtain consent for data that are not anonymised - consent is for
the use, retention and re-use of extended written contributions,
audio and video recordings and transcribed interviews. VIEW RESEARCH
ETHICS AT KING'S COLLEGE LONDON
- The University of Essex, in its Guidelines for Ethical Approval
of Research Involving Human Participants, points out to researchers
that informed consent should be obtained for the sharing of
research data and for the publication of findings
VIEW UNIVERSITY OF ESSEX SITE
Framework for Research Ethics
"Secondary use of datasets needs to be given careful consideration by both the researcher and the REC, especially with regard to presumed consent and the potential risk of disclosure of sensitive information. This applies to the user of data and also to the researcher who originates it. Researchers who collect the data initially should be aware that ESRC expects that others will also use it, so consent should be obtained on this basis and the original researcher must take into account the long-term use and preservation of data."
- Medical Research Council
data sharing policy and Personal Information in Medical Research
"Researchers, research participants and research regulators must ensure that, within the regulatory requirements of the law, opportunities for new uses are maximised." and "Researchers obtaining information with consent should, wherever possible, anticipate likely needs to archive the data, and to share data sets with other researchers, and make this clear to the people involved. Consent to this should be distinct from consent to the primary use of the information."
- UK Data Archive guidelines on consent and ethics in data
- UK Data Archive information for research participants on the purpose and benefits of data archiving