The UK Data Archive offices are closed from 12.30 GMT on Friday 23 December 2016 and will re-open on Tuesday 3 January 2017. Online services will run unattended during this period.
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CREATE & MANAGE DATA
CONSENT & ETHICS
CONSENT / OVERVIEW
Informed consent is an ethical requirement for most research and must be considered and implemented throughout the research lifecycle, from planning to publication. Gaining consent must include making provision for sharing data and take into account any immediate or future uses of data.
In the past, researchers have focused primarily on gaining informed consent to enable data collection but researchers should also inform participants about how research data will be stored, preserved and used in the long-term, and how confidentiality, where promised, will be maintained. Contrary to what some researchers or research participants believe, even sensitive materials can be shared ethically. At a minimum consent forms should not preclude data sharing, such as promising to destroy data unnecessarily.
To ensure that consent is informed, consent must be freely given with sufficient information provided on all aspects of participation and data use. There must be active communication between the parties. Consent must never be inferred from a non-response to a communication such as a letter.
FAILURE TO PROPERLY AND FULLY ADDRESS ISSUES OF INFORMED CONSENT MAY UNNECESSARILY RESTRICT THE OPPORTUNITIES FOR INITIAL USAGE OF DATA, PUBLISHING RESULTS AND SHARING DATA.
Consent procedures must be tailored for the specific research context, methods and sample, the nature of the data (personal, sensitive, level of detail), the format of the data (surveys, written, recordings,) and the planned data uses and handling. This will influence the type of consent and consent process used. More detailed requirements and examples of these are offered in the sections on gaining written or oral consent, and consent forms.
Here at the Archive we are aware that informed consent can be a contentious topic and we acknowledge that there are active debates about whether consent is always necessary or even if it is epistemologically possible. Our role is to provide concrete advice for researchers who have to make decisions regarding consent and who may be grappling with the practicalities of participant recruitment challenges, multiple and sometimes conflicting guidelines, and requirements of Research Ethics Committees (RECs). Consent for data sharing and archiving is more recently being addressed by RECs. See: You and your REC.
The provisions of both European and UK law, such as the Data Protection Act, and guidelines of many professional research organisations recommend the following principles be followed to ensure that consent is informed:
- consent must be freely given with sufficient detail to indicate what participating in the study will involve
- there must be active communication between the parties - what is expected from participants and why their participation is required
- documentation outlining consent has to differentiate between consent to participate and consent to allow data to be published and shared
- consent cannot be inferred from a non-response to a communication such as a letter or invitation to participate
The Data Sharing Review commissioned in 2008 by the UK Ministry of Justice stated that "the debate over consent was polarised and complex, and no consensus emerged" (p31).