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.
CONSENT / WRITTEN OR ORAL?
Whether informed consent is obtained in writing through a detailed consent form, by means of an informative statement, or verbally, depends on the nature of the research, the kind of data gathered, the data format and how the data will be used.
As with many other issues in research ethics, there is debate about the best format for gaining informed consent - written or oral. We recommend a pragmatic approach.
CONSENT / GAINING CONSENT
Discussing and obtaining consent for participation in research, use of information gathered for analyses, publications and outputs, and sharing data beyond the research can be a one-off occurrence or an ongoing process. Both approaches have advantages and disadvantages.
One-off consent is simple, practical, avoids repeated requests to participants, and meets the formal requirements of most Research Ethics Committees.
Consent is gained early in the research process and covers all aspects of participation and data use. For research where no confidential or sensitive information is gathered (e.g. surveys), or where data collection is a one-off event, this is usually sufficient and most practical. Criticism of this method is that it places too much emphasis on 'ticking boxes'. It can also be difficult to gain consent in one go in exploratory research or where not all data uses, research outputs and even methods are known in advance.
Process consent is considered throughout the research process and assures active informed consent from participants. This is generally recommended, such as in ESRC's Research Ethics Framework and is especially important in a research design which involves more than one point of contact with a respondent.
Consent for participation in research, for data use and for data sharing can be considered at different stages of the research, giving participants a clearer view of what participating in the research involves and what the data to be shared consist of.
CONSENT / CONSENT FORMS
Typically, written consent documentation includes an information sheet and a consent form signed by the participant. This division allows the background information to be as detailed as necessary, while keeping the signature form short and concise.
We do not provide a general template because information sheets are project specific, but provide an example from an ESRC research project and our own example of background information that can be given to participants to explain what archiving their data means. Feel free to tailor these to your own needs while remembering to ensure you use appropriate language or images according to the specific targeted social group or age group.
The consent form should be written in plain language free from jargon. It should allow the participant to clearly respond to each of these points:
This site contains useful information on consent, confidentiality and ethics:
A helpful introduction to informed consent, including sample forms:
Article: 'A question of method. The ethics of managing conflicts of interest'