The following statement has been adapted from an actual consent form: “Any information I give will be used for research only and will not be used for any other purpose“. Consider the implications for data sharing for any data generated using this consent statement. Do you have any suggestions for alternative wording or other changes?
Informed consent is the process by which a researcher discloses appropriate information about the research so that a participant may make a voluntary, informed choice to accept or refuse to cooperate.
Normally informed consent is given before the start of the research. Gaining informed consent is crucial to meet your legal and ethical obligations towards participants whilst simultaneously enhancing the value of your research data.
To obtain informed consent, researchers should:
- Inform participants about the purpose of the research;
- Discuss what will happen to their contribution (including the future archiving and sharing of their data);
- Indicate the steps that will be taken to safeguard their anonymity and confidentiality;
- Outline their right to withdraw from the research.
Consent needs to be freely given, informed, unambiguous, specific and by a clear affirmative action that signifies agreement to the processing of personal data.
Information sheets play an important role in gaining a participant’s informed consent to take part in a research project. They help provide participants with the background information which is necessary to make an informed decision about whether to take part in the research project.
A good information sheet discusses the following topics:
- The purpose of the research;
- What is involved in participating in the research;
- The benefits and risks of participating in the research;
- Details of the research, e.g. the funding source, sponsoring institution, name of project, contact details for researchers and how to file a complaint;
- The procedures for withdrawing from the research project;
- The planned usage of the data during the research, dissemination, storage, publishing and archiving of the data;
- The strategies for assuring ethical use of the data;
- The procedures for safeguarding personal information, maintaining confidentiality and anonymising data, particularly in relation to data archiving, sharing and reuse.
Gaining informed consent for data archiving and sharing
Gaining informed consent for data sharing is seen as 'one more small step' to gaining consent from participants to partake in your research project. As a researcher, you will already be acutely aware of the need to fully inform your participants about:
- What taking part in your research project will involve;
- How you will disseminate information from the project through publications or presentations;
- The impact taking part may have on them.
By adding the discussion of data sharing and archiving you permit the participant to make an informed decision. This empowers them and puts them in charge of choosing whether they wish for their contribution to your research project – and their data – to be available for use in future research projects.
The best way to achieve informed consent for data sharing is to identify and explain the possible future uses of their data and offer the participant the option to consent on a granular level. For example, in a qualitative study, this may involve allowing the participant to consent to data sharing of the anonymised transcripts, the non-anonymised audio recordings and the photographs.
Below an example of what granular consent for data sharing could look like on a consent form is detailed:
The interviews will be archived at ……………………..…. and disseminated so other researchers can reuse this information for research and learning purposes:
I agree for the non-anonymised audio recording of my interview to be archived and disseminated for reuse
I agree for the anonymised transcript of my interview to be archived and disseminated for reuse
I agree for any photographs of me taken during interview to be archived and disseminated for reuse
Approaches to informed consent
Consent can be gained from participants in written or oral form, one-off or continuously throughout the research project, retrospectively or not at all. The form of consent sought will depend on the project. In the accordion below the details and considerations of all three are stated.
European diversity in informed consent
Apart from being good scientific practice, in some countries gaining informed consent is mandated by law. In the accordion below, a consent requirement comparison for several European countries is given.