Consent to participate
Research involving humans - response to COVID-19
15 January 2021
Due to the current circumstances, researchers must consider using online or remote methods where at all possible.
Any in-person face-to-face research or research involving travel must be permissible, safe and ethical.
Due to the current circumstances and restrictions in Scotland and the rest of the UK, research involving in-person contact with human participants is only permissible in very limited situations. For more information see the University research and coronavirus page.
Researchers must check the University coronavirus information pages and travel and fieldwork guidance frequently and before commencing any activity to ensure they are complying with current requirements.
For more information on the ethical review process at this time, see the interim guidance for research involving humans.
Researchers must obtain consent from all living participants for their participation in a research project and maintain a record of their consent. This still applies to all research whether interacting with participants face-to-face or using remote or online methods.
There may be exceptional circumstances, such as when working with a large external dataset accessed via a 'gatekeeper', where individual consent may not be appropriate. If you think this applies to your research, seek guidance from your School ethics committee (SEC).
That consent must be:
- fully informed, requiring that participants are provided with key information about the project that they can consider before deciding whether to take part
- freely given, meaning that any issues such as dependent relationships have been addressed.
Researchers must keep a written record of the consent provided by participants and the information provided to the participant upon which they provided their consent.
Participants should always receive a copy of a participant information sheet (PIS) (Word) in a format that they can understand and retain. It may be necessary to make adaptations to meet literacy or accessibility requirements (for examples, see the simplified template documents developed for use with children). If the PIS is included as a downloadable document as part of an online survey or consent statement, the PIS information should also be relayed in the web page text to maximise the opportunity for participants to both read the information and retain a copy before they consent.
The default position for all research is that researchers should take written consent using the consent form (Word), because it was developed to capture the key ethical and legal issues and provides the most robust written record of participant consent.
Other forms of consent
There may be circumstances where it is more appropriate to use one of the methods described below.
If using any of these methods, there should be a good rationale and clear documentation of how consent will be obtained and how this will be recorded. If using an alternative to written consent results in additional ethical considerations, researchers should also describe these and how they will be mitigated in their ethical review application form (Word).
Researchers should let their participants know that this is how their consent will be recorded so that participants understand at what point in the research interaction they are giving their consent.
If a researcher wants to take verbal consent, they must give a rationale for this in their ethical review application form (Word) – for example, there may be accessibility or literacy reasons why other methods cannot be used. Researchers must provide in their ethical application an explicit description of how they will maintain a robust written record of the consent provided by participants and the information provided to the participant upon which they provided their consent.
Researchers should relay the contents of the consent form (or a pre-prepared script with the same effect) to the participant and ask them to indicate their consent to each statement.
A record must be kept of:
- the script or statements used
- the participant's details
- the date and time consent was obtained
- what medium of interaction was used (i.e. telephone)
A transcript of the consent interaction should be retained with the project paperwork in lieu of a consent form.
An online consent statement
Researchers can use the templates given on the Online Questionnaire and Survey guidance to create a consent statement in Qualtrics and ask the participant to complete this. This must be documented, and participants’ completed 'questionnaires' retained with the project paperwork. As this is the most anonymous form of consent, researchers may need to consider whether this brings additional ethical considerations such as those described below under ‘Obtaining consent when using online or remote methods’.
Consent by return email
Researchers can use their University email address to send participants an email where the consent form statements are in the body text of the email. Participants can then reply to the email, indicating 'yes' to each statement and sign off with their name and the date. These emails must then be retained, including the header information with emails addresses and dates, with the project paperwork.
Obtaining consent when using online or remote methods
If solely using online methods to interact with participants (i.e. for recruitment or data collection) it may be more challenging to obtain written consent, as this is traditionally done by having the participant physically sign a consent form. It is therefore likely that researcher may use one of the other forms of the consent described above.
It is important that consent is always fully informed. It is therefore essential that the participant always receives a participant information sheet (PIS) (Word) in a format that they can keep indefinitely. This will most likely mean emailing a copy to the participant, placing the file online (i.e. on OneDrive) for the participant to download, or possibly posting them a copy.
Once the participant has received the PIS and had time to consider whether to take part, their consent should be obtained and recorded using one of the methods described above.
Considerations when obtaining consent online – identity and anonymity
Researchers should be aware that it can be harder to verify the identity of participants when using online or remote methods and that there may be circumstances where the ‘normal’ consent process may compromise participants’ wishes to remain anonymous.
Not verifying participants’ identities can bring considerations over the integrity of the data (i.e. whether participants are of the target group) and concerns that participants may be children, adolescents or vulnerable adults.
Researchers should try to verify the identity of participants when possible and appropriate to ensure that participants are adults and not of a vulnerable group as well as to ensure the integrity of the data.
If the research is sensitive and where there is a risk to participants if they were indeed vulnerable and where it is not possible to verify this, researchers should carefully consider if their research may be better conducted using face-to-face methods.
However, there may also be circumstances where it is inappropriate to try to establish the ‘real’ identity of your participants and where doing so would compromise their choice to participate anonymously. In these cases, it may be more appropriate to gain the consent of a ‘user’ (i.e. username, pseudonym, online persona) or to use a ‘checkbox’ style consent statement as with Online Surveys and Questionnaires.
These issues are a particular challenge in online and remote data collection and researchers should ensure they weigh up the risks and benefits of their approach to consent in their ethical application.
Approach to consent: opt-in vs opt-out
To be freely given and fully informed, consent must be opt-in; opt-out consent is not acceptable.
The right to withdraw
Consent to participate is only freely given by participants if they are able to withdraw their consent to participate whenever they decide to.
Participants must be explicitly informed that they can withdraw their participation whenever they want and reassured that they will face no disbenefit from withdrawing their participation. This is particularly important when there are dependent relationships.
Although participants can withdraw their participation in a project whenever they want, the ability of participants to withdraw the data they have contributed depends on when they make the request to withdraw their data from the project and whether the data has been anonymised. Data that has been anonymised cannot be withdrawn, because it is not possible to know which data relates to which participant.
Data protection legislation allows for a balance between the needs of researchers and the rights of research participants. The University decided that its researchers must always explicitly provide their participants with the right to withdraw their un-anonymised data (the right to erasure) up to the end of the project’s data gathering period, despite the law not requiring this, as detailed in the research data protection guidance. Researchers do this by adjusting the relevant sentences on the participant information sheet (PIS) (Word) and consent form (Word)(guidance on how to do this is provided in the documents).
Researchers conducting focus groups should note that participants withdrawing data may adversely impact the integrity of the data for the entire focus group i.e. by removing context behind other participants’ responses. Researchers are therefore encouraged to consider this when forming their ‘right to withdraw’ periods in their Participant Information Sheet.
Consent and use of secondary data