Interim guidance for research involving humans
Research involving humans - response to COVID-19
27 July 2020
Due to the current circumstances (Phase 3 of the Scottish Government’s roadmap out of lockdown), research should be conducted using online or remote methods where at all possible.
New or restarting in-person face-to-face research or research involving travel must be permissible, safe and ethical. If that is not possible, it must be postponed.
For more information, see the interim guidance for research involving humans.
This guidance describes the changes to the ethical review and approval process and issues to consider for research involving human participants during the coronavirus pandemic.
Largely, the ethical review and approval application and amendment processes remain the same:
- complete the ethical review application or amendment form
- attach any additional documents required
- submit these to your School ethics committee.
However, there have been some temporary adjustments to the process put in place, depending on what the research involves, and there are also additional ethical issues to consider when thinking about any research at this time.
- Research involving humans at this time should be conducted using online or remote methods where at all possible (see ‘alternative data collection methods’ below).
- If this is not feasible, in-person face-to-face research and research involving travel may be possible if it is permissible, safe and ethical. To meet these conditions, in-person face-to-face research can only start with:
For more information, see ‘Changes to the ethical review process for in-person face-to-face research and research involving travel’ below.
If you are unsure if your research needs ethical approval, see the 'What projects require ethical approval' section of the ethical review application page.
How long will this guidance and amended process be in place?
This guidance and the amended ethical review and approval process will remain in place until the restrictions and additional considerations for research involving humans due to the coronavirus are no longer required.
It is expected that this means that this guidance will be in place throughout Phase 3 of the Scottish Government’s roadmap out of lockdown.
This guidance will be reviewed again at the end of Phase 3. It may continue to be in place after this point, depending on what, if any, safeguards are required as part of Phase 4 and, if so, how these impact research involving humans and the associated processes such as risk assessment.
Changes to the ethical review process and ethical considerations for all projects
A risk-proportionate review system has been introduced for all research:
- Researchers complete a brief ‘ethical risk checklist’ which is at the start of the ethical review application and amendment forms.
- ‘Low-risk’ projects undergo a lighter touch proportionate review.
- ‘High-risk’ projects undergo review as usual.
There are also several additional or enhanced ethical considerations to think about when doing any type of research involving humans at this time.
Changes to the ethical review process for in-person face-to-face research and research involving travel
Now that the initial phase of lockdown has passed, research involving in-person face-to-face contact with participants or travel may be able to resume if it satisfies the following conditions – that the research is:
If these conditions cannot be satisfied, then the research must be postponed until all restrictions on research are lifted (including research that has already been given ‘approval in principle’).
Researchers should also consider:
- if changing methods, whether this may impact the quality and integrity of their data or bring additional (or different) ethical considerations.
- the ethical considerations around conducting any kind of research during this period (see the section on enhanced and additional ethical considerations on this page).
- the often rapidly changing circumstances may mean having to pause, postpone, or even prematurely conclude, a project, particularly face to face research or research involving travel.