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Seeking consent in COVID-19 research

Last updated on 3 Jun 2020

This section summarises of how existing legal and ethical requirements for providing information to research participants and recording consent apply in COVID-19 research. 

In this section:

Information and consent in emergency research projects

Emergency research is when:

  • treatment needs to be given urgently, and
  • it is necessary to take urgent action for the purposes of the study.

In this situation, participants may or may not have capacity to consent. 

Where research participants do have capacity to consent in emergency research, there will be limited time available for them to consideration participation. Information about the study should therefore be short and easy to read but contain enough detail for the participant to be able to make an informed decision. 

Further guidance about this is in our consent and participant information guidance.

Where research participants do not have capacity to consent in emergency research, the law and associated requirements depend upon whether the research is a Clinical Trial of an Investigational Medicinal Product (CTIMP) and where in the UK your research will take place. Obtaining consent from a legal representative or consultee may not be reasonably practicable.

Further guidance about this is in our consent and participant information guidance.

Information and consent in other, non-emergency research projects

Although COVID-19 research is taking place as part of a public health emergency, that does not mean all studies are classed as emergency research. The requirements for providing information and seeking consent depend upon the type of research project, whether or not your research participants will have capacity to consent and where in the UK the research will take place. 

For information about general principles of consent, see our consent and participant information guidance. This guidance includes information about: 

It also includes example consent documentation for different types of research. 

Providing information to participants and recording consent

You should provide information to participants about your research using a format that is best suited to supporting the consent process and aiding understanding. We strongly encourage testing of this information with an appropriate group of people (patients, groups or other members of the public). Further guidance about this is in our consent and participant information guidance. You canrequest support for public involvement in COVID-19 research.

Text-based information on paper is not always be the best format for informing participants. Alternative formats, such as using images, diagrams, audio (e.g. pre-recorded or read out to the potential participant) or online materials, may be more appropriate. In COVID-19 research using these alternative formats for providing information make it easier to convey information and/or reduce risk of infection (e.g. if information is provided via an electronic device or via a laminated summary sheet that can be cleaned). For further guidance, see the informing participants and seeking consent section of our website.

You can use electronic methods for seeking, confirming and documenting informed consent in research studies.This may be particularly helpful in facilitating COVID-19 research where the consent process may be completed without any contact (e.g. electronic recording of process) or with minimal contact using surfaces that are more readily cleaned (e.g. a hand held electronic device is used to give information and record consent). For further guidance, please see the MHRA, HRA and Devolved Administrations joint statement on seeking consent by electronic methods. Our consent and participant information guidance also has links to examples of providing information in different formats.

Gathering tissue samples and/or data for COVID-19 bioresources

If your COVID-19 research activity is to gather tissue samples and/or data without a specific research project in mind, this is classed as establishing a research tissue bank (a collection of tissue and/or data) or research database (a collection of data only). 

It is best practice to apply for voluntary Research Ethics Committee (REC) review as this may facilitate programmes of research without the need for individual project-specific REC review. Fast-track REC review is available in this instance. 

If you are seeking to amend the scope of an existing research tissue bank or research database to include tissue samples and/or data for COVID-19 research, you should submit a substantial amendment for fast-track review.

For research tissue banks and research databases, it is likely that you will be seeking generic consent from potential participants. Generic consent is non-specific consent, where potential participants are given information about how the tissue samples and/or data might be used. Further guidance is about this is in our consent and participant information guidance

You may choose to seek tiered consent where you describe a number of discrete research activities that the tissue sample and/or data could be used for and enable potential donors to agree to some but not necessarily all. You should only offer tiered consent if you are confident that you will be able to deliver on all aspects of consent in any combination the donor specifies. 

If you are gathering patient data, see our guidance for using patient data

For further guidance about consent, ethical review and licensing requirements in relation to human tissue in research and the use of material from diagnostic archives, see the use of human tissue in research section of our website. 

DNA analysis 

If you intend to use tissue samples for DNA analysis, whether for diagnosis, treatment or research, you need to seek consent from the participant/donor. Where the participant lacks the capacity to consent, advice from a consultee will be required. 

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