This site uses cookies. By continuing to browse the site you are agreeing to our use of cookies.

Find out more here.

Research in emergency settings

Last updated on 19 Mar 2018

Emergency research poses its own set of challenges in terms of providing information about the research and obtaining consent.

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 some emergency situations potential participants may lack capacity to give consent themselves, and obtaining consent from a legal representative/consulting others is not reasonably practicable. Please see our Consent and Participant Information Sheet Preparation Guidance for more information

Below you will find specific guidance on emergency research taking place in England and Wales. 

Clinical Trials of Investigational Medicinal Products (CTIMPs)

Adults not able to consent for themselves in emergency

 In the UK the law allows adults not able to consent for themselves to be recruited into Clinical Trials of Investigational Medicinal Products (CTIMPs) without prior consent in emergency situations if: 

  • treatment needs to be given urgently
  • it is also necessary to take urgent action to administer the drug (IMP) for the purposes of the trial
  • it is not reasonably practicable to obtain consent from a legal representative
  • the procedure is approved by a NHS Research Ethics Committee
  • consent is sought from a legal representative as soon as possible.

Please note, adults recruited in such a manner may regain their capacity to give consent. 

As this is the case you must plan how you are going to involve them in the on-going consent process. In most cases it is appropriate to ask them to give their own consent when and if they are able. 

If you intend to ask participants who regain capacity for their on-going consent you should:

  • inform the legal representative (CTIMPs) or consultee (other intrusive research) of this at the outset
  • prepare an appropriate Participant Information Sheet and consent form for the participants themselves that explains what has happened so far, and what you are seeking their consent for;
  • plan how you will handle a participant withdrawing consent at each stage of your study, and tell them what they can expect. 

Children/young people in emergency CTIMPs 

The law allows children and young people (under the age of 16) to be recruited into Clinical Trials of Investigational Medicinal Products (CTIMPs) without prior consent in emergency situations if: 

  • treatment needs to be given urgently
  • it is also necessary to take urgent action to administer the drug (IMP) for the purposes of the trial
  • it is not reasonably practicable to obtain consent from a legal representative
  • the procedure is approved by a NHS Research Ethics Committee
  • consent is sought from a person with parental responsibility or a legal representative as soon as possible. 

Young people over the age of 16 are considered to be adults in terms of the law governing the conduct of clinical trials. 

CONNECT Guidance

Dealing with children and young people in an emergency research setting is a difficult area for researchers.  Guidance was developed in 2015 to provide further support on this topic: consent methods in children’s emergency Care Trials (CONNECT) study guidance on research without prior consent (deferred consent)  

What is included in the guidance?

The guidance covers: 

  • research at the pre-trial stage to inform trial design and the process of recruitment for potentially challenging trials; 
  • raising awareness about research without prior consent in critical care settings;
  • written trial information; 
  • discussing research without prior consent with parents; 
  • approaches to research without prior consent when a child has died; and
  • child assent and consent involving young people in this setting. 

Adults not able to consent for themselves in other intrusive emergency research 

In England and Wales the law allows adults not able to consent for themselves to be recruited into other intrusive research i.e. research other than CTIMPs, without prior advice from a consultee, in emergency situations if: 

  • treatment needs to be given urgently
  • it is also necessary to take urgent action to administer a drug for the purposes of the trial
  • it is not reasonably practicable to seek advice from a consultee
  • the procedure is approved by a NHS Research Ethics Committee
  • a consultee is consulted as soon as possible to seek advice on the participant's likely views and feelings. 

A person is not prevented from being a consultee if they are an attorney authorised under a registered Lasting Power of Attorney or are a deputy appointed by the Court of Protection; but that person must not be acting in a professional or paid capacity (for example, person';s solicitor).

Public health emergency research

In the event of a public health emergency, researchers may want to urgently set up clinical trials to test new treatments.  The HRA can arrange to fast track approval in these exceptional circumstances and has done so in the past, for example, in relation to bird flu and ebola.

Back to policies, standards & legislation