Consent and Participant Information Guidance

In the UK the law allows adults with incapacity 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.

Adults recruited in such a manner may regain their capacity to give consent; for further guidance visit ' Principles> AWI (Scotland)> Regain capacity'.

The law in Scotland demands that consent be in place before research other than Clinical Trials of Investigational Medicinal Products can begin. The law does not provide any 'exemptions' or alternatives for the involvement of adults not able to consent for themselves in non-CTIMP research, even in emergency situations.

Therefore, to include an adult not able to consent for themselves in emergency non-CTIMP research in Scotland, you must obtain consent before the adult can be involved in your study from:

• Welfare Attorney / Welfare Guardian, if not appointed
• Adults nearest relative

Adults recruited in such a manner may regain their capacity to give consent; for further guidance visit 'Principles> AWI (Scotland)> Regain capacity'.

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; and
• 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. For further guidance on adults not able to consent for themselves in Clinical Trials of Investigational Medicinal Products visit 'Principles>AWI (Scotland)> CTIMPs'.

The involvement of children and young people in research without prior consent in emergency situations would be considered ethical, if:

• You first obtain NHS Research Ethics Committee approval, and
• You cannot address the same research question by recruiting from a non-emergency environment, and
• Your research is of potential benefit to the child / young person themselves, and
• Someone with parental responsibility for the child / young person is informed about the research as soon as possible, and
• Consent (and assent) is sought as soon as possible, and
• You make clear to the child / young person or their parent (if the child / young person is not competent) that the child / young person can withdraw (or be withdrawn by their parent) at any time without penalty.

If you cannot guarantee a potential direct benefit, the law is unclear. In such cases, The Council of Europe recommends that you must be able to ensure your research will benefit others with a similar condition, and the risk to participants is minimal.