Consent and Participant Information Guidance

Principles of consent: Adults with incapacity (Scotland)

The legal frameworks that govern the inclusion of adults with incapacity in research in Scotland are:

  • Adults with Incapacity (Scotland) Act, and
  • Medicines for Human Use (Clinical Trials) Regulations – applicable to CTIMP research only.

These frameworks cover many aspects of research; here we provide guidance on the principles of consent when involving adults not able to consent for themselves in Scotland, in the following circumstances.

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Clinical Trials of Investigational Medicinal Products (CTIMPs)

A legal representative can be asked to give consent on behalf of an adult who lacks the capacity to do so themselves.

Those who are able to act as a legal representative in Clinical Trials of Investigational Medicinal Products (CTIMPs), in Scotland are:

  • Personal legal representative i.e.
  • Professional legal representative i.e. a doctor responsible for the medical treatment of the adult if they are independent of the study, or a person nominated by the healthcare provider.
  • There is further provision for emergency situations, visit 'Emergency research'.

The legal representative must be:

  • Told that they are being asked to give consent on behalf of the incapacitated adult,
  • Told that they are free to decide whether they wish to make this decision or not,
  • Told that they are being asked to consider what the adult would want, and to set aside their own personal views when making this decision.
  • Given sufficient information, in an understandable form, about your trial to ensure that they can make an informed decision.

The participant themselves must also receive information, according to their capacity of understanding, about the trial and its risks and benefits.

Non-CTIMPs (other medical, surgical, nursing, dental and psychological research)

A legal representative can be asked to give consent on behalf of an adult who lacks the capacity to do so themselves.

Those who are able to act as a legal representative in research other than Clinical Trials of Investigational Medicinal Products (i.e. non-CTIMPs), in Scotland are:

The legal representative must be:

  • Told that they are being ask to give consent on behalf of the incapacitated adult,
  • Told that they are free to decide whether they wish to make this decision or not, and
  • Told that they are being asked to consider what the adult would want, and to set aside their own personal views when making this decision.
  • Given sufficient information, in an understandable form, about your trial to ensure that they can make an informed decision.

You should also provide the participant themselves with information, according to their capacity of understanding, about your study and its risks and benefits.

If the participant expresses a view that they do not wish to take part in your study, this view must be acted upon.

Participants regaining capacity during your study

If it is likely that adult participants might regain capacity during the course of your study, 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 regaining capacity for their consent you should:

  • Inform the legal representative 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 on-going consent for.
  • Plan how you will handle a participant withdrawing consent at each stage of your study, and tell them what they can expect.

Participants losing capacity during your research

If you think there is a significant risk of participants' losing capacity during your study, you should consider discussing on-going options with them during the original consent and include information in the Participant Information Sheet.

CTIMPs

  • Consent to participate in a trial is presumed to remain legally valid after loss of capacity (provided your protocol does not change significantly).

Other medical, surgical, nursing, dental and psychological research (non-CTIMPs)

  • Legally there is no specific provision for adults who lose capacity while taking part in non-CTIMPs in Scotland.
  • Researchers and Research Ethics Committees (RECs) might expect that in most circumstances the original consent should be respected.
  • However, a request by a legal representative to withdraw someone from a study after they have lost capacity, should be considered carefully to ensure that it reflects the wishes of the person before they lost capacity, and that their current situation is fully considered, including possible benefits and harms that might arise as a consequence of their continued participation.

In all cases

  • You should consult with carers and take note of any signs of objection or distress from the participant.
  • You should withdraw a participant if they raise objections.
  • The legal representative may decide to withdraw an incapable participant from your study; it is important that they make this decision having considered the wishes of a participant before loss of capacity, in light of current circumstances.
  • If your protocol changes during your study or you plan to obtain further consent from participants during your study, you must ask the legal representative for their consent.

You can return to the interactive map to explore legal principles in place in other parts of the UK.