Consent and Participant Information Guidance

Principles of consent: Adults with incapacity (Northern Ireland)

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

  • Medicines for Human Use (Clinical Trials) Regulations – applicable to CTIMP research only
  • Common law.

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 Northern Ireland, 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 Northern Ireland are:

  • Personal legal representative i.e. a person not connected with the conduct of the trial who is suitable to act as the legal representative by virtue of their relationship with the adult, and is available and willing to do so. If one is not available:
  • 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, 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.

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

Non-CTIMPs

There currently is no specific legislation within Northern Ireland applicable to non-CTIMP research involving adults who lack capacity. All research must be approved by a Health and Social Care Research Ethics committee and must comply with common law principles.

Specific guidance and documentation for Northern Ireland based studies involving adults lacking capacity to consent (Non-Clinical Trials of Investigational Medicinal Products) can be found on the ORECNI website, details of which are provided under the header 'Adults who are not able to consent for themselves' in the 'Links' section.

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 who regain capacity for their on-going consent you must:

  • Inform the legal representative (Clinical Trials of Investigational Medicinal Products (CTIMPs)) or close relative/friend (for all other 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 to expect.

Specific guidance and documentation for Northern Ireland based studies involving adults lacking capacity to consent (Non-Clinical Trials of Investigational Medicinal Products) can be found on the ORECNI website, details of which are provided under the header 'Adults who are not able to consent for themselves' in the 'Links' section.

Losing capacity during participation in 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 study is presumed to remain legally valid after loss of capacity (provided your protocol does not change significantly).

Other research (non-CTIMPs)

  • Legally there is no specific provision for adults who lose capacity while taking part in non-CTIMPs in Northern Ireland.
  • Researchers and Research Ethics Committees (RECs) might expect that in most circumstances the original consent should be respected.
  • However, a request by a 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.
  • Specific guidance and documentation for Northern Ireland based studies involving adults lacking capacity to consent (Non-Clinical Trials of Investigational Medicinal Products) can be found on the ORECNI website, details of which are provided under the header 'Adults who are not able to consent for themselves' in the 'Links' section.

In all cases

  • You should consult with carers and take note of any signs of objection or distress from the participant.
  • You must consider withdrawing a participant if they raise any 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 / close relative or friend for this assent.

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