Consent and Participant Information Guidance

Principles of consent: Adults not able to consent for themselves (England and Wales)

The legal frameworks that govern the inclusion of adults not able to consent for themselves in research in England and Wales are:

  • Mental Capacity 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 England and Wales, 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 lacking capacity to do so themselves.

Those who are able to act as a legal representative in Clinical Trials of Investigational Medicinal Products (CTIMPs), in England and Wales 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 (other intrusive research)

You should seek advice from a consultee on whether an adult lacking capacity to consent would wish to be included in your research study or not.

Consultees are not asked to give consent on behalf of the adult, but rather to provide an opinion on the views and feelings of the potential participant.

Consultees for intrusive research other than Clinical Trials of Investigational Medicinal Products (CTIMPs), in England and Wales are:

  • Personal consultee, i.e. a person who cares for the adult lacking capacity or is interested in that person's welfare, but is not doing so for remuneration or acting in a professional capacity;
  • If not available or unwilling to give advice then a nominated consultee i.e. a professional who is independent of the study can do so.
  • There is further provision for emergency situations, visit 'Emergency research'.

The consultee must be:

  • Told that they are being asked to advise on the views and feelings they believe the adult would have towards participation in your study.
  • Told that they are free to decide whether they wish to provide this advice or not.
  • Given sufficient information, in an understandable form, about your study to ensure that they provide you with informed advice.

The advice given by consultees should be recorded on a Consultee Declaration form (rather than a consent form). A template is available to download from 'Examples & Templates'.

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

Participants regaining capacity during your study

If it is likely 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 should:

  • Inform the legal representative (Clinical Trials of Investigational Medicinal Products (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.

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 intrusive research

  • Where consent has been obtained prior to loss of capacity, you will need to consider if this consent remains valid following the loss of capacity. There are only a very limited set of circumstances where an earlier consent in common law endures a loss of capacity.
  • You should consider what steps you would take in the event of a participant losing capacity to consent during your study, in particular whether these participants would be withdrawn from, or remain in, the study.
  • If the intention is that the participant would remain in the study and would be required by the protocol to undergo further interventions and procedures then this constitutes “intrusive research” for the purposes of the Mental Capacity Act 2005 and you would require approval by an appropriate research ethics committee and seek advice from a consultee.
  • You have a legal obligation to carefully consider a request made by a representative to withdraw someone from a study, after they have lost capacity. You must consider their current situation, including possible benefits and harms that might arise as a consequence of their continued participation.
  • In situations where the potential for losing capacity was discussed as part of the original consent you should still review how best to proceed if the participant does subsequently lose capacity. The original consent given by participants should not automatically be considered absolute. The current circumstances of the participant must be considered (see above).

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.
  • 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 / or consultee for advice on behalf of any adults who have lost capacity.

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