Adults with Incapacity Amendment Act: consultation

Generally speaking, Clinical Trials of Investigational Medicinal Products (CTIMPs) are research studies that involve testing new drugs, or testing an existing drug for a purpose distinct from the one for which it was originally approved. CTIMP research is governed by UK-wide legislation, the Medicines for Human Use (Clinical Trials) Regulations 2004. In these Regulations, there are pathways for emergency waivers of consent that permit enrolling incapacitated adults in CTIMP research studies without seeking consent from the appropriate representative of that person. However, this is not the case for all other (non-CTIMP) studies involving adults with incapacity in Scotland, which are governed by the Adults with Incapacity Act. This makes conducting emergency non-CTIMP research in Scotland incredibly difficult, as a decision about whether a patient should be entered in a research study must be made as soon as possible, and there is often insufficient time to locate and consult an appropriate representative of a patient who has lost capacity in order to make this decision in a timely manner.

These proposals outline new provisions that could be added to Adults with Incapacity legislation which would offer some pathways for emergency waivers of consent for participation in non-CTIMP studies in Scotland.

The first proposal (Proposal 94) asks whether researchers should be permitted to consult with a registered medical practitioner to determine the suitability of an incapacitated individual to participate in a given study. If both are in agreement, the incapacitated adult could be enrolled in the research study.

The second proposal in this section (Proposal 95) asks whether researchers should be allowed to enrol adults with incapacity in research studies without seeking the consent of the appropriate representative of the adult in question OR the consent of a registered medical practitioner, provided that researchers adhere to protocols outlined in advance in their research application which has undergone review at the Scotland A REC.

It must be noted that both the proposals discussed here would only apply in emergency situations, where it is not practical to locate and consult with the adult’s usual representative (guardian, welfare attorney, or nearest relative). In addition, for both of these proposals, at the nearest practicable time, researchers would be required to seek consent from the adult’s usual representative (or, indeed, the adult themselves if they regain capacity) about the continued participation of the adult in the research study.