Adults with incapacity ( Scotland ) Act 2000: proposals for reform

Chapter Thirteen: Research (s.51-52)

There are now differences in the ways that research involving adults with incapacity is handled in Scotland and in the rest of the UK. In response to concerns expressed by some members of the research community in an informal consultation, Scottish Government officials have worked with stakeholders to identify areas which may benefit from change and invite comment on how these and any other issues are approached.

Currently, adults with incapacity cannot engage in emergency research; research cannot be conducted on adults with incapacity where it can be conducted on adults with capacity. For example, in respect to research into poisoning, there will be patients who lack capacity (temporary) because of the poison or alcohol co-ingestion and there will be patients who do have capacity. The current legislation means researchers cannot include anyone without capacity in such studies (because similar research could be done on adults who can consent). This limits recruitment and excludes an important group who may be different to those with capacity (such as may have more severe toxicity or respond differently due to alcohol exposure).

Research can only be conducted where there is a benefit to the direct cause of their incapacity; assent to engage in research is required by the nearest relative; clinical trials of medicinal products are permitted within the parameters set out above, but those involving non-medicinal products (e.g. medical devices, research studies etc) are not.

There is only a single committee in Scotland able to consider applications for research with adults with incapacity. Unlike every other ethics committee in the UK, this means there is no appeals process. A single committee also gives potential for a conflict of interest as research-active members can only apply in Scotland to the committee on which they serve. Part 5 (Section 51) of the Act may also be unnecessarily restrictive.

Questions

Where there is no appropriate guardian or nearest relative, should we move to a position where two doctors (perhaps the adult with incapacity’s own GP and another doctor, at least one of whom must be independent of the trial) may authorise their participation, still only on the proviso that involvement in the trial stops immediately should the adult with incapacity show any sign of unwillingness or distress?

When drafting their power of attorney should individuals be encouraged to articulate whether they would wish to be involved in health research?

Should there be provision for participation in emergency research where appropriate (e.g. if the adult with incapacity has suffered from a stroke and there is a trial running which would be likely to lead to a better outcome for the patient than standard care)?

Should authorisation be broadened to allow studies to include both adults with incapacity and adults with capacity in certain circumstances? (e.g. an adult with incapacity who has an existing condition not related to their incapacity may respond differently to different types of care or treatments to an adult with capacity)

Should clinical trials of non-medicinal products be approached in the same way as clinical trials of medicinal products?

Should there be a second committee in Scotland who are able to share the workload and allow for appeals to be heard respectively by the other committee?

Should part 5 of the act be made less restrictive?