Adults with Incapacity Amendment Act: consultation
Permitting adults with incapacity to be included in research studies without consent for the types of studies where consent is already not required from adults with capacity
We have heard from the Scottish research community about the difficulties associated with conducting research studies that wish to make use of patient data taken from incapacitated adults. Whilst there are pathways to allow researchers to access and use unconsented data from participants with capacity under certain circumstances, this is not the case for incapacitated participants. This is due to consent being obtained from a welfare attorney, guardian or nearest relative being a necessary requirement for incapacitated adults to participate in research under the Adults with Incapacity Act.
Ultimately, this leads to circumstances in which data collected from an adult with capacity can be included in a research study without their consent in special situations, but data collected from an adult with incapacity cannot. One of our proposals (Proposal 92) puts forward a high level question that seeks views on the general principle of allowing adults with incapacity to be included as participants without consent, for research studies in which adults with capacity are already able to be included as participants without consent.
Proposal 93 then provides one example of how this principle could be practically implemented. Instead of consent being an absolute requirement for adults with incapacity to participate in research as is outlined in the current legislation, this proposal asks whether legislation should be amended to allow Scotland A REC to determine that, just like current practices for research involving participants with capacity, there will be special circumstances in which researchers would not be required to obtain consent to include adults without capacity in their study.
If implemented, the aim of this proposal would be to allow adults with incapacity to follow the same research approval pathways that are already in place for adults with capacity. This would apply almost exclusively to studies that make use of patient data; and would not apply to interventional research that tests new forms of treatment or care.