Adults with Incapacity Amendment Act: consultation
Expanding the list of approved persons who can provide consent for adults with incapacity participating in research
Adults with Incapacity legislation only permits three types of persons to provide consent for an adult with incapacity to participate in research. Consent must be sought from the adult’s guardian or welfare attorney, or, in circumstances where both of these individuals cannot be reached, the adult’s nearest relative.
In circumstances where none of these individuals can be reached, there is no pathway in the legislation for incapacitated adults to participate in non-Clinical Trials of Investigational Medicinal Products (CTIMP) studies. Our proposal here would aim to expand the list of approved persons who can provide consent for adults with incapacity to participate in research.
This proposal puts forward the idea of allowing researchers to nominate a professional consultee (e.g. an individual’s GP or social care worker) to consult with about the suitability of involving an individual in a research project. We are not being prescriptive about the specific profession of this nominated consultee, other than the fact they must have a professional duty of care towards the adult in question. This provision would only apply if researchers have taken steps to identify and contact the adult’s usual representatives (guardian, welfare attorney, or nearest relative) without success.
Unlike proposals 94 and 95, if implemented, this above proposal (proposal 96) would not be restricted to emergency or urgent situations.