Response to Adults with Incapacity (Scotland) Act 2000 - Provision for research

Consultation body

Scottish Government

Response date

September 2010

Focus of consultation

Adults with Incapacity (Scotland) Act 2000 - Provision for research

We welcome the opportunity to respond to the consultation on provisions for research. In our Dementia Manifesto we make the case for increased investment in research into dementia causes, prevention, diagnosis, treatment and care.

We are concerned to learn from the Consultation Paper that in Scotland there are only 45 AWI specific applications compared to the 7000 research applications for the UK as a whole, indicating that the present arrangement is posing a serious barrier for researchers.

Our response is based on our knowledge and experience of the needs of people with dementia and their carers and informed by expert members of our Council and Standing Committees who are leading figures in dementia research in Scotland.

Consultation questions

1. In light of developments introduced through the 2004 Regulations and the Mental Capacity Act 2005 under which a number of designated RECs may consider AWI applications, should the exclusive power of Scotland A REC to consider ethics applications covered by the Act be amended to allow other RECs considered competent by Ministers to consider such applications?

Alzheimer Scotland's response:

Yes, we believe this will be helpful and should speed up the application process. Having all applications under AWI considered by one central committee must mean that there are delays which can have a serious impact on the time-frame for planning and implementing research proposals. We are not aware of any issues arising that would give us cause for concern from arrangements in England.

2. In light of the above, should there be a right of appeal to unfavourable opinions issued by RECs for all applications covered by the Act?

Alzheimer Scotland's response:

Yes, we believe that there should be a right of appeal.

3. The following compares the REC members required to consider a research ethics application where incapacitated adults will be participating:

Act

The Adults with Incapacity (Ethics Committee) (Scotland) Regulations 2002 (the Regulations) stipulate that the members of Scotland A must include:

Schedule 2 of the CT Regs stipulates that an ethics committee shall consist of expert members and lay members. The definition of expert members to ensure the REC has the relevant expertise in recognised RECs is expanded in the Governance Arrangements for NHS Research Ethics Committees in Scotland (GAfREC) to include:

REC membership requirements

A person experienced in treating incapacitated adults, a GP, a nurse or midwife, a pharmacologist, a pharmaceutical chemist, a hospital consultant, a public health medicine medical practitioner, a professional to which the Professions Supplementary to Medicine Act 1960 applies and three lay members.

Relevant methodological and expertise in clinical, non-clinical and qualitative or other research methods applicable to health/community research; clinical practice including hospital/community staff (medical, nursing and other) and general practice; statistics relevant to research and pharmacy/pharmacology. There will also be lay members.

4. Bearing in mind that CTIMP applications including incapacitated adults can go to a recognised REC, if all AWI applications were to go to recognised RECs is the current list of expert members required by a recognised REC sufficient to consider all AWI applications?

Alzheimer Scotland's response:

We disagree with the proposal that only ‘one person experienced in treating incapacitated adults’ should be on the committee. In general, AWI research affects three main groups a) those with dementia b) those with a learning disability c) those with temporary incapacity due to stroke, delirium etc. This last group c) is well covered. However we would suggest that there is an extension to cover both a) and b) so the requirement is for one person experienced in the healthcare of people with dementia and one person experienced in the healthcare of adults with a learning disability. The reason for this is that the nature of how one might conduct research with people with dementia is rather different from the way one would do so for people with a learning disability. If the person with experience knew about learning disability and not dementia (or vice versa), the committee may not be able top give such a helpful opinion.

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