Response 968972434

Back to Response listing

Part eight: proposals to amend the Adults with Incapacity Act in respect of the governance of incapacitated adults participating in research

91. Should the AWI Act be amended to allow the creation of more than one ethics committee capable of reviewing research proposals involving adults lacking capacity in Scotland?

Please select one item
Yes
No
Please give the reason(s) for your answer
Most critical care research cannot wait for prolonged ethics decisions to be made. Patients invariably do not have capacity in critical care, and it is a research field which has been hampered by inability to move quickly to recruit patients.

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

92. In research studies for which consent is not required for adults with capacity to be included as participants, should adults with incapacity also be permitted to be included as participants without an appropriate person providing consent for them?

Please select one item
Yes
No
Please give the reason for your answer
There should be equity across both of these groups.

93. Should Scotland A REC (or any other ethics committee constituted under Regulations made by the Scottish Ministers in the future) have the ability to determine that consent would not be required for adults with incapacity to be included as research participants, when reviewing studies for which consent would also not be required to include adults with capacity as research participants?

Please select one item
Yes
No
Please give the reason for your answer
There should be equity across these groups.

Pathways for emergency waivers of consent

94. Should the Adults with Incapacity Act be amended to allow researchers to consult with a registered medical practitioner not associated with the study and, where both agree, to authorise the participation of adults with incapacity in research studies in emergency situations where an urgent decision is required and researchers cannot reasonably obtain consent from a guardian, welfare attorney or nearest relative in time?

Please select one item
Yes
No
Please give the reason for your answer
Registered medical practitioners already act in the best interests of their patients. Non-CTIMP emergency research should be considered in the same manner, as beneficial to the patient/wider public.

95. Should the Adults with Incapacity Act be amended to allow researchers to enrol adults with incapacity in research studies without the consent of an appropriate representative of the adult, in emergency situations where a decision to participate in research must be made as a matter of urgency, where researchers cannot reasonably obtain consent from an appropriate representative of the adult, and where researchers act in accordance with procedures that have been approved by Scotland A REC (or any other ethics committee constituted by regulations made by the Scottish Ministers)?

Please select one item
Yes
No
Please give the reason for your answer
In such situations, the research may benefit the patient/public. Without this kind of research, we cannot advance certain aspects of critical care medicine (for example).

Expanding the list of approved persons who can provide consent for adults with incapacity participating in research

96. Should the Adults with Incapacity Act be amended to permit researchers to nominate a professional consultee to provide consent for adults with incapacity to participate in research, in instances where researchers cannot reasonably obtain consent from a guardian, welfare attorney or nearest relative?

Please select one item
Yes
No
Please give the reason(s) for your answer
A professional consultee will be expected to act in the patient's best interests, respecting their wishes/principles, whilst helping to enhance incapacitated patient recruitment to research.

Allowing adults with incapacity to participate in a wider range of research studies

97. In addition to being permitted to participate in research that investigates the cause, diagnosis, treatment or care of their incapacity, should the Adults with Incapacity Act be amended to allow adults lacking capacity to participate in research that investigates conditions that may arise as a consequence of their incapacity?

Please select one item
Yes
No
Please give the reason for your answer
This amendment would make such research more clinically relevant and generalisable.

98. In addition to being permitted to participate in research that investigates the cause, diagnosis, treatment or care of their incapacity, should the Adults with Incapacity Act be amended to allow adults lacking capacity to partake in research that investigates conditions they experience that do not relate to their incapacity?

Please select one item
Yes
No
Please give the reason for your answer
Excluding incapacitated adults from this type of research may have negative consequences in the accuracy of data and conclusions drawn from results.

99. Should the Adults with Incapacity Act be amended to allow adults with incapacity the opportunity to participate in any research regardless of whether the research explores conditions that relate to their incapacity or investigates conditions that they experience themselves?

Please select one item
Yes
No
Please give the reason for your answer
This would be most equitable.

About you

101. Are you responding as an individual or an organisation?

Please select one item
(Required)
Individual
Organisation