Ms. Sharav's stance astounds me. Left unchecked, a patient with AD has little to no opportunity for improvement. By participating in a clinical trial, the patient at least has a chance of improvement in quality of life. Why deny that to this population? Common sense dictates that most, when given a virtual death sentence, would opt to try an experimental treatment if available. Those with AD should have the same rights to clinical trials as those with cancer, heart disease, or any other life-threatening illness. Next-of-kin should suffice for consent purposes, just as in most other medical situations.

View all comments by J. Lucy Boyd

In our state (QLD, Australia) there is a guardianship tribunal that is able to provide approval for clinical trial participation by people with dementia who lack capacity. Depending upon the nature of the study, the tribunal might require submissions on a case by case basis or it might provide overall approval contingent upon the patient assenting and a substitute decision maker providing consent. Studies on marketed pharmaceuticals (e.g., donepezil) are more likely to be granted overall approval, whereas studies on novel agents (e.g., monoclonal antibodies) will require case by case submissions for approval.

The tribunal is required to ensure that the following conditions are met:

"(a) the special medical research or experimental health care is approved by an ethics committee;

(b) the risk and inconvenience to the adult and the adult’s quality of life is small;

(c) the special medical research or experimental health care may result in significant benefit to the adult or other persons with the condition;

(d) the special medical research or experimental health...  Read more

In our state (QLD, Australia) there is a guardianship tribunal that is able to provide approval for clinical trial participation by people with dementia who lack capacity. Depending upon the nature of the study, the tribunal might require submissions on a case by case basis or it might provide overall approval contingent upon the patient assenting and a substitute decision maker providing consent. Studies on marketed pharmaceuticals (e.g., donepezil) are more likely to be granted overall approval, whereas studies on novel agents (e.g., monoclonal antibodies) will require case by case submissions for approval.

The tribunal is required to ensure that the following conditions are met:

"(a) the special medical research or experimental health care is approved by an ethics committee;

(b) the risk and inconvenience to the adult and the adult’s quality of life is small;

(c) the special medical research or experimental health care may result in significant benefit to the adult or other persons with the condition;

(d) the special medical research or experimental health care cannot reasonably be carried out without a person who has or has had the condition taking part;

(e) the special medical research or experimental health care will not unduly interfere with the adult’s privacy." (1)

In Australia, human research ethics committees are increasingly interested in the methods employed to determine capacity and in whether a guardianship tribunal (or similar body) is involved in decision-making.

References:
1. Guardianship and Administration Act 2000 (Queensland Government). Section 72.

View all comments by Gerard Byrne

The problem of consent has been troubling me in Israel for the last few years. At what stage do we have to stop performing research on demented persons, even with consent of family members? The local IRBs have been increasingly demanding that the demented have guardianship before signing a consent form. This has even been extended to having a guideline to include a proxy/guardian for persons only with MCI.

Researchers worldwide have to find a means of bringing the problem to the forefront of dementia research.

View all comments by Gary Sinoff