AM. DUGUET Medical research in Alzheimer desease Second French Chinese Workshop Unesco 23 Février...

AM. DUGUET Medical research in Alzheimer desease Second French Chinese Workshop Unesco 23 Février 2007 [email protected]

Anne-Marie DUGUETMaître de conférences

INSERM Unité 558 Toulouse France

[email protected]

Medical research in ALZHEIMER desease


Do Alzheimer patients have the capacity to consent or to refuse to participate in research?

Should we exclude these patients when they become unable to give their consent ?

They have the right to access to innovation

The exclusion of the Alzheimer patients in research will slow down the knowledge of the Alzheimer disease

Medical research in Alzheimer disease : ethical issues


Ethical and legal issues

• Who give the consent? • With which information ? • Which ethical guarantees ?


Who consent?

Patient with full capacities

• The subject itself as long as he remains able to make decisions and to give a valid consent .

• The capacity to give a valid consent is evaluated by the physician.


Consent of incapable patients

Medical reasearch is allowed ( art L 1121-8 public Health Code) on subjects protected by the law or on patients unable to consent, under these conditions: – The researches cannot be conducted on

another group of subjects , and the future benefit justifies the risk

– The researches could be profitable to persons in the same conditions, and the constraints and risks are minimum.


Who gives the consent?

Patient protected by the law ( art L1122-2 CSP)

• The subject who looses the capacity to make decision should be represented in all civil acts by a « curateur » who consents with him or her, or by a « tuteur » who allows the participation to medical researches

• If the CPP (Comité de protection des Personnes : research ethics committee) considers that the protocol exposes the subject to a serious risk, the authorization to participate to research is given by the judge in charge of the legal protection (Juge des tutelles).


Who gives the consent?

Incapable patient without legal protection ( art L1122-2 CSP)

• It is not a consent , but only an autorisation given by:– The « person of trust »if the subject

has designed this person according to the law. This person will inform the physician on the wills of the subject, expressed previouly when he or she was fully competent.

– Or by a relative, or by any person close to the subject


Which information ?

• Subject incompetent protected by the law or subjects unable to express a valid consent ( art L 1122-2 CSP):

– The investigator must give an information in accordance the capacity of understanding of the subject

– This information is repeated by the ‘tuteur’ ou ‘curateur’or by the person who allows the participation to research

– The personal assent of the incompetent subject is required

– The refusal must be respected.


Which information?

– Appropriate time should be devoted to give an adequate simplified information

– With time for reflexion and information repeated afterwards to be sure that the subject has well understood.

– Complete information should be delivered to the person allowing the participation to research


Which ethical garantees?

• When the research is linked to medical care, make a clear distinction between medical acts due to care and medical acts for research (follow up, new analysis, constraints..)

• To avoid conflicts of interest: the consent should be given to a physician who is not in charge of the medical care or the subject.

AM. DUGUET Medical research in Alzheimer desease Second French Chinese Workshop Unesco 23 Février...

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