AnneMarie DUGUET

1
Medical research in ALZHEIMER desease

• Anne-Marie DUGUET
• Maître de conférences
• INSERM Unité 558 Toulouse France
• aduguet_at_club-internet.fr

2
Medical research in Alzheimer disease ethical
issues

• 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

3
Ethical and legal issues

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

4
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.

5
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.

6
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).

7
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

8
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
  curateuror by the person who allows the
  participation to research
• The personal assent of the incompetent subject
  is required
• The refusal must be respected.

9
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

10
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.