Ethical Issue in Psychiatric Research on Children and Adolescents

1
Ethical Issue in Psychiatric Research on Children
and Adolescents

• Shahin Akhondzadeh Ph.D., D.Sc.
• Professor of Clinical Psychopharmacology
• Roozbeh Hospital, Tehran University of Medical
  Sciences

2
Psychopharmacology is big business.
3
Psychiatric Medication Use - Antidepressants

• Antidepressants prescriptions
• 1988 40 million
• 1998 120 million
• 2004 150 million
• Antidepressant revenues
• 1986 - 263 million
• 2004 - 11.2 billion

4
As little evidence as there is for
psychopharmacology in adults, theres much less
for children.
5
What is a Child?

• Article 1 of the UN Convention on the Rights of
  the Child states that
• For the purposes of the present Convention, a
  child means every human being below the age of
  eighteen years unless under the law applicable to
  the child, majority is attained earlier.

6
Why carry out research on children?

• Children are not small adults
• They differ from adults in development,
  physiology, psychology and behaviour
• Vital for clinical trials of drugs tested in
  adults but also used to treat children
• Many drugs used to treat children have never been
  tested on them as a group
• Essential for research into diseases of childhood
  and conditions to which children are particularly
  susceptible

7
Why can Research on Children be Problematic?

• All research involving human subjects requires
  the individual to provide an informed consent
• Children are considered a vulnerable group
  because of their incapacity to protect their own
  interests. This incapacity includes the inability
  to provide a legally valid consent
• International law provides additional protections
  for children with the State having a particular
  duty to protect
• The age at which a child becomes legally
  competent to give consent can differ
  substantially from one jurisdiction to another

8
Resolving the Difficulties

• Researchers must obtain informed consent from a
  legally authorised representative
• Research should only be undertaken on children if
  similar results cannot be obtain using legally
  competent individuals
• Children should only be included if the research
  is likely to promote the health of the individual
  or the population they represent. If the latter
  the burden on participants must be minimal.
• The assent of the child should be sought through
  provision of age-appropriate information
• Assent alone is insufficient without the consent
  of the childs legal representative
• Deliberate objection by a child should always be
  respected

9
History

• 1947 - Nuremberg code

10
History

• 1964 - Helsinki declaration

11
History

• 1979 - Belmont report

12

• According to Emanuel and colleagues
• to be ethical, a clinical research study must
  have seven characteristics
• Social and scientific value,
• scientific validity,
• fair subject selection,
• a favorable risk/benefit ratio, independent
  review,
• informed consent,
• and respect for potential and enrolled
  participants.

13
What are the ethical principles in research
involving humans?

• respect for persons
• privacy, confidentiality
• autonomy - make own decisions
• informed consent

14
What are the ethical principles in research
involving humans?

• beneficence - promotion of well being
• maximize benefit
• non-maleficence - do no harm
  (commission or omission)
• minimize harm

15
What are the ethical principles in research
involving humans?

• justice - fairness
• risks and benefits
• is it justifiable to .

16
Role of EC/IRB

• ethics committee (EC)
• institutional review board (IRB)
• safeguard - dignity rights, safety and well being

17
Ethics committee Institutional review board

• review approval
• beneficence, autonomy, justice

18
Ethics committee Institutional review board

• membership
• non-scientist, community participant

19
Ethics committee Institutional review board

• scientifically sound research?
• scientific review board

20
??????? ?????? ????? ?? ??????? ???

• ???? ?????? ?? ????? ?? ??? ?????

??????? ??? ???? ???? ????? ????? ????? ?? ?????
???? ????? ?????? / ??? ?????? ? ? ???????
??????? ???????????? ????? ?? ????? ? ??? ??????
?? ???? ?????. ?????? ?? ??? ???? ???? ??????
???? ???? ????? ?? ?? ???? ??? ????? ?? ????
?????? ??? 7 ??? ? ?????? 15-7 ??? . ???. ??
?????? ??? 7 ??? ????? ?? ??? ?????? ???? ? ??
???? ???? ???? ??? ???? ? ?????? ???? ?? ??? ???
????? ???? ???? ????? ???. ?. ?? ?????? 15-7 ???
???? ????? ?? ?? ???? ? ?? ?? ??? ?????? ?????
???.?? ????? ?? ????? ??? ?? ???? ???? ??????
????? ???? ????? ?? ????? ????? ????? ???? ?? ???.
21
??????? ?????? ????? ?? ??????? ???

• ???? ?????? ?? ????? ?? ??? ?????
• ???? ?? ?? ???? ?????? ?? ?? ?????????? ????
  ??????? ?????? ? ????????? ???? ???. ???? ?? ????
  ?? ??????? ???? ?? ?? ?? ??????? ??? ??? ??????
  ???? ??? ??? ?? ???? ??? ? ????? ?????. ??????
  ???? ??????? ???? ????? ??????? ? ??? ?????? ????
  ?????? ?? ?? ? ???? ??? ???? ????.
• ?? ????? ?? ??? ????? ??? ?????? ???? ???????
  ???? ?? ????? ? ????? ???? ??? ?? ??? ????? ??
  ???? ??? ?? ????? ???? ?????? ????? ???? ????? ??
  ????? ????? ????? ???? ???.
• ?? ?????? ?? ??????? ?? ????? ?????? ???? ???? ??
  ??? ???? ?? ????? ???? ????? ???? ??? ??????
  ?????? ?? ???? ????? ???? ?????? ?? ??? ?????
  ??????? ???? ????? ? ????? ???? ?? ?? ????? ?????
  ? ?????? ???? ?????.
• ??? ?? ??? ?????? ???????? ?? 16 ??? ???? ????
  ???? ?? ????? ????????? ?? ????? ?? ???? ?????
  ???? ?? ????? ??? ??? ???? ????? ????? ??????????
  ????????.
•    

22
??????? ?????? ????? ?? ??????? ???

• ???? ?????? ?? ????? ?? ??? ?????
• ?????? ????? ????? ???? ????? ???? ?? ?????? ??
  ??????? ????? ?? ????? ???? ???? ??? ?? ?? ????
  ???? ?? ??? ???? ?????? ?????? ???.
• ?? ???? ?????? ???? ????? ?? ???? ???? ?????
  ??????? ?????? ???? ?? ?????? ???? ?? ???? ??????
  ???.
•  ??? ?????? ???? ???????? ?? ??? ?? ?????? ??
  ??????? ??? ???? ????? ???? ?? ??? ????
  ?????????? ???? ?? ??? ???? ??? ????? ?? ?? ???
  ?????? ??? ???? ????? ?? ??? ???? ??????? ???
  ???? ????.
•    ???? ???? ?? ????? ????? ??????? ????? ???? ??
  ?????? ?? ??? ??????  ???? ?????? ??? ???
  ?????????? ?? ?? ????? ???? ?? ????? ????? ???
  ??? ???? ?????? ????.
• .

23
??????? ?????? ????? ?? ??????? ???

• ???? ?????? ?? ????? ?? ??? ?????
• ?????? ???? ???? ????? ???? ?? ???? ???? ?? ?????
  ?? ??????? ??????? ??????? ? ??????? ????? ?????
  ????.
•   ????? ????? ?? ??? ???? ?? ????? ??????? ????
  ????? ????? ??? ?? ?? ?? ???? ????? ????? ??????
  ?????? ????? ? ?????? ???.
•     ??? ?? ????? ????? ?? ???  ???? ?? ?????
  ???????? ???? ?? ????? ???? ???? ??? ?? ?????
  ?????? ????? ?? ???? ? ?????? ???? ??? ??? ?
  ???????? ???? ???????? ???? ????? ???.