Areas of Research

1
Areas of Research

• Specific issues

2
Clinical Trials

• Phase I
• First use in humans of an experimental drug or
  treatment
• In a small group of healthy volunteers
• To evaluate its safety, determine a safe dosage
  range, and identify side effects.
• Involvement of children is not appropriate for
  Phase 1 clinical trials except possibly in the
  extreme circumstance of a child with a fatal
  disease, where the treatment has a strong
  therapeutic potential for the child and no
  alternative treatment is available.
• Phase II
• drug or treatment is given to a larger group of
  people to test effectiveness and to further
  evaluate its safety
• Strong justification required for use in children
  e.g.
• Drug or treatment is specific to a disease of
  childhood
• There is a significant expectation of therapeutic
  benefit

3
Clinical Trials

• Phase III
• Drug or treatment is given to large groups of
  people to confirm effectiveness, monitor side
  effects, compare it to other treatments, and
  collect information to enable it to be used
  safely.
• Trial should be carried out on adults unless it
  relates to a disease specific to children.
• Must have potential benefit for the participating
  child or exceptionally for their peer group
  (provided risk and burden are minimal)
• Phase IV
• Post-marketing studies to obtain additional
  information on risks, benefits, and optimal use
• Appropriate if used to test effectiveness
  specifically in children, as long as the criteria
  identified above are employed
• In most cases therefore, clinical trials in
  children should only be carried out after a
  successful Phase III clinical trial.

4
Clinical TrialsOther Considerations

• Assessing minimal burden
• Age of child is an important consideration
• For an infant or neonate a single blood sample
  could be considered minimal burden.
• However, successive samplings could well be
  considered excessive.
• Excising tissue could, depending on the site of
  the tissue, be considered excessive for a young
  child but possibly acceptable for a juvenile
• Ethical awareness needs to be demonstrated and
  justifications given.

5
Research in Emergency Situations

• Involving children without prior informed consent
  should be avoided if at all possible
• Where there is direct benefit to the child
• Relevant legal consent procedures must be
  followed
• At least two independent professionals must be
  involved
• Assent from the child must be obtained, if
  possible
• Retrospective consent from the legal
  representative must be obtained as soon as
  possible
• Right to withdraw must be highlighted

6
Social Science Research

• Demonstrate the necessity of the research being
  carried out with children rather than adults able
  to consent
• Demonstrate minimal risk and burden
• Comply with any national legal requirements for
  vetting prior to working with children
• Obtain consent from the legal representative and
  where possible assent from the child
• Research involving children in institutions
  should be avoided wherever possible. Informed
  consent and assent issues are very complex in
  such cases.
• Researchers should demonstrate awareness of
  sensitivities when conducting social research
  with children.
• Two researchers or one researcher and another
  appropriate adult should be present when
  interviewing a child
• The gender of interviewers should be appropriate,
  e.g. for research involving children who have
  been sexually abused

7
Behavioural and Psychological Research

• Participant response
• Recognise research situations where participant
  response may be difficult to predict and
  demonstrate adequate safeguards and support are
  in place
• Careful assessment and evaluation should be
  demonstrated showing that account has been taken
  of the age of the child, their environment,
  religious and cultural background
• Approval for the research protocol and consent
  procedures must be obtained from the relevant
  ethics committee
• Intentional deception over the purpose of the
  research should be avoided
• If information is withheld researchers should
• Ensure alternative approaches avoiding deception
  are not available
• Implement strict controls
• Consult with independent advisors
• British Psychological Society Ethical Principles
  for conducting Research with Human Participants

8
Behavioural and Psychological Research

• Any negative effects and misconceptions should be
  monitored and addressed
• Right to withdraw avoidance of the testing
  situation may be taken as evidence of failure to
  consent to the procedure and should be
  acknowledged
• In research involving children, great caution
  should be exercised when discussing the results
  with parents, teachers or others acting in loco
  parentis, since evaluative statements may carry
  unintended weight
• Observational research.
• Appropriate consent required unless research only
  takes place in situations where those observed
  would expect to be observed by strangers.
• Particular care must be taken when observing
  children
• The minimum amount of sensitive personal
  biographical data should be taken
• Sensitive data should be destroyed at the end of
  the research
• If not destroyed additional consent must be
  obtained for its retention

9
Food and Allergy Research

• Where dietary research is to be conducted with
  captive groups of children (e.g. diet in
  schools, care centres or other institutions for
  children)
• Consent must be sought from the legal
  representative. This may in some circumstances be
  a teacher or other person in loco parentis.
• The assent of the child should also be sought
• All children in the group should be empowered to
  freely opt out of the research and to be provided
  with an alternative diet that is not part of the
  research programme.

10
Food and Allergy Research

• Food challenge tests are a particularly sensitive
  ethical area and they must only be carried out
• With the consent from the legal guardian and the
  assent of the child.
• For the diagnostic benefit of the child.
• Within appropriately staffed childrens units in
  case of anaphylaxis.
• After very careful consideration of clinical
  status (e.g. not in those with severe, unstable
  asthma).