Download Ethics of Children in Research

Areas of Research
Specific issues
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
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.



Phase IV

Post-marketing studies to obtain additional information on risks,
benefits, and optimal use


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)
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.
Clinical Trials:
Other 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.
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
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;
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
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
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.
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 children’s units in case of
anaphylaxis.
 After very careful consideration of clinical status (e.g.
not in those with severe, unstable asthma).