Use of Children as Research Subjects

1
Use of Children as Research Subjects

• What information should be provided for an FP7
  ethical review?

2
Demonstrate awareness and provide solutions

• Recognition that ethical issues exist
• Identification of aspects of the research that
  need to be addressed including an assessment of
  potential risks to participants
• Justification of the procedures and the need to
  involve children including balance of risk and
  benefit to participants and/or others and
  Demonstration that alternatives approaches are
  unsatisfactory
• Informed consent and the information to be
  provided to participants and their legal
  representatives.
• Protection that will be given to safeguard the
  wellbeing and vulnerability of participants

3
Recognition that ethical issues exist

• Researchers should demonstrate that they
  understand
• the vulnerability of children in that
• they are under the control of others
• they are dependent on others for support and
  protection
• they may have limited yet progressive ability as
  they get older to understand what is involved and
  what it means for them
• they are not legally able to provide informed
  consent
• informed consent is required from the childs
  legal representative
• the childs assent should be sought
• that children should not be selected as research
  participants if comparable research might be
  carried out with others able to provide informed
  consent

4
Identification of aspects of the research to be
addressed

• Identify any aspects of the research protocol and
  design that have implications for a participating
  child and their legal representative. For
  example
• clinical procedures
• blood samples
• administration of drugs, vaccines or other
  substances
• exposure to mental, emotional or physical stress
• consent procedures
• procedures for handling possible adverse outcomes
• data management, data access and data protection
• post research support and/or monitoring

5
Justification of the procedures and the need to
involve children (1)

• Researchers should be able to
• demonstrate that the research is necessary
• explain that the purpose of the research is to
  obtain knowledge relevant to the health and/or
  welfare needs of children
• show that research of comparable effectiveness
  cannot be carried out on individuals capable of
  giving consent
• show why the proposed protocol is superior to
  other alternative approaches
• demonstrate that the age-group selected is
  appropriate
• explain how research results will potentially
  produce real and direct benefit to the
  participating child's health and/or welfare

6
Justification of the procedures and the need to
involve children (2)

• If benefit to participating children cannot be
  demonstrated then benefit to the health and/or
  welfare of other children of the same group may
  be acceptable in certain circumstances.
• However in such cases a stronger justification is
  required and
• the aim should be to contribute to scientific
  understanding to confer future benefit for the
  individual, others in the same age group or with
  the same disease or disorder
• the research should involve only minimal risk and
  minimal burden to the individual concerned
• additional potential benefits should not be used
  to justify an increased level of risk or burden

7
Justification of the procedures and the need to
involve children (3)

• Any non-therapeutic research involving children
  is an extremely sensitive area.
• If researchers believe that such research is
  legitimate great care must be taken to provide
  convincing justification.
• The research should involve
• no more risk or burden for the child than that
  associated with routine medical or psychological
  examination
• no more than a very slight and temporary negative
  impact on health
• only very slight and temporary discomfort
• The age and vulnerability of the child should
  also be taken into account

8
Informed Consent and Assent

• Informed consent must be obtained from the
  childs legal representative (parent, guardian or
  other legally recognised person as defined by
  national laws)
• They must
• have adequate time to consider information
  provided and the risks and benefits to the child
• be placed under no undue pressure by the
  researcher
• No financial inducements should be offered (other
  than compensation for expenses and time spent).
• The child should receive information on the
  research, its risks and benefits appropriate to
  its capacity to understand and the child's assent
  should be sought wherever possible.
• A childs deliberate objection should always be
  respected even where informed consent has been
  given by legal representative. (some guidelines
  suggest that it may be acceptable to override a
  childs objection if alternative treatment is not
  available and there is a strong possibility of
  therapeutic benefit).
• Commentary on Guideline 14 International
  Ethical Guidelines for Biomedical Research
  Involving Human Subjects CIOMS 2002

9
Information to be provided

• Purpose and plan of the research
• Nature and extent of any procedures
• Possible risks and benefits
• Local ethics committee approval (if available at
  submission date)
• Legal rights and safeguards of participating
  children
• Right to withdraw consent at any time without
  discrimination or disadvantage
• Arrangements for responding to adverse events
• Confidentiality and privacy arrangements
• Arrangements for access to information
• Compensation arrangements
• Any foreseen future uses of the research results,
  data or materials, including commercial uses
• Source of cofunding, if any, for the research
• See Guideline 5 International Ethical Guidelines
  for Biomedical Research Involving Human Subjects
  CIOMS 2002

10
Protection of Participating Children

• Demonstrate that all possible steps to minimise
  risk and burden and to safeguard the health and
  well-being of participating children have been
  taken including
• Showing that adequate pre-clinical or other
  relevant data has been assessed
• Age-appropriate end-points
• Appropriate provision for monitoring the childs
  health and well-being including recording any
  adverse events
• Enabling the legal guardian or representative
  have opportunity to observe the trial in order to
  be able to withdraw consent if they consider it
  in the childs best interests
• Ensuring that level of burden is assessed by
  someone enjoying the special confidence of the
  child
• Providing supervision and support from a
  professional with appropriate training and
  experience (e.g paediatrician, child psychologist
  etc.)
• Having in place procedures for dealing with
  adverse events
• Having in place adequate and appropriate
  insurance cover
• Having appropriate procedures for follow-up and
  monitoring
• Effective and appropriate mechanisms for data
  handling, data security and privacy