Presentation on theme: "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."— Presentation transcript:
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. 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.
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 childrens units in case of anaphylaxis. After very careful consideration of clinical status (e.g. not in those with severe, unstable asthma).
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