TABLE 1

Recommendations for Practice

Investigators always have ethical and legal obligations to obtain consent and assent (when age-appropriate) to undertake research. However, when a child objects to research participation, his or her dissent should be recognized and taken in the context in which it presents (such as the clinical procedure).
Investigators should minimize decisions not to approach every eligible patient for trial participation and when patients are not approached should justify their actions. The information provided for parents and children should always be age-appropriate, clear, concise, and on-going.
Researchers should always ensure that the presentation of payments does not influence parents and children to look upon payments or incentives as a benefit of the research. However, when payment is made to vulnerable populations, ethics committees need to ensure that research payment will not lead families to take unnecessary risks. In this situation, ethics committees and supporting communities need further development and empowerment.
Clinicians acting as investigators should always clearly differentiate the roles and aspects of care that are standard or part of research when approaching their own patients for research participation. In this situation, the best option is for another researcher not involved in the care of the patient to obtain the informed consent, although it may be the child's clinician who explained the trial to the family.