Children and clinical research: ethical issues

The report’s recommendations represent a significant shift in current practice, meaning that additional guidance will be needed for researchers and those responsible for the scrutiny of research. The following prompts should assist in the assessment of any research involving children and young people:

Points to consider when carrying out clinical research with children and young people

• Have you involved children, young people and parents in the development of your study?
  • in the design of the study itself? (e.g. the number of appointments or interventions required)
  • in the development of easy-to-understand information about the study?
• Does your study represent a fair offer to prospective participants? Are you confident that the value of the study, and its likely risks, burdens and benefits, have been carefully weighed up from the perspective of potential participants? Have children, young people and parents been involved in identifying possible benefits, risks and burdens?
• Is expertise in a particular area of children’s healthcare important in order for the REC to understand the approach taken in this study? Has this been communicated to the REC, so that it is well placed to obtain advice if necessary?
• Are you able to demonstrate how you will communicate, and discuss, information about the study appropriately and sensitively with potential participants and their parents, so that they are able to make free and informed choices about whether to take part? Does everyone in your team who will be interacting with children, young people and parents have the necessary communication skills?
• Good assent practice is about the process of involving children and young people meaningfully in decisions about research. Are the particular methods you have chosen for involving children and young people in decisions about taking part the most appropriate ones?
• Children and young people who have the capacity and maturity to make their own decision about your study should be invited to give consent (not assent), even if the law additionally requires parental consent. Does your consent process and documentation allow for this?
• Decisions about research participation should, wherever possible, represent a shared decision between parents and children/young people. How will you encourage shared decision-making?
• Is the subject matter of your research such that it may be appropriate or necessary to recruit children and young people without the involvement of their parents? If so, can you justify the approach you have chosen?
• What arrangements have you made to support children and young people who do not have a parent, or another adult exercising a parental role, so that they are not excluded from your study?
• Will clinicians be responsible for recruiting children and young people, for whom they are providing care, to take part in research? If so, is this the most appropriate approach? Have you considered alternative approaches?
• Does the information provided for children, young people and parents explain how and when they can find out about the outcomes of the research? Will those outcomes also be explained in accessible language?