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Assessment of risk in research on children
Insights
Federal regulations for pediatric clinical research require risk assessment. Some procedures, like venipuncture and intubation, pose greater than minimal risk, especially for young children.
Area of Science:
- Pediatric Clinical Research
- Medical Ethics
- Regulatory Science
Background:
- Proposed federal regulations necessitate Institutional Review Board (IRB) evaluation of pediatric clinical research.
- IRBs must determine research justification, child assent, and parental permission, with risk assessment being a key factor.
- Limited data exists on the frequency of risks associated with pediatric procedures used in clinical research.
Purpose of the Study:
- To survey pediatric experts on the perceived risks of procedures in child research.
- To identify procedures potentially posing greater than minimal risk to children.
- To understand criteria used for assessing a child's capacity for assent in research.
Main Methods:
- A survey was distributed to pediatric department chairmen and pediatric clinical research center directors.
- Respondents provided opinions on the risks of various pediatric procedures across different age groups.
- The survey also inquired about institutional criteria for determining a child's assent capability.
Main Results:
- Most surveyed procedures were deemed minimal or less than minimal risk.
- Certain venipuncture, arterial puncture, and gastric/intestinal intubation procedures were identified as potentially greater than minimal risk, particularly in younger children.
- In 73% of institutions, investigator clinical judgment primarily determines a child's capacity for assent.
Conclusions:
- Risk assessment for pediatric clinical research requires careful consideration of specific procedures and child age.
- Standardized criteria for assessing child assent in research are lacking, with reliance on clinical judgment being prevalent.
- Further research is needed to quantify procedural risks and inform ethical guidelines for pediatric research.
Abstract:
Proposed federal regulations regarding clinical research require that institutional review boards determine whether a research project involving children is justified and, if so, whether the child's assent and parent's permission should be required before the child becomes a research subject. A key factor in the IRB's decision is assessment of the risk to the child from participation in the research. Since data on frequency of risks associated with many pediatric procedures that may be employed in clinical research is lacking, a survey of pediatric department chairmen and pediatric clinical research center directors was conducted to ascertain their opinions of the risks of some procedures at various ages of childhood. Although most of these procedures were thought to be of minimal or less than minimal risk, a few (certain types of venipuncture, arterial puncture, and gastric and intestinal intubation) were thought to pose greater than minimal risk, especially in young children. Respondents were also asked to indicate the criteria used to decide whether a child is capable of giving assent to participate in an experimental procedure. In the majority of institutions (73%), it appears that this decision is left to the clinical judgment of the investigator or a member of the research group.