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Parental decisions on children participating in research
Mohamed Elemraid1, Kerry Pollard, Matthew Thomas
1Great North Children's Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
Insights
Parental consent for pediatric clinical research is influenced by child illness severity and study logistics. Addressing concerns about extra tests, delays, and information clarity improves participation rates.
Area of Science:
- Pediatric Clinical Research
- Informed Consent Process
- Medical Ethics
Background:
- Clinical research participation is vital for advancing pediatric medicine.
- Understanding parental refusal reasons is crucial for successful recruitment.
- Previous studies highlight various barriers to consent in pediatric research.
Purpose of the Study:
- To determine the rates and reasons for parental refusal of pediatric clinical research participation.
- To identify factors influencing parental consent decisions for child participation in research.
- To provide insights for improving recruitment strategies in pediatric studies.
Main Methods:
- Informed consent was sought from parents of children hospitalized with pneumonia or empyema.
- Data collected on consent agreements and refusals.
- Reasons for refusal were analyzed and compared with circumstances.
Main Results:
- Ten out of 144 consent requests were refused.
- Key refusal reasons included: avoiding additional tests, lack of participant interest, potential discharge delays, and concerns about consent forms and information length.
- Child's illness severity appeared to be a significant factor in parental decisions.
Conclusions:
- Parental decisions on pediatric research participation are complex and multifactorial.
- Effective recruitment strategies involve careful consideration of the child's condition, clear communication, and accessible study information.
- Collaboration with clinical staff and early researcher engagement can facilitate the consent process.
Aim:
To observe and report rates of, and reasons for, parents' refusal to consent to the participation of their children in appropriate clinical research.
Methods:
The parents of children admitted to hospital with a diagnosis of pneumonia or of empyema were asked for informed consent to research involving blood, urine and nasopharyngeal secretion samples from their child. Circumstances and numbers of agreements and refusals were compared and underlying reasons suggested.
Results:
Of 144 consent requests, ten were refused, which appeared to be linked to: not wanting the child to undergo further tests, lack of interest in participating in studies, research possibly delaying discharge, and anxiety regarding written consent and the length of information sheets.
Conclusions:
Severity of the child's illness appeared to determine the parent's decision. Involvement and assistance of non-research nursing and medical staff and previous introductions to the researchers are helpful. The timing and setting for the consent process should be selected carefully. Adequate, accessible study information for parents and children contributes to successful recruitment of participants.
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