Factors affecting consent in pediatric critical care research

Considering the vulnerabilities of surrogate decision-makers when obtaining consent for critical care research

“…Also in this issue, Menon and colleagues [7] report the results of an observational study examining 271 actual consent encounters involving 45 different studies and a range of study designs targeting critically ill children. They also sought to identify factors that influenced consent rates, and they recorded the unsolicited reasons provided by SDMs for declining consent.…”

Asking For Parents' Permission to Enroll Their Child Into a Clinical Trial: Best Practices

“…These strategies have been shown to increase the likelihood of obtaining parental permission. [10][11][12] Appropriate timing of consent discussions influences the likelihood that parental permission will be provided. It is simply uncaring to approach any parent for a research study when the timing is off.…”

“…10,13 Other factors identified as important to timing of the discussion include selecting times when both parents can be present and when both the family and research team are unlikely to be interrupted, and avoiding times when parents feel particularly stressed or anxious. 10,11,14,15 Parents who perceived the consent process to be rushed or pressured were less likely to provide permission. 16 Schedule the discussion to ensure there is sufficient time available on the part of both the parents and the research team, and plan on at least 2 visits to review information, assess understanding, and answer questions.…”

“…12,15 Establishing the research team's credibility with the clinical team in front of the parents may also increase the likelihood of obtaining parental permission because parents who have a positive perception of the research team are more likely to provide permission. 10,11,17 Investing the time to build a professional relationship between the research team and the family also promotes both recruitment and study retention. 10 Specific team members present during the consent discussion may affect parents' understanding.…”

“…13,16,19,23 Other factors resulting in unwillingness to provide permission included parental anxiety around making the decision, parental difficulty making the decision, parents with a higher educational level, and parents of children with a chronic disease. 11,13,17 This discussion highlights the many complex and interrelated components of the consent process when attempting to obtain parental permission for a child to participate in a clinical trial. Interestingly, most research team members learn how to obtain parental permission "on the job" through informal training and observation of a mentor.…”