Human Research Ethics Committee Experiences and Views About Children’s Participation in Research: Results From the MESSI Study

Abstract

As part of a larger study, Australian Human Research Ethics Committee (HREC) members and managers were surveyed about their decision-making and views about social research studies with child participants. Responses of 229 HREC members and 42 HREC managers are reported. While most HREC members had received ethical training, HREC training and guidelines specific to research involving children were rare. Most applications involving children had to go through a full ethical review, but few adverse events were reported to HRECs regarding the conduct of the studies. Revisions to study proposals requested by HRECs were mostly related to consent processes and age-appropriate language. One-third of HREC members said that they would approve research on any topic. Most were also concerned that the methodology was appropriate, and the risks and benefits were clearly articulated. Specific training and guidance are needed to increase HREC members’ confidence to judge ethical research with children.

Research ethics committee members’ perspectives on paediatric research: a qualitative interview study

“…This is the first study to present Swedish scientific REC members' experiences and perspectives on research applications involving children with severe health conditions. In accord with previous research, REC members in this study highlighted aspects related to information for children, protection and integrity, scientific quality and regulatory adherence (Angell et al, 2010;Bergstraesser et al, 2020;Taplin et al, 2022). The REC members saw it as their responsibility to promote research with children while ensuring that children's and parents' rights to participation should always be promoted through appropriately adapted information.…”

How do Research Ethics Committee Members Respond to Hypothetical Studies with Children? Results from the MESSI Study

“…Basic demographic characteristics are presented below (see Table 1). The characteristics of the 183 HREC members who responded to all scenarios are similar to the full sample of 229 HREC members who commenced the survey (Taplin et al, 2022).…”

“…The responses provided by HREC members to vignettes in relation to the sensitivity of the research are also consistent with those they provided to the other questions in the MESSI study survey. In a paper from the same study (Taplin et al, 2022), more than half the HREC members nominated particular topics that they would not approve children aged 7 to 14 years to take part in under any circumstances. However, nearly half the HREC members said that they would approve such research on any topic as long as there was a benefit arising from the research, the methods were robust, and the risks clearly managed (Taplin et al, 2022).…”

“…On the basis of our previous findings in relation to the children and young people, "undue influence" is unlikely to be as much of a concern as HREC members have previously thought, and should not even be a consideration with low risk studies. The origins of HREC members' concerns about the appropriateness of payments to children for their participation in any research study may reflect our previous findings about HREC members' lack of expertise and training in research with children (Taplin et al, 2022). Lower level research payments to children, such as $30 and voucher draws (a $200 draw was used in this study), are more commonly used and provide the benefit of increasing participation rates without "undue influence" on child participants (Taplin et al, 2019), Their use should be supported rather than used as a criteria by which a study is not approved by research ethics committees.…”

“…They were also asked a range of other questions in relation to their considerations of approval for social research involving children. The HREC member and HREC manager responses to these questions are reported elsewhere (Taplin et al, 2022).…”