- IRB: ETHICS & HUMAN RESEARCH
Parents’ Perspectives on the Consent Approach for Minimal-Risk Research Involving Children
This study assessed parents’ perspectives about a written versus a verbal consent approach for minimal-risk pediatric research. We conducted a survey of 161 parents of hospitalized children. Eighty-one percent of parents asked if they would allow their child to participate in a minimal-risk research study using a verbal consent approach only said yes, whereas 67% asked using a verbal consent approach combined with an informed consent document said yes (p = 0.05). Many parents said they prefer a written consent approach for studies involving taking an extra teaspoon of blood during a scheduled blood draw (60%), chart review (52%), and testing leftover blood (46%). Parents most often cited legal concerns as a benefit of signing a consent form but reported an increase in anxiety as a negative effect of a written consent approach. Thirty-eight percent of parents agreed that signing a consent form would make the research seem riskier than giving verbal consent. Inconsistencies in responses about the type of consent approach parents favored may reflect emotional responses to specific research scenarios, rather than preferences about written consent for all minimal-risk pediatric studies.
Key words/concepts: human subjects research, research ethics, informed consent, research risks, risk-benefit assessment, pediatric research, vulnerable populations
Melissa A. Cameron, Lauren E. Marsillio, Linda F. Cushman, and Marilyn C. Morris, “Parents’ Perspectives on the Consent Approach for Minimal-Risk Research Involving Children,” IRB: Ethics & Human Research 33, no. 6 (2011): 6-13.