An Approach to Community Consultation Prior to Initiating an Emergency Research Study Incorporating a Waiver of Informed Consent

Abstract

Abstract. Objectives: In November 1996, the Food and Drug Administration (FDA) and the Department of Health and Human Services (DHHS) enacted rules allowing a narrow exception to the requirement for prospective informed consent when enrolling critically ill patients in clinical research studies of emergency treatments. These rules require that, prior to initiation of the study, the applicable institutional review board (IRB) assess the acceptability of the proposed research study to members of the community in which the research will be conducted. Specifically, the IRB must perform community consultation-a process during which community members learn about the proposed research and communicate their opinions regarding its acceptability to investigators or IRB representatives. The FDA and DHHS rules do not define specific acceptable methods for performing this community consultation. The objective of this study is to demonstrate the feasibility and utility of one proposed method for performing such community consultation. Methods: Parents of children being seen for minor traumatic injuries in three pediatric EDs were asked to participate in a study regarding informed consent. After consent, an instructor described to the parent a prospective, randomized, placebo-controlled trial of phenytoin for the prophylaxis of posttraumatic seizures in children with severe closed head trauma. All parents were then asked whether they would have consented for their own child's participation, if their child had suffered such head injury. The parents were further asked to explain the reason(s) for their responses. Results: Parents of 227 children (children's mean Ϯ SD age 8.0 Ϯ 4.8 years, 57% male) were interviewed. Sixtysix percent of parents (149/227) stated they would give consent for their child's participation. Of the 149 consenting parents, 85% (126/149) cited potential benefit to their child, 72% (107/149) cited potential benefit to other children, and 60% (90/149) cited furthering medical knowledge. Of the 78 nonconsenting parents (34% of total), 54% (42/78) cited fear of adverse effects, 39% (30/78) did not want their child to be a research subject in general, 27% (21/78) believed they needed to discuss participation with family members who were unavailable, and 26% (20/78) stated they were unable to decide unless they were in the actual situation. Parental ethnicity and household income were found to influence the consent decision, while the parent's gender, religion, language, and educational level were not associated with the consent decision. Conclusions: Community consultation regarding the acceptability of an emergency research protocol can be obtained via interview techniques in the ED. This methodology may allow investigators to obtain data on opinion from a targeted community for IRB consideration during the review of emergency research studies proposing a waiver of informed consent.

Who will participate in acute stroke trials?

“…Previous studies of chronic illness and prevention trials are inconsistent but suggest a possible influence of age, sex, race/ethnicity, and educational level. [11][12][13][14][15][16][17][18][19][20] In our study, we were unable to identify any such factors associated with trial consent. Further, we expected that subjects with more severe strokes would be more inclined to participate in the face of a more dire prognosis, but could not find any relationship between participation and stroke severity.…”

Factors affecting consent in pediatric critical care research

“…Previous studies on participation in pediatric acute care research for purely altruistic reasons have focused mainly on parental opinion surveys. In these studies parents stated a variable willingness to participate ranging from 30.2% [11] and 31% [23] to 53% [10] and 72% [24]. In 1997, Pierro and Spitz [25] reported an increasing rate of parental refusal for non-therapeutic studies in their surgical unit which they attributed in part to lack of benefit for the individual.…”

Who Will Consent to Emergency Treatment Trials for Subarachnoid Hemorrhage?

“…The results from previous studies are inconsistent, but suggest a possible influence of age, 23 education, 24 sex, 24,25 and race or ethnicity. 20,22,24,25 In our sample, we were unable to identify any factors associated with trial consent.…”

“…Furthermore, the results are variable. For example, in one pretrial survey, 20 parents of children with minor traumatic brain injury were asked whether they would consent for their child's participation in a planned randomized controlled trial of phenytoin for prophylaxis for posttraumatic seizures in children with moderate to severe closed head injury. Two-thirds of the parents indicated their willingness to participate.…”