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. 2017 Jan 19:8:1-8.
doi: 10.2147/POR.S126509. eCollection 2017.

Parental opinions regarding an opt-out consent process for inpatient pediatric prospective observational research in the US

Danielle M Fernandes  1 , Allison P Roland  2 , Marilyn C Morris  3
Affiliations

Parental opinions regarding an opt-out consent process for inpatient pediatric prospective observational research in the US

Danielle M Fernandes et al. Pragmat Obs Res. .

Abstract

Objective: To explore parental opinions regarding opt-out consent for inpatient pediatric prospective observational research in the US.

Study design: A series of handouts describing hypothetical observational research studies with opt-out consent were reviewed by parents of hospitalized children. A verbal survey explored parental opinions about the proposed consent process.

Results: A total of 166 parents reviewed the handout and completed the survey. Only 2/166 parents (1.2%) objected to the study described and another 10 (6.0%) cited concern about the privacy of their child's medical information. A total of 157 parents were asked "Is it okay to tell you about this kind of research using this handout?" - 116 (74%) responded positively, 19 (12%) responded negatively, and 21 (13%) made an indeterminate or neutral response. When parents were asked to recommend a specific consent approach for observational research, 86 (52%) chose an opt-in approach, 54 (33%) chose opt-out, and 25 (15%) chose "no consent needed". There were no significant associations between parental preferences and whether the child was admitted to the intensive care unit vs. pediatric ward, and no significant difference found based on type of handout reviewed (generic vs. study-specific).

Conclusion: Few parents voiced objection to a hypothetical opt-out consent process for inpatient pediatric prospective observational research. When asked to recommend a specific consent approach, though, approximately half chose an opt-in approach. These data suggest that an opt-out consent process for observational inpatient research is likely to be acceptable to parents, but assessment of an opt-out consent process in a real-world setting is needed.

Keywords: informed consent; minimal risk; research ethics.

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Conflict of interest statement

The authors report no conflicts of interest in this work.

Figures

Figure 1
Figure 1
Sample handouts. The shown information was printed on hospital letterhead, with the words “FOR DEMONSTRATION PURPOSES ONLY” written across the top. (A) Generic handout. (B) For study-specific handouts, the title and the first paragraph of the generic handout were replaced with study-specific language. The remainder of the handout was the same as the generic handout. Abbreviation: IRB, institutional review board.
Figure 2
Figure 2
Parental responses to question “Is it ok to tell you about this kind of research using this handout?” Abbreviation: PICU, pediatric intensive care unit.
Figure 3
Figure 3
Parental responses when asked which approach they prefer for prospective observational research (one parent who did not choose among the available options has been excluded). Abbreviation: PICU, pediatric intensive care unit.
See this image and copyright information in PMC

References

    1. Code of Federal Regulations. 45 CFR 46.116—General Requirements for Informed Consent. [Accessed January 4, 2017]. Available from: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/
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