Factors that influence parental decisions to participate in clinical research: consenters vs nonconsenters.

TitleFactors that influence parental decisions to participate in clinical research: consenters vs nonconsenters.
Publication TypeJournal Article
Year of Publication2013
AuthorsHoberman A, Shaikh N, Bhatnagar S, Haralam MAnn, Kearney DH, D Colborn K, Kienholz ML, Wang L, Bunker CH, Keren R, Carpenter MA, Greenfield SP, Pohl HG, Mathews, iv R, Moxey-Mims M, Chesney RW
JournalJAMA Pediatr
Volume167
Issue6
Pagination561-6
Date Published2013 Jun
ISSN2168-6211
KeywordsAdult, Altruism, Anti-Infective Agents, Anxiety, Child, Child, Preschool, Cross-Sectional Studies, Female, Health Knowledge, Attitudes, Practice, Humans, Infant, Insurance, Health, Logistic Models, Male, Middle Aged, Multivariate Analysis, Parental Consent, Parents, Randomized Controlled Trials as Topic, Refusal to Participate, Secondary Prevention, Socioeconomic Factors, Surveys and Questionnaires, Trust, Urinary Tract Infections
Abstract

IMPORTANCE: A child's health, positive perceptions of the research team and consent process, and altruistic motives play significant roles in the decision-making process for parents who consent for their child to enroll in clinical research. This study identified that nonconsenting parents were better educated, had private insurance, showed lower levels of altruism, and less understanding of study design.

OBJECTIVE: To determine the factors associated with parental consent for their child's participation in a randomized, placebo-controlled trial.

DESIGN: Cross-sectional survey conducted from July 2008 to May 2011. The survey was an ancillary study to the Randomized Intervention for Children with VesicoUreteral Reflux Study.

SETTING: Seven children's hospitals participating in a randomized trial evaluating management of children with vesicoureteral reflux.

PARTICIPANTS: Parents asked to provide consent for their child's participation in the randomized trial were invited to complete an anonymous online survey about factors influencing their decision. A total of 120 of the 271 (44%) invited completed the survey; 58 of 125 (46%) who had provided consent and 62 of 144 (43%) who had declined consent completed the survey.

MAIN OUTCOMES AND MEASURES: A 60-question survey examining child, parent, and study characteristics; parental perception of the study; understanding of the design; external influences; and decision-making process. RESULTS Having graduated from college and private health insurance were associated with a lower likelihood of providing consent. Parents who perceived the trial as having a low degree of risk, resulting in greater benefit to their child and other children, causing little interference with standard care, or exhibiting potential for enhanced care, or who perceived the researcher as professional were significantly more likely to consent to participate. Higher levels of understanding of the randomization process, blinding, and right to withdraw were significantly positively associated with consent to participate. CONCLUSIONS AND RELEVANCE Parents who declined consent had a relatively higher socioeconomic status, had more anxiety about their decision, and found it harder to make their decision compared with consenting parents, who had higher levels of trust and altruism, perceived the potential for enhanced care, reflected better understanding of randomization, and exhibited low decisional uncertainty. Consideration of the factors included in the conceptual model should enhance the quality of the informed consent process and improve participation in pediatric clinical trials.

DOI10.1001/jamapediatrics.2013.1050
Alternate JournalJAMA Pediatr
PubMed ID23546617
PubMed Central IDPMC3674159
Grant ListU01 DK074053 / DK / NIDDK NIH HHS / United States
U01 DK074053 / DK / NIDDK NIH HHS / United States
U01 DK074059 / DK / NIDDK NIH HHS / United States
U01 DK074062 / DK / NIDDK NIH HHS / United States
U01 DK074063 / DK / NIDDK NIH HHS / United States
U01 DK074082 / DK / NIDDK NIH HHS / United States
U01DK074064 / DK / NIDDK NIH HHS / United States
UL1 RR024153 / RR / NCRR NIH HHS / United States
UL1 TR000005 / TR / NCATS NIH HHS / United States
UL1RR024153 / RR / NCRR NIH HHS / United States
UL1TR000003 / TR / NCATS NIH HHS / United States
UL1TR000005 / TR / NCATS NIH HHS / United States