Parental Views of Facilitators and Barriers to Research Participation: Systematic Review.

BACKGROUND AND OBJECTIVES: Low enrollment within pediatric research increases the cost of research, decreases generalizability, and threatens to exacerbate existing health disparities. To assess barriers and facilitators to pediatric research participation and evaluate differences by enrollment status. METHODS: Data Sources include PubMed, Embase, PsycInfo, Cumulative Index to Nursing and Allied Health Literature, and Web of Science. Study selection include peer reviewed articles that contained information related to facilitators and barriers to the parental decision whether to enroll their child in research and included the views of parents who declined. We extracted barriers and facilitators to research, enrollment status, and study characteristics, including study design, quality, and patient population. RESULTS: Seventy articles were included for analysis. Facilitators of participation included: benefits, trust, support of research, informational and consent related, and relational issues. Common facilitators within those categories included health benefit to child (N = 39), altruism (N = 30), and the importance of research (N = 26). Barriers to participation included: study-related concerns, burdens of participation, lack of trust, general research concerns, informational and consent related, and relational issues. Common barriers within those categories included risks to child (N = 46), burdens of participation (N = 35), and the stress of the decision (N = 29). We had a limited ability to directly compare by enrollment status and no ability to analyze interactions between facilitators and barriers. We only included studies written in English. CONCLUSIONS: This review identified key facilitators and barriers to research participation in pediatrics. The findings from this review may guide researchers aiming to create interventions to improve the parental experience of recruitment for pediatric studies and to optimize enrollment rates.

The Challenges of Informed Consent in High-Stakes, Randomized Oncology Trials: A Systematic Review.

Importance. Oncology trials often entail high-stakes interventions where potential for morbidity and fatal side effects, and for life-prolongation or cure, intensify bioethical issues surrounding informed consent. These challenges are compounded in multistage randomized trials, which are prevalent in oncology. Objective. We sought to elucidate the major barriers to informed consent in high-stakes oncology trials in general and the best consent practices for multistage randomized trials. Evidence Review. We queried PubMed for original studies published from January 1, 1990, to April 5, 2018, that focused on readability, quality, complexity or length of consent documents, motivation and sickness level of participants, or interventions and enhancements that influence informed consent for high-stakes oncologic interventions. Exclusion criteria included articles focused on populations outside industrialized countries, minors or other vulnerable populations, physician preferences, cancer screening and prevention, or recruitment strategies. Additional articles were identified through comprehensive bibliographic review. Findings. Twenty-seven articles were retained; 19 enrolled participants and 8 examined samples of consent documents. Methodologic quality was variable. This body of literature identified certain challenges that can be readily remedied. For example, the average length of the consent forms has increased 10-fold from 1987 to 2010, and patient understanding was shown to be inversely proportional to page count; shortening forms, or providing a concise summary as mandated by the revised Common Rule, might help. However, barriers to understanding that stem from deeply ingrained and flawed sociocultural perceptions of medical research seem more difficult to surmount. Although no studies specifically addressed problems posed by multiple sequential randomizations (such as change in risk-benefit ratio due to time-varying treatment responses or organ toxicities), the findings are likely applicable and especially relevant in that context. Concrete suggestions for improvement are proposed.