Comparison of Approaches for Notification and Authorization in Pragmatic Clinical Research Evaluating Commonly Used Medical Practices

Abstract

Background For pragmatic clinical research comparing commonly used treatments, questions exist about if and how to notify participants about it and secure their authorization for participation. Objective To determine how patients react when they seek clinical care and encounter one of several different pragmatic clinical research studies. Research Design In an online survey using a between-subjects experimental design, respondents read and responded to one of 24 hypothetical research scenarios reflecting different types of studies and approaches to notification and authorization (eg, general notification, oral consent, written consent). Subjects English-speaking US adults 18 years and older. Measures Willingness to participate in the hypothetical study, acceptability of the notification and authorization approach, understanding of the study, perceptions of benefit/harm, trust, and perception of amount of study information received. Results Willingness to participate did not differ by notification and authorization approach. Some (21% to 36%) of the patients randomized to general notification with an explicit opt-out provision were not aware they would be enrolled by default. Acceptability was greatest for and similar among notification and authorization approaches that actively engaged the patient (eg, oral or written consent) and lower for approaches with less engagement (e.g., general notification). Problems of understanding were found among 20% to 55% of respondents, depending on the particular scenario. Most respondents (77% to 94%) felt that participation in the hypothetical study posed no risks of harm to their health or privacy. Conclusions Current attitudes about notification and authorization approaches and difficulties understanding pragmatic clinical research pose significant challenges for pragmatic research. Data from this study provide a starting point to developing solutions to these surprisingly complex issues.

Research Use of Electronic Health Records: Patients’ Views on Alternative Approaches to Permission

“…For our participants, the acceptability and appropriateness of any of the approaches depended on its clarity, simplicity, and usability; the level of transparency, trustworthiness, choice, and respect for patients it conveys; and its effects on research. These findings are largely consistent with other US studies that have examined public perceptions of various permission models in the context of sharing EHR data for healthcare and research (Botkin et al 2014;Damschroder et al 2007;Kim, Joseph, and Ohno-Machado 2015;Weinfurt et al 2017;Weinfurt et al 2016;Kass et al 2016;Cho et al 2015).…”

Public views regarding the responsibility of patients, clinicians, and institutions to participate in research in the United States

“…The final analyzable sample was 2955 (61.4% completion rate) and was diverse with respect to age, education, race/ethnicity, and geographic region. 2 ARR item scores were slightly higher when the ARR items were administered after the review of scenarios and other items. However, while four of five responses were statistically different (p \ 0.05) between the two orderings (N = 1545 and 1410, respectively), differences were relatively small (mean difference range = 0.03-0.21 on a 5-point scale), so item responses were pooled ( Table 1) for purposes of descriptive statistics and the latent class analysis.…”

“…Details about study sample, recruitment, measures, and procedures are described elsewhere. 2 Briefly, between 9 March and 26 March 2018, 4879 English-speaking potential respondents were randomly sampled from Growth from Knowledge's (GfK) web-enabled KnowledgePanel of 55,000 adults who were recruited using probability selection algorithms that allow a statistical representation of the US population with a higher degree of accuracy than results derived from volunteer panels. 3 Consent and study execution were done online via GfK.…”

Public Attitudes toward Consent When Research Is Integrated into Care—Any “Ought” from All the “Is”?

“…Survey studies . To date, five nationally representative surveys have examined public and/or patient views on approaches to consent for pragmatic research 16 . In all, they represent the views of more than ten thousand American adults.…”