Preferences for Various Approaches

Research has been conducted on views about research and consent to understand individuals’ perspectives on various approaches. Findings include:

• Most U.S. respondents prefer that conversations about participating in randomized or retrospective observational studies occur with their physician rather than with researchers. Most are comfortable using an alternative approach to written consent if research cannot otherwise take place, but would prefer to have a traditional consent form documented and signed (Cho et al 2015).
• People are more likely to want notice of research when it involves use of health information (as compared to biospecimens), identified data and specimens (as compared to deidentified), and commercial research (as compared to academic) (Spector-Bagdady et al. 2022)
• People believe their physicians will only propose worthwhile and safe research (Kelley et al 2015).
• People are comfortable waiving consent for minimal-risk quality improvement activities (Kaplan et al 2016).
• Effective policy and guidance on informed consent in comparative effectiveness research will involve balancing patients’ interests (Weinfurt et al 2016).
• Differences in consent rates can be associated with recruitment methodology as well as prospective participant demographics including age, race and ethnicity, and socioeconomic status (Jones et al. 2020; Spector-Bagdady et al. 2022).

People generally endorse research, want to participate, and indicate comfort with alternate approaches. However, a substantial minority still want to be somewhat engaged in decision-making (Sugarman 2016). The data on individual preferences support the need to give some information even when the research qualifies for a waiver.

A series of web-based surveys comparing different models for notification and authorization in different types of comparative effectiveness research was conducted to determine the level of participant understanding and the acceptability of these approaches (Weinfurt et al 2017), and found that most participants had trouble understanding pragmatic trials. Based on these findings, the authors suggest that effort and resources be expended to develop, field, and test alternate approaches to notification and authorization (Weinfurt et al 2017). As research practices evolve, more work is needed to improve our understanding of people’s desire to receive information about the risks, burdens, and benefits of interventions and therapies involved in research.

Methodological Challenges for Studying Different Approaches to Disclosure/Notification and Authorization

In most of the research regarding people’s preferences, it is unclear whether people have a full understanding of the nature of the research being described or the differences between conventional research and related activities (eg, pragmatic research, quality improvement research, comparative effectiveness research). Our current understanding relies in large part on hypothetical examples, and may not reflect actual practice. To gain further insight, investigators need to be inquisitive about different approaches to notification and authorization and test them as part of future embedded trials. This will help determine acceptability of approaches across a spectrum of types of research (Sugarman 2016).