Preferences for Various Approaches

Individuals have different preferences regarding various approaches to consent and participation in research. Consent preferences may differ in various demographic populations, by geographic regions, or by type of ailment under study. To better understand the most appropriate forms of notification or consent for a given study, research has been conducted to elicit people’s preferences regarding various approaches to research and consent. These issues are perhaps most salient in acute care contexts, where severe illness, time constraints, and other barriers to consent exist.

Key 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 the 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 a balancing of “different patients' interests and potentially different sets of interests for different types of research studies on usual medical practices.”(Weinfurt et al 2016).
• Most people prefer brief oral consent over written consent for acute care, such as myocardial infarction (Dickert et al 2018).
• 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 web-based randomized vignette study was conducted to compare different models for notification and consent in different types of comparative effectiveness research with respect to the level of participant understanding and the acceptability of these approaches (Weinfurt et al 2017). It 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 consent (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 (e.g., 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 the acceptability of approaches across a spectrum of types of research (Sugarman 2016).