People's Preferences for Different Approaches

Research has been done to elicit people’s views on different types of research and their preferences regarding consent and disclosure.

• In a survey regarding research on medical practices (ROMP), ¾ of US respondents indicated that they prefer to have conversations about participating in randomized or retrospective observational studies with their physician as opposed to researchers (Cho et al 2015).
• Focus group data indicate people want and expect information about ROMP to come from their physicians, in part because of the responsibility that the physician has for the patient and people trust their physicians and believe they will only propose research that is worthwhile and safe (Kelley et al 2015).
• Two-thirds of the people in the ROMP survey indicated that they would be comfortable using an alternative approach to written consent if the research could not otherwise take place, but would prefer to have traditional consent documented in a signed form if possible (Cho et al 2015).
• In another survey, people were generally comfortable waiving consent for minimal-risk quality improvement activities (Kaplan et al 2016), but pragmatic research can exist on the borderline between quality improvement and traditional clinical research (Finkelstein et al 2015), raising questions about what people are comfortable with across the continuum of these activities.

In another study, focus group respondents “desire to be actively notified and asked was more prominent with regard to CER [Comparative Effectiveness Research] studies than with regard to Operations studies (Weinfurt et al 2016).” The authors suggest that effective policy and guidance will involve a balancing of “different patients' interests and potentially different sets of interests for different types of research studies on usual medical practices.”

Although people generally endorse research and want to participate, and a majority indicate that they are comfortable with alternate approaches, there remains a substantial minority of people who want to be at least minimally engaged in decision making about this type of research (Sugarman 2016), and this raises ethical questions regarding the most appropriate ways to protect these individual’s rights and interests.

Weinfurt et al conducted a series of web-based surveys to compare different models for notification and authorization in different types of CER to determine how acceptable these approaches were to participants as well as their level of understanding (Weinfurt et al 2017).

Key findings:

• Many people have significant difficulty understanding certain aspects of pragmatic trials of commonly used medical practices, especially randomization and extra burden. They tend to automatically assume that a medical research study will involve extra visits, calls, etc, even when the consent form explicitly states that there will be no extra requirements of them.
• Although willingness to participate did not differ by notification or authorization approach (opt out, opt in, broad notification, oral or written consent, etc), it was not universal; 28% to 49% of respondents would decline to participate. This could lead to nontrivial consent bias because the people who decline could be different in some significant way to the people who agree to participate. However, this bias was the same for all approaches for notification and authorization
• Most of the respondents viewed less active approaches to notification, such as no notification ahead of time or broad notification, as unacceptable for some types of pragmatic research.
• When using written consent in cases where researchers are testing accepted medical interventions that have known clinical risks but with no incremental risks of participating in the research, it could be acceptable to omit the clinical risks from the consent documents, thereby shortening the form.
• Active alternatives to written consent—such as oral consent—did not compromise consent quality (from the patient’s perspective).

Based on these findings, the authors suggest that effort and resources should 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 balance our understanding of what people want and the desire to gather more information about the risks, burdens and benefits of interventions and therapies to improve health care.

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 and the differences between conventional research and related activities, such as pragmatic research, quality improvement research, and comparative effectiveness research. Our current understanding relies, in large part, on hypothetical examples, such as those described above, and may not reflect what would happen in actual practice. To gain further insight, investigators would need to be inquisitive about the different approaches to disclosure and authorization and test them as part of future embedded trials to help determine what is and is not acceptable across a spectrum of different types of research (Sugarman 2016).