October 28, 2016: Research on Medical Practices

October 28, 2016: Research on Medical Practices


Research on Medical Practices: Willingness to Participate and the Investigational Misconception


Benjamin Wilfond, MD, Director of the Treuman Katz Center for Pediatric Bioethics at Seattle Children's Research Institute, and Professor in the Department of Pediatrics at the University of Washington School of Medicine

David Magnus, PhD, Director of the Center for Biomedical Ethics, Professor of Medicine and Biomedical Ethics, and Professor of Pediatrics at Stanford University


Research on medical practices; ROMP; Research ethics; Comparative effectiveness research; Learning healthcare system; CER; Informed consent; Cluster randomization; Privacy/confidentiality; Institutional review board; Qualitative research

Key Points

  • The Research on Medical Practices (ROMP) Ethics Study asks:
    - What do the public and regulators think about the ethical implications of randomization within usual clinical practices?
    - How should these attitudes influence policy about approaches to informed consent?
  • ROMP can be considered an umbrella concept that includes pragmatic trials, point-of-care randomization, comparative effectiveness research, learning healthcare systems, and quality improvement efforts.
  • The ROMP Ethics Study conducted an online survey (n=1095) that was representative by age, geography, gender, and race/ethnicity. Posing three hypothetical research scenarios, the survey asked respondents about their willingness to participate, and then rated responses along major themes such as perceived benefits and risks, trust, randomization and experimentation, informed consent, privacy and confidentiality, and misconceptions about research.
  • ROMP—research that evaluates and compares common medical practices—is distinct from RENT—research that evaluates new treatments or drugs. Yet these two investigational approaches have been conflated, causing confusion for patients and decision makers. Efforts to correct misconceptions about ROMP include the use of animated videos and specific language explaining the nature of this research.

Discussion Themes

Some IRBs consider that any time randomization is introduced, it must be considered research. Is research a narrowly defined concept—or is it more inclusive?

A related challenge is the notion that doctors always know what’s best. But uncertainty as part of clinical practice should be more recognized and acknowledged. Education materials can help dispel these misconceptions.

Education materials should be appropriate for the cultural context and health literacy of patient participants and include simplified illustrations that effectively convey information across cultural and linguistic barriers.

For More Information

For more information about the ROMP Ethics Study, visit www.rompethics.org.

A ROMP publication (2016) in AJOB Empirical Ethics is available at http://bit.ly/2eYV9Lg.

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