Demonstrating Respect and Acceptable Consent Strategies: What Matters to Patients in Patient-Centered Outcomes Research (PCOR)? [Methods Study], United States, 2017 (ICPSR 39575)
Version Date: Nov 17, 2025 View help for published
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Nancy E. Kass, Johns Hopkins University
https://doi.org/10.3886/ICPSR39575.v1
Version V1
Summary View help for Summary
Before people can join a research study, they need to provide informed consent. Informed consent is a process that helps people know
- What a study is about
- What will happen in the study
- The benefits and risks people may experience
- That they have a choice whether to join the study
Getting informed consent can take a long time, and people may not understand all the details. Researchers want to know what patients think about having short or longer discussions with doctors for studies with low risk. Low risk means the study's risks are no greater than those in daily life or from usual health care. In this study, the research team compared people's views about a shorter consent discussion for a study on blood pressure with the usual, longer discussion.
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Study Purpose View help for Study Purpose
To determine whether viewing animated videos of streamlined informed consent discussions for low-risk comparative effectiveness studies, compared with viewing animated videos of traditional informed consent interactions, affects people's perceptions of the consent process
Study Design View help for Study Design
This randomized controlled trial compared respondents' views after watching one of seven animated videos showing a doctor and patient engage in either a streamlined or traditional informed consent discussion about a low-risk comparative research study. Researchers wanted to determine whether the streamlined videos affected respondents' willingness to join a study and their perceptions of the informed consent process viewed. Low-risk comparative studies compare treatments that are widely used, similar in patient experience and burden, and pose no greater risks than those typically encountered in daily life.
Researchers randomly assigned respondents to one of seven groups. Each group viewed one of the animated videos of a doctor-patient discussion about a hypothetical study comparing two widely used blood pressure medications. One showed a traditional informed consent process involving a doctor briefly introducing the study to a patient and then the patient reviewing the study and consent form with a research nurse. The other six showed a streamlined process, in which a doctor verbally explained the study to a patient and indicated that the patient would be enrolled in the study unless the patient opted out. Doctors did not ask patients in these videos to sign a consent form. These videos also varied by the amount of other information included, such as
- Additional background information on the need for research that compares widely used treatments
- Emphasis on the patient having a choice to participate in the study
- Descriptions of ways patients are engaged and of transparency and accountability processes in the research and in place at the provider's location
The study included 2,600 adult respondents recruited from two health systems and an online survey panel. Of these, 70% were white, 15% were black, and 6% were other races; also, 9% were Hispanic. In addition, 52% were male, and 56% were age 45 or older.
Respondents viewed their randomly assigned videos and answered a survey immediately after. A group of 21 people receiving care from the two health systems provided feedback on the videos and study outcomes.
Universe View help for Universe
2,600 people recruited from two health systems and from an online nationally representative survey panel maintained by Growth from Knowledge (GfK)
Data Source View help for Data Source
RCT; recruited patients from two health systems and from an online nationally representative survey panel maintained by Growth from Knowledge (GfK)
Notes
The public-use data files in this collection are available for access by the general public. Access does not require affiliation with an ICPSR member institution.
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This study is maintained and distributed by the Patient-Centered Outcomes Data Repository (PCODR). PCODR is the official data repository of the Patient-Centered Outcomes Research Initiative (PCORI).