Results Summary

PCORI funded the Pilot Projects to explore how to conduct and use patient-centered outcomes research in ways that can better serve patients and the healthcare community. Learn more.


Before a patient can join a research study, the researchers doing the study need to get informed consent. Informed consent is a process in which a doctor or researcher explains what the research study is about and what the benefits and risks of joining the study are. The patient then chooses whether or not to join the study.

Getting informed consent can take a long time and a lot of paperwork. Researchers wanted to know if they could use a simpler informed consent process for studies that compare two or more available treatments. For example, a researcher may compare two headache medicines to find out which one works better for people who have severe headaches. Such studies are called comparative effectiveness research studies. They are different from studies in which one of the treatments studied is experimental or one group of patients receives no treatment.

Project Purpose

The research team wanted to know how patients, doctors, and researchers felt about three ways to get informed consent in comparative effectiveness research studies:

  • Opt In occurs when a doctor gives a patient an information sheet or talks to the patient about the research study. The sheet or conversation includes the purpose, risks, and benefits of the study. The patient then decides whether or not to join the study. If the patient agrees to join the study, they sign a consent form or tell the doctor that they agree. This is the traditional approach that doctors use to get informed consent.
  • Opt Out occurs when a doctor wants to look at information that a patient has already given. This may include information from a patient’s health record. In this case, the doctor first gives the patient a brief overview of the study. Doctors tell patients that they will be part of the research study unless they say that they do not want to participate.
  • General Approval occurs when patients receive information through newsletters, posters, or information sheets stating that their doctor or hospital often participates in research that won’t affect the care that patients receive. In this kind of informed consent, the doctor doesn’t always explain the research study to patients. Thus, there is no opportunity for patients to tell the doctor that they don’t want to participate in the study.

The research team wanted to find out which informed consent option participants preferred for two types of studies on blood pressure medicine.

Specifically, the researchers wanted to learn from patients, doctors, researchers, and others

  • Which informed consent option they liked best
  • What part of the informed consent process was most important to them
  • What their attitudes were about informed consent
  • Whether they thought it was okay to use one of the three informed consent processes for different types of studies


The researchers held two day-long meetings with patients. One meeting occurred at Geisinger Health System in Pennsylvania and included 62 patients. The other meeting took place at Johns Hopkins Community Physicians in Maryland and included 75 patients. The researchers randomly called patients and asked them to participate in one of the meetings. All of the patients were age 40 or older. Patients either lived less than 35 miles from Geisinger Health System or got care from Johns Hopkins Community Physicians. The researchers asked different groups of people to participate in the study: men and women, people with and without high blood pressure, and people of different races. 

The research team also held a day-long meeting with 58 doctors, representatives from insurance companies, hospital staff, research experts, and patient advocates. This group is called a stakeholder group.

Before each meeting, participants filled out a survey that asked them about their attitudes toward research. It also asked what they thought about the three informed consent options. During the meetings, the research team explained comparative effectiveness research. Then they described two examples of comparative effectiveness research studies. The examples were from a hospital or clinic that regularly did research studies to learn from patients about how to improve health care as quickly as possible. Both examples included an ethics board that reviewed all research studies.

The research team then explained the three ways to get informed consent. Participants talked about the options in small groups. After the meeting, participants filled out another survey asking them how they felt about research and the informed consent options. The research team reviewed the surveys and notes from the meetings to see which informed consent option the participants liked best and why.


At the end of the day-long meetings, patients preferred the Opt In and Opt Out informed consent options. Seventy percent of patients liked Opt In, 65 percent liked Opt Out, and 40 percent liked General Approval.

Patients described the factors they cared about most in informed consent. Ranked from most common to least common, these factors included: choice, information, privacy and confidentiality, the quality of the research, how the study might change the care that patients get, trust, and respect.

The stakeholder group gave different answers. At the end of the day-long meeting, 80 percent of stakeholders liked Opt In, 55 percent liked Opt Out, and only 11 percent liked General Approval.

The research team also found that patients and stakeholders changed how they answered some survey questions after the meeting. At the end of the day, more participants liked General Approval than at the beginning of the day, and fewer liked Opt In than at the beginning of the day.


The study was small. The research team doesn’t know if the results would be the same with patients from other health systems. However, the results were the same in the two health systems the researchers worked with, even though they were in different parts of the country and served patients with somewhat different needs. Also, participants went to only one meeting, so the researchers don’t know whether their opinions about informed consent might stay the same or change over time.


Participants were open to informed consent options that make the process simpler and faster than standard methods. Study participants also said that it’s important for patients to choose whether they participate in research. Because of this, participants would support a simpler informed consent process only if it’s clear that patients are making a choice about whether to participate in a research study.

Sharing the Results

The research team has presented this work at research meetings and in professional research journals. The research team is developing more papers on the findings of this work.

Project Information

Ruth Faden, PhD, MPH
Nancy Kass, ScD
Johns Hopkins Berman Institute of Bioethics
Stakeholder Views of Streamlined Informed Consent Options for CER Studies

Key Dates

June 2012
December 2014

Study Registration Information


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Last updated: March 4, 2022