Demonstrating Respect and Acceptable Consent Strategies: What Matters to Patients in Patient-Centered Outcomes Research (PCOR)? [Methods Study], United States, 2017 (ICPSR 39575)
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.
Patient-Centered Approaches to Research Enrollment Decisions in Acute Cardiovascular Disease [Methods Study], United States, 2014-2019 (ICPSR 39584)
Some research studies, called clinical trials, test treatments to see if they are safe and effective for patients. Before patients enroll in a trial, researchers ask patients for informed consent. In informed consent, a doctor or researcher explains what the trial is about and the benefits and risks of taking part. Patients then choose whether to enroll in the trial. If a patient is too sick to decide, a surrogate, such as a family member or friend, can decide on the patient's behalf.
Trials that test treatments in health emergencies, such as heart attack or stroke, may need a different informed consent process. Emergency situations can be stressful, and patients may have little time to learn about the trial.
In this study, the research team worked with patients and surrogates who had experience with informed consent for trials in health emergencies. They created a new informed consent process to use for trials about stroke and heart attack.
Privacy-Preserving Analytic and Data-Sharing Methods for Clinical and Patient-Powered Data Networks [Methods Study], California, Colorado, and Washington, 2014-2018 (ICPSR 39563)
Sometimes a study can get better results using data from different sites. In these cases, researchers may want to share patient data, including personal and private information such as dates of birth and addresses. However, researchers may not want to share data across sites because of worries about patient privacy. Some statistical methods can change patients' sensitive individual data into summary data that hides individuals' personal information. These privacy-protecting methods, or PPMs, make it safe to share data across sites. But researchers don't know if PPMs produce accurate results.
In this study, the research team compared combinations of PPMs with methods that use patients' individual data.
To access the methods, software, and R package, please visit the distributed GitHub.
Research Ethics in Patient-Centered Outcomes Research (PCOR) [Methods Study], United States, 2015-2019 (ICPSR 39567)
Patient-centered outcomes research, or PCOR, is a type of research that focuses on patient values and needs. PCOR includes patients in many parts of the research process, including helping to plan and conduct the study. Institutional Review Boards, or IRBs, oversee research studies to make sure patients participating in a study are protected from harm. But current IRB guidance may not address ethical issues that arise when patients are involved in other roles.
In this study, the research team created recommendations to guide IRB oversight of PCOR studies.