July 23, 2012

Berman Bioethics Institute to study informed consent options

The Johns Hopkins Berman Institute of Bioethics is a recipient of one of 50 pilot projects to be funded by the Patient-Centered Outcomes Research Institute to study stakeholder views of streamlined informed consent options for comparative effectiveness research studies.

“We are so pleased that questions of informed consent will be included in these pilot projects,” said Nancy Kass, co-principal investigator on the project and deputy director for public health at the Berman Institute. “Traditional informed consent has been a barrier to routinely making patient-centered research part of clinical practice. Our project will capture the views of patients, doctors, researchers and other stakeholders about what types of information or formal consent make sense to them,” she said.

After obtaining and characterizing the viewpoints of diverse stakeholders, the researchers aim to identify the least burdensome, ethically acceptable strategies for consent, disclosure and authorization for prospective PCORI studies, both observational and randomized clinical trials. Ruth Faden, director of the Berman Institute, is co-principal investigator on the study.