Stakeholder Views on Streamlined Informed Consent

Stakeholder Views of Streamlined Informed Consent Options for CER

Principal Investigators:

RuthFadenSq-100x100Ruth Faden, PhD, MPH, Philip Franklin Wagley Professor, Johns Hopkins Berman Institute of Bioethics
kasssq-100x100Nancy Kass, ScD, Phoebe R. Berman Professor of Bioethics and Public Health, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Deputy Director of Public Health, Johns Hopkins Berman Institute of Bioethics

About the Project:

This project focused on better understanding how patients and other stakeholders feel about different ways of being informed about research projects that compare commonly-used treatments or widely-practiced medical procedures. We held three Deliberative Engagement Sessions (DES) with patients and stakeholders to understand their views on three different disclosure/consent approaches to comparative effectiveness research (CER) case studies. The DES alternated between large group sessions that involved all participants and small group sessions that happened at each of the tables. large group sessions lasted 15-20 minutes and provided participants with information about: 1) research projects that compare commonly-used treatments or widely-practiced medical procedures (comparative effectiveness research or CER); 2) Learning Health Care Systems (LHS); 3) the difference between observational and randomized study designs; and 4) the three disclosure/consent models.

The two patient DESs involved patients from Johns Hopkins Community Physicians (JHCP) in Baltimore, MD and Geisinger Health System (GHS) in Danville, PA, respectively. We specifically selected two health systems that differed in health system structure, racial background of patients, and geographic setting. The third DES was held in Baltimore, MD and involved a variety of stakeholders including patient advocates, doctors, researchers, research funders, health care payers and individuals involved in research oversight.

We asked patients before and after each DES how much they liked different consent/disclosure approaches, given the specific CER case studies. We also transcribed the small group conversations during the DES to look for themes in patient discussions.


 uabr21Nancy Kass, Ruth Faden, Rachel Fabi, Stephanie Morain, Kristina Hallez, Danielle Whicher, Sean Tunis, Rachael Moloney, Donna Messner and James Pitcavage. Alternative Consent Models for Comparative Effectiveness Studies: Views of Patients from Two Institutions” AJOB Empirical Bioethics 2016.

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