Changing the Traditional Approach to Clinical Research Consent

Every day, physicians make care decisions for their patients, often choosing from an array of available products and courses of action.  Ideally a physician weighs the potential risks and benefits associated with each course of action, but in actual practice, they often do not have the information needed to do so.  Clinical decisions are often based on a combination of the physician’s training, previous patient experience, and the established routines of the medical practice.

While patients do benefit from decisions made this way, we have no way of knowing if another course of action would have worked better.  Plus, in uncertain situations doctors often use their judgment to try new things.  We have no way of learning the results of these judgment calls, and whether these innovations would help other patients, too.

To learn what works best for patients in clinical practice, we need to be able to learn from routine care decisions.   But under the current rules guiding clinical research, even the simplest data-gathering in a doctor’s office is considered “research,” requiring  each patient to review and sign an (often lengthy) informed consent document. While these rules exist to prevent patients from being exposed to potential research-related risks without their knowledge and consent, the way they are applied to data-gathering in routine care inhibits learning from daily decision-making.  To learn lessons from daily care, we need to change the traditional approach to informed consent for low-risk practice-based research.

This project, led by the Johns Hopkins Berman Institute of Bioethics, seeks to determine whether a streamlined informed consent model for low-risk, practice-based research will be acceptable to patients and other stakeholders.  CMTP is partnering with the Berman Institute to hold deliberative discussion sessions with patients from two different health systems,  Geisinger Health Plan and Johns Hopkins Community Physicians, and with a multi-stakeholder group that will include patients, physicians, regulators, researchers, insurers, medical technology industry representatives, and others. 

With each of these groups, we will explore whether, and under what circumstances, patients and stakeholders would accept simpler and less time-consuming methods of informed consent.  At the conclusion of the project in late 2014, the team will share the results of these discussions, which may have implications on revising informed consent practices for low-risk, systematic learning in routine practice settings.

For more information on this project and its objectives, please review recently published articles:

• The Research-Treatment Distinction: A Problematic Approach for Determining Which Activities Should Have Ethical Oversight
• An Ethics Framework for a Learning Health Care System: A Departure from Traditional Research Ethics and Clinical Ethics
• Ethics and Informed Consent for Comparative Effectiveness Research with Prospective Electronic Clinical Data
• Informed Consent, Comparative Effectiveness and Learning Health Care