This publication is meant to assist those interested in developing consistently high-quality policies, processes, and written forms that are suitable for informed consent in everyday clinical practice. It is intended not only for the clinician who has the central role in the informed consent process but also for the many other healthcare team members who share this responsibility to ensure that patients truly understand any procedure they are considering. This team includes the full clinical staff (e.g., nurses, nurse specialists, technicians, pharmacists), administrative and clinical leadership, risk managers, legal counsel, health educators, and interpreters.
As with any proposal for change in institutional or personal
practices, there may be reluctance to alter established
informed consent policies preferring to rely on the status
quo. For that reason, any movement for improved informed
consent will likely require an internal advocate for change—one
person or one team who accepts the responsibility for initiating
and achieving change. This Guide is especially intended
for that person or team. Throughout this Guide we provide
ammunition for this individual or group—such as
the Training Slide Set in Tool 1a and the Tools for reevaluating
and improving consent—help raise awareness about
the inadequacies of the status quo and motivate colleagues
to change. The key potential benefits of improving informed
consent that must be conveyed include:
Greater patient safety and satisfaction
Attainment of higher ethical standards and organizational
morale
Closer adherence to legal requirements and reduced risk
of litigation
Increased levels of institutional quality (e.g., compliance
with accreditation standards)
Potential time and money savings (or offsets) related
to reduced litigation
To help the advocacy team achieve these goals, the Guide has been organized into the following sections:
The Background section provides clinicians
and administrators with an introduction to the definitions
and published standards for informed consent. Then, based
on a review of the literature on informed consent, including
an analysis of the main barriers to effective informed
consent (all presented in the Appendices A and B),
a few suggested solutions are summarized.
The core of the practical guidance in this publication
appears in the How to Improve Your Informed Consent
section. Here you will find specific suggestions on how
to upgrade the quality of your informed consent process
and written materials. Several easy-to-photocopy or download
Tools are included to help you manage the tasks
of preparing your organization, prioritizing needs, and
then improving your institution's disclosure procedures.
An array of other resources including full-page reproductions
of actual consent forms can be found in the Resources
and Appendices sections of this guide.
As the choices facing patients
become ever more complex and as the U.S. population grows
even more diverse, the need to improve informed consent
will only grow. This is an effort that is ongoing. We hope
this publication encourages you and your organization to
begin rethinking and improving your entire approach to informed
consent. We thank the Robert Wood Johnson Foundation for
their support of this important project.
Developed with a grant from the Robert Wood Johnson Foundation
