Many of the barriers
to attaining more effective informed consent are rooted
in long-established practices or patterns of clinical care.
Changing these institutional or individual habits will take
time. It may also require some up-front training or education
of staff who harbor questions such as: “Why are
any changes needed? What’s the problem with our current
informed consent forms? Aren’t we just opening a can
of worms? My patients are fine with the forms I use.”
To set the stage for your improvement efforts, therefore,
you may need to devote some time to educating the appropriate
clinical and management staff about the purpose of informed
consent and the nature of the problem with informed consent
in actual practice. In some cases, this first step in the
improvement process may just be a simple one-on-one conversation
with a department head about the possibility of reviewing
and updating informed consent forms for certain procedures.
In other cases, you may want to create a memo or newsletter
article for all staff describing the purpose of your planned
effort. And in some situations, you may have the opportunity
to introduce the improvement plan at a departmental staff
meeting or even a hospital-wide gathering.
Whatever the venue for your education, information similar
to that presented in Introduction and Background
sections of this guide may help you in setting the stage
for change. To assist you in preparing your case for improvement,
many of the key points from the previous sections of this
guide and Appendices A and B have been
summarized and reformatted into a presentation format (Tool
1A: Staff Training Slides) for your adaptation
and use. You will also of course want to customize your
presentation—for example by showing examples of actual
forms used in your institution; summarizing your institutional
policies on informed consent; or describing specific case
studies involving problems or successes with informed consent.
As in all steps suggested in this guide, close coordination
with your institution’s legal counsel is advised.
Note that this first step should be a two-way interchange
of information. While you are reminding your colleagues
of the ideals and realities of informed consent, they will
be telling you about the challenges, questions, or success
stories happening within your own organization. As suggested
in the next section, you may also want to create a more
formal mechanism for assessing your local state of affairs
regarding informed consent. Based on this input, you may
decide that you need to address issues beyond those suggested
in the final sections of this guide. For example, you may
need to clarify institutional policies about when informed
consent is required, or you may find that a broader CME
course on basic patient-physician communication skills would
be appropriate.
Developed with a grant from the Robert Wood Johnson Foundation