You can also consider
a more objective mini-study of select procedures by reviewing
patient files to see what percentage of patients having
a certain procedure (for which your institutional policy
is to obtain informed consent) actually have a completed
and signed form within their file. A formal audit that evaluates
the process as well as the form may also be appropriate
as a mechanism of quality improvement (See Tool
2Bfor a sample
audit form). Although more difficult, a sampling of
patients via phone survey might provide some baseline data
on the effectiveness of the informed consent process. Review
of facility records to determine the percentage of law suits
involving informed consent issues may also provide insight
into the current state of affairs.
Either as part of this same study or in a separate effort,
creation of a full inventory of informed consent practices
would be ideal. Such an inventory would help shape training
needs and identify high-priority areas for improvement.
Such a comprehensive listing of current practices would
also establish a baseline for monitoring improvement efforts.
Key elements for entries or fields in such an inventory
might include:
In addition to this basic tracking information, an assessment
of the style and appropriateness of the written consent
form would also be appropriate (see Tool 3Ba checklist for assessing
the informed consent form).
Developed with a grant from the Robert Wood Johnson Foundation
