A Self-Assessment Guide for Health Care Organizations - IFC
A Self-Assessment Guide for Health Care Organizations - IFC
A Self-Assessment Guide for Health Care Organizations - IFC
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Measurable Element Look <strong>for</strong> Score Observations<br />
What is required<br />
5) Written in<strong>for</strong>med<br />
consent is obtained from<br />
participants and includes<br />
the following in<strong>for</strong>mation:<br />
a. expected benefits,<br />
b. potential discom<strong>for</strong>ts<br />
and risks,<br />
c. alternatives that might<br />
help them,<br />
d. procedures that they<br />
must follow<br />
e. process <strong>for</strong> reviewing<br />
research protocols,<br />
f. process <strong>for</strong><br />
withdrawing<br />
participation, and<br />
g. process <strong>for</strong> weighing<br />
the benefits and risks<br />
to the subjects.<br />
How is this element<br />
assessed<br />
Research files demonstrate that all<br />
patients were in<strong>for</strong>med about the<br />
required elements. Patient<br />
interviews could be used to<br />
validate this requirement.<br />
0 5 10 Why did you give this score<br />
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6) Patients are assured<br />
that their refusal to<br />
participate or withdraw<br />
from participation will not<br />
compromise their access to<br />
the organization’s services.<br />
Written documentation of this<br />
right is located in the research file<br />
<strong>for</strong> each patient.<br />
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38 <strong>IFC</strong> <strong>Self</strong>-<strong>Assessment</strong> <strong>Guide</strong> <strong>for</strong> <strong>Health</strong> <strong>Care</strong> <strong>Organizations</strong>