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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 />

........................................................<br />

........................................................<br />

........................................................<br />

........................................................<br />

........................................................<br />

........................................................<br />

........................................................<br />

........................................................<br />

........................................................<br />

........................................................<br />

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 />

........................................................<br />

........................................................<br />

........................................................<br />

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>

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