IS
FULLY DOCUMENTED CONSENT PRACTICABLE?
YES
NO |
Prior
Consent Not Practicable
Example:
Health
services studies where subjects' knowledge of the study may invalidate
the research
IF:
A
waiver or alteration will not adversely affect the rights and welfare of
the subjects;
AND
Whenever
possible, subjects will be provided with additional pertinent information
after they have participated in the study. |
| Not
Safe
Example:
Subjects
are users of illegal drugs
IF:
There
may be a significant risk to the subject from linking a consent document
to him/her |
|
|
Fully
Documented Consent Not Practicable
Examples:
Subject
does not understand English; or
All
contact will take place over the telephone.
IF:
An
IRB-approved summary of the verbal presentation will be used;
AND
An
independent witness to the oral presentation signs the summary;
AND
Copies
of the signed summary and short form are provided to subject and witness,
with short form in language understandable to subject |