|
ADULT SUBJECT?
YES
NO |
|
Lack of decision making
capacity must be evaluated and documented, and confirmed by independent
physician
|
|
ABLE
TO COMPREHEND RESEARCH PARTICIPATION
(~AGE 7 OR OLDER)?
NO
YES |
| Fetus |
Child |
Child
or Adolescent |
Adolescent |
| APPROPRIATE
SURROGATE AVAILABLE?
NO
YES |
Both
maternal and paternal consent may be required |
Developmentally
appropriate explanation must be provided to subject |
ONLY
IF:
This
is research on clinical services which adolescent may receive without parental
permission
OR
Subject
is legally emancipated |
EMERGENCY
MEDICAL
RESEARCH
ONLY
IF:
All
regulatory requirements have been met for waiver of consent in emergency
medical research
OTHERWISE:
Subject
may not be enrolled |
Subject
must be present during informed consent procedure
Relationship
of surrogate to subject and presence of subject must be documented on consent
form
Subject
should be asked for assent whenever possible |
| Waiver
of Consent |
Permission
of Surrogate |
Permission
of Parents/ Guardian |
Permission
of Parents/ Guardian
AND
Assent by Subject |
Consent
by Subject, with IRB Approval |
