|
ADULT SUBJECT (OR EMANCIPATED MINOR)?
YES
NO |
CAPABLE
OF MAKING DECISION TO PARTICIPATE?
(If NO, protocol
must include methodology for determining lack of decision making
capacity)
YES
NO |
Survey/interview
research may not be exempted (except studies using public observations
of behavior with no investigator participation)
Limits
on blood draws under expedited review
Research
involving more than minimal risk usually must hold potential for subject's
benefit |
PREGNANT?
YES
NO |
WILL
PERMISSION OF APPROPRIATE SURROGATE DECISION MAKER BE OBTAINED?
YES
NO |
| IRB
should include a member or consultant with expertise on disability involved |
All
requirements for emergency medical research with waiver of consent must
be fulfilled |
| No
exemptions from review allowed
Limits
on blood draws under expedited review
Must
consider risks to both mother and fetus |
PRISONER/
DETAINEE?
YES
NO |
| No
exemptions from review allowed
Prisoner
advocate must participate in review
Research
must potentially benefit the individual or a group to which he/she belongs |
|
|
ALL OTHER
REVIEW CONSIDERATIONS FROM DECISION TREE I APPLY
|
