| SUBJECTS
IDENTIFIABLE |
SUBJECTS
NOT IDENTIFIABLE |
RESEARCH
PROCEDURES USED
TO ACQUIRE MATERIAL
(specimens acquired using
additional procedures beyond
those required for clinical purposes) |
CLINICAL
PROCEDURES ONLY
(material gathered for clinical
purposes; specimens would otherwise be discarded) |
CLINICAL
PROCEDURES ONLY
(material gathered for clinical
purposes; specimens would otherwise be discarded) |
| MORE
THAN MINIMAL RISK
(e.g., genetic material will be
studied) |
MINIMAL
RISK |
MINIMAL
RISK |
MINIMAL
RISK |
|
DATA GATHERED PROSPECTIVELY |
DATA
GATHERED PROSPECTIVELY
|
DATA
GATHERED PROSPECTIVELY OR RETROSPECTIVELY |
DATA
GATHERED RETROSPECTIVELY
("retrospective" means the data
already exist at the time the research commences) |
| Full
IRB Review |
Expedited
Review May Be Allowed * |
Expedited
Review May Be Allowed * |
Exemption
from Review May Be Allowed** |
| Prior
Informed Consent Required |
Prior
Informed Consent Required |
Waiver
or Variation of Consent May Be Allowed |
Waiver
of Consent May Be Allowed |
