Download Review Type Algorithm: Exempt, Expedited, Full Board

Review Type Overview-Human Subject Research
Exempt, Expedited, Full Board Review
START HERE
NOTE: If you will only be receiving data/specimens and not collecting them yourself- see Receiving Data/ Specimens
Are data/specimens existing* and
will they meet the criteria of Deidentified or Limited Data Set per
HIPAA**?
*Existing-specimens are currently in
lab or the data is in a file
Submit: EXEMPT APPLICATION
On Goldenrod answer:
Yes to Human Subjects
Yes to Exempt
Yes
**Only HIPAA identifiers allowed:
• Address info- zip code or bigger
• DOB is under the age of 89
• Age is under the age of 89
No
Is the study “Minimal Risk”?
Minimal risk is the probability and
magnitude of physical or
psychological harm that is normally
encountered in the daily lives, or in
the routine medical, dental, or
psychological examination of healthy
persons (45 CFR 46.303(d)).
No
Yes
Do all of the procedures in the
study fall under the
Expedited Categories
per 45 CFR 46.110 and
21 CFR 56.110 ?
No
Submit:
• IRB Application for Full Board Review OR
• Request for IRB Authorization Agreement:
• External IRB/Ethics board MUST have an FWA and notify IRB-HSR Director .
No
• dbGaP Data Use Certification Form if receiving data from dbGaP
• On goldenrod answer:
• YES to Human Subjects Research
• NO to Exempt
**NOTE: You will also have to submit Grant Proposal
to IRB for review and approval if
.
the protocol has outside funding.
For Grant Submission Process see IRB-HSR Website at
http://www.virginia.edu/vpr/irb/hsr/submit_grant.html
Yes
Submit:
IRB Application for Expedited Review OR
• Request for IRB Authorization Agreement:
• External IRB/Ethics board MUST have an FWA and
notify IRB-HSR Director .
• dbGaP Data Use Certification Form if receiving data from
dbGaP
• On goldenrod answer:
• YES to Human Subjects Research
• NO to Exempt
**NOTE: You will also have to submit Grant Proposal to IRB for
review and approval if the protocol has outside funding.
For Grant Submission Process see IRB-HSR Website at
http://www.virginia.edu/vpr/irb/hsr/submit_grant.html
Version Date 8/20/15