Expedited Review Procedure

1
Expedited Review Procedure

• Initial Review of Research

2
Overview Expedited Process for Initial Review
No
Yes
No
Yes
45 CFR 46.110 DHHS, Categories of Research That
May be Reviewed by the Institutional Review Board
(IRB) through an Expedited Procedure,
http//www.hhs.gov/ohrp/humansubjects/guidance/exp
edited98.htm.
3
Chart 1 Expedited Process for Initial Review
No
Yes
Yes, IND is required.
No
OR
No
Yes
No
45 CFR 46.110 DHHS, Categories of Research That
May be Reviewed by the Institutional Review Board
(IRB) through an Expedited Procedure,
http//www.hhs.gov/ohrp/humansubjects/guidance/exp
edited98.htm.
4
Chart 2 Expedited Process for Initial Review
No
Yes
No
Yes
Yes
Yes
No
No
Yes
Yes
Yes
Yes
Yes
No
No
5
Chart 3 Expedited Process for Initial Review
No
Yes
No
No
Yes
Yes
No
Yes
45 CFR 46.110 DHHS, Categories of Research That
May be Reviewed by the Institutional Review Board
(IRB) through an Expedited Procedure,
http//www.hhs.gov/ohrp/humansubjects/guidance/exp
edited98.htm.
6
Chart 4 Expedited Process for Initial Review
No
Yes
No
No
Yes
Yes
No
Yes
Yes
No
45 CFR 46.110 DHHS, Categories of Research That
May be Reviewed by the Institutional Review Board
(IRB) through an Expedited Procedure,
http//www.hhs.gov/ohrp/humansubjects/guidance/exp
edited98.htm.
7
Chart 5 Expedited Process for Initial Review
No
Yes
No
Yes
No
Yes
45 CFR 46.110 DHHS, Categories of Research That
May be Reviewed by the Institutional Review Board
(IRB) through an Expedited Procedure,
http//www.hhs.gov/ohrp/humansubjects/guidance/exp
edited98.htm.
8
Chart 6 Expedited Process for Initial Review
No
Yes
No
No
Yes
Yes
45 CFR 46.110 DHHS, Categories of Research That
May be Reviewed by the Institutional Review Board
(IRB) through an Expedited Procedure,
http//www.hhs.gov/ohrp/humansubjects/guidance/exp
edited98.htm.