Attachment G -- RAND Human Subjects Protection Committee (IRB) Exemption Notice

http://rhino/Rhino/Doc/0/BFH09F19C4A4PC8SI0GEGRUS0D/...

NOTIFICATION - EXEMPT

From:

Jim Tebow

To:

Peter Hussey - PI

Cc:

Rachel Burns - Primary Contact
Courtney Armstrong - Study Team
Courtney Gidengil - Study Team

ID:

2014-0059

Title:

Updating and Expanding the AHRQ QI Toolkit for Hospitals

Description:

The above study is exempt from further HSPC review. This does *not* mean the research is
exempt from meeting ethical requirements; rather it means the investigators are on their own
recognizance to assure that basic ethical principles are met (for clarity on these principles, see
http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm). If there is another
organization also "engaged" in the research, that organization may do its own review and may
not exempt the study. Please contact the HSPC immediately if the research changes in any
ways that may affect human subjects involvement.

Action
Required:

No action is required of you at this time. If you wish to view the status of your
application, please login to RHINO, then click on the study ID above to navigate to the
project workspace.

Date of
2/20/2014
Determination:

CURRENT STUDY REVIEW STATUS

1 of 2

Project
Number:

HQ365

Funding
Source:

Agency for Healthcare Research and Quality

Prime
Recipient:

RAND

RAND Unit(s):

Health

Human
Subjects:

Yes

Type of
Review:

Exempt

2/25/14 12:24 PM

http://rhino/Rhino/Doc/0/BFH09F19C4A4PC8SI0GEGRUS0D/...

Exemption
Categories:

Category
2

Component
Approvals:

Exemption Category
Adult Interviews and Surveys Exemption
Procedure

Approved Motion

Category
Exempt
Category:

Interviews with
teams
implementing
quality
improvement
managers on the QIs
and
clinical
staff at
hospitals
Quarterly
update
interviews with
implementation
team leaders

Assurance
number:

FWA00003425

IRB number:

IRB00000051

Administrator:

Jim Tebow

Thu Feb
20
Exempt 16:57:15
Determination
PST
2014

2 - Adult
Interviews
and
Surveys
Exemption

Exempt
Category:
Thu Feb
20
Exempt 16:57:43
Determination
PST
2014

2 - Adult
Interviews
and
Surveys
Exemption

The HSPC is RAND's Institutional Review Board to review research involving human subjects, as
required by federal regulations. RAND's "Federalwide Assurance for the Protection of Human Subjects"
(FWA00003425, effective through July 1, 2018, at http://intranet.rand.org/groups/hspc/fwa.pdf ) serves as
our assurance of compliance with the regulations of 16 federal departments and agencies. According to
this assurance, the Committee is responsible for review regardless of source of funding.

2 of 2

2/25/14 12:24 PM