RAND IRB Determination

Page 1 of 3

NOTIFICATION - EXEMPT

From:

Carolyn Tschopik

To:

Thomas Concannon - PI

Cc:

Nupur Nanda - Primary Contact
Ramya Chari - Study Team
Amy DeSantis - Study Team
Laura Faherty - Study Team
Liisa Hiatt - Study Team
Patrick Orr - Study Team

ID:

2017-0666

Title:

The World Trade Center Health Program: Impact Assessment and Strategic Planning for
Translational Research

Description:

The HSPC re-reviewed the study and determined that the study is exempt under Category 2.
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.

Date of
10/20/2017
Determination:

CURRENT STUDY REVIEW STATUS
Project
Number:

There are no items to display

Funding
Source:

Center for Disease Control and Prevention, National Institute for
Occupational Safety and Health

Prime
Recipient:

RAND

RAND Unit(s):

Justice, Infrastructure, and Environment *

Human
Subjects:

Yes

Type of
Review:

Exempt

Exemption
Categories:

https://rhino.rand.org/Rhino/Doc/0/C5T9MMIPN7BKF7IGP91ARABC55/fromString.html 12/22/2017

Page 2 of 3

Category
2
Component
Approvals:

Exemption Category
Procedure

Systematic
Review
Articles

Approved

Motion

Fri Oct 20
Systematic
Exempt 12:21:55
Review
Determination
PDT 2017

Procedure Approved

Focus
Groups

Motion

Fri Oct 20
Exempt 12:21:54
Determination
PDT 2017

WTCHP
Funders
Fri Oct 20
Exempt Interviews 12:21:55
Determination
PDT 2017

Procedure Approved

Focus
Groups
WTCHP
Research
Users

Motion

Fri Oct 20
Exempt 12:21:54
Determination
PDT 2017

Fri Oct 20
Exempt Interviews 12:21:54
Determination
PDT 2017

WTCHP
Procedure Approved
Researchers
Focus
Groups

Motion

Fri Oct 20
Exempt 12:21:55
Determination
PDT 2017

Category
Exempt
Category:
• 2 - Adult
Interviews
and Surveys
Exemption
Category
Exempt
Category:
• 2 - Adult
Interviews
and Surveys
Exemption
Exempt
Category:
• 2 - Adult
Interviews
and Surveys
Exemption
Category
Exempt
Category:
• 2 - Adult
Interviews
and Surveys
Exemption
Exempt
Category:
• 2 - Adult
Interviews
and Surveys
Exemption
Category
Exempt
Category:
• 2 - Adult
Interviews
and Surveys
Exemption

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Page 3 of 3

Interviews Fri Oct 20 Exempt Exempt
12:21:55 Determination Category:
PDT 2017
• 2 - Adult
Interviews
and Surveys
Exemption
Contingencies:

Description
Date Due
There are no items to display

Assurance
number:

FWA00003425

IRB number:

IRB00000051

Administrator:

Carolyn Tschopik

Date Completed

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 January 31, 2020, 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.

https://rhino.rand.org/Rhino/Doc/0/C5T9MMIPN7BKF7IGP91ARABC55/fromString.html 12/22/2017