Appendix D - Study Information

Task Order 24: Study of the
Title III Native American and
Alaska Native Children in
School (NAM) Program
Office of Management and Budget
Clearance Request
Appendix D: Institutional Review
Board Letter of Approval
Prepared for
U.S. Department of Education
Office of Planning, Evaluation and Policy Development
Policy and Program Studies Service
By
American Institutes for Research
June 29, 2016

4880_01/16

JANUARY 2015

Appendix D. Institutional Review Board (IRB) Letter
of Approval
The following letter is the signed IRB determination for the proposed study.

Task Order 24: Study of the Title III Native American and Alaska Native Children in School Program—92

IRB Determination
Institutional Review Board
American Institutes for Research
1000 Thomas Jefferson Street, NW
Washington, DC 20007
IRB00000436 FWA00003952
B&P Number:
Project number:
Project/Proposal title:
Program:
Project Director:
IRB Reviewer:

85669
03118.024
PPSS TO24: NAM Prog Eval
Undetermined
Erin F. Haynes
Deanna L. Achorn

1. Type of Review:
i Requested re-review (e.g., new data collection component, research plan change)
j
k
l
m
n
2. Is the activity a systematic investigation designed to contribute to generalizable knowledge? [45
CFR 46.102(d)]
i Yes
j
k
l
m
n
3. Does the activity involve living individuals about whom the investigator conducting research
obtains:
(1) Data through intervention or interaction with the individual, or
(2) Identifiable private information?
i Yes
j
k
l
m
n

4. Is this activity eligible for expedited IRB review, as authorized by 45 CFR 46.110 and 21 CFR
56.110?
b Yes
c
d
e
f
g
b Yes
c
d
e
f
g
5. Does the project meet any of the exemption categories (45 CFR 46.101)?
b No
c
d
e
f
g
6. Is a waiver of documentation of informed consent, a waiver/alteration of informed consent, or
a HIPAA waiver of authorization approved in this submission?
i Yes
j
k
l
m
n
7. The waiver(s) granted:

i Waiver
j
k
l
m
n

of documentation of informed consent

8. Are there conditions this project needs to meet to approve this submission?
i No
j
k
l
m
n
9. After reviewing the submission, the Institutional Review Board (or member signing below) has
determined the following:
approval of the materials contained in this submission is granted and data collection can
proceed. In keeping with our Federalwide Assurance mandate, the IRB must conduct reviews at
least annually for each project.
10. Consent Procedures
The Institutional Review Board has determined that consent procedures:
i are
j
k
l
m
n

approved as submitted

11. Individually Identifiable Information Safeguards
The Institutional Review Board has determined that the safeguards planned for individually
identifiable information:
i are
j
k
l
m
n

approved as submitted

12. Determination:
On the basis of this review, the IRB has determined that the project, as described in the
materials submitted, is research and does involve human research participants. The research is
approved because the selection of participants is equitable and the risks to the participants are
minimized and are reasonable in relation to the knowledge that may reasonably be expected to
result. There are no risks greater than those ordinarily encountered in daily life or during routine
test or activities. The procedures for obtaining informed consent are appropriate and the
procedures for protecting the confidentiality of the collected data are adequate. Because the
conditions stipulated in 45 CFR §46.117(c) are met, a waiver of documentation of consent is
granted. Data collection may proceed.
13. IRB Signature(s):

Deanna L. Achorn, IRB Representative
02/11/2016
Please keep in mind that any material changes made to the study or the study procedures require the
submission of an updated IRB package.