Att J - IRB Approval

REQUEST FOR DETERMINATION OF RESEARCH STATUS
To be completed by the staff member with lead responsibility for the project and approved by branch chief (if applicable) and Division ADS.
A separate PGO funding memo is required if project is research and involves human subjects regardless of the CDC staff role.
Instructions:

(1) Use this form to declare: (a) the research status of any project, (b) role or roles of CDC staff
(2) A short summary should be attached offering specific details about the project and the role of staff.
(3) Be sure to complete all applicable items, obtain appropriate signatures and submit this form for appr oval.

Tracking Number:

200-2007-20015/2007-C-009

(Use PGO number if cooperative agreement, grant, etc.)
05/05/2010

Date submitted:

Development and Marketing of Youth Eagle Books

Title of Project:

Dates for project period:

Dates for funding (if applicable):

Beginning:

08/28/2007

Beginning:

Ending:

08/24/2012

Ending:

Project is (choose one):
NOTE: Revision, as used below, refers to any substantive change made to the project including scope of project, funding restrictions,
personnel, role of CDC staff member, determination of research status, etc.
[X]

New

[ ]

Revision

[ ]

Continuation, without revision(s)

[ ]

Continuation, with revision(s)

Lead staff member:

Contact information:

LEMYRA DEBRUYN

Division:

DDT

[ ]

Project officer

[X]

Technical monitor

User ID:

LDD5

Telephone:
Mailstop:

505-232-9906

[ ]

Principal investigator
Consultant

[ ]

Investigator
Other (please explain)

8172

Scientific Ethics number:

1.

Please indicate your role(s) in this project:

Name:

[ ]

[ ]

Are any or all of the activities within this project DESIGNED to contribute to generalizable knowledge (i.e., research)?
[ ]

YES

[X]

NO

If YES, list those activities which are research:

2.

Is this CDC project research or public health practice (check all that apply)?
[ ]

Research
Check one:
[ ]
[ ]

3.

[X]

Public health practice
Check all that apply:

Human subjects involved

[ ]

Emergency Response

[ ]

Surveillance

Human subjects not involved

[X]

Program evaluation

[ ]

Other (please explain)

If RESEARCH involving human subjects, has the project or research activities been reviewed by the CDC IRB for human subjects
protection?
a.

[ ]

NO, New project, not yet reviewed

b.

[ ]

NO, Existing project, not ready to submit

c.

[ ]

NO, Submitted for approval

d.

[ ]

YES, Reviewed and approved by CDC
If YES, please list protocol number
expiration date

and

e.

[ ]

NO, RESEARCH, no CDC investigators (CDC IRB not required)

f.

[ ]

N/A (Not Applicable)

If RESEARCH, list any other CDC staff involved in this project, please include the name, role, and scientific ethics number
Name

Form 684R_NR (revised January 2003)
ID: 17836

Role (project officer, investigator,
consultant, etc.)

Scientific ethics number Prin

1

200-2007-20015/2007-C-009

Tracking NO.

IF YOU THINK THE RESEARCH PROJECT MIGHT QUALIFY AS EXEMPT RESEARCH (as identified in 45CFR46.101), PLEASE
ANSWER questions 4-6, OTHERWISE SKIP TO question 7.
4.

Does the proposed research involve prisoners?
[ ]
[ ]

5.

YES

If YES, this research cannot be exempted and must be reviewed by an IRB (skip to question 7).

NO

Does the proposed research involve fetuses, pregnant women, or human in vitro fertilization as targets (such that Subpart B would
apply)?
[ ]

YES

[ ]

NO

If YES, this research cannot be exempted and must be reviewed by an IRB (skip to question 7).

Educational Research
6.1

Is this research conducted in established or commonly accepted educational settings, AND does the research involve normal
educational practices (e.g., research on regular and special education strategies or research on the effectiveness of, or
comparison among instrucational techniques, curricula or classroom management methods)?
YES

[ ]

NO

[ ]

Research Involving Surveys, Interview Procedures (including Focus groups), Observation of Public Behavior, or Educational Tests
6.2

Will this research use educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures
or observation of public behavior?
[ ] YES

NO

[ ]

If NO skip to 6.3

Will children (<18 years of age) be research subjects?
[ ]

YES

[ ]

NO

6.2.1

If YES, this research cannot be exempted and must be reviewed by an IRB (skip to item 7)

Is the information obtained recorded in such a manner that human subjects can be identified directly or indirectly
through identifiers (such as a code) linked to the subjects;
[ ] YES

6.2.2

[ ]

[ ] YES

6.3

NO

Will any disclosure of the human subjects' responses outside of the research setting have the potential to place the
subjects at risk of criminal or civil liability, or be damaging to the subjects' financial standing, employability or
reputation? (Examples here may include: the collection of sensitive data regarding the subjects' (or relatives' or
associates') possible substance abuse, sexuality, criminal history or intent, medical or psychological condition,
financial status, or similarly compromising information).
[ ]

NO

Will this research use educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview
procedures, or observation of public behavior but the research is not exempt under paragraph 6.2 of this section:
[ ] YES

6.3.1

Will this research involve human subjects that are elected or appointed public officials or candidates for public office?
[ ] YES

6.3.2

If NO skip to 6.4

NO

[ ]

[ ]

NO

Does federal statute(s) require(s) without exception that confidentiality of the personally identifiable information will
be maintained throughout the research and thereafter? (Note: CDC can use this exemption criterion only in the case
where a 308(d) Assurance of Confidentiality has been obtained to cover the research).
[ ] YES

[ ]

NO

Existing Data Which Is Publicly Available or Unidentifiable
6.4

Does this research involve only the collection or study of existing* data, documents, records, pathological or diagnostic
specimens? (* 'existing' means existing before the study begins)?
[ ] YES

6.4.1

[ ]

NO

Is this material or information publicly available?
[ ] YES

6.4.2

If NO skip to 7

[ ]

NO

Is this material or information recorded in such a manner by the investigator that the subjects cannot be identified
directly or indirectly through identifiers linked to the subjects?
(Note: If a link is created by an investigator even temporarily, for research purposes, this criterion is not met. If a
temporary link is created by clinical staff who already have access to the data, this criterion is met).
[ ]

YES

(there are no identifying information and no unique identifiers or codes)

[ ]

NO

(there are identifiers (including codes))

Form 684R_NR (revised January 2003)
ID: 17836

2

Tracking NO.
7.

200-2007-20015/2007-C-009

Please prepare and attach a short summary paragraph (<1 page);
if this is new:
a.

Be sure to include the purpose of the project, specific details about the project and the role of the CDC staff member(s) in the
project. In explaining one's role as a consultant be particularly careful to identify involvement in things like: study design
decisions, oversight of protocol development, participation in review of data collection procedures, and particpation in data
analysis and/or manuscript preparation, as well as whether there will be access to identifiable or personal data.

b.

Explain your project status selection (research--non-exempt, exempt, no CDC investigator or not involving human subjects;
public health practice). If you selected research not involving human subjects be sure to indicate if the data includes any personal
information (e.g., name, SSN), linkable study identification numbers or codes, or geographical information.
The purpose of this program evaluation is to gather qualitative data through focus groups and individual interviews about 1) the use and
impact of the original Eagle Books for grade school children in communities that also use the Diabetes Education in Tribal Schools curriculum
(the DETS curriculum K-4 lessons incorporate Eagle Book messages) and 2) determine the potential for integration into the DETS school
curriculum the newly developed Youth Eagle books for middle school children that will be completed by 2012. CDC staff will oversee and
participate in gathering qualitative data in 12 American Indian/Alaska Native communities over 3 years who have used the Eagle Books and
the DETS curriculum. Westat staff and contract evalutor will complete the evaluation team. Focus groups will be conducted with teachers,
parents, and children who have familiarity with the Eagle Books and the DETS curriculum. Interviews will be conducted with school
administrators. Data will be aggregated with no identifiers and will be used to disseminate Eagle Books to appropriate audiences with
messages gained from data gathered.

8. Please list the primary project site and all collaborating site(s).
See Attached
Explanation of project components:
The remaining 12 sites represent school districts that will provide the data for the evaluation effort. All are using the Diabetes Education in Tribal
Schools (DETS) curriculum and all have used the Eagle Books. The messages of the new Eagle Books for middle school children will be tested at
these sites in conjunction with questions about the DETS curriculum and the original Eagle Books.

9.

If project involves research that is funded extramurally, list amount of award that should be restricted pending IRB approval and
describe which project components will be affected, if known:

Approvals (signature and position title)

LEMYRA DEBRUYN - DIRECTOR
REGULATORY

Date
05/13/2010

Research Determination / Remarks
[X ]

Public health practice

[ ]

Research not involving human subjects
Research involving human subjects, no CDC investigators
Research involving human subjects, CDC investigators, exempt
Research involving human subjects, CDC investigators, not exempt

[ ]
[ ]
[ ]

(check if applicable)
[ ]
Local IRB
[ ]
CDC Exemption
[ ]
CDC IRB
Comments:

staff member completing this form

Bob, please look at the 684 and see if ready for Darlene to
review. I am in tomorrow morning and then back next
Tuesday, May 18th. Thanks for your help!
Lemyra

ROBERT LIEB - PUBLIC HEALTH
ADVISOR

05/14/2010

[X]
[ ]
[ ]
[ ]
[ ]

Public health practice
Research not involving human subjects
Research involving human subjects, no CDC investigators
Research involving human subjects, CDC investigators, exempt
Research involving human subjects, CDC investigators, not exempt

(check if applicable)
[ ]
Local IRB
[ ]
CDC Exemption
[ ]
CDC IRB
Team Lead

Form 684R_NR (revised January 2003)
ID: 17836

Comments:

3

Tracking NO.

200-2007-20015/2007-C-009

DARLENE THOMAS - PROGRAM
ANALYST

05/14/2010

[X]
[ ]
[ ]
[ ]
[ ]

Public health practice
Research not involving human subjects
Research involving human subjects, no CDC investigators
Research involving human subjects, CDC investigators, exempt
Research involving human subjects, CDC investigators, not exempt

(check if applicable)
[ ]
Local IRB
[ ]
CDC Exemption
[ ]
CDC IRB
Comments:
Because this is a contract, OMB approval will be obtained for the data
collection.

Division ADS

[ ]
[ ]
[ ]
[ ]
[ ]

Public health practice
Research not involving human subjects
Research involving human subjects, no CDC investigators
Research involving human subjects, CDC investigators, exempt
Research involving human subjects, CDC investigators, not exempt

(check if applicable)
[ ]
Local IRB
[ ]
CDC Exemption
[ ]
CDC IRB
ADS, Deputy ADS, or Human Subjects
Contact

Comments:

List of Grantees
Grantee #

Grantee Name

Primary project site:
Site name and Location

Assurance Number
(FWA, MPA or SPA) if applicable

Primary Site

Westat, Inc. Atlanta, Georgia

00005551

Site 2

Lower Kuskokwim School District Bethel, Alaska

n/a

Site 3

Dena'ina Health Clinic Kenai, Alaska

n/a

Site 4

Rocky Mountain School Good News Bay, Alaska

n/a

Site 5

Ramah Navajo School District Pine Hill, New Mexico

n/a

Site 6

Santo Domingo Schools Santa Domingo Pueblo, New Mexico

n/a

Site 7

Hannahville Indian School Hannahville, Michigan

n/a

Site 8

L'Anse and Baraga Public Schools Baraga, Michigan

n/a

Site 9

Standing Rock Schools Fort Yates, South Dakota

n/a

Site 10

Ahfachkee Day School Clewiston, Florida

n/a

Site 11

Poplar Elementary School Poplar, Montana

n/a

Site 12

Rocky Boy School Rocky Boy, Montana

n/a

Site 13

Warm Springs Elementary School Warm Springs, Oregon

n/a

Form 684R_NR (revised January 2003)
ID: 17836

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