684 Form

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 approval.

Tracking Number: DP08-801
(Use PGO number if cooperative agreement, grant, etc.)
Date submitted:
Title of Project:

12/29/2010

Indicators of the performance of local, state, territorial, and tribal education agencies in HIV prevention,
coordinated school health programs, and asthma management activities for adolescent and school health
programs.

Dates for project period:
Beginning: 06/01/2011
05/31/2014
Ending:

Dates for funding (if applicable):
Beginning:
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
Continuation, without revision(s)

Lead staff member:
Catherine Rasberry
Name:
User ID: FHH6
Scientific Ethics number: 9625

[ ]

Revision
Continuation, with revision(s)

Contact information:
DASH
Division:
Telephone: 770-488-5635
K33
Mailstop:

Please indicate your role(s) in this project:
[ ]
Project officer
Technical monitor
[ ]
Investigator
Principal investigator [ ]
Consultant
[ X ] Other (please explain)
[ ]
[ ]

Oversees data analysis.
1.

Are any or all of the activities within this project DESIGNED to contribute to generalizable knowledge (i.e., research)?
[ X ] NO
YES

[ ]

If YES, list those activities which are research:

2.

3.

Is this CDC project research or public health practice (check all that apply)?
[ X ] Public health practice
Research
[ ]
Check one:
Check all that apply:
[ ] Human subjects involved
[ ] Emergency Response
[ ] Human subjects not involved
[ X ] Program evaluation

[ ]
[ ]

Surveillance
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
d. [ ] YES, Reviewed and approved by CDC
b. [ ] NO, Existing project, not ready to submit
If YES, please list protocol number and
c. [ ] NO, Submitted for approval
expiration date
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: 19293

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

Scientific ethics number Prin

1

Tracking NO. DP08-801
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.

5.

Does the proposed research involve prisoners?
If YES, this research cannot be exempted and must be reviewed by an IRB (skip to question 7).
[ ] YES
[ ]
NO
Does the proposed research involve fetuses, pregnant women, or human in vitro fertilization as targets (such that Subpart B would
apply)?
If YES, this research cannot be exempted and must be reviewed by an IRB (skip to question 7).
[ ] YES
NO
[ ]

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?
If NO skip to 6.3
[ ] YES
[ ] NO
Will children (<18 years of age) be research subjects?
YES
If YES, this research cannot be exempted and must be reviewed by an IRB (skip to item 7)
NO
[ ]
[ ]

6.2.1

6.2.2

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
[ ] 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).
[ ] YES

6.3

[ ]

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:
If NO skip to 6.4
[ ] YES
[ ] NO
6.3.1

Will this research involve human subjects that are elected or appointed public officials or candidates for public office?
[ ] YES
[ ] NO

6.3.2

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)?
If NO skip to 7
[ ] YES
[ ] NO
6.4.1

Is this material or information publicly available?
[ ] NO

[ ] YES

6.4.2

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: 19293

2

Tracking NO. DP08-801
7.

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 project is to assess programmatic activities among local, state, territorial, and tribal education agencies (LEA, SEA, TEA,
and TG) funded by the Centers for Disease Control and Prevention (CDC), Division of Adolescent and School Health (DASH) through funding
announcement DP08-801. The Indicators for School Health Programs (Indicators) are a set of four questionnaires that are used to provide
basic process evaluation data on HIV prevention activities, coordinated school health program for physical activitiy, nutrition, and tobacco-use
prevention (CSHP/PANT) activities, and asthma management activities conducted under FOA DP08-801. The CDC staff members involved
in the project will provide assistance in the analysis and reporting of the data.
The Indicators provide basic program evaluation data on the activities of DASH-funded partners as part of routine public health practice. The
data (basic process evaluation data) describe activities such as the types of materials distributed, the number of professional development
events held, and the topics of technical assistance provided. All data collected are representative of education agency activities. No
information is collected about individuals; no personal data are collected.

8. Please list the primary project site and all collaborating site(s).

Explanation of project components:

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)
Catherine Rasberry - HEALTH SCIENTIST

Date
12/29/2010

Research Determination / Remarks
[X ]
[ ]
[ ]
[ ]
[ ]

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

staff member completing this form

Stephen Banspach - ASSOCIATE
DIRECTOR FOR SCIENCE

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

12/29/2010

[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: 19293

Comments:

3

Tracking NO. DP08-801
Stephen Banspach - ASSOCIATE
DIRECTOR FOR SCIENCE

12/29/2010

[X]
[ ]
[ ]
[ ]
[ ]

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

Division ADS

Joan Redmond Leonard - PUBLIC
HEALTH ANALYST

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

01/22/2011

[ 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
ADS, Deputy ADS, or Human Subjects
Contact

Form 684R_NR (revised January 2003)
ID: 19293

Comments:

4

List of Grantees
Grantee #
1189
1214
1187
1262
1199
1216
1264
1218
1231
1204
1236
1226
1210
1221
1309
1246
1181
1258
1271
1180
1233
1208
1234
1205
1232
1186
1229
1193
1254
1255
1206
1265
1239
1241
1307
1270
1185
1203
1224
1179
1269
1220
1178
1192
1188
1195
1201
1243
1209
1253
1202
1251
1215
1213
1196
1256
1237
1252
1230
1225
1260

Grantee Name
Tennessee Department Of Education
Texas Education Agency
Utah State Department of Health
Vermont Department Of Education
Virginia Department Of Education
Virginia Department of Health
Washington Office Of Superintendent Of Public Instruction
West Virginia Department Of Education
Winnebago Tribe of Nebraska
Wisconsin Department Of Public Instruction
Wyoming Department Of Education
Alabama Department Of Education
Alaska Department Of Education and Early Development
Albuquerque Public Schools
American Samoa Department of Education
Arizona Department Of Education
Arkansas Department Of Education
Baltimore City Public School System
Boston Public Schools
California Department Of Education
Charlotte-Meckleburg Schools
Cherokee Nation Health Service Group
Chicago Public Schools
Clark County School District
Colorado Department Of Education
Common Wealth of the Northern Marianas Islands
Confederated Salish & Kootenai Tribes
Connecticut State Department of Education
Dallas Independent School District
Delaware Department of Education
District of Columbia Department of Education
Duval County Public Schools
Florida Department Of Education
Fresno Unified School District
Georgia Department Of Community Health.
Georgia Department Of Education
Guam Public School System
Hawaii Department of Education
Hillsborough County Public Schools
Houston Independent School District
Idaho Department Of Education
Illinois State Board Of Education
Indiana Department Of Education
Iowa Department Of Education
Kansas State Department Of Education
Kentucky Department of Education
Los Angeles Unified School District
Louisiana Department Of Education
Louisiana Department Of Education
Maine Department of Education
Maryland State Department Of Education
Massachusetts Department Of Education
Memphis City Schools
Michigan Department Of Education
Milwaukee Public Schools
Minnesota Dept of Education
Mississippi Department Of Education
Missouri Department Of Elementary And Secondary Education
Montana Office Of Public Instruction
Native Village of Kotzebue
Nebraska Department Of Education

1227
1217
1263
1190
1200
1194
1240
1238
1259
1235
1250
1197
1212
1191
1228
1207
1248
1303
1245
1392
1261
1211
1182
1177
1223
1198
1249
1242
1222
111222
1257
1244
1247
1219

Nevada Department Of Education
New Hampshire Department Of Education
New Jersey Department of Education
New Mexico Public Education Department
New York City Department Of Education
New York State Department of Education
Newark Public Schools
Nez Perce Tribe
NORTH CAROLINA DEPARTMENT OF PUBLIC INSTRUCTION
North Dakota Department of Public Instruction
Ohio Department of Education
Oklahoma State Department Of Education
Oneida Tribe of Indians of Wisconsin
Orange County Public Schools
Oregon Department Of Education
Pennsylvania Department of Education
Public Health Institute
Puerto Rico Department Of Education
Republic Of Palau Ministry Of Education
Republic of the Marshall Islands
Rhode Island Department of Elementary & Secondary Education
San Bernardino City Unified School District
San Diego Unified School District
San Francisco Unified School District
School Board of Broward County, Florida
School board of Miami-Dade County, Florida
School Board of Palm Beach County
School District Of Philadelphia
School District of the City of Detroit
School District of the City of Detroit
Seattle Public Schools
South Carolina Department Of Education
South Dakota Department Of Education
State Of Ohio Department Of Health