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:        
Tracking  Number:
(Use PGO number if cooperative agreement, grant, etc.)
 (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.
DP08-804
Title of Project:
Date submitted:
The WISEWOMAN Program
04/15/2009
Dates for project period:
Dates for funding (if applicable):
Beginning:
Ending:
Beginning:
Ending:
06/30/2008
06/29/2013
06/30/2009
06/29/2010
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.
[  ]
New
[  ]
Continuation, without revision(s)
[  ]
Revision
[ X ]
Continuation, with revision(s)
 Lead   staff member:
 Contact information:
Please indicate your role(s) in this project:
Name:
TARISHA COCKRELL
User ID:
FBQ1
Division:
DHDSP
Telephone:
770-488-5032
Scientific Ethics number:
Mailstop:
K77
[  ]
Project officer
[  ]
Principal investigator
[  ]
Consultant
[  ]
[  ]
[ X ]
Technical monitor
Investigator
Other (please explain)
Contractor (WISEWOMAN Program Associate)
Are any or all of the activities within this project DESIGNED to contribute to generalizable knowledge (i.e., research)?
[  ]    YES
[ X ]    NO
1.
If YES, list those activities which are research:
2.
Is this CDC project research or public health practice (check all that apply)?
[  ]
Research
[ X ]
Public health practice
Check one:
[  ]
Human subjects involved
[  ]
Human subjects not  involved
Check all that apply:
[  ]
Emergency Response
[ X ]
Program evaluation
[  ]
Surveillance
[  ]
Other (please explain)
3.
If RESEARCH involving human subjects, has the project or research activities been reviewed by the CDC IRB for human subjects protection?
NO, New project, not yet reviewed
YES, Reviewed and approved by CDC
a.
d.
[  ]
NO, Existing project, not ready to submit
If YES, please list protocol number    and
b.
[  ]
NO, Submitted for approval
expiration date
c.
[  ]
NO, RESEARCH, no CDC investigators (CDC IRB not required)
e.
[  ]
[  ]
N/A  (Not Applicable)
[  ]
f.
If  RESEARCH, list any other CDC staff involved in this project, please include the name, role, and scientific ethics number
Role (project officer, investigator, consultant, etc.)
Name
Scientific ethics number Prin
 Form 684R_NR (revised January 2003)
1
ID: 15935

Tracking NO.
DP08-804
[  ]      
If YES, this research cannot be exempted and must be reviewed by an IRB (skip to question 7).
[  ]      
5.
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).
[  ]      
Does the proposed research involve prisoners?
4.
ANSWER questions 4-6, OTHERWISE SKIP TO question 7.
IF  YOU THINK THE RESEARCH PROJECT MIGHT QUALIFY AS EXEMPT RESEARCH (as identified in 45CFR46.101), PLEASE
YES
YES
NO
NO
[  ]
Educational Research
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)? 
6.1
[  ]    NO
[   ]   
 Research Involving Surveys, Interview Procedures (including Focus groups), Observation of Public Behavior, or Educational Tests
Will this research use educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior?
6.2
[  ]   YES
[  ]     NO
Will children (<18 years of age) be research subjects?
 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;
6.2.1
[  ]   YES
[  ]    NO
YES
[  ]   
YES
NO
If NO skip to 6.3
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).
6.2.2
[  ]   YES
[  ]    NO
Will this research use educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview
6.3
procedures, or observation of public behavior but the research is not exempt under paragraph 6.2 of this section:
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
If NO skip to 6.4
[   ]    NO
[  ]   YES
 Existing Data Which Is Publicly Available or Unidentifiable
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)?
6.4
[  ]   YES
[  ]    NO
 Is this material or information publicly available?
6.4.1
[  ]   YES
[  ]    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?  
6.4.2
[  ]    
[  ]      
(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).
 (there are no identifying information and no unique identifiers or codes)
(there are identifiers (including codes))
If NO skip to 7
YES
NO
 Form 684R_NR (revised January 2003)
2
ID: 15935

Tracking NO.
DP08-804
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.
7.
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 WISEWOMAN Program (Well-Integrated Screening and Evaluation for Women Across the Nation) extends the preventive health services provided to women who participate in the CDC-funded National Breast and Cervical Cancer Early Detection Program (NBCCEDP).  The purpose of the program is early detection and prevention of heart disease and stroke risk factors. Participants have access to additional preventive health services by screening for heart disease and stroke risk factors and using national clinical care guidelines to refer women to quality care.  Lifestyle interventions are tailored to women's heart disease and stroke risk factors, screening results, and readiness to make lifestyle behavior changes.  The goals of the WISEWOMAN Program are: 1) maximizing the reach of the program; 2) working to eliminate health disparities; 3) decreasing the heart disease and stroke risk factors of the WISEWOMAN population; 4) maximizing the number and variety of settings that deliver WISEWOMAN services; and 5) sustaining the benefits of the WISEWOMAN Program over time at the individual level.

Twenty-one (21) state and tribal programs will be funded under this program announcement, DP08-804, of which 15 are previously funded programs.  CDC staff members will provide technical assistance and program monitoring to assure that funded projects adhere to program requirements. The funded programs are designated as public health practice as no research activities will be conducted in this program announcement.
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:

[  ]
[  ]
[  ]
[  ]
[  ]
[  ]
[X ]
04/15/2009
TARISHA  COCKRELL -  CONTRACTOR/ARRA SCIMETRIKA
Comments:
  staff member completing this form
CDC Exemption
Local IRB 
(check if applicable)
Research  involving  human subjects,  CDC investigators, not exempt
Research  involving  human subjects,  CDC investigators, exempt
Research  involving  human subjects, no CDC investigators
Research not involving human subjects
Public health practice
Research Determination / Remarks
Date
Approvals (signature and position title)
CDC IRB 
[  ]
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 
Comments:
SANDRA  LOPEZ-CARRERAS  -  HEALTH SCIENTIST-TRAINING COORD
04/16/2009
[ X ]
[   ]
[   ] 
[   ]
[   ]
[   ]
[   ]
CDC IRB 
[   ]
Team Lead
 Form 684R_NR (revised January 2003)
3
ID: 15935

Tracking NO.
DP08-804
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 
Comments:
04/27/2009
[ X ]
[   ]
[   ]
[   ]
[   ]
[   ]
[   ]
YULING  HONG -   SENIOR SERVICE FELLOW/ASSOC DIR
CDC IRB 
[   ]
Division ADS
CDC IRB 
[   ]
[   ]
[   ]
[   ]
[   ] 
[   ]
[ X ]
05/14/2009
  ADS, Deputy ADS,  or Human Subjects Contact
Comments:
CDC Exemption 
Local IRB 
(check if applicable)
Research  involving  human subjects,  CDC investigators, not exempt
Research  involving  human subjects,  CDC investigators, exempt
Research  involving  human subjects, no CDC investigators
Research not involving human subjects
Public health practice
[   ]
JOAN  REDMOND-LEONARD  -  PUBLIC HEALTH ANALYST 
Grantee Name
Grantee #
List of Grantees
1398
Connecticut Department Of Public Health
1393
Illinois Department Of Public Health
1382
Iowa Department Of Public Health
1428
Massachusetts Department of Health
1439
Michigan Department Of Community Health
1433
Minnesota Department Of Health
1421
NE Department of Health & Human Services
1415
North Carolina Department Of Health And Human Services
1430
Oregon State Dept of Human Services
1396
Pennsylvania Department Of Health
1399
SD Department of Health
1436
South Carolina Department Of Health And Environmental Control
1437
Southcentral Foundation
1425
Southeast Alaska Regional Health Consortium
1394
State of California Department of Public Health
1431
State of Missouri Department of Health
1407
Utah Department Of Health
1380
Vermont Department Of Health
1395
Virginia Department of Health
1381
West Virginia Department Of Health And Human Services
1423
Wisconsin Department Of Health And Family Services
 Form 684R_NR (revised January 2003)
4
ID: 15935