Non research determination

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