Att 8_IRB 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:

(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:

N/A/N/A/2202000200

(Use PGO number if cooperative agreement, grant, etc.)
Date submitted:

12/13/2012

Title of Project:

National Program of Cancer Registries – NPCR Program Evaluation Instrument (PEI)

Dates for project period:

Dates for funding (if applicable):

Beginning:

09/30/2012

Beginning:

Ending:

09/29/2017

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.
[]

New

[]

Revision

[]

Continuation, without revision(s)

[X]

Continuation, with revision(s)

Lead staff member:

Contact information:

Name:

Netta Apedoe

Division:

User ID:

ize6

Telephone: 770-488-4570

Scientific Ethics number:

1.

Please indicate your role(s) in this project:

Mailstop:

DCPC

K69

[X]

Project officer

[X]

Technical monitor

[]

Principal
investigator

[]

Investigator

[]

Consultant

[]

Other (please explain)

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

[X]

YES

NO

If YES, list those activities which are research:

2.

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

3.

Research

[X]

Public health practice

Check one:

Check all that apply:

[]

Human subjects involved

[]

Emergency Response

[X]

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

d. [ ]

b. [ ] NO, Existing project, not ready to submit

YES, Reviewed and approved by CDC
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

Form 684R_NR (revised January 2003)
ID:

22472

1

Tracking NO. N/A/N/A/2202000200
Name

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

Scientific ethics
number Prin

Netta Apedoe
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?
[ ]

YES

[ ]

NO

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

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 6.3

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

YES

[ ]

NO

6.2.1

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;
[ ]

6.2.2

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).
[ ]

6.3

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

YES

[ ]

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?
[ ]

6.3.2

[ ]

YES

NO

[ ]

If NO skip to 6.4

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

Is this material or information publicly available?
[ ]

[ ]
YES

Form 684R_NR (revised January 2003)
ID:

22472

NO
[ ]

If NO skip to 7
NO

2

Tracking NO. N/A/N/A/2202000200
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).

7.

[ ]

YES

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

[ ]

NO

(there are identifiers (including codes))

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.
This project is a public health practice because it is designed to collect data about CDC funded central cancer registries’ operations
to evaluate and monitor the success of these programs at meeting the requirements of the NPCR Standards. The PEI project is
intended to help answer questions about how well the registries are doing and provide some data about what areas they could
improve. The project does not attempt to answer any research questions and the knowledge obtained through this project is not
generalizable. The project also does not collect any personal information and the previous human subject determination found this
project to be public health practice.
The annual collection of performance indicator data from state and territorial programs funded through the National Program of
Cancer Registries (NPCR) began 17 years ago and was changed to biennial collection in 2009. The data collected is limited to
registry operations information and does not include individual record level data. The data include information on registry staffing
levels, the status of cancer registry legislation in the state, the type and scope of advanced surveillance activities, case sharing
agreements with neighboring states, the number and type of reporting facilities, computer infrastructure, etc. The information
collection allows CDC to provide routine feedback to grantees based on their data submissions, to tailor technical assistance as
needed, and to support program planning, surveillance and secondary data analysis activities. The evaluation data will be used by
CDC to help monitor progress in meeting NPCR standards and assisting CDC project officers with providing technical assistance to
the states.
This Human Subject determination is a component of an OMB application. The survey instrument has been revised with updated
NPCR Program Standards, questions that are no longer relevant have been deleted and new requirements around Meaningful Use
have been added.
This project will be administered through a contract. CDC Staff will manage and monitor the contract, review and make
suggestions for revising the survey, have monthly calls with the contractor, review and monitor the budget and work plan.

8.

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

Primary Site

Site Name

Site Location

CDC

Atlanta, GA

Assurance Number
(FWA, MPA or SPA)
if applicable

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:

Form 684R_NR (revised January 2003)
ID:

22472

3

Approvals (signature and position title)
Netta Apedoe - PUBLIC HEALTH
ADVISOR

Date
12/21/2012

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
staff member completing this form

Comments:
01/02/2013

-

[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

Comments:

Cheryll Thomas - EPIDEMIOLOGIST

01/07/2013

[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
Division ADS

Comments:

Joan Redmond Leonard - PUBLIC
HEALTH ANALYST

01/23/2013

[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
cuc ADS, Deputy ADS, or Human Subjects
Contact

Form 684R_NR (revised January 2003)
ID:

22472

Comments:

4