Att 5 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 appr oval.

Tracking Number:

200-2010-37195/005

(Use PGO number if cooperative agreement, grant, etc.)
05/21/2012

Date submitted:

Early Hearing Detection & Intervention- Pediatric Links to Services (EHDI-PALS)

Title of Project:

Dates for project period:

Dates for funding (if applicable):

Beginning:

08/31/2012

Beginning:

Ending:

08/30/2013

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:

Winnie Chung

Division:

DHDD

[ ]

Project officer

[X]

Technical monitor

User ID:

IHX9

Telephone:
Mailstop:

404-498-6744
E88

[ ]

Principal investigator
Consultant

[ ]

Investigator
Other (please explain)

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

[ ]

Program evaluation

[X]

Other (please explain)

Searchable facility
database

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: 21487

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

Scientific ethics number Prin

1

200-2010-37195/005

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: 21487

2

Tracking NO.
7.

200-2010-37195/005

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 create a pediatric audiology facility searchable database. The facility information gathered will be structured
and programmed into a searchable database so hospital staff, parents, and providers can find a facility that can provide the type of audiology
service they need. For example if a parent is looking for a facility equipped to evaluate candidacy for cochlear implant, they can access the
EHDI-PALS’ facility database and locate one close to their residence. State EHDI coordinators will also be able to export the database for
better visualization and management of their state and neighboring states’ resource.
The database will not include any identifiable or personal data and is considered public health practice.
See attached document for full project description.

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)

Date

John Eichwald - TEAM LEAD-PUBLIC
HEALTH ADVISOR

05/23/2012

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

staff member completing this form

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:
Reviewed and approved

[ ]
[ ]
[ ]
[ ]
[ ]

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: 21487

Comments:

3

Tracking NO.

200-2010-37195/005

Michael Fox - RESEARCH SCIENCE
OFFICER

05/23/2012

[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:

Division ADS

Scott Campbell - HEALTH SCIENTIST

05/25/2012

[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

Comments:

List of Grantees
Grantee #

Grantee Name

Form 684R_NR (revised January 2003)
ID: 21487

4