Research Determination

NCEH/ATSDR Human Subjects Research Determination Form
Use th
is form and the flowcharts for either:
1
.CDC projects and activities that do not require CDC IR B review under HHS HumanSubjects (45 CFR part 46) or FDA (21CFR parts SO and 56) Regulations, which
include "non-research", "research not involvingidentifiable human subjects."or "humansubjects research for which CDCis not engaged";OR
2
.Human subjects research that will be submitted to the Human Research Protection Office (HRPO) as .an Exempt category of Human Subjects Research.

Project Tjtle: National Environmental Assessment Reporting System (NEARS)
Project Location(s)/Site(s): Voluntary State Safety Programs and CDC, Atlanta
Project Officer(s): Erik W. Coleman, MPH

Telephone:

Proposed Project Dates: Start:

(770) 488-3438

Division or Office: DEEHS

End:

Time sensitive:

Project Funding and Partners (answer both): HHS: CDC Funding - Internal Activity

Non-HHS: Choose an item

If applicable,name participating external lnstitution(s).
Indicate the holder of the key to decipher the identities of coded data or biological specimens.

No key/code/identifiers

Specify CDC role (mark all that apply):

L CDC is the sole institution conducting activity; OR
If not the sole institution,indicate if:
_ CDCis NOT a recipient or provider of private data, specimens, materials or services;
_ CDC is provider of private data/speci mens to an institution.

_ CDC is recipient of private data/speci mens from an institution.

_ CDC is provider of materials/services to aninstitution.

_ CDCis recipient of materials/services from an institution

Questions 1-4 pertainto the HHS Human Subjects Regulations (45 CFR 46):
1. For CDC:Is this activity classified as research?

NO X

YES

x

A. Is the activity a systematic investigation including research development, testing,and evaluation?

YES

B. Is the activity intentionally designed to develop OR contribute to generalizable knowledge?

YES

NO

YES

NO

YES

NO

YES

NO

c. Do CDC employees intervene with,interact with,or obtain informed consent from living persons?

YES

NO

D.Are/Were the data or specimens collected from living persons specifically for this proposed activity?

YES

NO

E. Are/Were extra data or specimens collected from living persons specifically for this proposed activity?

YES

NO

F. Do/Will CDC employees or agents have access to the link between the data or specimens and the

YES

NO

YES

NO

A. Does the research pose more than minimal risk?

YES

NO

B.Will prisoners be involved?

YES

NO

C. Willinteraction with children occur or will identifiable private information about them be obtained?

YES

NO

D.Based on the HRPO Worksheet for Exemption from Human Subjects Regulations, is there an HHS Exempt

YES

NO

NO

X

CDC activity IS researchif both A and 18 are "YES."
If 1
is "NO," then STOP; otherwise continue.

2. For CDC:Is this research classified as human subjects research?

A. Does the activity only involve the collection or analysis of non-human data or specimens,including
entities,organizations, or environmental materials?

B. Does the activity only involve the collection or analysis of data or specimens from deceased persons?
CDC activityIS NOT human subjects researchif either 2A or 28 are "YES."
If 2 Is "NO,"then STOP; otherwise continue.

identity of these living persons?
CDC activityIS human subjects researchIf 2C
Is "YES."
CDC activity IS NOT human subjects researchif 20,2E, and 2F are all "NO."
If 2 is "NO,"then STOP; otherwise continue.

3. For CDC: Will th
is activity be submitted to HRPO for approval as exempt human subjects research?

Research Category for which this activity will be reviewed? If "YES," specify the Category number: Choose an item
CDC activityIS exempt human subjects researchif 3A, 38, and 3C are all "NO," and an exempt category (3D) applies.
Exempt research must go to HRPO; use CDC Form 0.12SOX.
If 3 is "YES,"then STOP; otherwise continue.

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4. s CDC engaged in the non-exempt research involvingidentifiable human subjects?

YES

NO

A. Did CDC receive funding directly from another HHS agency?

YES

NO

B. Do CDC employees or agents intervene or interact with livingindividuals for research purposes?

YES

NO

C.Do CDC employees or agents obtain individually identifiable private information?

YES

NO

CDC IS engaged if 4A, 48, or 4C are "YES."
If 4Is "NO," then STOP. Otherwise, research must go to HRPO; use CDC Form 0.1250.

Question 5 pertains to research involving FDA regulated products (21 CFR parts SO and 56), not including the use of an FDA
approved product in the course of medical practice:

5. Based on the HRPO Worksheet to Determine FDA Regulatory Coverage,is the research activity subject

YES

NO X

to FDA human subjects regulations?
Additional Notes:
Although CDC HRPO review is not required,investigators or project officers must adhere to ethical principles and standards to
respect and protect the privacy, confidential ty, and autonomy of participants. All applicable State and Federal privacy laws must
be followed. Informed consent may be appropriate. Information disclosed in the consent process should address the basic
elements of consent. The consent form and all other required supporting documents must be submitted with this form for
review. The list of required documents is found in the NCEH/ATSDR Guided Checklist for Human Subjects and PRA

Determinations.
Division Approval Signatures and Dates:

John Sarisky -S

03/21/2016

Branch Chief

Date Signed

Date Signed

For Office of Science Use Only: Final NCEH/ATSDR Center Determination
Request Received Date:

------

CDC's role does not require HHS human subjects review beyond the center level because:
X_ Activity is not research (Flow chart category NR-1).
_ Activity is not human subjects research (Flow chart category NR-2 through NR-8).
_ Activityis non-exempt human subjects research,but CDCis not engaged (Flow chart category HSR-3).
_ CDC's role does require HHS human subjects review beyond the center level because:
_ Activity qual fies as exempt human subjects research (Flow chart category HSR-1).
_ Activity qualifies as non-exempt, engaged human subjects research (Flow chart category HSR-2).
_X CDC's role does not require FDA human subjects review beyond the centerlevel because:
_ Activity does not require human subjects review under FDA regulations (Flow chart category NFDA-3 through NFDA-4).
_ CDC's role does require FDA human subjects review beyond the centerlevel because:
_ Activity qualifies as human subjects research under FDA regulations (Flow chart category FDA-1 through FDA-2).

NCEH/ATSDR Human Subjects Contact Signature and Date:

Padmaja Vempaty -S
Stephanie I. Davis, MSPH

Page 2 of 3

Digitally signed by Padmaja Vempaty -S
DN: c=US, o=U.S. Government, ou=HHS, ou=CDC, ou=People, 0.9.2342.19200300.100.1.1=1000236464,
cn=Padmaja Vempaty -S
Date: 2016.04.01 11:24:16 -04'00'

Date Signed

NCEH/ATSDR
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.7e
Updated
Sept9, 2014

Guidance for Completing the NCEH/ATSDR Human Subjects Research Determination Form
For question 1:
•

To determine if your project is research for purposes of human subjects protection, consult:
o

The CDC Policv on Distinguishing Public Health Research and Public Health Nonresearch

o
o

Guidance from the Office of Human Research Protections (OHRP)
The FDA regulations,if applicable

See the Research Determination Flowchart 1for examples of nonresearch activities.

•

For quest on 2:
•

Research involving living human subjects must adhere to the protection of humans subjects under either the Human
Sub1ects 45 CFR part 46 or FDA 21 CRF part SO and part 56.

•

Guidance on research involving coded private information or biological specimens is available from OHRP.

•
•

Moreinformation on human subjects research can be found on the HRPO website.
See the Research Determination Flowcharts 1-3.

For question 3:
•

45 CFR part 46(b) outlines the Exempt Research Categories.

•

The HRPO Worksheet for Exemption from Human Subjects Regulations provides more details on Exempt

•

The categories most often used for Exempt Research conducted at CDC/ATSDR are 2 and 4.

•

See the Research Determination Flowchart 4.

Research Categories.

For question 4:
•

Guidance on Engagement of institutions in research can be found from OHRP.

•

See the Research Determination Flowchart 4.

For quest on 5:
•

Research involving living human subjects that are 21 CFR Part 50 and part 56

•

See the Research Determination Flowchart 5 and the HRPO Worksheet to Determine FDA Regulatory
Coverage for moreInformation on how to make this determination.

•

Differences between HHS and FDA human subjects regulations can be found here.

NOTE:If CDC is only providing/receiving materials and services, the Research Determination Flowcharts do not apply.

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NCEH/ATSOR
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.7e
Updated
Sept9, 2014