Research Determination

NCEH/ATSDR Human Subjects Research Determination Form
Use this form and the flowcharts for either:
1. CDC projects and activities that do not require CDC IRB review under HHS Human Subjects (45 CFR part 46) or FDA (21 CFR Parts 50 and 56) Regulations,
which include "non research", "research not involving identifiable human subjects", or "human subject research for which CDC is 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 Title:

2018 Customer Satisfaction Survey for CDC Laboratory Accredited to ISO 17043 (Proficiency Testing)

Project Location(s)/Site(s):
Project Officer(s):

CDC/NCEH/DLS 4770 Buford Highway, NE, Atlanta, GA 30341-3724

John Bernstein

Proposed Project Dates: Start:

Telephone:

9/24/2018

Project Funding and Partners (answer both): HHS:

End:

12/31/2018

CDC Funding - Internal Activity

If applicable, name participating external institution(s).

(770) 488-7950

Division or Office:

DLS

Time sensitive: ___
Non-HHS: NO external funding

CDC Funding - Internal Activity

Indicate the holder of the key to decipher the identities of coded data or biological specimens.

No key/ code/ identifiers

Specify CDC role (mark ll that apply):
CDC is the sole institution conducting activity; OR
If not the sole institution, indicate if:
CDC is NOT a recipient or provider of private data, specimens, materials, or services;
CDC is a provider of private data/specimens to an institution.
CDC is a provider of materials/services to an institution.

X

CDC is a recipient of private data/specimens from an institution.
CDC is a recipient of materials/services from an institution.

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

YES

NO

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

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

YES

NO

B. Does the activity only involve the collection or analysis of data or specimens from deceased persons?

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
identity of these living persons?

YES

NO

YES

NO

A. Does the research pose more than minimal risk?

YES

NO

B. Will prisoners be involved?

YES

NO

C. Will interaction 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 Research Category for which this activity will be reviewed? If "YES," specify the
Category Number:

YES

NO

X

X

NO

X

CDC activity IS research if both 1A and 1B are "YES."
If 1 is "NO," then STOP: otherwise continue.

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

CDC activity IS NOT human subjects research if either 2A or 2B are "YES."
If 2 is "NO," then STOP: otherwise continue.

CDC activity IS human subjects research if 2C is "YES,"
CDC activity IS NOT human subjects research if 2D, 2E, and 2F are all "NO.".
If 2 is "NO," then STOP: otherwise continue.

3. For CDC: Will this activity be submitted to HRPO for approval or exempt human subjects research?

CDC activity IS exempt human subjects research if 3A, 3B, and 3C are all "NO," and an exempt category (3D) applies.
Exempt research must go to HRPO: use CDC Form 0.1250X.
If 3 is "YES," then STOP; otherwise continue.

NCEH/ATSDR Human Subjects Research Determination Form (DLS STARLIMS version 4/27/2017)
Modeled after the NCEH/ATSDR Version 1.7e Updated Sept 9, 2014
Printed: 9/26/2018 2:24:55 PM

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4. Is CDC engaged in the non-exempt research involving identifiable 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 living individuals for research purposes?

YES

NO

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

YES

NO

CDC IS engaged if 4A, 4B, or 4C are "YES."
If 4 is "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 50 and 56), not including the use of an FDA
papproved product in the course of medical practice:
5. Based on the HRPO Worksheet to Determine FDA Regulatory Coverage, is the research activity subject
to FDA human subjects regulations?

YES

NO

Additional Notes:
Although CDC HRPO review is not required, investigators or project officers must adhere to ethical principles and standars to
respect and protect the privacy, confidentiality, and autonomy of participants. All applicable State and Federal privacy lsws 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:
Carla Cuthbert

9/25/2018 8:19 AM

Jerry Thomas

9/26/2018 2:22 PM

Branch Chief

Date Signed

Division ADS/Director

Date Signed

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

Request Received Date: ______________________
X

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 coverage NR-2 through NR-8).
Activity is non-exempt human subjects research, but CDC is not engaged (Flow chart category HSR-3).

CDC's role does require HHS human subjects review beyond the center level because:
Activity qualifies as exempt human subjects research (Flow category HSR-1).
Activity qualifies as non-exempt engaged human subjects research (Flow category HSR-2).
X

CDC's role does not require FDA human subjects review beyond the center level because:
X

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 center level because:
Activity qualfies 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

Digitally signed by Padmaja Vempaty -S
Date: 2018.09.26 15:34:15 -04'00'

Date Signed

NCEH/ATSDR Human Subjects Research Determination Form (DLS STARLIMS version 4/27/2017)
Modeled after the NCEH/ATSDR Version 1.7e Updated Sept 9, 2014
Printed: 9/26/2018 2:24:55 PM

Page 2 of 3

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:
◦ The CDC Policy on Distinguishing Public Health Research and Public Health Nonresearch
◦ Guidance from the Office of Human Research Protections (OHRP)
◦ The FDA regualtions, if applicable
See the Research Determination Flowchart 1 for examples of nonresearch activities.

For question 2:

•
•
•
•

Research involving living human subjects must adhere to the protection of human subjects under either the Human
Subjects 34 CFR part 46 or FDA 21 CRF part 50 and part 56.
Guidance on research involving coded private information or biological specimens is available from OHRP.
More information 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
Research Categories.
The categories most often used for Exempt Research conducted at CDC/ATSDR are 2 and 4.
See the Research Determination Flowchart 4.

For question 4:

•
•

Guidance on Engagement of institutions in research can be found from OHRP.
See the Research Determination Flowchart 4.

For question 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 more information 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.

NCEH/ATSDR Human Subjects Research Determination Form (DLS STARLIMS version 4/27/2017)
Modeled after the NCEH/ATSDR Version 1.7e Updated Sept 9, 2014
Printed: 9/26/2018 2:24:55 PM

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