Non-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 subjects 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: Emergency Cruise Ship Outbreak Investigations (CSOIs) Generic Clearance ICR
Project Location(s)/Site(s): On Cruise ships experiencing acute gastroenteritis (AGE) outbreaks in the U.S. jurisdiction
Division or Office: DEEHS
Project Officer(s): Amy Freeland
Telephone: (770) 488-7140
01/28/2019
12/30/2021
Time sensitive:
Proposed Project Dates: Start:
End:
Project Funding and Partners (answer both): HHS: No CDC/FDA/HHS Funding
Non-HHS: Other
If applicable, name participating external institution(s). Cruise ships carrying 13+ passengers within 15 days of arriving in US from foreign port
Indicate the holder of the key to decipher the identities of coded data or biological specimens. External Institution
Specify CDC role (mark all 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 provider of private data/specimens to an institution.
CDC is recipient of private data/specimens from an institution.
CDC is provider of materials/services to an institution.
CDC is 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?
A. Is the activity a systematic investigation including research development, testing, and evaluation?
B. Is the activity intentionally designed to develop OR contribute to generalizable knowledge?

YES

NO

YES
YES

NO
NO

YES

NO

YES

NO

YES

NO

YES
YES

NO
NO

YES
YES

NO
NO

YES

NO

YES
YES

NO
NO

YES

NO

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?
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 activity IS NOT human subjects research if either 2A or 2B are “YES.”
If 2 is “NO,” then STOP; otherwise continue.

C. Do CDC employees intervene with, interact with, or obtain informed consent from living persons?
D. Are/Were the data or specimens collected from living persons specifically for this proposed activity?
E. Are/Were extra data or specimens collected from living persons specifically for this proposed activity?
F. Do/Will CDC employees or agents have access to the link between the data or specimens and the
identity of these living persons?
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 as exempt human subjects research?
A. Does the research pose more than minimal risk?
B. Will prisoners be involved?
C. Will interaction with children occur or will identifiable private information about them be obtained?

YES
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: Choose an item

NO

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.

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4. Is CDC engaged in the non-exempt research involving identifiable human subjects?
A. Did CDC receive funding directly from another HHS agency?
B. Do CDC employees or agents intervene or interact with living individuals for research purposes?
C. Do CDC employees or agents obtain individually identifiable private information?

YES

NO

YES

NO

YES
YES

NO
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
approved 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 standards to
respect and protect the privacy, confidentiality, 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:
signed by Aimee T.
Aimee T. Treffiletti - Digitally
Treffiletti -S7
Date: 2019.01.28 10:14:30 -05'00' 01/28/2019
S7
_______________________________________________

Date Signed

Branch Chief

Timothy Dignam -S

Digitally signed by Timothy
Dignam -S
Date: 2019.01.28 14:20:28 -05'00'

01/28/2019
_______________________________________________
Date Signed
Division ADS/Director

For Office of Science Use Only: Final NCEH/ATSDR Center Determination
01/28/2019
Request Received Date: ____________

CDC’s role does not require HHS human subjects review beyond the center level because:
Activity is not research (Flow chart category NR-1).
Activity is not human subjects research (Flow chart category 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 chart category HSR-1).
Activity qualifies as non-exempt, engaged human subjects research (Flow chart category HSR-2).
CDC’s role does not require FDA human subjects review beyond the center level 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 center level 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:
Alisha Etheredge -S

Digitally signed by Alisha Etheredge -S
Date: 2019.01.28 16:06:29 -05'00'

01/28/2019
_______________________________________________
Date Signed
Stephanie I. Davis, MSPH

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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 Policy on Distinguishing Public Health Research and Public Health Nonresearch
o Guidance from the Office of Human Research Protections (OHRP)
o The FDA regulations, 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 humans subjects under either the Human
Subjects 45 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.

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Updated
Sept 9, 2014