Human Subjects Determination

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Determination of Applicability of Human Subjects Regulations

For Any Activities/Projects When Human Information/Specimens Will Be Collected

Project Title: The National Notifiable Diseases Surveillance System (NNDSS): Vaccine Preventable Diseases and Other Diseases
and Illnesses

Date to Begin:

End:

New Project or

✔

Primary Contact:Sandy Roush
Division/Branch: NCIRD/OD/OSIP

Changes to Existing Project
Phone: 639-8741

Supervisor’s Name: David Swerdlow/Jane Seward

Below describe the nature of the activity or project, considering the intended purpose and all aspects that are
planned to date. This form should be completed by the CDC scientist, project officer, or other staff responsible
for the project. Attach a description of the activity or project (i.e. protocol, concept paper, précis, etc).
I. PUBLIC HEALTH NON-RESEARCH: Mark all that apply.
The activities/project is not intended to include research, but to:
Identify, control or prevent disease, illness, disability, or death in response to an immediate public health threat
Assess the implementation, performance, coverage, and/or satisfaction with an existing

public health program, service, function, intervention or recommendation

✔

Routinely monitor indicators of the public’s health and known risk factors
Provide public health services, interventions, education, etc.

II. RESEARCH-NO HUMAN SUBJECTS: Mark all that apply.
The activities/project is not intended to involve human subjects. CDC will obtain:
Data in the aggregate only or about groups, organizations, etc. No individual level data will be collected
Data/specimens from or about deceased persons
Data/specimens from animal subjects
Microbiological isolates only without the ability to link to individuals’ data/specimens
Data/specimens:
Not collected specifically for the currently proposed research through interaction or intervention
with human subjects;
Never collected with individually identifiable private information about human subjects or
the key or linkages to such information was removed or destroyed by the holders of the data/specimen;
Individually identifiable private information was collected but the holders of the data/specimens are
prohibited from releasing the identifying link due to conditions of IRB approval or non-disclosure agreement.
III. HUMAN SUBJECTS RESEARCH: The activities/project is human subjects research. However, the following is
being requested with respect to review for human subjects protections:

CDC IRB Review Requested – by completing the CDC form 1250 and other required forms along with the study

materials (i.e. Protocols, consent forms, data collection forms, recruitment fliers, collaborator IRB approvals)

Reliance on a Non-CDC IRB – to have an outside non-CDC IRB review for human subjects protections

review in lieu of CDC IRB.

Exemption from IRB Review at CDC – as we believe the study meets one of the criteria for exemption.

CDC Non-Engagement - CDC will not be engaged. Mark all that apply.
CDC employees (FTE or contractors) will not have contact with human research subjects;
CDC employees will not obtain nor access any individual level data/specimens (included coded) for this study;
CDC involvement is limited to providing assistance and guidance with technical aspects of the research such as
study design, methodology, analytic plan, interpretation of results, and training.
All collaborating institution(s) conducting human research or receiving federal funds for research will have
appropriate review for human research protections and hold a valid Federal-wide Assurance (FWA).
Note: Non-engagement requests are considered on a case-by-case basis. If non-engagement status is granted then CDC
scientists cannot, at any point, have access to data/specimens or research participants for the purposes of this study.
CDC 50.151 (E) , 2/2011, CDC Adobe Acrobat 8.0 Electronic Version, 02/2011

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Other Considerations: Mark all that apply.

FDA review is required under IND, IDE, or EUA.

✔

Data security has been addressed, including security of personally identifiable information.

Clinical, pharmacological, or therapeutic intervention will be involved.

Involves greater than minimal risk to participants.

Results may be of clinical relevance for individuals and/or their family members.

Involves potentially controversial, sensitive, or high profile issues, populations or testing.

Informed consent will be sought.

CDC will fund the study through grant, cooperative agreement, or contract mechanisms.

Findings will be submitted for publication in the peer reviewed literature.

Approvals and Determinations- This section to be completed by reviewers only. Clearance requirements will depend
on the NC, division, and branch specific policies and procedures. Please indicate all that provided review and comment.
The proposed project has been reviewed by the following:
Branch Chief ______________________________
✔

Division ADS ____________________________

Micah Bass
NC Human Subjects Contact ____________________

✔

Jane Seward (acting)
NC ADS ________________________________

Determination of Applicability of Human Subjects Regulations and Review Requirements
The proposed project was determined to be: Public Health Non-Research
No further review required at this time. If changes to the project/activities are considered, re-review is required
before implementing the changes.
✔

Further action and review is required. Please complete the forms and submit them division clearance:
HR Exemption from IRB Review - Include Form(s) 1250X ____________________________________________

HR Review by Non-CDC IRB for Reliance - Include Form(s) 1250, 1370, 1371 ___________________________

HR Review by CDC IRB - Include Form(s) 1250 ____________________________________________________

HR Oversight of Activities Not Reviewed by CDC HRPO _____________________________________________

NR Non-Disclosure Requirements ________________________________________________________________

Public Health Non-Research: Monitoring Human Participation in CDC Public Health Activities
Comments/Rationale:
The purpose of NNDSS is routinely monitor diseases/illness of public health importance. NNDSS is a platform to assist state, local,
and territorial health depts collect, manage, analyze, interpret, and disseminate health-related data for diseases and conditions
designated as nationally notifiable. CDC is notified by state/local health depts of cases of diseases and conditions under national
surveillance using electronic reporting and data management systems. NCIRD subsequently obtains data for vaccine preventable
diseases other diseases and illnesses from NNDSS that are made available on the consolidated statistical platform to routinely
monitor certain notifiable diseases. These data are routinely analyzed and reported through CDC MMWRs and other publications.

Tracking System ID Number:

2013 6263

Final Determination Made by (print name): Micah Bass
Signature:

Micah Bass

Digitally signed by Micah Bass
DN: cn=Micah Bass, o=Centers for Disease Control and Prevention,
ou=NCIRD Office of Science and Integrated Programs,
[email protected], c=US
Date: 2013.02.04 15:02:09 -05'00'

Date: February 1, 2013
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CDC 50.151 (E) , 2/2011, CDC Adobe Acrobat 8.0 Electronic Version, 02/2011

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