IRB Determination

Project Determination

Evaluating Deep Learning Algorithm Assessment of Digital Photographs for Dental Public Health Surveillance

Project ID:	0900f3eb8218c113
Accession #:	NCCDPHP-ST-6/14/23-8c113
Project Contact:	Susan Griffin
Organization:	NCCDPHP/OD/OMS
Status:	Pending Clearance
Intended Use:	Project Determination
Estimated Start Date:	11/01/23
Estimated Completion Date:	10/31/24
CDC/ATSDR HRPO/IRB Protocol#:	NA
OMB Control#:	Currently undergoing OMB approval

Description

Priority

Standard

Date Needed

08/01/23

Determination Start Date

06/16/23

Description

Please note that this project was been determined to be research in 2023. The purpose of this form is to determine if CDC needs to obtain CDC IRB approval to receive and store de-identified data and digital images of teeth. CDC is funding an outside institution, Purdue University, and the Colorado Department of Public Health to collect and analyze data for this project. Purdue University has submitted an IRB that includes the Colorado dental examiners. This project will examine the feasibility and validity of using digital photos taken by non-dental professionals, which in turn would be analyzed by deep learning algorithms to assess youth’s oral health status in lieu of human examination. This deep learning assessment tool ultimately could be used by public health officials for dental public health surveillance at the local, state, and national level. In order to train and test the deep learning algorithms to identify caries, sealants, and fluorosis, data on these conditions as assessed by standardized examiners and corresponding photos are required. CDC requests a one-year OMB approval for the one-time collection of oral health data from 1,000 middle- and high-school students in Colorado communities with naturally occurring fluoride in the tap water at or exceeding 1 part per million. The Colorado state health department will implement the collection by recruiting selected schools and dental examiners, gaining consent, arranging logistics, and collecting data from dental examination and photos taken by the dental examiners. CDC will provide dental examination and photo taking protocols and train the examiners. Data collected for each student will include 1) human assessment of fluorosis severity in the 6 upper anterior teeth and caries/sealant assessment of the occlusal surfaces of the 8 permanent molars and 2) 9 smartphone digital photos of the upper anterior teeth and 24 intraoral camera digital photos of the occlusal surfaces of the 8 permanent molars. Only de-identified data will be collected. All de-identified data—digital photos of the teeth and the completed paper screening form—will be uploaded to a HIPAA compliant cloud storage box that only can be accessed by examiners and designated CDC researchers with administrative rights. CDC is authorized to collect this information under the Public Health Service Act, Title 42, Section 247b–14, Oral health promotion and disease prevention; and the Public Health Service Act, Title 42, Section 301.

IMS/CIO/Epi-Aid/Lab-Aid/Chemical Exposure Submission

No

IMS Activation Name

Not selected

Select the primary priority of the project

Not selected

Select the secondary priority(s) of the project

Not selected

Select the task force associated with the response

Not selected

CIO Emergency Response Name

Not selected

Epi-Aid Name

Not selected

Lab-Aid Name

Not selected

Assessment of Chemical Exposure Name

Not selected

Goals/Purpose

Develop effective and efficient tool that would provide public health practitioners with valid and reliable national, stat, and local estimates of youth' dental health.

Objective

Obtain dental data from youth including digital photos and human assessment of oral health status that can be used to develop tool.

Does this project include interventions, services, or policy change work aimed at improving the health of groups who have been excluded or marginalized and/or decreasing disparities?

Yes

Project does not incorporate elements of health equity science

Not selected

Measuring Disparities

Yes

Studying Social Determinants of Health (SDOH)

Not selected

Assessing Impact

Not selected

Methods to Improve Health Equity Research and Practice

Not selected

Other

Not selected

Activities or Tasks

New Collection of Information, Data, or Biospecimens

Target Population to be Included/Represented

Children

Tags/Keywords

Dental Care for Children; Dental Fissures; Dental Caries

CDC's Role

Activity originated and designed by CDC staff, or conducted at the specific request of CDC, or CDC staff will approve study design and data collection as a condition of any funding provided

Method Categories

Convenience Sample

Methods

The Division of Oral Health (DOH) proposes using data collected from 1000 Colorado middle- and high-school students to train and test deep learning algorithms to identify caries, sealants, and fluorosis from digital photos. The following data will be collected for each child:1) human assessment of fluorosis severity in the 6 upper anterior teeth and caries/sealant assessment of the occlusal surfaces of the 8 permanent molars and 2) 9 smartphone digital photos of the upper anterior teeth and 24 intraoral camera digital photos of the occlusal surfaces of the 8 permanent molars. Data from 750 students will be used to train the deep learning algorithms to assess caries, sealants, and fluorosis and data from 250 students to evaluate the accuracy of the algorithms in terms of agreement with standardized examiner assessment. All de-identified data—digital photos of the teeth and the completed paper screening form—will be uploaded to a HIPAA compliant cloud storage box that only can be accessed by examiners and designated CDC researchers with administrative rights. CDC is authorized to collect this information under the Public Health Service Act, Title 42, Section 247b–14, Oral health promotion and disease prevention; and the Public Health Service Act, Title 42, Section 301.

Collection of Info, Data, or Bio specimens

Data will be collected at approximately 50 Colorado middle- and high-schools. Dental examiners who have been calibrated to a standardized examiner will be examining 1,000 youth and taking digital photos of their teeth. The human assessment portion of the data collection is quite similar to that used for the Basic Screening Survey, which the DIvision of Oral Health funds states to perform. Only de-identified data will be collected. All de-identified data—digital photos of the teeth and the completed paper screening form—will be uploaded to a HIPAA compliant cloud storage box that only can be accessed by examiners and designated CDC researchers with administrative rights.

Expected Use of Findings/Results and their impact

This deep learning assessment tool ultimately could be used by public health officials for dental public health surveillance at the local, state, and national level. It is anticipated that obtaining information on dental conditions via deep learning assessment of digital images as opposed to human assessment will 1) be more cost-effective as it would not require dental personnel and 2) improve the accuracy of assessment due to minimal bias and less confounding factors associated with the examiner (e.g., subjective index and thresholding). This tool also would offer mobility, simplicity, and affordability for rapid and scalable adaptation in community-based settings.

Could Individuals potentially be identified based on Information Collected?

No

Funding
Funding Type	Funding Title	Funding #	Original Fiscal Year	# of Years of Award	Budget Amount

HSC Review

Additional Ethical Considerations

may have potential for human subjects research; CDC is not engaged in human subjects research.

Regulation and Policy
Do you anticipate this project will be submitted to the IRB office
Yes
Estimated number of study participants
1000
Population - Children
Targeted	Page:
Population - Minors
N/A	Page:
Population - Prisoners
N/A	Page:
Population - Pregnant Women
N/A	Page:
Population - Emancipated Minors
N/A	Page:
Suggested level of risk to subjects
Minimal
Do you anticipate this project will be exempt research or non-exempt research
Non-Exempt
Requested consent process waivers
Informed consent for adults
No Selection
Children capable of providing assent
No Selection
Parental permission
No Selection
Alteration of authorization under HIPPA Privacy Rule
No Selection
Requested Waivers of Documentation of Informed Consent
Informed consent for adults
No Selection
Children capable of providing assent
No Selection
Parental permission
No Selection
Consent process shown in an understandable language
Reading level has been estimated
Yes
Comprehension tool is provided
No Selection
Short form is provided
Yes
Translation planned or performed
No Selection
Clinical Trial
Involves human participants
No Selection
Assigned to an intervention
No Selection
Evaluate the effect of the intervention
No Selection
Evaluation of a health related biomedical or behavioral outcome
No Selection
Registerable clinical trial
No Selection
Other Considerations
Exception is requested to PHS informing those bested about HIV serostatus
No Selection
Human genetic testing is planned now or in the future
No Selection
Involves long-term storage of identifiable biological specimens
No Selection
Involves a drug, biologic, or device
No Selection
Conducted under an Investigational New Drug exemption or Investigational Device Exemption
No Selection

Institutions
Institution	FWA #	FWA Exp. Date	IRB Title	IRB Exp. Date	Funding #

Staff
Staff Member	SIQT Exp. Date	Citi Biomedical Exp. Date	Citi Social and Behavioral Exp. Date	Citi Good Clinical Exp. Date	Staff Role	Email	Phone #	Organization/ Institution
Lorena Espinoza	03/10/2026				Co-Investigator	lee6@cdc.gov	770-488-5319	DIV OF ORAL HEALTH

DMP
Proposed Data Collection Start Date	11/30/23
Proposed Data Collection End Date	06/29/24
Proposed Public Access Level	Non-Public
Reason for not Releasing the Data	CIO conducting this project does not fund or own the data and is not responsible for making it available
Public Access justification	These de-identified data will be used to develop learning algorithms to identify dental conditions with digital images. They will not be used after that.
How Access Will Be Provided for Data	De-identified data obtained at collection site will be automatically uploaded to HIPPA compliant box that can only be accessed by authorized researchers.
Plans for archival and long-term preservation of the data

Spatiality (Geographic Location)
Country	State/Province	County/Region

Determinations
Determination	Justification	Completed	Entered By & Role
HSC: Does NOT Require HRPO Review	Non-Exempt Human Subjects Research when CDC is not engaged 45 CFR 46.102(a) HHS/OHRP 2008 Engagement Guidance at III B(1-11) Research that involves de-identified/unlinkable data or biospecimens, but not involving FDA investigational products 45 CFR 46.102(e)	07/21/23	Redmond Leonard_Joan (jrl3) CIO HSC
PRA: PRA Applies		07/25/23	Still-LeMelle_Terri (cse6) OMB / PRA