Science Policy

The American Association for Dental, Oral, and Craniofacial Research (AADOCR) is the leading professional community for multidisciplinary scientists who advance dental, oral, and craniofacial research. We appreciate the opportunity to provide comments on EPA’s Preliminary Assessment Plan and Literature Survey for the upcoming Fluoride Human Health Toxicity Assessment. To respond to this request for comments, AADOCR engaged its Science Information Committee.

We support the EPA’s stated intent to use systematic review methods and to provide transparency early in the process, however, we urge EPA to strengthen the Assessment Plan to ensure the ultimate toxicity assessment is policy-relevant to U.S. drinking water exposures, methodologically coherent, and consistent with the principles the EPA invokes as “Gold Standard Science.” Furthermore, we urge the EPA to seek an independent peer review of its assessment plan and systematic review by the National Academies of Sciences, Engineering, and Medicine (NASEM). This will assist in ensuring future regulatory decisions relative to community water fluoridation are based on reproducible, objective, and high-quality evidence.

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The American Association for Dental, Oral, and Craniofacial Research (AADOCR) is the leading professional community for multidisciplinary scientists who advance dental, oral, and craniofacial research. We appreciate AADOCR appreciates National Institutes of Health (NIH)’s efforts to establish harmonized, transparent, and risk-proportionate requirements for protecting human participant research data while enabling responsible data sharing. To respond to this request for comments, AADOCR engaged its Science Information Committee.

We support the NIH’s goals to clarify which data types should be shared via controlled-access systems under NIH sharing policies, and to simplify and harmonize requirements by revising the NIH Genomic Data Sharing Policy. The dental, oral, and craniofacial (DOC) research ecosystem includes data modalities that carry unique privacy risks (e.g., high-dimensional imaging, facial morphology, longitudinal dental EHR data, oral microbiome paired with clinical phenotypes). Harmonized controlled-access expectations will be particularly valuable for DOC datasets where re-identification risk may be underestimated if decisions rely solely on de-identification labels rather than data type and context. NIH’s existing guidance on when data may warrant controlled access under the DMS framework is an important foundation; AADOCR supports NIH’s emphasis that privacy risk can remain even when data are de-identified.

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The American Association for Dental, Oral, and Craniofacial Research (AADOCR) is the leading professional community for multidisciplinary scientists who advance dental, oral, and craniofacial research. We appreciate the National Institutes of Health (NIH)’s efforts to reduce administrative burden and improve the clarity, consistency, and reviewability of investigator-initiated clinical trial applications. To respond to this request for comments, AADOCR engaged its Science Information Committee.

The organization of required content around the core elements of trial design, conduct, and oversight will likely improve navigation within clinical trial applications. Therefore, AADOCR supports the proposed changes, as they are likely to promote more consistent formatting, reduce duplication, and facilitate review without materially increasing burden. The proposed approach would benefit both dental, oral, and craniofacial (DOC) researchers and reviewers. Clinical trial applications within the DOC space often involve behavioral interventions, devices, procedures, prevention strategies, community-based approaches, and multi-site or pragmatic designs. Under the current application framework, important details may be distributed across both the narrative Research Plan and the Human Subjects and Clinical Trials Information Form. Therefore, the proposed consolidated form should reduce fragmentation, make essential information more prominent, and improve both efficiency and consistency of review. Additionally, AADOCR also supports the proposed form’s consistency and alignment with established clinical trial reporting frameworks.

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The National Institute of Dental and Craniofacial Research (NIDCR) requested information on a proposed concept (research initiative) presented at the January 2024 National Advisory Dental and Craniofacial Research Council meeting. The goal of the proposed concept Reissuance of NIDCR Small Grant Program for New Investigators is to provide support for research conducted by scientists who are in the early stages of establishing their independent research career in dental, oral, and craniofacial research. In our response, AADOCR provided support for the re-issuance of this research initiative and encouraged the NIDCR to reassess the scoring criteria for R01s that evaluates the expertise and capability of the investigator. The removal of the criterion for researchers that are within the early career categorization may further increase their likelihood of securing an R01.

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The U.S. Office of Global Affairs (OGA) requested information as they prepared for the G7 Health Ministers Meeting. AADOCR, on behalf of IADR, submitted written comments in which we encouraged the OGA to support efforts to integrate oral health into universal health coverage (UHC) by i). integrating essential oral health services and the basic package of oral care, ii). creating an oral health workforce geared towards population health needs and the social determinants of health and iii). financial protection and inclusion of dental care coverage in health insurance packages, as well as expanding fiscal space for oral health care. Our response also called on the OGA to bolster the oral health global strategy, with a call for the integration of oral health prevention and the basic description of oral health problems during the life course within the nursing career curriculum. Additionally, our response supported the issuance of a call for all countries to enact health care policies similar to the US Preventive Services Task Force to encourage the incorporation of basic oral health services within health systems to increase equity and accessibility, promote water fluoridation as a cost-effective means for improving population oral health, and continue financial support for the WHO.

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The 21st Century Cures Act has been credited for playing a critical role in the advancement of medical research and health care delivery in areas such as biomedical research funding and innovation, mental health care reform, drug development, and health information technology. The newer version, Cures 2.0, aims to further accelerate medical research, increase patient access to novel therapeutics, and enhance telehealth services. It called for the creation of a new agency that would prioritize funding for high-risk, high-reward research; a long-term study of COVID-19 impacts; preparedness planning initiatives; and increased diversity in clinical trial participants, changes to FDA operations, Medicare reimbursement, and coverage of innovative health technologies. To ensure that they are moving in the right direction and fully realizing the goals of the 21st Century Cures Act and Cures 2.0, and as they envision Cures 3.0, Senators DeGette and Bucshon requested information on the Cures Act.

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The National Institute of Dental and Craniofacial Research (NIDCR) requested information on proposed concepts (research initiatives) presented at the September 2024 National Advisory Dental and Craniofacial Research Council meeting. In our response, AADOCR provided input on the following concepts (i) Digital Twins for Advancing Innovation and Optimizing Clinical Outcomes in Dental, Oral, and Craniofacial (DOC) Medicine, (ii). Integration of Medically Necessary Prevention, Treatment, and Monitoring of Oncologic-related Oral, Dental, and Craniofacial Complications, (iii). Community Engaged Research to Advance Oral Health Intervention Models for Racial/Ethnic Minority HIV/AIDS Populations, (iv). Modulating the Microbiome Towards Health, (v). Dental Primary Care Practice-Based Research Network to Support Research in Clinical Practices.

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The NIDCR requested information on a proposed concept (research initiative) presented at the January 2023 National Advisory Dental and Craniofacial Research Council meeting. The goal of the proposed concept “ Reissuance of NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement (U01 Clinical Trial Not Allowed)” is to provide investigators with the support necessary to conduct prospective cohort studies or biomarker validation studies. The first version of this funding opportunity was published in 2017, and since then it has been consistently utilized by junior and senior investigators to request support for resource intensive studies. AADOCR, in consultation with its Science Information Committee and Board, provided feedback on this concept during its concept clearance process

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The NIH requested information from its stakeholders to gather public input on the NIH Plan to Enhance Public Access to the Results of NIH-Supported Research (NIH Public Access Plan). This plan provides a roadmap for how NIH will enhance access to research products, namely scholarly publications and scientific data, and will ensure these research products are useful and accessible to the public. NIH sought input on (i). how to best ensure equity in publication opportunities for NIH-supported investigators, (ii). steps for improving equity in access and accessibility of publications, (iii). methods for monitoring evolving costs and impacts on affected communities, and (iv). early input on considerations to increase findability and transparency of research. AADOCR, in consultation with its Science Information Committee and Board, provided responses to this request.

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The NIH requested information on the National Toxicology Program’s (NTP) draft NTP Monograph on the State of the Science Concerning Fluoride Exposure and Neurodevelopmental and Cognitive Health Effects: A Systematic Review document. The monograph was reviewed by the National Academies of Sciences, Engineering, and Medicine (NASEM) on two different occasions. On both occasions, NASEM found the monograph’s conclusion unsubstantiated by the data included within. An independent working group of subject-matter experts was also convened to evaluate the adequacy of NTP responses to external peer review and/or federal agency comments received during the development of the State of the Science Monograph and the Meta-Analysis Manuscript. AADOCR, in consultation with its Science Information Committee and Board, provided feedback on the NTP Monograph and the Working Group Report. 

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The Department of Health and Human Services’ Office of Global Affairs (OGA) hosted a stakeholder listening session in preparation for the upcoming G7 Health Ministers meeting. The Stakeholder Listening Session was designed to seek input from stakeholders to help inform and prepare for U.S. government engagement in the Health Ministers' Meeting. In addition to the listening session, they invited stakeholders to submit written comments on priority areas that were expected to be discussed during the G7 meeting. One of those priority areas was “Contribute to achieving more resilient, equitable and sustainable universal health coverage through strengthening health systems”. AADOCR, in consultation with its Board, provided feedback on the G7 Health Ministers’ agenda.

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The NIH, Office of the Director, Office of Disease Prevention (ODP) requested information on its draft strategic plan for Fiscal Years 2024–2028, Prevention Research: Creating a Healthier Future for All. Feedback was invited on areas where targeted efforts could help accelerate prevention research. AADOCR, in consultation with its Science Information Committee and Board, provided a response that focused on the following priority areas: (i). systematically monitor NIH investments in prevention research and the progress and results of that research, (ii). identify prevention research areas for investment or expanded effort by NIH, (iii). advance tobacco regulatory and prevention science, (iv). promote and coordinate prevention research that addresses health disparities, and (v). improve the availability and visibility of information about prevention research, inform diverse audiences about the scope and impact of disease prevention research, and engage with ODP's partners to enhance and support ODP's mission. 

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The NIDCR requested information on a proposed concept (research initiative) presented at the May 2023 National Advisory Dental and Craniofacial Research Council meeting. The goal of the proposed concept “Renewal of the NIDCR FaceBase Program” is to support a state-of-the-art, public repository of dental, oral, and craniofacial (DOC) research and clinical data to enable and accelerate data-driven efforts in knowledge discovery, translation of knowledge gained into health and health care solutions, and the delivery of those solutions. AADOCR, in consultation with its Science Information Committee and Board, provided feedback on this concept during its concept clearance process. 

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The NIH requested information on the DRAFT “Scientific Integrity Policy of the National Institutes of Health”. The DRAFT NIH Scientific Integrity Policy codifies NIH's long-standing expectations to preserve scientific integrity throughout all NIH activities, establishes key roles and responsibilities for those who will lead the agency's scientific integrity program, and, as appropriate, establishes relevant reporting and evaluation mechanisms. Feedback was requested on the following new additions (i). role and responsibilities of the NIH Scientific Integrity Officer, (ii).  role and responsibilities of the NIH Chief Scientist (CS), (iii). responsibilities of the NIH Scientific Integrity Council, and (iv). prohibitions against Political Interference. AADOCR, in consultation with its Science Information Committee and Board, provided feedback on this proposed policy. 
 

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The NIDCR requested information on their proposed concepts (research initiatives) presented at the September 2023 National Advisory Dental and Craniofacial Research Council meeting. The research initiatives were as follows:

• Accelerating Product Excellence in Innovation and for Clinical Adoption (APEx)
• Advancing HIV/AIDS and Oral Health Research
• Bacteriophage Therapy: Tipping the Balance to Oral Health
• Community-Based Participatory Research Consortium: Advancing DAta and Practice Transformation (ADAPT) for Caries Equity
• Determining the Tri-directional Relationship Between Oral Health, Nutrition, and Comprehensive Health
• NIDCR Mentoring Networks for Underrepresented and Early-Career Investigators (Reissue)
• Organs-on-a-Chip in Dental, Oral, and Craniofacial Research (DOC-OoCs)

AADOCR, in consultation with its Science Information Committee, Committee on Diversity and Inclusion, and Board, provided feedback on these concepts during their concept clearance processes. 

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