The purpose of this Funding Opportunity Announcement (FOA) is to stimulate research that addresses gaps in our knowledge of how best to treat the oral diseases of medically compromised patients, to identify risk factors that further compromise treatment outcomes in these selected patient groups, and to generate evidence for treatment guidelines.
Background:
Systemic diseases and disorders such as Sjögren’s syndrome, head and neck cancers, cleft lip/palate, Ectodermal Dysplasias (ED), and diabetes severely compromise factors that maintain oral health. Consequently, oral diseases are more prevalent and severe in these patients. Most evidence supporting treatment for caries or periodontal diseases is derived from clinical trials/studies in relatively healthy subjects, and the long term success of different treatment and restorative approaches for oral diseases has not been assessed in individuals with the highest risk for poor oral health. Patients with certain systemic diseases or disorders can spend significant time and resources maintaining their oral health. For example, a recent case-control study of Sjögren’s syndrome patients found out-of-pocket spending for dental care was two to three fold higher in Sjögren’s patients as compared with peer controls. A survey of ED patients found costs for dental treatment could exceed $40,000 for those with severe hypodontia, and over 50% of patients paid for all dental services out of pocket. Small studies suggest some standard treatments for oral diseases are not as successful in compromised patient groups. For example, glass ionomer and composite resin restorations placed in post head-and-neck radiation cancer patients are reported to have very high two-year failure rates. A recent review of the literature concerning the success of dental implants in patients with ED and tooth agenesis concluded the evidence to support treatment guidelines was scarce, and studies lacked long term outcomes. Children born with oral clefts have multiple reparative procedures from birth through early adulthood, but there is little evidence to support the use of many cleft treatment protocols.
Scope:
The objective of this FOA is to support effectiveness research to inform prioritization of evidence-based treatment for patients with disorder or disease-related compromised oral health, and suggest appropriate adaptations (in timing, frequency, procedure or material) of recommended preventive and restorative guidelines for these patients. This Funding Opportunity will not support epidemiological studies of disease prevalence without assessment of treatment outcome. It also will not support randomized clinical trials.
Examples of research that could be supported through this FOA include, but are not limited to:
1. Dental restoration, implant, crown or prosthetic survival in post head-and-neck radiation patients, patients with Sjögren's syndrome or individuals with Ectodermal Dysplasias;
2. Impact of early interventions (such as those for babies born with oral clefts) on later clinical outcomes;
3. Effectiveness of prophylactic interventions (such as hyperbaric oxygen therapy) to prevent post-surgical complications; and
4. Outcomes of grafting or particular techniques for facial reconstruction after major surgery or trauma.
Funding Instrument: Grant
Application Types Allowed: New submissions only for the November 18, 2011 receipt date; New and resubmissions will be accepted for the September 18, 2012 receipt date.
Funds Available and Anticipated Number of Awards: The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications. NIDCR intends to support approximately 4-5 R01 applications solicited through this Funding Opportunity Announcement. A companion Funding Opportunity Announcement, RFA-DE-12-007, will support approximately 5-6 R21 additional grant applications. NIDCR intends to commit up to $4 million to support meritorious projects solicited through these two announcements.
Award Budget: Costs appropriate for the project may be requested.
Award Project Period: A project duration of up to five years may be requested.
Criteria
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Overall Impact
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Scored Review Criteria
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is there evidence that the condition or disease group selected for study is associated with an increased risk for the prevalence or severity of a particular oral disease? Does the proposed investigation address a clinically meaningful outcome? Will the outcomes of the research generate new evidence that could answer a meaningful clinical question rather than simply confirming findings of other studies? Do the investigators articulate how the results of the proposed research will impact existing treatment guidelines?
Investigator(s)
Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
Do all subjects in the target patient group have the disease or condition of interest? How will the diagnosis or condition be established? If proposing retrospective data analyses, does the data set have sufficient numbers of the target patient group and do oral health outcomes exist in the data set? Does the application discuss the quality of existing data, missing data bias and any methods that will be used to control or account for deficiencies? Is the analysis plan adequate? If proposing a longitudinal study, does the study timeline allow sufficient time for enrollment and evaluation of clinically meaningful outcomes within the proposed period of the grant? If the study uses a longitudinal design, is the retention plan adequate?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?Do the investigators have access to sufficient numbers of potential subjects or subject records to complete the research within the grant period?
Additional Review Criteria
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewals
Not Applicable.
Revisions
Not Applicable.
Additional Review Considerations
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.
Applications from Foreign Organizations
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Moreinfo: http://grants.nih.gov/grants/guide/rfa-files/RFA-DE-12-006.html
