❤❤❤ US Preventative Service Task Force (SBIRT) Analysis
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Addressing Substance Use Issues in Primary Care SBIRT and Emerging Opportunities
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Disparities in health care are a clear contributor to disparities in health outcomes. Differences in health care utilization patterns and quality of care indicators between populations affected by health disparities and the general population have been well documented. More work is needed to understand how best to eliminate these inequities by understanding the causal mechanisms and evaluating the effectiveness of interventions. In addition, with the emerging Coronavirus disease COVID pandemic, differences in health care utilization patterns and quality of care need to be reevaluated and interventions to reduce health disparities generated by this pandemic and improve minority health need to be developed and evaluated.
The focus of this FOA is on all services provided in the healthcare setting where individuals from health disparity populations seek care with a clinician for preventive services, chronic disease management, urgent symptomatic care, emergency care, and hospital care. These health services do include tele-medicine or virtual or remote encounters and home visits. The overarching purpose of this FOA is to promote research to generate new knowledge to improve health care access, delivery, utilization and quality, and health outcomes of racial and ethnic minority populations and other groups affected by health disparities. Projects may address health services pertaining to health promotion, screening for disease or risk factors, prevention at any level, diagnosis and the treatment of particular health conditions including chronic diseases, mental and substance abuse disorders, and infectious diseases such the Novel Coronavirus , specific segments of populations affected by health disparities e.
Projects should involve the use of relevant health system-level data in some way. Projects that include populations that identify across more than one health disparity group are encouraged. The primary interest of this FOA is research on system-wide health services research that encompasses the diversity of individuals served within these health care systems. It is expected that projects will include patient or participant samples that are representative of the population served by the health care system s to be studied. Examples of projects that will not be considered responsive to this FOA include:. Note: Non-responsive applications will not be reviewed. Applicants are encouraged to reach out to scientific contacts for this FOA to discuss responsiveness.
For example, the U. But uptake of this recommended preventive service in the population eligible for screening is very low. An estimated , people are expected to die of lung cancer disease in , and the burden of lung cancer is higher in African Americans, in members of other minority groups, and in adults ages 65 and older. The ODP encourages applications using interventions or observational research designs that have strong implications for disease prevention and make use of innovative design, measurement, and analytic methods.
In the context of this FOA, examples of research areas of interest include, but are not limited to:. Investigators seeking to evaluate the effect of an intervention on a health-related biomedical or behavioral outcome may propose a study design in which 1 groups or clusters are assigned to study arms and individual observations are analyzed to evaluate the effect of the intervention, or 2 participants are assigned individually to study arms but receive at least some of their intervention in a group format or through a shared facilitator. Designs that might be proposed include parallel group- or cluster-randomized trials, stepped-wedge group- or cluster- randomized trials, individually randomized group-treatment trials, multiple baseline designs, time-series designs, and other quasi-experimental designs.
Whenever participants are assigned in groups or clusters e. Applicants will need to show that their methods are appropriate given their plans for assignment of participants and delivery of interventions. ODP does not award grants. Please contact the relevant IC program contact listed for questions related to IC research priorities and funding. Other Information for award authorities and regulations. Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Only those application types listed here are allowed for this FOA. Need help determining whether you are doing a clinical trial? The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
The scope of the proposed project should determine the project period. The maximum project period is 5 years. Non-domestic non-U. Entities Foreign Institutions are not eligible to apply. Organizations are not eligible to apply. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission. Obtaining an eRA Commons account can take up to 2 weeks. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:. See your administrative office for instructions if you plan to use an institutional system-to-system solution. Only limited Appendix materials are allowed. Note: Delayed onset does NOT apply to a study that can be described but will not start immediately i.
See Part 1. Section III. Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day. Organizations must submit applications to Grants. NIH and Grants. Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission. This initiative is not subject to intergovernmental review. Paper applications will not be accepted. Applicants must complete all required registrations before the application due date.
Eligibility Information contains information about registration. For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply — Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. See more tips for avoiding common errors. Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy. Only the review criteria described below will be considered in the review process. In addition, for applications involving clinical trials: A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs.
Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation. Reviewers will provide an overall impact 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. 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. Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is the trial needed to advance scientific understanding? If Early Stage Investigators or those 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? Do they have appropriate expertise in study coordination, data management and statistics?
For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center? 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? Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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?
Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? In addition, for applications proposing clinical trials: Does the application adequately address the following, if applicable:. Is the trial appropriately designed to conduct the research efficiently? Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate?
Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate?
Is there a plan to obtain required study agent s? Does the application propose to use existing available resources, as applicable? Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site s or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award? 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? Does the application adequately address the capability and ability to conduct the trial at the proposed site s or centers? Are the plans to add or drop enrollment centers, as needed, appropriate? 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 score, but will not give separate scores for these items.
Specific to applications proposing clinical trials: Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources e. Are potential challenges and corresponding solutions discussed e. For research that involves human subjects but does not involve one of the 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 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 Guidelines for the Review of Human Subjects.
For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: 1 description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; 2 justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; 3 interventions to minimize discomfort, distress, pain and injury; and 4 justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals.
For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section. 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. For Renewals, the committee will consider the progress made in the last funding period. For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project.
If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident. 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 score.
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. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by an appropriate Scientific Review Group s convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures , using the stated review criteria. As part of the scientific peer review, all applications will receive a written critique. Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit generally the top half of applications under review will be discussed and assigned an overall impact score. Applications will compete for available funds with all other recommended applications.
Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:. A formal notification in the form of a Notice of Award NoA will be provided to the applicant organization for successful applications. Awardees must comply with any funding restrictions described in Section IV. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
This includes any recent legislation and policy applicable to awards that is highlighted on this website. Additionally, ICs may specify any special reporting requirements for the proposed clinical trial to be included under IC-specific terms and conditions in the NoA. For example: If the proposed clinical trial has elevated risks, ICs may require closer programmatic monitoring and it may be necessary to require the awardee to provide more frequent information and data as a term of the award e. All additional communications and information related to programmatic monitoring must be documented and incorporated into the official project file.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA. NIH expects registration of all trials whether required under the law or not. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies clinical trials to ensure the safety of participants and the validity and integrity of the data.
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions including licensed products and devices for a purpose other than that for which they were licensed in humans under a research protocol must be performed under a Food and Drug Administration FDA investigational new drug IND or investigational device exemption IDE.
Recipients of federal financial assistance FFA from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency.
Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.
The Federal Funding Accountability and Transparency Act of Transparency Act , includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY or later. In accordance with the regulatory requirements provided at 45 CFR The recipient must also make semiannual disclosures regarding such proceedings.
Proceedings information will be made publicly available in the designated integrity and performance system currently FAPIIS. This is a statutory requirement under section of Public Law , as amended 41 U. As required by section of Public Law , all information posted in the designated integrity and performance system on or after April 15, , except past performance reviews required for Federal procurement contracts, will be publicly available. We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Rada K. Laura E. Minnjuan Flournoy-Floyd, Ph. Melissa C. Dara R. Blachman-Demner, Ph. OBSSR does not award grants. Please contact one of the IC program contacts listed above for questions regarding funding interest. Damiya E. Whitaker, Psy. Examine your eRA Commons account for review assignment and contact information information appears two weeks after the submission due date. Recently issued trans-NIH policy notices may affect your application submission. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.How will successful completion US Preventative Service Task Force (SBIRT) Analysis the Essay On Discrimination In Health Care change the concepts, methods, technologies, US Preventative Service Task Force (SBIRT) Analysis, services, or preventative interventions that drive this field? All our papers are US Preventative Service Task Force (SBIRT) Analysis as US Preventative Service Task Force (SBIRT) Analysis are all written from scratch. An applicant, US Preventative Service Task Force (SBIRT) Analysis its option, may review information in the designated Tim Burton Film Techniques and performance systems accessible The False Memory Experiment: Elizabeth Loftus FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. Brands with generic equivalents. Assignment Essays Features. NIH and Grants.