Virtual Reality Technologies for Research and Education in Obesity and Diabetes (R01)

Virtual Reality Technologies for Research and Education in Obesity and Diabetes (R01) is sponsored by National Institutes of Health (NIH). This Funding Opportunity Announcement encourages submission of hypothesis-testing research applications that capitalize on the unique capabilities of Virtual Reality (VR) technologies to visualize outcomes, teach, motivate, and to extend healthcare and learning environments, in …

Expired PA-11-211: Virtual Reality Technologies for Research and Education in Obesity and Diabetes (R01) This notice has expired. Check the NIH Guide for active opportunities and notices. Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) U.S. Army Medical Research and Materiel Command ( USAMRMC ) Components of Participating National Heart, Lung, and Blood Institute ( NHLBI ) Office of Behavioral and Social Sciences Research ( OBSSR ) Telemedicine and Advanced Technology Research Center ( TATRC ) Eunice Kennedy Shriver National Institute of Child Health and Human Funding Opportunity Title Virtual Reality Technologies for Research and Education in Obesity and Diabetes (R01) R01 Research Project Grant May 30, 2013 ( NOT-OD-13-074 ) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013.

Forms-C applications are required for due dates on or after September 25, 2013. July 6, 2011 - See Notice NOT-HL-11-152 Notice of Publication of FAQs.

Funding Opportunity Announcement (FOA) Number PA-11-212 - R21 - Exploratory/Developmental Grant RFA-HL-12-020 - STTR R43/R44- Phase I, Phase II, and Fast Track RFA-HL-12-024 - STTR R43/R44- Phase I, Phase II, and Fast Track Additional Information on Eligibility Catalog of Federal Domestic Assistance (CFDA) Number(s) 93. 837, 93. 838, 93.

839, 93. 233, 93.

865 The purpose of this Funding Opportunity Announcement (FOA) is to encourage submission of hypothesis-testing research applications that capitalize on the unique capabilities of Virtual Reality (VR) technologies to visualize outcomes, teach, motivate, and to extend the health care and learning environments, in order to foster to foster desirable eating, physical activity, self-care, and other health-related behaviors necessary for prevention and management of obesity and diabetes.

Of highest interest are well-designed multidisciplinary projects drawing on expertise in VR technologies and biomedical behavioral and pedagogical sciences. The overall goal is to develop the potential of VR technologies as research tools for behavioral science-oriented studies in diabetes and obesity, and as practical tools for clinical and public health-level prevention and management of obesity and diabetes.

Open Date (Earliest Submission Date) Letter of Intent Due Date dates apply, by 5:00 PM local time of applicant organization. AIDS Application Due Date(s) dates apply, by 5:00 PM local time of applicant organization.

Required Application Instructions It is critical that applicants follow the instructions in 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information Part 2. Full Text of the Announcement Section I.

Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information I. Funding Opportunity Description BACKGROUND AND RATIONALE : The public health infrastructure is being overwhelmed by problems related to over-eating and under-exercising, and it has become clear that many, perhaps most, people have difficulty assimilating and implementing information on optimal diet and physical activity.

Furthermore, the emotional, cognitive, and logistical complexities of diabetes management have resulted in a situation where a large fraction of patients are in sub-optimal glycemic control, leading to poor clinical outcomes and high expenses.

Even if individuals are willing to adhere to professional and public health guidance, it is hard to navigate the emotional demands, environmental choices and opportunity cost issues that present themselves at the point of decision.

This is the cause of failure for many approaches seeking to promote positive behavioral changes, which is of particular concern for individuals with obesity Virtual Reality (VR) technologies might prove useful in bridging the gap between information (healthy population guidance or therapeutic lifestyle change guidance for obesity and diabetes) and sustainable behavior change.

VR technology allows users to interact with (rather than simply observe) computer-simulated environments, typically with adapted flat-screen monitor displays or stereoscopic goggles, but also sometimes with tactile ( haptic ) or other sensory feedbacks including taste and smell.

Online communities and virtual worlds with avatars (animated characters representing oneself or others) are increasingly a component of the everyday social world for many VR applications are currently in development and use for a number of health- and medicine-related issues, notably rehabilitation medicine (stroke, Parkinson’s disease, pain control in burn victims), behavioral medicine (phobias, post-traumatic stress disorder, drug addiction, autism), and surgery (technical training, robotics, remote site treatment).

However, except for small studies in clinical eating disorders (anorexia, binge eating), there has been almost no development of the field in relation to common issues of food intake, food choice and encouragement of physical activity among the VR technology could be used to complement motivational interviewing, assess emotional states of readiness for behavioral change, and help patients to grapple with their emotional reactions to food choices.

The visual presentations could assist patients in adjusting their distorted assessments of portion sizes; correcting their unrealistic expectations of the rate of weight loss; managing sensory experiences that occur as a result of behavior change, such as hunger or satiety from altered consumption patterns, or delayed muscle soreness from unaccustomed exercise; and enhancing their sense of self-efficacy by giving them successful experiences in navigating virtual environments.

VR also might be suitable for addressing adherence barriers in cardiovascular exercise rehabilitation (particularly for coronary artery disease, heart failure, and peripheral arterial disease) such as perceived exertion, anxiety, and capacity to walk to a prescribed duration and intensity.

Another clinical use of VR might be in the provision of non-judgmental support for patients with various medical conditions through virtual coaches, and it might be especially suitable for housebound or reclusive individuals with social anxieties or mobility restrictions due to morbid obesity or other medical conditions.

VR could be used in the therapeutic setting as a component of patient visits, to help guide and select educational materials and strategies and timelines. It might be an especially suitable modality for children, adolescents and young adults, who already are becoming familiar with VR as an entertainment technology.

VR could also be applicable to individuals with low verbal or numerical literacy who may be more oriented to pictorial (vs. written or abstract) information. An evolving body of evidence indicates that poor sleep behaviors and insufficient sleep may be causally linked with disordered endocrine and appetite regulation and with risk of metabolic syndrome, diabetes, hypertension and clinical cardiovascular disease.

VR technology presents new opportunities to apply recent advances in sleep research in relation to obesity and diabetes risk by objectively evaluating individual sleep and alertness status, delivering personalized guidance on healthy sleep behaviors, implementing physician-recommended treatments (e.g., positive airway pressure devices, light therapy), and assessing treatment outcomes in terms of changes in sleepiness, psycho-motor vigilance, and ocular markers of sympathetic tone.

Sleep parameters (e.g., schedules, phasing, quality and quantity), perceptive and affective aspects of sleepiness (e.g., cognizance of sleepiness, self-monitoring of sleep habits), and sleep deprivation consequences (slower reaction times and impairments in memory, cognition, emotional processing, judgment, and decision-making) are all amenable to study VR has some unique characteristics as a research tool.

The virtual environments can be designed to address specific hypotheses, and data on the study participant’s response to the intervention can be collected in high detail without additional intrusiveness. Phenomena that are amenable to study, and also treatment, include cue responsiveness and extinction through virtual exposure, a feature that has been used to advantage in treatment of phobias and addictions.

Visual presentations can be tailored to the user, along with therapeutic guidance to modify affective reactions and choices, and can prepare the user for future real-world encounters, thus making VR suitable for role-playing and training.

Performance feedback, an essential component of learning and skill acquisition, can occur in real-time; thus VR can be used as a teaching tool and also to study cognitive processing of information presented in increasingly complex ( hierarchical ) environments, a research approach that often is not practical in real world settings.

Also, the capability to distribute identical virtual environments across multiple locations gives new meaning to the concept of multi-site data collection. For researchers, an advantage is that the VR approach can simultaneously deliver an intervention and collect data on how it is utilized, particularly with regard to the cognitive and emotional processes involved.

Study design and methodology challenges include: identification of appropriate control groups and control conditions, and of characteristics of rigorous efficacy and effectiveness studies of VR; exploration of ethical issues with different types of studies such as direct comparison designs (Standard of Care [SOC] vs. VR) and additive designs (SOC vs. SOC+VR); characterization of how participant traits (such as age, literacy and numeracy level, motivation and other cognitive and psychosocial traits), and previous gaming experience moderate technology usability and study outcomes; development of well-defined metrics for assessment of interventions and outcomes, including actual as well as intended VR dose; development of VR research tools that could be used in group or multi-site formats (e.g. classrooms); and development of methods for mining data from existing health games for research purposes.

There is a need for both developmental VR research leading to new methods and technologies and marketable commercial products. There is also the need for research that provides a venue for well-powered effectiveness trials of the new interventions.

Progress in the field will be enhanced by multidisciplinary collaborations between the technology industry and academia, and among researchers with diverse expertise in biomedical sciences (such as endocrinology, nutrition, and exercise physiology), behavioral science and pedagogical disciplines, and computer sciences including VR technologies. There is a need to document and evaluate currently available off-the-shelf programs.

Projects will need to be clearly defined with regard to: research questions, technical approach, VR platforms, target population (by age, health condition, psychological status, education or literacy level, etc), and research outcomes. Many projects can be usefully conducted taking advantage of already existing tools, games, and software, although there is also a need to develop unique technologies.

Army Medical Research and Materiel Command ( USAMRMC ) The Telemedicine and Advanced Technology Research Center ( TATRC ) has substantial in-house subject matter expertise and experience in the application of information technologies, virtual reality, augmented reality, and gaming technologies for healthcare.

If the applicant would like to have the research project considered for supplemental funding from TATRC, a paragraph defining the military relevance should be included as such. Note that NIH grants policies as described in the NIH Grants Policy Statement will apply to all applications submitted and awards made in response to this joint-agency FOA.

Applications should involve development, use or adaptation of immersive or non-immersive VR environments. Those projects focusing only on electronic means of research data collection (so-called e-tools ), without VR components, will not fit the research objectives of this FOA.

Potential areas for hypothesis-testing research, and for exploratory, developmental or evaluation research, include (but are not limited Using VR to foster desirable eating, physical activity, and other health-related behaviors: Making smarter eating choices in various locations (such as home, restaurants, school cafeteria).

Understanding the effects of chemical senses input (taste, smell) in combination with VR modalities on learning and motivation processes related to food intake and food choice. Training for more healthful food purchasing and food use decisions (including shopping lists, budgeting, menu planning and food Counteracting food marketing efforts.

Assisting parents in teaching small children better eating habits (e.g. eat at table, eat variety of foods, try new foods, eat fruits and Training in portion size effects on weight gain and loss. Retraining conditioned emotional and behavioral responses to food and eating contexts (cue-exposure of unhealthful foods or contexts where unhealthful eating behaviors occur).

Assessing reliability and outcomes of existing health games or Improving self-efficacy by VR-guided practice of desired behaviors, including role-playing, scenario navigation, and presentation of information matched to individual learning style and motivational factors.

Evaluating genetic/familial influences on perception of portion size and other visual dimensions of food availability/appearance in relation to food choices, caloric intake, and satiety. Evaluating and modifying sleep patterns and behaviors, especially in relation to diet, physical activity, and other aspects of obesity and diabetes prevention and management.

Using VR to motivate by fast-forwarding to the future: Illustrating how changes in physical activity or diet will lead to changes in weight and body size. Using avatars or intelligent agents to show consequences of unhealthful behavior and to model healthful behavior.

Understanding characteristics of avatars that modify effectiveness of interventions, including the degree to which they must be sufficiently similar to how user views self. Modifying perception of body image and other aspects of Modeling effects of changes in community food choice availability and built environments on weight, physical activity, health, and illness.

Utilizing social network capabilities of VR: Evaluating impact of social network systems with reward systems (points or credits) for desirable health-related behaviors (buying or eating healthful foods; engaging in regular physical activity; improving sleep habits; improving diabetes self-monitoring). Exploring how social context affects competitive or collaborative Providing and evaluating family interventions.

Evaluating usefulness of VR for social support for diabetes. Utilizing motivational and teaching aspects of VR technology: Embedding obesity and diabetes education and motivation in existing VR games and systems. Using VR to make behavior change more reinforcing and Monitoring behavior and providing individualized feedback, including rewards and goal-setting.

Understanding the cognitive processes involved in learning and applying health- and nutrition-related information.

Understanding the short-term vs. long-term motivational aspects of VR, including attenuation of novelty, and how this influences effectiveness Understanding determinants of decision processes involved with acceptance, adoption, maintenance, and other aspects of good vs. poor adherence to prevention and treatment regimens for obesity and diabetes.

Understanding the role of external visual cues in providing reinforcement and motivation for exercise and increased daily physical activity in sedentary patients with diabetes or obesity or in patients needing cardiovascular exercise rehabilitation.

Understanding components of cue responsiveness in diabetes and obesity management skills under environmental conditions of increasing Understanding cognitive processing of written vs. visual presentations of health and nutrition information in obese or diabetic patients with low print or numerical literacy skills. Using VR to extend the availability and capacity of health Establishing extended classrooms for diabetes education.

Providing less threatening and more accessible behavioral Enhancing displays and presentations of patient data for review by health care providers. Providing clinician training in how to counsel subjects on weight Providing training to clinicians and other health care professionals (dietitians, clinical exercise physiologists) in health behavior-related referral for obese or diabetic patients. Techniques for patient counseling.

Modification of bias in the clinical interaction setting (such as negative views towards obese patients). Enhanced displays and presentations of patient data for review by Less threatening, more accessible behavioral coaching for patients of various ages.

capabilities of VR, including: Social support through online communities for conditions such as obesity (particularly morbid obesity), post-bariatric surgery status, diabetes in children and adults, and extreme de-conditioning through inactivity.

Impact of social network systems with reward systems (points or credits) for desirable health-related behaviors (buying or eating healthful foods; engaging in physical activity; improving sleep habits; improving diabetes Effects of social context on competitive or collaborative As a modality for individual and family interventions in various research, preventive, and therapeutic settings (home, school, clinic).

Motivational , learning, affective, and perceptual aspects of VR Optimal characteristics for obestity and diabetes education as embedded in existing VR games and systems. Optimal characteristics for obesity and diabetes education as embedded in existing VR games and systems. Efficacy, reliability, and outcomes of game orientation ( serious games ) to make behavior change more enjoyable and participatory.

Monitoring behavior and providing individualized feedback, including rewards and goal-setting. Components of cue responsiveness in diabetes and obesity environmental conditions of increasing complexity.

Understanding the short-term vs. long-term motivational and decision-making aspects of VR, including attenuation of novelty, and how this influences treatment effectiveness as well as acceptance, adoption, maintenance, and other poor adherence to prevention and treatment regimens.

Cognitive processes involved in learning and use of health- and nutrition-related information, especially in obese or diabetic patients with low print or numerical literacy skills. Genetic and/or familial influences on perception of portion size and other visual dimensions of food availability/appearance in relation to food choices, caloric intake, and satiety.

Pain distraction, motivation enhancement, and balance training using immersive visual environments, haptic systems (i.e., simulated tactile feedback based on pressure, touch, and vibration sensors), and other VR modalities in supervised rehabilitation exercise therapy for cardiovascular diseases and diabetes complications such as coronary heart disease, peripheral neuropathy, stroke, and peripheral arterial disease.

Application Types Allowed Glossary and the SF 424 (R&R) Application Guide provide details on 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.

In addition, pending availability of funds and identification of suitable projects, TATRC may decide to co-fund collaborative projects through offsets or administrative supplements when such opportunities arise. Funds would be transferred through MIPR mechanisms (equivalent to Interagency Agreement). TATRC has requested $250,000 for such Application budgets are not limited, but need to reflect actual needs of the proposed project.

described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA. Section III.

Eligibility Information Higher Education Institutions: Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American tribal organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Organizations) are Foreign (non-U.S.) components of U.S. Organizations are not allowed.

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award.

Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

This FOA does not require cost sharing as defined in the NIH Grants Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide. IV.

Application and Submission Information 1. Requesting an Application Package Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants. gov .

Form of Application Submission It is critical that applicants follow the instructions in (R&R) Application Guide , except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for Required and Optional Components The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for application submission.

Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

All page limitations described in the SF424 Application Guide and the Table of Page PHS 398 Research Plan Component All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification: All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) 3. Submission Dates and Times Part I.

Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission. Organizations must submit applications via Grants.

gov , the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide. 4. Intergovernmental Review (E.

O. 12372) This initiative is not subject to intergovernmental All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Pre-award costs are allowable only as described in the NIH Grants 6. Other Submission Requirements and Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.

Paper applications will not be accepted. must complete all required registrations before the application due date. Section III.

Eligibility Information contains information about registration. For assistance with your electronic application or for more information on the electronic submission All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package .

Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR).

Additional information may be found in the SF424 (R&R) Application Guide. tips for avoiding common errors. Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review.

Applications that are incomplete will not be reviewed.

Requests of $500,000 or more for direct costs in any year Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF 424 (R&R) Application Guide.

and experimental approaches that are being sought to achieve the objectives of Applications responding to this FOA should contain multidisciplinary research strategies drawing on expertise in VR technologies, biomedical sciences (such as endocrinology, nutrition, exercise physiology, cardiology), and behavioral sciences.

Projects should be clearly defined with regard to aspects such as the research question to be answered, the technical approach, VR platform, target population (by age, health condition, psychological status, education or literacy level, etc), and research outcomes. Many projects can usefully be conducted taking advantage of already existing tools, games, and software, although applications also could seek to develop unique technologies.

Applications focusing only on electronic means of research data collection (so-called e-tools ), without VR components, will not be considered to fit the Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115 . V. Application Review Information 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 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).

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? 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?

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? 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?

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 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?

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 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 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 .

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