NIH: International Research in Infectious Diseases, including AIDS

NIH: International Research in Infectious Diseases, including AIDS is sponsored by National Institute of Health (NIH), U.S. Department of Health and Human Services (DHHS). This funding opportunity encourages applications from organizations/institutions in eligible foreign countries that propose research related to infectious diseases that are of interest/importance to that country, including AIDS.

Expired RFA-AI-14-001: International Collaborations in Infectious Diseases Research (U01) This notice has expired. Check the NIH Guide for active opportunities and notices. of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) of Participating Organizations National Institute of Allergy and Infectious Diseases ( NIAID ) Funding Opportunity Title International Collaborations in Infectious Diseases Research (U01) U01 Research Project Cooperative Agreements Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity U19 Research Project - Cooperative Agreements Additional Information on Eligibility .

Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications from U.S. institutions and collaborating foreign (non-U.S.) institutions to study infectious diseases (excluding HIV/AIDS) of public health significance in resource-constrained countries.

The collaboration must include, at a minimum, one U.S. institution and one eligible foreign institution. Eligible foreign countries are defined as low-income economies, lower-middle-income economies, and upper-middle-income economies, as defined by the World Bank.

This work is expected to increase scientific knowledge on public health related issues, enhance relevant research experience for U.S. and foreign investigators, promote the development of research capacity, and encourage future collaborative Open Date (Earliest Submission Date) Letter of Intent Due Date(s) March 7, 2014, by 5:00 PM local time of applicant Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s) Required Application Instructions It is critical that applicants follow the instructions in (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 Full Text of Announcement Section I. Funding Opportunity Description The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), supports extramural research focused on understanding, controlling and preventing diseases caused by virtually all infectious agents.

The NIAID has a long-standing interest in and commitment to global health and international research on infectious diseases. A solid foundation of international research and collaborations enhances the U.S. capacity for infectious disease research and the ability to respond to newly emergent disease threats.

Moreover, the availability of NIAID-sponsored overseas study sites for field research advances our global public health agenda and allows for research that might not be possible in the U.S. The International Collaborations in Infectious Disease Research (ICIDR) Program, initiated in 1980, makes awards to institutions in the US and foreign countries to engage in substantial international collaborations in infectious disease research (excluding HIV/AIDS).

The goals of the ICIDR program are to: support high-quality, collaborative research that will lead to or result in detection, prevention, amelioration, and/or improved treatment of infectious diseases; increase relevant and collaborative research experience for both U.S. and foreign investigators; and facilitate and enhance scientific linkages between U.S. and foreign investigators to enhance the independent research capacity of the collaborating foreign institutions and foster further international collaborative research projects.

This FOA invites applications from U.S. institutions or institutions in eligible, resource-limited foreign countries proposing collaborative research focused on infectious diseases that disproportionately affect the health of people living in resource-limited countries. The collaboration must include, at a minimum, one US institution and one eligible foreign institution.

However, additional collaborations may be included with other developed countries, and/or with more than one eligible foreign country. Both the U.S. and eligible foreign institutions must have a lead investigator identified as key personnel; each lead investigator (U.S. and foreign) must have a primary appointment at the collaborating institution.

Both the U.S. and foreign lead investigators must have a significant role in the design, implementation, monitoring, and administrative management of the research projects. Eligible foreign countries are defined as low-income economies, lower-middle-income economies, and upper-middle-income economies, as defined by the World Bank. (See Section III.

1 Eligible applicants). Applicants may choose to submit single project applications (U01) or multiple project applications (U19 - see companion RFA-AI-14-002). Areas of Research Interest The ICIDR program supports research requiring access to populations of infected human and/or other mammalian hosts, parasites, and/or vectors limited or unavailable in the U.S. and other developed countries.

Therefore, the majority of research supported under the ICIDR program must be conducted at one or more foreign sites with an emphasis on field and clinical studies of endemic diseases.

Characteristics of the proposed research should include the Research on infectious diseases (except HIV/AIDS), including emerging infections, that are of importance and/or interest to the foreign collaborating country, including one or more of the following: Research addressing infectious diseases of significant public health importance within the collaborating foreign country that cannot be addressed in the U.

S or other developed countries, such as (but not limited to): dengue, tuberculosis, trachoma, Nipah, and malaria. Research may also include studies of vector-borne pathogens for which the vector is not endemic to the U.S. and colonies are not available in U.S. labs.

Research addressing neglected or understudied infectious diseases where little may be known about the impact on public health in areas outside developed countries, and where there is reason to believe that these infections contribute to the disease burden in the foreign country, including recently emerging diseases, such as MERS-CoV.

Research on infectious diseases in special populations or in the setting of co-infections that are particular to the eligible country/countries. Examples include but are not limited to: pertussis, pneumonia, and diarrhea in infants.

For diseases that can be studied within U.S. populations, research must focus on aspects of disease or on populations that are not available in the U.S. Examples include but are not limited to: vector-pathogen-reservoir interactions, regional epidemiology, Chagas disease, congenital syphilis, influenza in tropical areas and hepatitis.

Also included are emerging and unique diseases that are rare in the US, such as those caused by the viral hemorrhagic fever viruses. Research may focus on more than one organism/infectious disease (e.g. diarrheal or respiratory diseases), including co-infections and microbiome studies, provided a strong rationale is given.

Within the guidelines above, studies may be proposed on any aspect of infectious diseases, including, but not limited to: the epidemiology, natural history of disease, pathogenesis, and immunopathogenesis; epidemiologic or natural history studies to define the incidence, clinical presentations, time course, and outcomes of diseases; studies of correlates of immunity to infectious diseases in patients with little or no disease; identification of resistance patterns; identification of biomarkers that can be used to develop diagnostics, targets for therapy or vaccines; characterization of susceptible cohorts for a particular pathogen; and pilot or feasibility studies in preparation for larger studies.

Development and/or evaluation of point-of-care or improved diagnostics is encouraged. Evaluation of new diagnostics is allowed as long treatment/care is determined by standard, accepted procedures and results of the evaluated diagnostic for an individual are not reported back to the treating physician and do not impact care. Routine diagnosis, treatment, and care must be provided outside of the proposed research project.

Development of immunological, microbiological, biostatistical, epidemiological, data management and clinical research capacity at the endemic sites is strongly encouraged.

Multidisciplinary collaborations are encouraged to ensure the appropriate breadth of scientific expertise in contributing fields, including but not limited to: infectious diseases, biochemistry, immunology, genetics, pharmacology, molecular biology, microbiology, zoology, Annual Programmatic Meetings will be held to facilitate communication and collaboration among funded ICIDRs.

Responsibilities associated with organizing and attending these meetings are detailed in the cooperative agreement terms and conditions of award below. areas of research are not responsive to this FOA and will NOT Research focused on HIV/AIDS, the interaction of HIV/AIDS and an infectious organism/disease or other disease/condition, or the study of interventions intended to treat or prevent HIV/AIDS.

Research limited to sample collection at a foreign site for detailed sample evaluation in developed/high economy [U.S. and non-U.S.] Research proposing clinical trials of interventions in humans. Section II. Award Information Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement.

Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed Glossary and the SF424 (R&R) Application Guide provide details on Funds Available and Anticipated Number of Awards NIAID intends to commit $5 million in FY 2015 to fund 5-8 Direct costs are limited to $500,000 per year excluding The scope of the proposed project should determine the project period. The maximum project period is 5 years.

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

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 Asian American Native American Pacific Islander Serving 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 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 Institutions) Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to Foreign components, as defined in the NIH Grants Policy Statement , are allowed. To be eligible, foreign institutions must be located in a country defined as low-income economies, lower-middle-income economies, and upper-middle-income economies by World Bank definition: http://siteresources. worldbank.

org/DATASTATISTICS/Resources/CLASS. XLS . The application must include a collaborative arrangement between the U.S. and one or more established institutions (e.g. university, research institute, federal or state health department, hospital) located in one or more eligible foreign (non-U.S.) countries.

Non-domestic (non-U.S.) components of U.S. organizations are NOT eligible to apply as the foreign institution, but are eligible to apply as However, organizational components (e.g., branches, posts) of institutions headquartered in the U.S. and other upper income economies that are physically located in an otherwise eligible country will not be eligible as the foreign country institution; they may apply as an additional collaborator.

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. 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 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 Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number.

After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application. System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually .

The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.

must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants. gov registration.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to must have an active DUNS number and SAM registration in order to complete the Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account.

If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 support. 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 SF424 (R&R) Application Guide.

The PD(s)/PI(s) must hold a primary appointment at either a U.S. institution or at an institution in an eligible country. Investigators at other U.S. or other high economy country institutions may be included as collaborators on the project(s). However, the majority of the research must be conducted in an eligible resource-limited This FOA does not require cost sharing as defined in the NIH Grants Policy Statement .

3. 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 that is essentially the same as one already reviewed within the past thirty-seven months (as described Grants Policy Statement ), except for submission: To an RFA of an application that was submitted previously as an investigator-initiated application but not paid; Of an investigator-initiated application that was originally submitted to an RFA but not paid; or Of an application with a changed grant activity code.

Section IV. Application and Submission Information 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 .

2. Content and 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 For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications .

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed activity Name(s), address(es), and telephone number(s) of the PD(s)/PI(s) Names of other key personnel Participating institution(s) Number and title of this funding opportunity The letter of intent should be sent to: Annie Walker-Abbey, Ph. D.

Division of Extramural Activities National Institute of Allergy and Infectious Diseases (NIAID) Zip Code for express couriers: 20817-1821 All page limitations described in the SF424 Application Page Limits must be followed. Required and Optional Components The forms package associated with this FOA includes all applicable components, required and optional.

Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

Instructions for Application Submission The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an All instructions in the SF424 (R&R) Application Guide SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide Key personnel must be identified for both the U.S. and eligible foreign institution(s).

If both U.S. and foreign PD(s)/PI(s) are not identified, then someone in key personnel must be identified as the major collaborator (MC). The MC must have a primary appointment at the collaborating U.S. or foreign institution. The MC must participate in the design, implementation, monitoring, and administrative management of the proposed research.

All instructions in the SF424 (R&R) Application Guide must Effort of ICIDR Personnel: It is expected that ICIDR scientists from the U.S. institution will travel to the foreign affiliate for long-term collaborations at the foreign site. It is anticipated that the U.S. PD(s)/PI(s) or MC will spend up to 2 months per year at the foreign site.

Other U.S. ICIDR investigators may be expected to spend longer periods of time at the foreign site. The U.S. PD(s)/PI(s) or MC must expend at least 2. 4 person months effort on the ICIDR program.

The foreign PD(s)/PI(s) or MC must commit at least 3. 6 person months effort to the ICIDR program. Each ICIDR must have a designated biostatistician and data manager.

A data manager with minimum 3 person months effort is required at the major foreign site. The biostatistician must expend no less than 0. 6 Meetings: Applicants should request funds for the Annual Programmatic Meeting and Kick-Off Meeting in the budget.

Annual Programmatic Meeting of all ICIDRs funded under this FOA are to start during the second year of award and should be attended by the PD(s)/PI(s), MC(s), and selected key personnel. These individuals should also budget and plan to attend the kick-off meeting, to be held within three months of award.

PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Aims: List the objectives and goals of the proposed program. Concisely and realistically describe the hypothesis or hypotheses to be tested.

Strategy: A strong justification must be made in each application for the selection of the organisms/disease, especially if it is heavily funded by NIAID, the relevance of the disease/organism to the public health of the foreign country, the need to do studies using foreign populations or sites, as well as addressing a gap in the current understanding of the In the Research Strategy, the applicant must: Identify and describe overall goals and objectives of the proposed ICIDR, the potential importance of the proposed research to the health and well-being of the population in the disease endemic country, the organization of the ICIDR, the role of the participating institutions, and the role of all Include the research question(s) to be addressed Include plans for quality control and analysis Include a Management Plan to show the organization of the ICIDR, including how the research will be coordinated between/among sites and a Include a timeline for the planning, implementation, conduct and completion of all research project(s) proposed.

If clinical studies are proposed, include the following: A description of the study population, documentation of access to necessary patients and/or samples, and plans for the recruitment and retention A brief concept proposal for each clinical study, detailing the following aspects of the proposed clinical research: title, hypothesis, objectives, clinical sites, eligibility and exclusion criteria, number of subjects, anticipated duration of recruitment, total study duration, endpoints and outcomes, and summary of data analysis plans.

Data Management: A data management system, managed at the foreign site must be maintained for the ICIDR project. Applicants must provide a description of the existing or planned data management system, including security features for controlled access to project data, tracking system for forms and activities, date and time stamps for all data records with electronic signatures, and audit trails to track all changes made to records.

Training requirements for data managers and data entry personnel must be specified in the application. It is recommended that data management systems be developed using U.S. Food and Drug Administration (FDA) guidelines on electronic records issued in 21 CFR part 11 ( http://www. biotechnicalservices.

com/downloads/21CFRpart11. pdf ). Biostatistics: Biostatical support must be maintained for the ICIDR project.

A description of how biostatistical support will be provided must be included in the application. Arrangements: ICIDR research activities conducted at the foreign affiliate must be supported under a consortium agreement made with the Capacity Building: The applicant should include a strategic plan for strengthening research capacity at the foreign site(s) and for disseminating research findings to host country health leaders.

This plan A summary of training needed by investigators and field staff to conduct the proposed research. A summary of how capacity building and research and training objectives will be evaluated. of Support: A letter of support, signed by the institutional official, must be included for each collaborating institution.

The applicant must include a countersigned letter of commitment from the foreign institution indicating acceptance of the proposed research and documenting both foreign investigators and the site to be used as the foreign headquarters.

Sharing Plan : 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) Application Planned Enrollment Report When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) PHS 398 Cumulative Inclusion Enrollment Report When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Foreign (non-U.S.) institutions must follow policies Grants Policy Statement , and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide. Part I. Overview Information contains information about Key Dates.

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. Organizations must submit applications to 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 administration. NIH and Grants. gov systems check the application against many of the application instructions upon submission.

Errors must be corrected and a changed/corrected application must be submitted to Grants. gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

are responsible for viewing their application before the due date 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 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 Statement . Pre-award costs are allowable only as described in the NIH Grants Policy Statement .

Requirements and Information Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted. Applicants 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(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(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. See Section III of this FOA for information on registration requirements.

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 System for Award Management. 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 and responsiveness by components of participating organizations , NIH. Applications that are incomplete and/or nonresponsive will not be Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030. Section 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 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 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? Is the proposed research relevant and important to the foreign (non-U.S.) country?

Is the work likely to influence the public health or policy of the foreign country? Does the proposed research address a scientific problem that cannot be addressed in the U.S.? Are the PD(s)/PI(s), 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?

Are the time and effort proposed by the Project Director(s)/Principal Investigator(s), MC, Data Manager and Biostatistician 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 managed? Are plans for collaboration adequate?

Is research capacity development well integrated into the research?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy 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 Does the proposed research require access to populations or resources outside of the U.S.? Are the field sites and/or clinical facilities appropriate for the research?

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 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