Research on the Health of Sexual and Gender Minority Populations (R01)

Research on the Health of Sexual and Gender Minority Populations (R01) is sponsored by National Institutes of Health. Funds scientific research into health outcomes for sexual and gender minorities, which can include behavioral studies regarding adult industry participation, consumption impacts, and related occupational health.

Expired PA-18-037: The Health of Sexual and Gender Minority (SGM) Populations (R01 Clinical Trial Optional) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) of Participating Organizations Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) National Cancer Institute ( NCI ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) National Institute of Allergy and Infectious Diseases ( NIAID ) National Institute on Deafness and Other Communication National Institute of Dental and Craniofacial Research ( NIDCR ) National Institute on Drug Abuse ( NIDA ) National Institute of Mental Health ( NIMH ) National Institute on Minority Health and Health Office of Behavioral and Social Sciences Research ( OBSSR ) Funding Opportunity Title The Health of Sexual and Gender Minority (SGM) Populations (R01 Clinical Trial Optional) R01 Research Project Grant May 10, 2017 - New NIH "FORMS-E" Grant Application Forms and Instructions Coming for Due Dates On or After January 25, 2018.

See NOT-OD-17-062 . Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity PA-18-054 , R03 Small Grant Program PA-18-040 , R21 Exploratory/Developmental Grant PA-18-210 , R15 Academic Research Enhancement Award (AREA) Additional Information on Eligibility . Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.

865, 93. 399, 93. 396 , 93.

395, 93. 394, 93. 393, 93.

273, 93. 855, 93. 856, 93.

173, 93. 121, 93. 279 93.

242, 93. 307 Funding Opportunity Purpose The National Institutes of Health (NIH) is committed to supporting research that will increase scientific understanding of the health status of diverse population groups and thereby improve the effectiveness of health interventions and services for individuals within those groups. Priority is placed on understudied populations with distinctive health risk profiles.

This funding opportunity announcement (FOA) focuses on sexual and gender minority (SGM) populations, including lesbian, gay, bisexual, transgender, and intersex populations. Basic, social, behavioral, clinical, and services research relevant to the missions of the sponsoring Institutes and Centers may be Open Date (Earliest Submission Date) Letter of Intent Due Date(s) dates apply, by 5:00 PM local time of applicant organization.

All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates. 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) dates apply, by 5:00 PM local time of applicant organization.

All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates. 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.

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 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 This FOA calls for research on the health of lesbian, gay, bisexual, transgender, intersex, and related populations.

In reference to LGBTI health, an Institute of Medicine (IOM) Report (March 2011) stated that the "existing body of evidence is sparse and that substantial research is needed." Despite improvements, there remains a need for further research on the health of these populations.

Applicants are urged to read the IOM report, which delineates numerous SGM populations encompass several partially overlapping groups, which are defined in the IOM report as follows: One group includes individuals whose sexual orientation as typically conceptualized in terms of sexual attraction, behavior, and/or sexual orientation and identity is not exclusively heterosexual.

This group includes people who label themselves (or are labeled) as gay, lesbian, or bisexual, as well as people who do not adopt such labels but nevertheless experience same-sex attraction or engage in same-sex sexual behaviors.

A second group includes individuals whose gender identity differs from the sex originally assigned to them at birth; whose gender expression varies significantly from what is traditionally associated with or typical for that group; and/or who vary from or reject traditional cultural conceptualizations of gender in terms of male-female dichotomy.

This group includes people who label themselves (or are labeled) as transgendered, transsexual, cross-dressers, transvestites, and/or two-spirit. A third group includes individuals who are born with external and/or internal genitalia that vary from typical male or female genitalia, or a chromosomal pattern that varies from XX (female) or XY (male).

This group includes people who label themselves (or are labeled) as intersex or with Disorders of Sexual Development [DSD]. Following recent usage, the term Sexual and Gender Minority [SGM] is used to designate both these populations overall and the individuals within these populations. Applicants may adopt other classification frameworks and terminologies as appropriate for their proposed research.

Recent data from national health surveys and targeted studies suggest that prevalence rates for some health conditions are higher among SGM populations than for the general population. This FOA encourages research that will enrich scientific understanding of how sexual orientation and gender identity influence health, perceptions and expectations about health, health behaviors, and barriers and access to health-related services.

This FOA encourages research that describes the biological, clinical, behavioral, and social processes that affect the health and development of SGM populations and individuals and their families, and that leads to the development of acceptable and appropriate health interventions and health service delivery methods that will enhance health and development of these populations.

Research submitted to this FOA should focus on clearly defined health outcomes, rather than on general measures of well-being or adjustment.

This FOA encourages researchers to investigate new research questions related to the health and development of SGM populations and individuals and their families and to develop and/or apply innovative methodologies to improve understanding of mechanisms affecting their health and This FOA encourages four main types of research.

Basic social and behavioral science studies addressing the processes involved as individuals discover, uncover, address and/or adapt to their sexual orientation and claim or do not claim identity as SGM, and how these processes affect the mental and physical health of the individual. Research leading to interventions to ameliorate health disparities in SGM populations.

Formative research may be necessary because evidence-based preventive and treatment interventions for SGM individuals, particularly for adolescents and young adults, are scarce. Large-scale design, implementation and evaluation of preventive and/or treatment interventions addressing health issues in SGM populations.

Research on how family structures and processes-including both families of origin and families of choice-affect the health of SGM individuals and their family members, including whether and how being raised in a family headed by SGM individuals affects the health, development, and well-being of Research should be designed so that it is readily discernable whether the findings from the study sample can be generalized to other populations.

Applicants should provide a precise description of the target population and of the sampling methods to be employed, paying attention not only to sexual behavior, identity, orientation, and gender characteristics, but to such variables as age, generational cohort, race/ethnicity, culture, geography, socioeconomic status, and physical and psychological qualities.

Given the diversity of SGM populations, and their unknown distribution in the general population, it is expected that most projects will focus on one or a Proposed research may draw from the full range of approaches within biological, clinical, behavioral, and social sciences, including both quantitative and qualitative approaches.

Applicants are encouraged to build on and/or incorporate approaches and findings from research on other types of health disparities and from research on the influences of sex and gender in biological and behavioral functioning. Proposed research projects must consider the potential risks to and vulnerability of research participants and must ensure their confidentiality and protection.

The ethical and legal implications of the proposed research on SGM populations must be considered.

While the primary domain of interest is populations within the United States, research with non-U.S. populations is acceptable if the applicant can demonstrate the proposed work will contribute to scientific understanding of U.S. SGM Examples of research areas include but are not limited to the following and combinations of these approaches: Epidemiology and Epidemiological Methods Epidemiological studies to characterize SGM populations across the lifespan, by age, race/ethnicity, sexual orientation and gender identity, education, occupation, social networks, family structures, and urban/rural or Research on the similarities and differences in development, nature and diversity of health-related roles perceptions, attitudes, and expectations that influence sexual orientation and gender identity in SGM populations and in Studies to improve measures and methodologies related to SGM populations, including studies that address various logistical and ethical challenges in obtaining representative samples of populations that may be for a number of reasons hidden or difficult to reach.

Studies that develop new tools for assessing and evaluating how social and peer influences impact SGM health, including new information technologies that may influence such health behaviors. Studies of how social structures, including the internet, built environments and legal and cultural expectations may influence the health, including emotional health and resilience, of SGM populations.

Of particular interest are studies that address SGM individuals who may have unique experiences overcoming discrimination or social marginalization associated with being in other minority groups such as ethnic/racial minority groups, Studies of SGM-health relevant issues in elderly and aging populations such as (but not limited to) end of life and long-term care planning and the role of biological and chosen families in social support and Socio-Demographic Characteristics and Human Development, cross-sectional and longitudinal Studies of health-relevant demographic and socioeconomic characteristics of SGM populations.

Studies of interactions and influences of sexual orientation and gender-related characteristics with affective, cognitive, personality and identity processes including identity processes related to race and ethnicity that may differentially affect health and health risk behaviors among SGM Studies of the determinants and consequences of the timing of individuals' recognition of and disclosure to others of their sexual or gender identity on their health and health risk behaviors.

Research on how the health and health outcomes of SGM individuals are colored by interpersonal relationships, social networks, religious affiliations, and by family relationships, structure, and processes. This includes research on how characteristics of family or origin affects the process and health consequences of "coming out".

Studies of protective and resiliency factors and of coping processes within and between SGM populations, including how these factors and processes are related to health, partner selection, partner concurrency, family structures, sexual practices, and cross-generational family relationships. Research on how health-related outcomes may be influenced by changing social perceptions and attitudes toward SGM populations.

Research on the role of social networks on the health, health-related behavior, and use of health care among SGM populations. Research on how gender identity and sexual orientation may be related to health, health behaviors, and health care use across the life course and how health-related outcomes differ across groups. (See Background section for discussion of clusters.)

Research on barriers to SGM individuals seeking health care treatment, including such factors as fear of stigmatization, prior negative experiences related to their sexual orientation or gender identity, and fear that health care providers lack knowledge and experience working with SGM Health Concerns and Conditions Studies of suicidality and stress-related illnesses in SGM populations, including prevalence, risk and protective factors, and of preventive interventions.

Longitudinal studies of the mechanisms by which experiences of stigmatization, discrimination, and violence may affect health in SGM populations. Such studies could include examination of bullying and harassment of youth in schools and employment venues.

Studies of social network dynamics and how they may foster behavioral risks or, conversely, resiliency and protective norms that help buffer the cumulative effects of discrimination, abuse, or stigma.

Studies of current and emerging patterns of drug and alcohol use and substance use-related risk behaviors and outcomes, including HIV/AIDS and other infectious diseases in SGM populations and communities (including such topics as differential contexts of substance use, social diffusion of particular forms of substance use, and related risk behaviors and distribution Studies of the interactions of measured health differences associated with sexual orientation and gender-related characteristics with other forms of health disparities (associated with, for example, race/ethnicity, the prevalence and incidence of HIV/AIDS and other infectious as well as noninfectious diseases, socioeconomic status, geography, etc.).

Biological and Clinical Factors Research with transgender people, including transsexual people who intend to seek, have sought, or have received hormonal or surgical Studies of the acoustic factors that contribute to perception of femininity and masculinity and of other non-voice factors (such as articulation, prosody and body language) that interact to create the perception of femininity or masculinity.

Longitudinal or retrospective studies of the health and developmental effects of gender assignment in cases of infants born with Developmental and longitudinal studies of gender-related and other biological and behavioral characteristics of intersex [DSD] people, including follow-up studies of persons who have received hormonal or surgical Studies of the development and evaluation of approaches to psychosocial assessment and counseling for intersex [DSD] people and their Studies of competency and training needs among clinicians, employers, and other service providers who work with SGM populations.

Research to develop and evaluate training and knowledge dissemination programs for clinicians, employers, and service providers on Intervention and Services Research Studies to evaluate the stability, fluidity, and other temporal attributes of social norms and networks and how such attributes affect perceptions, attitudes, and behaviors among SGM individuals and populations.

Conversely, studies that utilize findings on the social norms and networks within SGM populations to develop novel designs and approaches for targeted disease prevention interventions. Comparative effectiveness of treatment approaches to change voice to match individuals' chosen gender.

Research that develops and evaluates new preventive, treatment, counseling and rehabilitative interventions for substance abuse [including the abuse of tobacco, alcohol and drugs] and co-occurring health and mental health disorders that are sensitive to the needs and characteristics of SGM people Network-based intervention designs that build on the diffusion capacities of social support networks among individuals.

Studies of the beliefs, expectations, norms, and attitudes of SGM populations regarding substance abuse and mental health services, including how such beliefs, expectations, norms, and attitudes affect service utilization and Exploration of the utility of and efficacy of the use of SGM-frequented venues for developing, implementing, and evaluating new interventions to promote health and behavioral risk reduction, and to provide linkages to health services and care.

Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed Glossary and the SF424 (R&R) Application Guide provide details on Optional: Accepting applications that either propose or do not propose clinical trial(s) Need help determining whether you are doing a clinical trial?

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. Application budgets are not limited but need to reflect the actual needs of the proposed project. 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 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 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. 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.

PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. 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 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. The NIH will not accept duplicate or highly overlapping applications under review at the same time.

This means that the NIH will A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101 ). 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 , including Supplemental Grant Application Instructions 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 All page limitations described in the SF424 Application Page Limits must be followed.

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 All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide 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: Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Do not use the Appendix to circumvent page limits.

Follow all instructions for the Appendix as described in the SF424 (R&R) Application PHS Human Subjects and Clinical Trials Information When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions: If you answered Yes to the question Are Human Subjects Involved?

on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a delayed onset study record. Study Record: PHS Human Subjects and Clinical Trials Information: All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed. PHS Assignment Request Form All instructions in the SF424 (R&R) Application Guide must be followed. 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 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 Electronically .

If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must for Applicants Experiencing System Issues . 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. 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, NIH.

Applications that are incomplete or non-compliant will not be 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 a Scientific/ Research Contact 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 SF424 Post Submission Materials Applicants are required to follow our Post Submission Application Materials policy.

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 For this particular announcement, note the following: 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 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 there a strong scientific premise for the project?

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?

In addition, for applications proposing clinical trials: Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms?

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?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? 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)?

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?

In addition, for applications proposing clinical trials: With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? 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?

In addition, for applications proposing clinical trials: Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice? Are the overall strategy, methodology, and analyses well-reasoned and