Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH

Components of Participating Organizations

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Funding Opportunity Title

Promoting Organ and Tissue Donation Among Diverse Populations (R01)

Activity Code

R01 Research Project Grant   

Announcement Type

Reissue of RFA-DK-06-016

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-DK-12-006

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.847

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) issued by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), invites investigators to apply for a grant to develop hypothesis-driven educational programs to increase the number of both living and deceased donor organs and tissue donated for transplantation from minority and other health disparity populations. This FOA intends to stimulate investigators to develop  effective culturally sensitive educational and behavioral interventions to improve the attitudes, beliefs and behaviors towards organ and tissue transplantation, as well as the need for organ transplantation, among minority and other health disparity populations. The grant will provide support for the development and testing of educational and behavioral programs in  minority and other health disparity populations to enhance their understanding of the need, risks and benefits of organ and tissue donation, and ultimately to increase the number of minority and other health disparity populations participating in living and deceased organ donation.

Key Dates
Posted Date

May 2, 2012

Open Date (Earliest Submission Date)

June 3, 2012

Letter of Intent Due Date

June 3, 2012

Application Due Date(s)

July 3, 2012, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

July/August, 2012

Advisory Council Review

October, 2012

Earliest Start Date(s)

December, 2012

Expiration Date

 July 4, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 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.

Table of Contents

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 Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background:

For many Americans with end-stage organ disease, the best therapeutic option is to receive either a deceased or living donor organ for transplantation. The introduction of organ transplantation, beginning with kidneys in 1954 and the liver in 1967, revolutionized the care and prognosis for individuals with end-stage kidney disease (ESRD) and end-stage liver disease (ESLD).

Unfortunately, the need for organ transplantation continues to exceed the availability of donated organs for transplantation. Additionally, the number of Americans with ESRD and ESLD who require organ transplants continues to rise. In order to increase the number of organs available for transplantation, many efforts have arisen for the lagging supply to meet the demand. Initially, organs for transplantation were recovered from living donation donors (LDD), initially taking place between identical twins due to the absence of potent immunosuppressive medications. Living donors may be related to the organ recipient, but increasingly is occurring between genetically unrelated persons, such as spouses, friends, other emotionally related individuals. The second source of organs for donation come from deceased donation donors (DDD), who are brain dead but still heart-beating. Organs recovered from DD outnumber the total number of organs recovered from LD, but are not without complications. However, the morbidity and mortality rates associated with organ transplantation remain significantly lower than those rates seen with ESRD and ESLD treated medically. Furthermore, the economic cost is lower for the post-transplant care of individuals with ESRD and ESLD compared to the continued medical care of these patients without organ transplantation. Unfortunately, the number of organs recoverable from DD has been relatively stable, despite the continuing growth in the number of ESRD and ESLD patients.

The incidence and prevalence of ESRD continue to rise slowly in the United States (US). In the Annual Data Report 2011, the United States Renal Data Systems (USRDS) reports that the incidence of new ESRD in the US rose 1.1 percent in 2009, to 355 cases per million population. Similarly, the prevalence of ESRD in the US rose 2.1 percent from 2008 to 1,738 cases per million population. Translated in to the actual numbers, the overall incidence and prevalence of ESRD in 2009 were more 116,000 and 570,000 Americans, respectively. In 2009, the cost to the US economy totaled approximately $29 billion, representing nearly 9% of the total Medicare spending (approximately $318 million) in the same year while accounting for less than 2% of the total Medicare recipients. The expenditures per person per year (PPPY) vary according to the renal replacement modality used to treat ESRD, with hemodialysis costing approximately $80,000 PPPY, peritoneal dialysis costing approximately $60,000 PPPY, and transplantation costing approximately $30,000 PPPY.

In addition to the extraordinary costs associated with the care of persons with ESRD, these same individuals experience unacceptably high morbidity and mortality rates, with the adjusted rates of all-cause mortality 6.5 to 7.4 times greater for dialysis patients with ESRD than for individuals in the general population. While the adjusted rates of all-cause mortality are lower for ESRD patients who receive renal transplants, the rates remain 1.1 to 1.6 times greater than for the general population. While the overall adjusted all-cause mortality rates have declined over the last 20 years, renal transplant recipients experience the lowest all-cause mortality rates from one to five-years post transplant compared to ESRD patients treated with either hemodialysis or peritoneal dialysis for one to five years. Adjusted survival probabilities for one and five-year are worst for ERSD patients treated with hemodialysis (0.75 and 0.34, respectively) compared to peritoneal dialysis (0.85 and 0.40, respectively) and to renal transplant (0.92 and 0.73, respectively). Finally, the adjusted hospitalization rates tend to be higher among women than men with ESRD, and among Black or African Americans compared to whites.

Similar to the incidence and prevalence of ESRD in the US, chronic liver disease and ESLD exact a significant toll on the population. In 2002, chronic liver disease reportedly was the 12th leading cause of death in the US, accounting for more than 27,000 deaths/year (mortality rate of 9.4/100,000 population). For many of the causes of ESLD in the US (e.g., alcohol-related cirrhosis, Hepatitis B, immune-mediated liver injury, hepatotoxic drugs, cholestatic diseases, genetic abnormalities, and nonalcoholic steatohepatitis), the incidence and prevalence have been declining. In contrast, the incidence and prevalence of ESLD secondary to Hepatitis C and hepatocellular carcinoma have been increasing. The estimated cost to the healthcare system in the US for the care of chronic liver disease and cirrhosis, excluding patients with Hepatitis C infection, is approximately $1.6 billion per year.

As of February 24, 2012, the Organ Procurement and Transplantation Network (OPTN) reports that there are 91,015 candidates on the wait list for a kidney transplant; 16,060 candidates on the wait list for a liver transplant; 1,297 and 2,129 candidates on the wait list for a pancreas and kidney/pancreas transplant; and 285 candidates on the wait list for intestine transplant. In contrast, as of November 30, 2011, there were 15,416 kidneys; 5,840 livers; 270 pancreas and 738 kidney/pancreas; and 124 intestines transplanted in 2011.

Thus, not only does transplantation result in significant savings in the expenditures PPPY, transplantation also improves the all-cause and specific-cause hospitalization rates and the adjusted mortality rates at one and five years for both ESRD and ESLD patients. Therefore, the NIH and the NIDDK seek to promote the selection of organ transplantation as a more economical and efficacious treatment modality for ESRD and ESLD patients.

Research Objectives:

Data from the 2010 United States Census ("Census") documents the composition of the US population. The current US population is 308,745,538 persons. With regards to the ethnicity of the US population, 16.3% identify themselves as "Hispanic or Latino," an increase of 43% from the 2000 Census. Racially, the US population identifies themselves as 72.5% "White," 12.6% "Black or African American," 6.2% "Some Other Race," 4.5% "Asian," 2.9% "Two or More Races," 0.9% "American Indian or Alaska Native" and 0.2% "Native Hawaiian or Other Pacific Islander." Additionally, the 2010 Census reports that the "rural" population in the US is approximately 51 million, accounting for approximately 16.5% of the US population. These data serve as the baseline metrics for the diversity of the US population.

Unfortunately, ESRD does not afflict the US population equally. The USRDS Annual Data Reports have clearly demonstrated that certain minority and other health disparity populations are disproportionately represented in the ESRD population. According to the USRDS Annual Data Report 2011 (website: http://www.usrds.org), ESRD disproportionately affects Black or African Americans, American Indian or Alaska Native, and males.

Similarly, ESRD patients living in rural environments have been shown to have longer waiting time to transplant, and Black or African Americans living in rural environments have lower survival rates compared to Black or African Americans living in urban environments, despite more frequent treatment of ESRD using peritoneal dialysis among the former. Similarly, O'Hare AM, et al. (Kidney Int, 2006) reported that nearly 22% of the ESRD population live in rural environments, in contrast to the 16.5% of the total US population living in rural environments.

As these data demonstrate, ethnicity, race, gender and environment all impact the morbidity and mortality of Americans with ESRD, even after adjustment for factors that may affect the calculated risks. Therefore, the NIH and the NIDDK recognize the importance of addressing these health disparities among minority and other health disparity  populations in order to improve the morbidity and mortality of these individuals with ESRD. As has been shown, renal transplantation is the preferred treatment modality for ESRD, associated with the lowest expenditures PPPY, the lowest all-cause and cause-specific hospitalizations, and the lowest all-cause and specific-cause mortality rates.

According to the Organ Procurement and Transplantation Network (OPTN) of the Health Resources and Services Administration (HRSA) (website: http://optn.transplant.hrsa.gov/), differences exist between minority and other health disparity populations organ donors for both kidneys and livers, and that other differences exist between LD and DD organs.

For kidneys, from 2000 through 2010, the total number of kidneys recovered for organ donation from LDD increased by only 14.2%. Among Whites, the total number of kidney recovered increased by 12.7%, whereas the total number of kidneys recovered from Black or African American donors increased by only 6.8%. While the numbers are quite small, organs recovered from American Indian or Alaska Natives and Native Hawaiians or Other Pacific Islanders actually decreased by 29% and 58%, respectively. By gender, the number of kidneys recovered from male LDD decreased by 0.3% during the same decade, whereas female LDD increased by 25%. Women LDD now account for approximately 60% of all of the LDD kidneys recovered annually in the US.

In contrast, during the same decade, the total number of kidneys recovered for organ donation from DDD increased by 31.9%. In contrast to LDD, the growth in DDD kidneys recovered from White donors increased by only 16.9%, compared to an increase of 90% and 70% for Black or African Americans and Hispanics, respectively. Native Hawaiians and Other Pacific Islander DDD decreased by 45%, similar to the trend seen among LDD. In contrast to the LDD data for DDD kidneys recovered by gender, males account for nearly 60% of all of the DDD kidneys recovered annually in the US, with a 34% increase during the last decade compared to a 29% increase among female DDD.

Similar to the kidney data, the OPTN data demonstrates similar disparities in organ donation among both LDD and DDD for livers. During the decade from 2000 through 2010, the total number of livers transplanted annually from DDD increased by 25.8%, with only an 18% increase among Whites but a 57% increase among Black or African Americans and 37% increase among Hispanics. Similar to the DDD kidneys, the total number of livers recovered for transplantation from DDD increased by 34% among male donors compared to 13% among female donors.

Perhaps most concerning, the OPTN data demonstrates a significant decrease in the number of livers available for transplantation from LDD during the decade. The number of LDD livers transplanted annually in the US actually decreased by 30%, with large declines among Whites (34%), Blacks or African Americans (42%), Hispanics (11%) and Native Hawaiians or Other Pacific Islanders (75%). Gender again demonstrates differences, with a 38% decrease in LDD livers among male donors compared to a 22% decrease among female donors.

The disparities in the LDD and DDD donations rates for both kidneys and livers, and particularly the decline in LDD for liver transplantation, have led to significant differences in the median duration of time on the wait list for candidates for kidney and liver transplantation.

For kidney transplant candidates, the current median wait list times are:

For liver transplant candidates, the current median wait list times are:

Therefore, the NIH and the NIDDK seek to promote research into the barriers to both DDD and LDD organ transplantation among non-White racial populations, Hispanic or Latino ethnic populations, males for LDD, and rural populations.

Previously, the NIH and the NIDDK have supported the National Minority Organ Tissue Transplant Education Program (MOTTEP) in order to promote research, community outreach, and program development within the Black or African American population within the District of Columbia in order to address the shortage of organ donors in the Black or African American communities. As a result of the MOTTEP, reasons for reluctance among Black or African Americans to be organ donors included:

Thus, the goal of this FOA is to develop educational and behavioral interventions specifically designed to increase the number of both LDD and DDD organs and tissue donated for transplantation from minority and other health disparity populations. This FOA intends to stimulate investigators to develop effective and culturally sensitive educational and behavioral programs to improve the attitudes, beliefs and behaviors towards organ and tissue transplantation, as well as the need for organ transplantation, among minority and other health disparity populations and rural communities. The grant will provide support for the development of culturally sensitive educational and behavioral programs in minority and other health disparity populations to enhance their understanding of the need, risks and benefits of organ and tissue donation, and ultimately to increase the number of minority and other health disparity populations participating in living and deceased organ donation.

After the award project period (e.g. 5 years), the NIDDK will review the overall success of the entire program in order to determine whether to continue funding it as currently configured. This review may be distinct from the individual reviews that take place under the auspices of the annual Progress Reports. The discontinuation of the program is a policy option that may be made at the discretion of the NIDDK.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The NIDDK intends to commit $1,500,000 in FY 2012.

Award Budget

Application budgets are limited to an annual direct cost per application of $150,000.

Award Project Period

The total project period for an application submitted in response to this FOA may not exceed 5 years.

NIH grants policies as 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

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

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 registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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. NIH recognizes a unique and compelling need to promote diversity in the NIH-funded biomedical, behavioral, clinical and social sciences workforce.  The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; improve the quality of the educational and training environment; balance and broaden perspectives into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities. 

Accordingly, given that the target research populations for FOA represent individuals from minority health and other health disparity populations, individuals from these populations are strongly encouraged to apply, as well as individuals with experience providing culturally and linguistically competent care to these populations.

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

Additionally, eligible individuals to serve as the PD/PI for this research program grant should demonstrate their clinical and research abilities to provide "cultural and linguistic competent" care. The definition of "cultural and linguistic competence" has been established by the Office of Minority Health as "a set of congruent behaviors, attitudes, and policies that come together in a system, agency or among professionals that enables effective work in cross-cultural situations. ‘Culture' refers to integrated patterns of human behavior that include the language, thoughts, communications, actions, customs, beliefs, values, and institutions of racial, ethnic, religious, or social groups. ‘Competence' implies having the capacity to function effectively as an individual and an organization within the context of the cultural beliefs, behaviors, and needs presented by consumers and their communities." (From "National Standards for Culturally and Linguistically Appropriate Services in Health Care - Final Report," available at: http://minorityhealth.hhs.gov/assets/pdf/checked/finalreport.pdf). 

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

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.

Section 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.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (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 review.

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

Letter of Intent

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 plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent should be sent to:

Francisco O. Calvo, Ph.D.
Chief, NIDDK Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 752, MSC 5452
Bethesda, MD 20892-5452 (courier Zip Code 20817)
Telephone: 301-594-8897
Email: calvof@mail.nih.gov

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 submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

SF424(R&R) Other Project Information Component

10. Facilities and Other Resources:

Information regarding the facilities to be used and the Applicant Organization must be provided documenting the facilities' and organization's compliance with the standards for culturally and linguistically appropriate service (CLAS). The standards for CLAS are provided in the "National Standards for Culturally and Linguistically Appropriate Services in Health Care (Final Report)," issued by the U.S. Department of Health and Human Services' (HHS) Office of Minority Health (OMH) (available at: http://minorityhealth.hhs.gov/templates/browse.aspx?lvl=2&lvlID=15).

Specifically, the CLAS Standards regarding Culturally Competent Care (Standards 1 through 3) and Language Access Service (Standards 4 through 7) are mandatory to be considered an eligible Applicant Organization. These specific standards are:

Culturally Competent Care:

The documentation must include details regarding how the Applicant Organization and all involved facilities meet each of the aforementioned Standards. Failure to document any of the four Language Access Service standards will be considered evidence of an Organization's ineligibility to participate in this FOA.

Additionally, information regarding the Applicant Organization's and involved facilities' compliance with the CLAS standards demonstrating the Organizational Supports for Cultural Competence (Standards 8 through 14) lends further evidence to the cultural and linguistic competence of the Applicant Organization, involved facilities, and research staff. The aforementioned Standards are:

Additionally, the Applicant Organization must demonstrate their adherence to the best practices in deceased organ donation as outlined in "The Organ Donation Breakthrough Collaborative: Best Practices Final Report," as issued by the HHS (available at: http://www.lewin.com/content/publications/OrganDonationBreakthroughCollaborative.pdf). Specifically, the Applicant Organization must document the institutional efforts to meet each of the 15 "Best Practices" outlined in the Final Report. The 15 "Best Practices" are summarized here:

SF424(R&R) Senior/Key Person Profile Expanded Component

Biographical Sketch

Include biographical sketches of all senior/key personnel and Other Significant Contributors. The Biographical Sketch may not exceed four pages per person. This 4-page limit includes the table at the top of the first page.

Following the educational block, complete sections A, B and C as described in the SF424 (R&R) instructions. However, complete section D as described below.

D. Training in Cultural Competence:

The PD/PI, all senior/key personnel and Other Significant Contributors shall provide documentation of their formalized training in cultural competence. If no formal training in cultural competence has been received, then please state "None" under section D and please provide a justification for the absence of such formalized training.

If formal training in cultural competence has been received, then please provide information as to the provider of the training, the location of the training, the dates of training, and a synopsis of the training received (including format, duration of training, certification, recertification, etc.). Online training is acceptable, as is in-person training. An example of such training is the "Think Cultural Health" website developed by the HHS OMH available at: https://www.thinkculturalhealth.hhs.gov/Content/ContinuingEd.asp. If a certification is earned as a result of one's training in cultural competence, please provide a copy of the certification in the Appendix.

Attach Current & Pending Support

As the normal section D of the Biosketch is replaced with information documenting the training of the PD/PI, all senior/key personnel and Other Significant Contributors, please submit the "Research Support" for all of the applicable persons as an attachment in the "Attach Current & Pending Support" field. Please use the instructions described in the SF424 (R&R) instructions, including using the format on the Biographical Sketch Format Page to prepare this section.

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy:

(b) Innovation:

Describe quantitative and qualitative research methods to be used in the assessment of the effectiveness of the culturally sensitive education and behavioral intervention to increase the knowledge and willingness of the study participants to become LDD or DDD organ and tissue donors. Copies of any novel or established and validated quantitative or qualitative research methods should be included in the Appendix.

Furthermore, describe the applicability of all quantitative and qualitative research methods in the particular health disparity-targeted population.

(c) Approach:

Describe the alternate and null hypotheses for the proposed culturally sensitive educational and behavioral intervention. Describe the predefined endpoints to demonstrate the effectiveness of the intervention to increase the organ and tissue donation rates among the health disparity-targeted populations. Sample size for the intervention groups should be supported by appropriate sample size and power calculations. The control group needs to be well-defined and justified. If the control group is either a historical control cohort or will not receive any intervention, then provide a justification for the selection of the particular control group and an explanation of the benefits and risks of comparing the intervention group to the aforementioned control group. All primary and secondary measures of effectiveness of the educational and behavioral interventions must be defined a priori, and require appropriate statistical analysis plans with predefined parameters for the “success” of the educational and behavioral intervention.

Evaluation Plan (Component of Research Strategy):

As part of the Research Strategy, the PD/PI must submit an evaluation plan for assessing the cultural competency and the quality of the intervention plan(s) of the PD/PI, all senior/key personnel and Other Significant Contributors from the target population's perspective. As described by The Commonwealth Fund's Cultural Competency and Quality of Care: Obtaining the Patient's Perspective" (available at: http://www.commonwealthfund.org/usr_doc/Ngo-Metzger_cultcompqualitycareobtainpatientperspect_963.pdf), the evaluation must address the five (5) domains:

1. Subject-Research communication.

2. Respect for subject preferences and shared decision-making.

3. Experiences leading to trust or distrust.

4. Experiences of discrimination.

5. Linguistic competency.

Finally, the PD/PI must state how the results of the target population's perspective of the cultural competency and the quality of the intervention plan(s) will be used to enhance the intervention so as to improve the cultural competency and, ultimately, to increase the living and deceased donor organ donations from minority and other health disparity populations.

Use the appendix to include the evaluation instruments as a single document.

Resource 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.

Appendix

If no modifications to Appendix instructions, delete editable text below (“with the following modifications” ). If you are making changes to the Appendix instructions, add bullets below.

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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 administration.

Applicants 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 review.

5. Funding Restrictions

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.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (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 process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) 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.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by the NIDDK, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIDDK Referral Office by email at calvof@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  

Investigator(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(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Have the PD(s)/PI(s), senior/key personnel and Other Significant Personnel received formalized training in cultural competence? If so, is the training adequate: If not, has the individual provided any justification for the absence of such training?   

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?  Are the proposed quantitative and qualitative research methods culturally sensitive and appropriate for the targeted health disparity population? 

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Have the PD(s)/PI(s) provided alternate and null hypotheses for the proposed culturally sensitive educational and behavioral intervention? Are sample sizes for the intervention and control groups based upon calculations or convenience? Have the PD(s)/PI(s) provided an appropriate statistical analysis plan, with appropriate definitions a priori for the demonstration of “effectiveness” of the intervention? Do the proposed cultural competence and quality of the intervention plan(s) address all five (5) domains as specified? Is the evaluation plan based on appropriate literature and methodology? Has the applicant proposed appropriate formative (process) evaluations, and proposed a mechanism for the application of these metrics to the improve the effectiveness of the intervention (e.g., to increase the donation rates for LLD and DDD organs and tissue donation)?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Have the institution and the proposed PD/PI provided evidence of their ability to provide "cultural and linguistic competent" care to the targeted population? Has the Applicant Organization documented their adherence to CLAS Standards 4 - 7 in the application? Does the Applicant Organization support CLAS Standards 1 - 3 for the provision of Cultural Competent Care?

Has the Applicant Organization demonstrated their adherence to the "Best Practices" for promoting deceased donor organ donation? If not, does the absence of any of the "Best Practices" impair the Applicant Organization's ability to carry out the goal of the FOA? 

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), in accordance with NIH peer review policy and procedures, using the stated review criteria.  Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Diabetes and Digestive and Kidney Diseases Advisory Council. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Kevin D. McBryde, MD
Program Director
Office of Minority Health Research Coordination
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard
II Democracy Plaza, Room 906B, MSC 5454
Bethesda, MD 20892-5454
Telephone: 301-594-9652
Email: mcbrydekd@mail.nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Francisco O. Calvo, Ph.D.
Chief, NIDDK Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 752, MSC 5452
Bethesda, MD 20892-5452 (courier Zip Code 20817)
Telephone: 301-594-8897
Email: calvof@mail.nih.gov

Financial/Grants Management Contact(s)

Carolyn S. Kofa
Grants Management Specialist
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 746, MSC 5456
Bethesda, MD 20892-5456
Telephone: 301-594-7687
Email: kofac@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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