Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
National Institute of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov)
National Heart, Lung and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov)

Title: Clinical Outcomes of Live Organ Donors

Announcement Type
New

Request For Applications (RFA) Number: RFA-AI-05-015

Catalog of Federal Domestic Assistance Number(s)
93.855, 93.838

Key Dates
Release Date: February 10, 2005
Letters of Intent Receipt Date(s): June 13, 2005
Application Receipt Dates(s): July 13, 2005
Peer Review Date(s): November, 2005
Council Review Date(s): January, 2006
Earliest Anticipated Start Date: April, 2006
Additional Information To Be Available Date (Url Activation Date): http://www.niaid.nih.gov/ncn/budget/QA/rfa-05-015.htm
Expiration Date: July 14, 2005

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

  Section I. Funding Opportunity Description
    1. Research Objectives

  Section II. Award Information
    1. Mechanism(s) of Support
    2. Funds Available

  Section III. Eligibility Information
    1. Eligible Applicants
      A. Eligible Institutions
      B. Eligible Individuals
    2.Cost Sharing or Matching
    3. Other - Special Eligibility Criteria

  Section IV. Application and Submission Information
    1. Address to Request Application Information
    2. Content and Form of Application Submission
    3. Submission Dates and Times
      A. Receipt and Review and Anticipated Start Dates
        1. Letter of Intent
      B. Sending an Application to the NIH
      C. Application Processing
    4. Intergovernmental Review
    5. Funding Restrictions
    6. Other Submission Requirements

  Section V. Application Review Information
    1. Criteria
    2. Review and Selection Process
      A. Additional Review Criteria
      B. Additional Review Considerations
      C. Sharing Research Data
      D. Sharing Research Resources
    3. Anticipated Announcement and Award Dates

  Section VI. Award Administration Information
    1. Award Notices
    2. Administrative and National Policy Requirements
      A. Cooperative Agreement Terms and Conditions of Award
        1. Principal Investigator Rights and Responsibilities
        2. NIH Responsibilities
        3. Collaborative Responsibilities
        4. Arbitration Process
    3. Reporting

  Section VII. Agency Contact(s)
    1. Scientific/Research Contact(s)
    2. Peer Review Contact(s)
    3. Financial/ Grants Management Contact(s)

  Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description

1. Research Objectives

The National Institute of Allergy and Infectious Diseases (NIAID) and the National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH) invite applicants to participate in a program of epidemiologic research focusing on the medical and functional outcomes of individuals who have donated a kidney or a lobe of lung for transplantation into an individual with end-stage organ failure. This program will support a consortium consisting of clinical transplant centers and a Data Coordinating Center (DCC).

Less than one third of individuals currently listed for organ transplant in the U.S. can expect to receive a transplant in the coming year, and one in fourteen of those waiting will die before an organ becomes available. Efforts to increase the donor pool have led to an increase in the number of organ transplants from live donors: the number has more than doubled over the last 10 years, and, since 2001, the number of living donors has been greater than the number of deceased donors. Most live donors give a single kidney (94.3%); the remaining live donor transplants utilize a lobe of donated liver (5.4%) or lung (0.3%).

From the perspective of the organ recipient and the health care team, there are many benefits associated with live donor organ transplant. These include elective scheduling of transplantation, allowing the operation to occur at a time that optimizes both recipient status and health care resources; minimization of organ ischemic time; and, in many cases, reduced waiting list time. Recipient and graft survival rates are improved after live donor kidney transplantation, whether from a related or unrelated donor, as compared with deceased donor transplantation. Additionally, living donor liver transplantation in children has reduced waiting list mortality; and obliterative bronchiolitis may occur less frequently in recipients of lung lobes from a living donor as compared with a deceased donor whole lung transplant.

From the perspective of the donor, there may be a psychological benefit associated with the altruistic satisfaction of having assumed a risk to help a loved one or a stranger. However, there is limited information about the medium- and long-term risks and outcomes for those who chose to become living donors. The mortality rate of living donor nephrectomy has been estimated at 0.03%, and the rate of morbidity between 1 and 10 percent. The medical risks associated with live donor liver and lung transplants are higher: the mortality rate associated with partial hepatectomy is estimated in the range of 0.2%, and the rate of morbidity at about 10 percent. Living donor lung transplantation places two donors at risk for each recipient. While there has been no reported mortality in association with lobar lung donation, the perioperative morbidity is high, with 20-50% of donors experiencing complications. The long-term psychological and medical consequences of live organ donation are not well described.

The Secretary of the Department of Health and Human Services (DHHS), in response to recommendations made by the Secretary's Advisory Committee on Transplantation, has requested that the NIH support a research program investigating the outcomes and health care needs of living donors. In response to that DHHS request, a study of the outcomes of living liver donors is incorporated into the Adult to Adult Living Donor Liver Transplant Cohort (A2ALL) Study, sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases. NIAID and NHLBI are also responding to the DHHS request through this initiative which will focus on those who chose to donate a kidney or a lobe of lung. Because the outcomes of interest occur both in the peri-donation period and as much as 25 or more years following donation, an epidemiologic approach will be taken, using data collected at clinical transplant centers, as well as information available through other federally-funded registries and studies. The NIH will support a research consortium of 2 – 3 Clinical Centers and one Data Coordinating Center (DCC). This consortium will be centrally coordinated and monitored by a Steering Committee that will provide input on and approval for implementation of all studies developed by consortium members. This consortium will be funded to develop and implement a scientific agenda to address issues relevant to living organ donors, including survival and health outcomes, risk assessment, and medical care needs. Existing registries or cohorts of living organ donors at Clinical Centers will be the basis for the development of an expanded, reliable data set of demographic and clinical information that will allow exploratory epidemiologic research into the risks to, and outcomes of, living organ donors. Efforts to contact living organ donors to ascertain their current health status will be supported.

The specific objectives of this RFA are to:

Examples of research questions to be addressed by the consortium include, but are not limited to, the following:

This RFA will not support animal-based research, long-term prospective cohort studies, clinical trials, or basic mechanistic studies.

The DCC will provide coordination, assistance, centralized data management, and analytical support for consortium studies. The DCC responsibilities include statistical design and logistical support for the Consortium Steering Committee. Specifically, the DCC will provide assistance in the following areas:

A Steering Committee will serve as the governing board for the Consortium; its actions and decisions will be determined by majority vote. Membership will include, at a minimum, the Clinical Center and DCC PIs and the NIAID Project Scientist. Additional members may be added by majority vote of the Steering Committee.

A Steering Committee Chair will be elected by majority vote from among the non-Federal Steering Committee members at the first Steering Committee meeting. The Steering Committee Chair will be responsible for scheduling and developing the agenda for Steering Committee meetings and for promoting collaborative, productive research among the members of the consortium. The first Steering Committee meeting will be scheduled by the NIAID Project Scientist. Responsibilities of the Steering Committee include the following:

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the U01 award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions. Otherwise follow the instructions for non-modular research grant applications.

The NIH (U01 ) is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

Plans for this cooperative agreement project beyond the current funding opportunity are indefinite.

2. Funds Available

The participating IC(s), NIAID and NHLBI, intend to commit approximately $2.1 million in FY 2006 to fund two to three Clinical Centers and one DCC as new grants in response to this RFA. An applicant may request a project period of up to 5 years. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the ICs provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs are not included in the direct cost limitation, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

Applications may be submitted by individual institutions or by consortia of institutions that have pooled their resources in order to be responsive to the terms of this RFA. Foreign institutions are not eligible to apply as the primary institution, but may enter into a consortium or subcontract with a domestic institution as the primary applicant.  

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution 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 programs.

Individuals applying as Principal Investigator for a Clinical Center should have expertise in organ transplantation and clinical research. Individuals applying as Principal Investigator for the DCC should have expertise in clinical research, including a Masters Degree or Doctorate in Clinical Epidemiology, Biostatistics, or a related field. The PI of the DCC should also have experience in the field of organ transplantation.

2. Cost Sharing

Cost sharing is not required.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

Applicant institutions may submit up to two applications, one as a Clinical Center and one as a DCC. However, individuals may appear as “key personnel” on only one application. Organizations submitting applications as a DCC need not be affiliated with a Clinical Center.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

Applicants must indicate whether they are applying as a Clinical Center or as a DCC by (1) including the words “Clinical Center” or “Data Coordinating Center” in the title of their application (PHS 398 Face Page item 1), and (2) stating their intention in the specific aims portion of the research plan (PHS 398 Section 7.a.)

3. Submission Dates
Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: June 13, 2005
Application Receipt Date(s): July 13, 2005
Peer Review Date: November, 2005
Council Review Date: January, 2006
Earliest Anticipated Start Date: April, 2006

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Edward W. Schroder, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3136, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: 301-435-8537
FAX: 301-480-2310
Email: eschroder@niaid.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Edward W. Schroder, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3136, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: 301-435-8537
FAX: 301-480-2310
Email: eschroder@niaid.nih.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf. Personal deliveries of applications are no longer permitted.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NIAID. Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
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. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (see also Section VI.3. Reporting).

Awarded funds may be used for both completion of a data set and for implementation of specific research projects. Project-specific funds will be restricted, conditional upon submission of a data set for consortium use. The submitted data set must meet acceptability criteria to be established by the consortium Steering Committee (see VI.2.A.3, Collaborative Responsibilities).

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

6. Other Submission Requirements

Applicants must indicate whether they are applying as a Clinical Center or as a DCC by (1) including the words “Clinical Center” or “Data Coordinating Center” in the title of their application (PHS 398 Face Page item 1), and (2) stating their intention in the specific aims portion of the research plan (PHS 398 Section 7.a.)

Clinical Center Applications – Research Plan: The Research Plan submitted by Clinical Center applicants in response to this RFA must include:

1) A well-designed epidemiologic study of live organ donors that is consistent with the research objectives of this RFA. This study will be performed using a merged data set or cohort created from the pooled resources of the consortium. Study design, sample size, endpoints, and analysis plans must be presented in detail. The applicant should discuss the feasibility of the proposed study in the context of a range of possible sample sizes, given that the final content and size of the data set are unknown. Potential barriers to implementation of the study and strategies to circumvent those barriers also should be presented. In addition, the relevance of the proposed research question(s) for current and future needs of living donors should be addressed.

2) A description of the data set that the applicant will contribute to the shared data resource. Specific required content includes the following:

A description of the data currently available on living donors at the applicant institution, including format and location of the data archive (e.g., “spreadsheet on a personal computer,” “relational database on a shared university hard drive with daily backup,” etc.); number of donors; organs donated; titles of data fields; percent completeness of data fields; percent of donors who have complete survival data (that is, known to be alive or known to be deceased as of 6 months prior to application submission date); percent of donors whose whereabouts are known, and percent of donors who have been contacted within the last 12 months.

Information on sex, ethnicity and race must be supplied using the Targeted/Planned Enrollment Report (http://grants.nih.gov/grants/funding/phs398/enrollment.pdf) as described in the instructions for the PHS 398 application form (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html).

3) A plan for verifying and completing the data in the data set. Plans for obtaining data that are currently missing from the data set should be presented in detail. These plans must be based on proven methods or known data sources, although the applicant may acknowledge lack of access to known data sources. Barriers to data collection and strategies to overcome those barriers also should be described in detail.

Clinical Center budgets should include support for a full-time data coordinator who will be responsible for data and project management at the site, coordination of activities with the DCC and NIAID, and other administrative and operational activities as directed by the PI; and funds for the PI and the data coordinator to travel to annual Steering Committee meetings.

Data Coordinating Center Applications – Research Plan: The Research Plan submitted by DCC applicants in response to this RFA must include:

1) A detailed discussion of the research questions that can be effectively addressed using the approach described in this RFA. This discussion should address issues of study design, sample size, endpoints, and analysis plans. In addition, potential barriers to implementation of the study and strategies to circumvent those barriers should be presented, and the relevance of the proposed research question(s) for current and future needs of living donors should be addressed.

2) A detailed description of plans for providing expertise and assistance to the Clinical Centers in supplementing and validating their data, and linking the data from the Clinical Centers with other existing data sets. Specific plans for obtaining data from other existing registries, databases, etc. should be included.

DCC budgets should include funds for travel to annual Steering Committee meetings for the PI and two additional members of the DCC staff. DCC budgets also should include travel costs for up to 20 additional Clinical Center participants in annual meetings.

Institutions applying as DCC must have the facilities necessary for electronic data submission and data management as well as the generation and electronic transmission of graphic representations of study data and data analyses. The information technology infrastructure necessary to support these functions will not be funded by this initiative.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Data sharing in this consortium will have two components. (1) Data sets from awardee institutions will be shared within the consortium during the funding period of this award, becoming part of a common data set that will be the basis for epidemiologic research to be conducted by the successful applicants. (2) Applicants should describe a timetable and plan for sharing their research results with the scientific community and the general public.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

The following will be considered in making funding decisions:

2. Review and Selection Process

Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIAID. Incomplete applications will not be reviewed.

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIAID in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

The goals of NIH-supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

2. Approach. Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are strategies proposed by the DCC and Clinical Centers for expanding, refining, and verifying the available data on live donors well thought-out and feasible? Do the proposed data sets/cohorts represent a reasonable representation of the population of U.S. organ donors with respect to race, ethnicity, and gender?

3. Innovation. Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

4. Investigators. Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? Do the applicants present evidence of appropriate training, experience and expertise in the field of organ transplantation and in epidemiologic research involving health outcomes?

5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? For DCC a pplications, is there evidence of previous experience and accomplishments in the design and analysis of large-scale patient datasets for health outcomes research, and of the availability of an infrastructure adequate to support the appropriate storage, management, and analysis of data generated by human subjects research?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates
Not Applicable.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

NIAID will transmit the NGA via U.S. mail for a hard copy and/or via email for an electronic copy.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement ( U01 ), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined above.

2.A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for: defining the research objectives, approaches and details of the projects within the guidelines of the RFA. Each PI will be a voting member of the Consortium Steering Committee, will participate in all Steering Committee activities, and will follow the policies and procedures developed by the Steering Committee. Each Clinical Center PI will have primary responsibility for development and implementation of at least one of the studies approved by the Consortium Steering Committee. The PIs will be required to provide primary study data to the DCC for management and quality control. The data on living donors that forms the basis for research conducted by this consortium will be made available to all consortium PIs via the DCC for projects approved by the Steering Committee. The PIs' responsibilities regarding Steering Committee membership, protocol development and conduct, are described under Collaborative Responsibilities.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

2.A.2. NIH Responsibilities

An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The NIAID Project Scientist will serve as a voting member of the Steering Committee and will participate in all Committee activities, serving as a resource with respect to the study design and implementation. The NIAID Project Scientist may contribute, through review, comment, analysis, and/or co-authorship, to reporting results of consortium studies to the investigator community and other interested scientific and lay organizations. Co-authorship by the NIAID Project Scientist will be subject to approval in accordance with NIH policies regarding staff authorship of publications resulting from extramural awards.

The NIAID Project Scientist, together with the Steering Committee, will review the performance of each participating Center through consideration of the annual reports, site visits, compliance with the Consortium procedures, meeting timelines, adherence to uniform data collection procedures, and the timeliness and quality of data reporting.

The NIAID reserves the right to terminate or curtail any study or any individual award in the event of (a) substantial shortfall in data collection or submission, quality control, or other major breach of a study protocol or Consortium policy and procedure, (b) substantive changes in a study protocol that are not in keeping with the objectives of the RFA, and/ or (c) human subject ethical issues that may dictate a premature termination.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The assigned program official may also serve as an NIH Project Scientist.

2.A.3. Collaborative Responsibilities

A Steering Committee will serve as the governing board for the Consortium; its actions and decisions will be determined by majority vote. Membership will include, at a minimum, the Clinical Center and DCC PIs and the NIAID Project Scientist. Additional members may be added by majority vote of the Steering Committee. A Steering Committee Chair will be elected by majority vote from among the non-Federal Steering Committee members at the first Steering Committee meeting. Responsibilities of the Steering Committee include the following:

  1. Provide input on and approval of all studies developed by consortium members prior to study implementation. Any study proposal may be modified prior to implementation by majority vote of the Steering Committee.
  2. Review and approval of all data analyses, public presentations, and publications of research conducted within the consortium.
  3. Develop policies and procedures for submission and approval of research proposals using consortium resources.
  4. Develop acceptability criteria for data sets submitted by consortium members for use in consortium-based protocols.

The Steering Committee Chair will be responsible for scheduling and developing the agenda for Steering Committee meetings and for promoting collaborative, productive research among the members of the consortium. The first Steering Committee meeting will be scheduled by the NIAID Project Scientist.

The DCC will be responsible for providing administrative support to the Steering Committee. The Steering Committee will meet face-to-face at least once yearly and by teleconference or face-to-face (as funding permits) on at least one additional occasion yearly.

Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies and procedures approved by the Steering Committee.

2.A.4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. These members are: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Nancy D. Bridges, M.D.
Division of Allergy, Immunology, and Transplantation
National Institute of Allergy and Infectious Diseases
Room 3039, MSC-6601
6610 Rockledge Drive
Bethesda, MD 20892-6601
Telephone: (301) 451-4406
FAX: (301) 480-0693
Email: nbridges@niaid.nih.gov

2. Peer Review Contacts:

Edward W. Schroder, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3136, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
Telephone: 301-435-8537
FAX: 301-480-2310
Email: eschroder@niaid.nih.gov

3. Financial or Grants Management Contacts:

Ann Devine
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room Number 2114, MSC-7614
6700B Rockledge Drive
Bethesda, MD 20892
Telephone: (301) 496-7075
FAX: (301) 480-3780
Email: adevine@niaid.nih.gov

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.

Public Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/in the following citations: No. 93.855, Immunology, Allergy, and Transplantation Research and No. 93.838, Lung Diseases Research and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.


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