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
Fogarty International Center (FIC), (http://www.fic.nih.gov)
National Cancer Institute (NCI), (http://www.cancer.gov)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)
National Institute of Dental and Craniofacial Research (NIDCR), (http://www.nidcr.nih.gov)
Office of Research on Women’s Health, Office of the Director (ORWH/OD), (http://orwh.od.nih.gov/)

Title: International Tobacco and Health Research and Capacity Building Program (R01)

Announcement Type
This is a reissue of RFA-TW-02-005, which was released on June 25, 2001.   

Update:

Request For Applications (RFA) Number: RFA-TW-06-006

Catalog of Federal Domestic Assistance Number(s)
93.989, 93.399, 93.279, 93.121

Key Dates
Release Date:  May 8, 2006
Letter of Intent Receipt Date(s):  August 25, 2006 
Application Receipt Date(s):  September 25, 2006
Peer Review Date(s):  January 2007
Council Review Date(s):  May 2007
Earliest Anticipated Start Date(s):  July 15, 2007
Additional Information To Be Available Date (Url Activation Date):  N/A
Expiration Date:  September 26, 2006

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
  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

This Request for Applications (RFA) solicits research and capacity building projects that address the burden of tobacco consumption in low- and middle-income nations by (1) pursuing observational, intervention and policy research of local relevance and (2) building capacity in regions in epidemiological and behavioral research, prevention, treatment, communications, health services and policy research.  The level of research and research training specialization in any given research project grant will vary based on the strengths of the particular investigators and institutions that apply and the need to build capacity to support research and future interventions.  The overall intent of the program is to encourage trans-disciplinary approaches to the international tobacco epidemic to reduce the global burden of tobacco-related illness.  The program is designed to promote international cooperation between investigators in the U.S. or other high-income nation(s) pursuing research programs on tobacco control, and scientists and institutions in low- and middle-income nation(s) where tobacco consumption is a current or anticipated public health urgency.  The major portion of the research must be conducted in a low- and/or middle-income nation(s), and greater than 70 percent of the direct costs requested must be used in a low- and/or middle-income nation(s) in research and research-training.  Thus, the program allows U.S. and other high-income nation investigators to gain expertise working under low- and middle-income nation-specific conditions and strengthens the research base of the U.S. and foreign institution(s), especially those institutions in low- and middle-income nations.  To this end, capacity strengthening must be an integrated and significant part of the research proposal.  In this RFA, the term “tobacco” includes both smoking and smokeless (chewing or unburned) tobacco.

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

Background

Despite the continuing devastation caused by infectious diseases, tobacco consumption remains the leading cause of preventable deaths and disability in adults globally.  As cited by the World Health Organization (WHO), at present, seven and one-half percent of the world’s 53 million annual deaths are attributable to tobacco use.  If current smoking patterns persist, the number of tobacco deaths will rise to ten million deaths annually by 2025, surpassing the combined deaths of AIDS, tuberculosis, automobile accidents, maternal mortality, homicide and suicide.  Notably, 70 percent of this increase will occur in developing nations. 

New figures from WHO World Health Report, 2002, Reducing Risks, Promoting Health Life, p. 65, “Worldwide, it is estimated that tobacco causes about 8.8% of deaths (4.9 million) and 4.1% of DALYs (59.1 million).  The rapid evolution of the tobacco epidemic is illustrated by comparing these estimates for 2000 with those for 1990; there are at least a million more deaths attributable to tobacco, with the increase being most marked in developing countries.

The WHO termed tobacco control the quintessential challenge of sustainable development, since it carries implications for trade and taxation, agricultural subsidies, the environment, social policies, and health care expenditures, among other sectors.  Blunting the epidemic requires a better basic understanding of the addictive properties of nicotine, including the manifestations, determinants and outcomes of dependence for the individual and society.  While aware that the complications of nicotine risks and tobacco exposure in low- and middle-income countries may be distinct or different from those in high-income nations, this RFA is not directed at repeating research that is already well-established.

Although the Framework Convention for Tobacco Control has ended its deliberations with a positive outcome and major end results are now part of international law, much more work needs to be done, both in developed countries where there is some indication of a lessening of tobacco use and in low- and middle-income countries where there is a clear rise in tobacco use.

Trends show that most smokers begin at a young age.  In high-income nations, about eight out of ten smokers begin in their teens, while many smokers in low- and middle-income nations begin in their early twenties.  The peak age of tobacco uptake in low- and middle-income nations, however, is dropping.  The younger the smoker, the less likely the individual will quit at a later time.  Half of all long-term smokers will eventually be killed by tobacco, and of these, half will die during their most productive middle years, losing 20 to 25 years of life expectancy.  While the impact of tobacco mortality is well-studied in established market economies, important questions remain unsolved in other regions, particularly in low- and middle-income nations.

There is little research in low- and middle-income nations of the possible interaction of smoking and shifting dietary patters on the pathogenesis of ischemic heart disease.  Evidence clearly implicates Environmental Tobacco Smoke (ETS) as a cause of lung cancer, excess respiratory disease, and cardiovascular disease mortality in non-smokers.  Recent research suggests that smoking is an important cause of death from tuberculosis. (ref Lancet 2003; 362: 507-515).  Smoking is causally related to cervical cancer, though further study is needed to understand the independent association between smoking and HPV infection.  Few studies have looked at the interaction of tobacco use or ETS exposure with occupational and ambient air pollution (both indoor and outdoor) in contributing to chronic obstructive pulmonary disorders in developing countries, or the importance of ETS as a risk factor for the already high burden of childhood respiratory infections.  The disease burden of tobacco is of such magnitude that even minor epidemiological difference among populations may have major implications for health.  There is also a dearth of information on gender and age differences with respect to incentives and disincentives for tobacco use and cessation. 

In low- and middle-income nations, the prevalence of cigarette smoking among women is low (10.3%) as compared to men (47.5%). (ref: Guindon GE, Boisclair D.  HNP Discussion Paper, Economics of Tobacco Control Paper No. 6. February 2003.  The World Bank.)  However, there is continued evidence that this index is rising, particularly among younger, educated, affluent women living in larger cities.  An increased prevalence among women will have grave consequences not only for the health of women, but also their families.  Research is needed to assist low- and middle-income nations to maintain or, preferably, decrease the currently low prevalence that exists among women, and to better understand how tobacco use can be decreased within the family. 

Two previous studies in the Journal of the American Medical Association focus on the association of cigarette smoking with psychiatric disorders among adolescents and young adults and the propensity to smoke if an individual has a mental illness (2000; 284: 2348-2351 and 284:  2606-2610).  Studies are needed to trace links between mental illness, and smoking uptake and cessation to better explain the unique health situation in low- and middle-income nations, where links between mental illness and tobacco are rarely diagnosed.  Such studies would also provide an opportunity for investigators to learn whether heavy smokers in low- and middle-income nations are more likely to experience mental illness as a result of tobacco use or whether individuals with mental illness have a predilection towards tobacco use.  Furthermore, little is known about risk taking behavior among adolescents and young adults.  In this group, tobacco may be linked with other risk taking behaviors such as alcohol use, drug abuse, unprotected sexual activity and reckless driving of vehicles, all of which could have a unique profile in low- and middle-income nations. 

Several countries have begun to explore programs to prevent and treat tobacco use and dependence, but the data are still sparse on the effectiveness of those interventions.  For example, data from the U.S. Public Health Service Treatment Guideline, Treating Tobacco Use and Dependence, indicate that telephone-based “quit lines” may be effective and cost-effective.  It is unknown, however, whether such related approaches would work in low- and middle-income nations.  A study in the Journal of Community Health highlighted the contribution of nurse researchers in identifying tobacco consumption variables (i.e., demographic, cultural, cognitive, and behavioral factors and patterns of consumption) among rural Ohio Appalachians.  Findings from this study are being used to develop effective smoking cessation interventions targeting this high-risk population. 

Finally, in those countries that have implemented policy-based controls, including legislation, research is needed to assess the impact and effectiveness of these measures.

This RFA is intended to support research that clarifies important issues on tobacco consumption and risks that are relevant to low- and middle-income nations.  Such studies will provide a better understanding of the tobacco burden in low- and middle-income nations and the possible actions and interventions that may be taken to reduce the epidemic.

Statistical trends demonstrate the steady geographic shift in tobacco production and consumption.  In the early 1960s, low- and middle-income nations constituted 53 percent of the world’s tobacco production; by the late 1980s, this share had expanded to almost 75 percent.  Global consumption has also increased.  In the mid-1970s, 41 percent of the world’s cigarettes were consumed in the developing world.  In the 1980s, total cigarette consumption in these countries had increased to 60 percent.  Tobacco use in low- and middle-income nations is now considered to have reached 82 percent of global consumption with a dramatic increase in local production.  

In addition to the human costs associated with tobacco-related morbidity and mortality, enormous economic costs are associated with tobacco use, including medical care for treatment of tobacco-related diseases, absenteeism from work, decreased productivity, losses due to fire, and lost income due to early mortality.  A 1993 World Bank study estimated that tobacco use results in a global net loss of $200 billion per year, half of which occurs in low- and middle-income nations.  The impact of tobacco-related losses on the world economy exceeds the total current health expenditures in all developing countries combined. 

Individuals spend significant personal and household income to support their tobacco use.  Expenditures on tobacco products can be as much as 17 percent of household income and 60 percent of personal income.  Some governments are hesitant to curtail tobacco production and may be diffident towards aggressive tobacco controls, since they can draw significant revenue from excise taxes and exportation.  Furthermore, most tobacco reporting lacks data to substantiate the magnitude of the international tobacco epidemic and the effectiveness of interventions.  U.N. Economic and Social Council. Ad Hoc Inter-Agency Task Force on Tobacco Control, Report of the Secretary General. E/2004/55. (http://www.un.org/esa/coordination/ecosoc/document.htm)

In developing countries, among poor families, the proportion of household expenditures used to purchase tobacco products can easily represent up to 10% of total household expenditures.  This means that these families have less money to spend on basic items such as food, education and health care.

A recent study in Bangladesh showed that over 10.5 million people currently malnourished could have an adequate diet if money spent on tobacco were spent on food instead.

Much of the available research on tobacco control is based on the experiences of established market economies.  This research is only partially relevant to the social, economic, and cultural climate in many low- and middle-income nations.  Recent epidemiological data from Brazil, India, South Africa, and the Republic of China allows for more accurate projections of other low- and middle-income nations than those previously attempted with data from high-income nations.  The implication of these trends for morbidity, mortality and lost productivity is enormous because tobacco control research capacity in low- and middle-income nations is severely circumscribed.

Evidence from the 1999 World Bank Report, Curbing the Epidemic, a monograph on the economics of tobacco control, shows that price increases, particularly through increased taxes, advertising bans and counter-advertising, and ETS restrictions have a measurable impact to decrease smoking.  These factors are likely to reduce the initiation of smoking and use of smokeless tobacco products, specifically in youth and adolescents, and enhance permanent cessation by those addicted to nicotine.  Behavior change is favored when context-specific causes and motivations are understood.  Policy change is favored when committed individuals in leadership positions have relevant information available to them, especially information showing economic gain from policy changes.  Ideally, a variety of research will be conducted since a single strategy is unlikely to suffice for most low- and middle-income nations.

Progress in global tobacco control will depend upon standardized and comparable surveillance data; international research networks and information; and heightened capacity for tobacco control research among developing nations.  In recent years, there have been a number of reviews to identify international tobacco control research needs.  In 1998, the Institute of Medicine’s Board on Global Health outlined research needs in a report on cardiovascular disease prevention (http://www.nap.edu/catalog/6218.html).  Also in 1998, a working group was convened at the 10th World Conference on Tobacco or Health to identify research fields and public health data with the highest potential to affect tobacco control policy.  The Research for International Tobacco Control (RITC) group, hosted by the Canadian International Development Research Centre, convened regional workshops in the Caribbean, Southeast Asia and Sub-Saharan Africa to outline regional agendas.  Curbing the Epidemic, also includes areas of needed research.  These analyses have been instrumental to the development of this RFA. 

The goal of this RFA is to solicit applications for hypothesis-testing and hypothesis-generating studies, and to train low- and middle-income nation investigators who will examine the manifestations, determinants and outcomes of tobacco use, including smokeless tobacco products, and evaluate interventions in a range of areas.  Research related to hypothesis-building from tobacco industry document review would be considered relevant for this application.  We particularly encourage resarch related to tobacco use and addiction, especially in adolescencts, including issues related to in utero exposure to tobacco use.

Scientific Objectives

1. Research:  This RFA encourages trans-disciplinary research.  Applications may address one or more of the provided categories of research.  Both research and capacity strengthening must be included in the application.  Categories of research may include, but are not necessarily limited to, the following activities: 

a.  Epidemiological and Surveillance Research:  A broad spectrum of epidemiological and surveillance research may be pursued to enhance the knowledge of tobacco-related health problems and risks relevant to low- and middle-income nations.

b. Susceptibility and Risk:  Examine the differences of tobacco initiation, consumption and cessation by gender, ethnicity, culture, income and education relevant to low- and middle-income nations.

c. Biobehavioral and Social Research:  Biobehavioral and social research may emphasize tobacco advertising and awareness, smoking uptake and quit rate, and intervention strategies relevant to the cultural differences and needs of low- and middle-income nations.

d. Intervention Research:  Building on established intervention research conducted in high-income nations, investigators may engage in studies that examine different methods of tobacco control implementation and interventions that are appropriate to developing country needs, infrastructure and resources.

e. Policy-Related Research:  Policy-related research may examine current tobacco control policy and enforcement, or lack thereof, in low- and middle-income nations.  Studies may also determine the impact of current and needed tobacco control policies, regulations and trade on public health and the risk factors associated with tobacco consumption relevant to low- and middle-income nations.

2.  Capacity and Infrastructure Strengthening:  A strategic goal of this RFA is to strengthen capacity and infrastructure within low- and middle-income nations.  Capacity building and infrastructure strengthening promote the advancement of research and the enhancement of the number and the knowledge of tobacco investigators in low- and middle-income nations.  A long-term outcome of capacity and infrastructure strengthening is the ability to augment scientific competence and skills nationally and internationally, and develop a cadre of tobacco researchers with proper research training and support who will continue to carry out tobacco control research in (a) low- and middle-income nation(s).  Capacity and infrastructure strengthening provide important opportunities for investigators from high-income nations to gain knowledge of and experience in tobacco control issues of both high-income and low- and middle-income nations.  Capacity strengthening provides investigators in low- and middle-income nations with the skills and infrastructure to expand and enhance their work in tobacco control research.  Capacity strengthening is a requirement of this RFA.  Applications should include plans to: 

a. Support research training of faculty to meet the goals of the proposed research, as well as the needs of the low- and/or middle-income nation(s).  Capacity strengthening will focus on the outcomes of tobacco consumption, and the evaluation of public health and policy interventions relevant to the low- and/or middle-income nation(s).  This research training will provide opportunities to augment field experiences and perspectives of investigators from low- and/or middle-income nations.  Collaborations should extend or enhance, in a mutually beneficial manner, the tobacco control research interests of the Principal and Co-Investigators.  At the same time, the potential capacity of the low- and/or middle-income nation investigator or institution should increase to provide sustainable and productive behavioral, intervention and policy research capacity, which will address the tobacco burden in the participating low- and/or middle-income nation(s);

b. Promote institutional strengthening in tobacco control research through support for and linking of relevant departments or institutions working on tobacco-related scientific research;

c. Encourage research training opportunities for low- and middle-income nation investigators, including long-term research training as part of the research, practical and applied short-term courses and workshops “in-country” for professionals or technicians; and course work, laboratory or field research training in essential research skills for technical assistants, graduate degree candidates, or other health professionals;

d. Promote the advancement of tobacco control-related training for tobacco control investigators and health professionals from low- and/or middle-income nation(s) by career enhancement and institutional capacity strengthening in low- and/or middle-income nations.  The research grants funded from this RFA will provide research training for individuals considered associated with an institution and designated as “Research Associates.”  This research training should not be confused with National Research Service Award (NRSA) support, in which trainees do not have an employee-employer relationship.  The following types of training may be included:  long-term (more than nine months and up to three years) research training in pre- or post-doctoral programs; short-term (less than three months) research training (could encompass workshops focused on program and grants administration, technology transfer, protocol development of projects, and data management and analysis); intermediate-term research training (could include specialized activities in support of tobacco control research).  The emphasis for research training for this RFA will be on intermediate- to longer-term training, including mid-career training.  This approach will accelerate building an enduring tobacco control research environment, facilitate the adoption of tobacco control policies, and strengthen public health capacity at foreign “in-country” sites;

e. Post-doctoral and degree candidates must be listed as research associates on PHS application Form 398, page DD, and would be considered as having an employee-employer relationship.  Salaries, tuition remission, and other forms of compensation paid as, or in lieu of, wages to degree candidates or post-doctoral trainees to conduct research related to the goals of this RFA are allowable.  Costs and plans must be included in the text of the proposal and reflected in the proposal’s budget;

f. Enhance low- and/or middle-income nation investigators’ observational, intervention and policy research on tobacco control by promoting multidisciplinary approaches to research training.  Institutional capacity strengthening could encompass basic, social and behavioral sciences, economics, community-based research, and legal studies.  Using resources available under this award, applicants could broaden their knowledge of tobacco-related disease or illnesses with courses related to polydrug abuse, cardiovascular disease and cancer control and prevention.  An example of an appropriate curriculum would be a course concentrating on the principles and practice of cancer prevention and control, with discussions on a range of issues, including genetics and cancer biology, and behavioral science and community interventions (http://dcp.nci.nih.gov/pob/courses.index.html);

g. Promote clinical, operational and health services research on the effects, risk assessment and risk reduction related to tobacco use;

h. Support tobacco-related institutional infrastructure development and research training in bioethics, informatics, economics and other crosscutting disciplines; and

i. Support the development of “in-country” tobacco control infrastructure at the institution, academic, and non-government organization (NGO) level, including laboratory and field research on a country- and project-specific basis.

Special Requirements

Collaborations:  This program is intended to generate useful scientific information and promote collaboration between investigators and institutions in the United States or other high-income nations and low- and middle-income nations with shared interests in reducing the consequences of tobacco consumption.  To achieve this, research and capacity strengthening may reflect new or ongoing activities and may demonstrate a collaboration between a Principal Investigator (PI) from the U.S. or other high-income country and (a) Co-Investigator(s) from (a) low- and/or middle-income nation(s).  The Foreign Collaborator must be at an institution in a “developing country.”

If the PI is from a low- or middle-income nation, the proposal will be developed jointly by the PI and one from the U.S. or other high-income nation.  Collaboration between the foreign investigators and (a) U.S. investigator(s) is highly encouraged.  Research findings must be relevant to the collaborating low- and/or middle-income nation(s).  (For operational and analytic purposes, the World Bank’s main criterion for classifying economies, gross national income per capita, will be employed for this RFA to determine eligibility.  A list of countries representing low- and middle-income economies, which are eligible for this program may be found at http://www.worldbank.org/data/countryclass/classgroups.htm).  Interdisciplinary approaches to examining the dynamics of tobacco consumption are especially encouraged.  Advances are most likely to be achieved through interdisciplinary collaborations (i.e., economics, epidemiology, demography, anthropology, sociology, communications, behavioral science, basic biological sciences, psychology and pediatrics). 

Establishing Research Priorities:  The applicant should demonstrate that the research proposed relates to the burden of tobacco and reflects the priorities of the low- and/or middle income collaborating nation(s), and should describe in detail the procedures to ensure that both research and research training reflect these priorities.

Strategy for Regional Impact:  The applicant should emphasize tobacco control capacity building at the collaborating foreign institution(s) and in low- and/or middle-income nations.  The applicant should describe in detail strategies and specific activities to achieve a wider regional impact.  This will occur by strengthening other institutions and/or international organizations in the low- and/or middle-income nation(s) and/or in the neighboring countries, with the long-term strategic goals of disseminating and educating the public on tobacco control and policy, and building a regional center.  The program would offer training on tobacco research and control to other areas and countries consistent with regional resources.

National Support for the Program:  Letters of support for the proposed research and capacity strengthening program from the collaborating foreign academic and governmental institution(s) must be submitted with the application.  Evidence should be provided in writing of national support for the program through cost-sharing (e.g., supplies, funds, salaries, equipment, laboratory space, personnel, etc.) support by the host country, and willingness of the foreign government to utilize investigators’ experience and knowledge gained from the program to build policy and initiatives in tobacco control and research, and capacity strengthening.  This could be done, for example, through a regional or national research-training center in the collaborating foreign country supported by the program.  Note that cost-sharing funds will be subject to NIH cost-accounting rules.  Additionally, NIH hopes that the research and training funded through this RFA will have a long-term positive impact to reduce tobacco use in low- and middle-income nations.  NIH hopes that collaborating low- and/or middle-income nations will utilize the expertise of those who receive research training under this RFA; that, following their training, trainees will be able to return to the host country and assume positions of responsibility in research and/or public health in tobacco control and prevention.  For this reason, the review process will include the criteria of sustainability--whether or not an application demonstrates the ability to sustain and utilize the research and training provided through this RFA after the completion of the grant period. 

Continued Collaboration:  Descriptions of plans for continued collaboration with foreign collaborators and investigators after trainees return home must be included in the application, including strategies for continued mentoring of trainees and tracking career paths of trainees after they have returned home.  Tracking of short- and long-term research training and other institutional capacity strengthening, including mentoring, will be done by a web-based reporting system, Annual Reports and other means. 

Grantees of the previous International Tobacco and Health Research and Capacity Building Program should demonstrate both the capacity-building success and research success of the previous grant.  This could potentially be done through demonstrated trainees return to their low- or middle-income countries and the establishment of research programs there as well as the trainees’ publication records. 

Assurances:  Before an award will be made, the grantee institution must show written evidence of formal approval (assurances) from responsible authorities at the collaborating institution, from an institutional (or ethical) review board or committee at both the U.S. and foreign institutions, and from the relevant government authority.  Please see “Procedures for Registering Institutional Review Boards and Filing Federal-Wide Assurances of Protection for Human Subjects (FWAs)” (http://www.hhs.gov/ohrp/assurances/assurances_index.html). 

Annual Meetings:  There will be periodic network meetings of awardees, co-funding agencies, and selected international tobacco researchers in Bethesda, Maryland or other mutually acceptable site, possibly in conjunction with national or international meetings.  Those receiving awards will be expected to participate in these meetings (generally one annual two-day meeting).  The purpose of these meetings will be to exchange and benefit from research and research-training experiences and to coordinate program activities.  In Year One, PIs should budget for themselves and their Co-Investigator(s) to attend the annual network meeting.  In subsequent years, PIs should budget for themselves, their Co-Investigator(s) and two to three other project personnel (selected trainees and/or program administrators) to attend.  Funds for this two-day activity (travel, lodging and per diem) should be included in the budgetary requests.  Consideration will be given to holding annual network meetings in developing countries when this would provide benefits to those persons and be cost-effective.

Inclusion of Student and Post-Doctoral Research Assistants/Associates:  Post-doctoral and degree candidates must be listed as research associates on PHS application Form 398, page DD, and would be considered as having an employee-employer relationship.  Salaries, tuition remission, and other forms of compensation paid as, or in lieu of, wages to degree candidates or to post-doctoral trainees to conduct research related to the goals of this RFA are allowable.  Costs and plans must be included in the text of the proposal and reflected in the proposal’s budget. 

Dissemination:  All applications should include a detailed discussion of a) how the results of the research being proposed can be rapidly disseminated and adopted on a large scale; and b) why the results of the research being proposed, if disseminated and adopted on a large scale, could have a significant effect on the reduction of tobacco use in the community, host country or region. 

Research Involving Human Subjects:  If the proposed research involves human subjects, applicants must inform the FIC program staff that approval of research protocols involving human subjects has been obtained from U.S. and developing country institutional review boards and required U.S. and foreign government agencies before an award will be made.

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the individual research grant (R01) award mechanism.

As applicants, the Principal Investigator and Co-Investigator(s) will be responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

The Fogarty International Center, in collaboration with the National Cancer Institute, intends to commit approximately $3 million in fiscal year (FY) 2007 to fund eight new and/or competing continuation grants in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs of up to $300,000 per year.

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 requested by consortium participants are not included in the direct cost limitation; see NOT-OD-05-004.

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:

All current policies and requirements that govern the research grant programs of the National Institutes of Health (NIH) will apply to grants awarded under this RFA.  Awards under this RFA to foreign institutions will be made only in accordance with NIH policy governing such awards. 

Only one application from an eligible institution will be accepted.  For the purposes of this RFA, components of a large or multi-component organization that are sufficiently independent to constitute, in effect, separate organizations are considered separate institutions and thus may submit separate applications.  For example, the multiple campuses of the University of California system are considered separate institutions.  However, the medical school, engineering school, or dental school, etc., of a university, even if on different campuses, constitute a single institution.  Multiple applications from different divisions, faculties, schools, centers, etc., at the same institution will be returned without review. 

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 support.

Principal Investigators from the U.S. or other high-income nations are required to collaborate with (an) investigator(s) from (a) low- and/or middle-income nation(s).  Principal Investigators from a low- and/or middle-income nation are strongly encouraged to collaborate with the U.S. and/or other high-income nation(s). 

FIC strongly encourages applications from women and individuals from underrepresented racial, ethnic and socially disadvantaged groups.  Where appropriate, the design of the projects should take into account potential sex and gender differences that may affect the questions asked and the analyses performed.  These might include different responses to and impacts of health interventions, differences in physiology, and different behavioral bases for disease prevention strategies. 

2. Cost Sharing or Matching

Cost sharing is not required.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

Only one application per distinct institution is allowed.

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.

Foreign Organizations
Several special provisions apply to applications submitted by foreign organizations:

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

3. Submission Dates and Times

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(s):  August 25, 2006 
Application Receipt Date(s):  September 25, 2006
Peer Review Date(s):  January 2007
Council Review Date(s):  May 2007
Earliest Anticipated Start Date:  July 15, 2007

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.  Therefore, it would be helpful to have a few paragraphs describing the research to be done.

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:

Aron Primack, MD
Division of International Training and Research
Fogarty International Center
31 Center Drive, MSC 2220
Bldg 31, Room B2C39
Bethesda, MD 20892-2220
Telephone: (301) 496-4596
FAX: (301) 402-0779

Email:  primacka@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and five 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)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

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.

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 Fogarty International Center.  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.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

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.

All clinical trials supported or performed by the NIH require some form of monitoring.  The method and degree of monitoring should be commensurate with the degree of risk involved in participation and the size and complexity of the clinical trial.  Monitoring exists on a continuum from monitoring by the Principal Investigator/project manager or NIH program staff to a Data and Safety Monitoring Board (DSMB).  These monitoring activities are distinct from the requirement for study review and approval by an Institutional Review Board (IRB).  For details about the Policy of the NIH for Data Safety Monitoring of Clinical Trials, see http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm.  For Phase I and II clinical trials, investigators must submit a general description of the data and safety monitoring plan as part of the research application.  See NIH Guide Notice on “Further Guidance on a Data and Safety Monitoring for Phase I and II Trials” for additional information:  http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html 

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/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Specific Instructions for Modular Grant applications.

Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

Plan for Sharing Research Data

A data sharing plan is not required. 

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/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.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

 The following will be considered in making funding decisions:

2. Review and Selection Process

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 the National Cancer Institute 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.

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?

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?

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?

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)?

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?  Is there evidence of the ability to sustain and utilize the research and research training provided through the RFA, after the completion of the grant period?

Research Capacity Building:  Does the proposed program contribute to the capacity of scientists and institutions in low- and middle-income nations to perform research related to tobacco consumption?  Does the proposed program contain explicit strategies or plans to strengthen this capacity through research training, career development, mentoring and other modes?  Will enhancement of specific departments in foreign institutions lead to overall institutional excellence?  (Grantees of the previous International Tobacco and Health Research and Capacity Building Program should demonstrate the capacity-building success and research success of the previous grant program.  This could potentially be done through demonstrated trainees return to their low- or middle-income countries and the establishment of research programs there as well as the trainees’ publication records.)

International Research Collaboration:  In the course of research, will collaborating foreign scientists and their institutions develop the capacity to become independent investigators and national leaders in tobacco research and public health intervention (i.e., develop their independently supported research and capacity development programs and obtain financial support nationally and internationally)?  How will this occur?

Does the proposed project present special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the U.S. or that augment existing U.S. resources?

Does the proposed project have specific relevance to the mission and objectives of the sponsoring ICs, and have the potential to significantly advance health sciences in the U.S.? 
 

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/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.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

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

N/A

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/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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. See Also Section IV.5. Funding Restrictions.

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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.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/grants/policy/nihgps_2003/NIHGPS_part9.htm).

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:

FIC
Aron Primack, M.D.
Division of International Training and Research
Fogarty International Center
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 496-4596
FAX: (301) 402-0779
Email: primacka@mail.nih.gov

NCI
Michele Bloch, M.D., Ph.D.
Medical Officer
Tobacco Control Research Branch
Behavioral Research Program
Division of Cancer Control and Population Sciences

National Cancer Institute
6130 Executive Boulevard, MSC 7337
Executive Plaza North, Room 4036
Bethesda, MD  20892-7337
Telephone: (301) 402-5284
FAX: (301) 496-8675
Email: blochm@mail.nih.gov

NIDA
Thomas F. Hilton, Ph.D.
Program Official for Organizational & Management Sciences
National Institute on Drug Abuse
National Institutes of Health
6001 Executive Blvd. Rm. 5197
Bethesda, MD  20892-9565
Telephone:  (301) 435-0808
Fax:  (301) 443-6815
Email:  tom.hilton@nih.gov


NIDCR
Patricia S. Bryant, Ph.D.
Director, Basic and Applied Behavioral/Social Science Research Program
Center for Health Promotion and Behavioral Research
National Institute of Dental and Craniofacial Research
Building 45, Rm 4AS-43A
45 Center Drive
Bethesda Md 20892
Telephone: 301-594-2095
FAX: 301-480-8322
E-mail: Patricia.bryant@nih.gov

ORWH
Lisa Begg, Ph.D.
Office of Research on Women’s Health
1 Center Drive
Bethesda, MD  20892
Telephone:  (301) 402-1770
Email:  beggl@od.nih.gov

Programmatic inquiries can also be addressed to the NIH program contacts listed on the FIC website (http://www.fic.nih.gov/programs/grants.html) for the International Tobacco and Health Research and Capacity Building Program.  Frequently asked questions and responses to these inquiries will also be listed at this website. 

2. Peer Review Contacts:

Michele Bloch, M.D., Ph.D.
Medical Officer
Tobacco Control Research Branch
Behavioral Research Program
Division of Cancer Control and Population Sciences

National Cancer Institute
6130 Executive Boulevard, MSC 7337
Executive Plaza North, Room 4036
Bethesda, MD  20892-7337
Telephone: (301) 402-5284
FAX: (301) 496-8675
Email: blochm@mail.nih.gov

3. Financial or Grants Management Contacts:

Andy Jones
Grants Management Specialist
Fogarty International Center 
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 402-9592
FAX: (301) 594-1211
Email: jonesan@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

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.

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 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 funding opportunity 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.

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.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_manual.htm).

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.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ 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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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