and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)
Components of Participating Organizations
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov)
Title: Economics of Prevention and Treatment Services for Drug and Alcohol Abuse
Announcement Type
Program Announcement (PA) Number: PA-05-111
Catalog of Federal Domestic Assistance Number(s)
93.279, 93.273
Key Dates
Release Date: May 18, 2005
Application Submission Dates(s): Standard receipt dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
Peer Review Date(s): October-November, February-March, and June-July: http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): February, May, and September: http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date: March, June, and October: http://grants.nih.gov/grants/funding/submissionschedule.htm
Additional Information To Be Available Date (Url Activation Date):
EXPIRATION DATE for R03 and R21 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R03 and R21 AIDS and AIDS-Related Applications: May 2, 2006
Expiration Date for R01 Non-AIDS Applications: November 2, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007
Due Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
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. Submission, 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 Announcement1. Research Objectives
Purpose
NIDA and NIAAA seek research on the economics of prevention and treatment services associated with drug and alcohol abuse. Drug abuse and dependence were estimated to generate an economic burden of $143 billion in 1998, driven by health care expenditures (drug abuse services and medical consequences), productivity losses (death, job problems, incarceration, crime careers, and crime victims), and juvenile and adult criminal justice expenditures. In 2004, the Federal government budgeted $12.6 billion for prevention, treatment and enforcement related to drug abuse. The NIDA Services Research and the Prevention Research Branches of the Division of Epidemiology, Services and Prevention Research, as part of the Institute's health services research program, will jointly support these economic research projects.
Similarly, alcohol abuse and dependence were estimated to generate an economic burden of about $185 billion in 1998. The NIAAA Division of Epidemiology and Prevention Research will support these economic research projects.
Research Objectives
NIH solicits applications to conduct research related to: (1) financing of prevention and treatment services associated with either drug or alcohol abuse, including health insurance and/or payment mechanisms; (2) alternative delivery systems and managed care; (3) cost-benefit, cost-effectiveness, or cost-utility analyses; (4) services costs and production; and (5) methodological research.
Background
Economic research on services for drug and alcohol abuse informs decisions related to the allocation of resources and efforts to enhance efficiency and equity in the delivery of such resources. Applied research on alternative payment systems, public and private financing systems, and the design of insurance must be grounded in sound microeconomic principles. Economic research on interventions may build on prevention and treatment effectiveness studies or on randomized clinical trials. With social policy and institutional changes, many natural experiments are suitable for the application of economic analysis.
Public financing for services associated with drug and alcohol abuse is derived from federal, state, and local government funds. Private sources of funding for these services include health insurance, consumer out-of-pocket expenditures, and charity. Scientific inquiry into financing these services requires normative and positive economic analyses on allocation and distribution issues. For example, because different levels of government are involved in public financing for these types of health care services, fiscal federalism is a central issue. Because indigent health status is a major concern, distributive issues must be addressed. Analyses of both public and private provision of health insurance would be essential. Service delivery systems for prevention and treatment associated with drug and alcohol abuse are undergoing redesign, and studies about payment mechanisms are encouraged to examine implications and outcomes related to such redesigned systems.
Behavioral health care organizations (BHOs) have expanded dramatically, and require economic analyses in conjunction with organizational and management aspects of service delivery. Usually for-profit, BHOs administer the mental health, alcohol, and drug abuse prevention and treatment benefits in private or publicly sponsored health insurance plans. BHOs utilize managed care mechanisms to manage the access to, quality, outcomes, and costs of delivering services related to drug abuse and alcohol abuse. Managed care systems require research on principal-agent relationships and design of incentives, contracts, and regulations for drug abuse services. Economic analysis also has a role in outcome monitoring that contributes to improving the quality, allocation, and distribution of resources and interventions within such delivery systems.
Cost-benefit, cost-effectiveness, and cost-utility analyses are collaborative activities conducted by economic and health services researchers who investigate the effectiveness of innovative preventive or therapeutic interventions, as well as the effectiveness of delivering such services in real-world settings. Rigorous methodological work is needed to quantify health costs, benefits, and outcomes, as well as other non-health-related costs, benefits, and outcomes.
Costs could include direct and indirect costs associated with prevention and treatment programs, as well as savings associated with the social costs related to drug and alcohol abuse. Unfortunately, most currently available information on the unit costs of substance abuse services is rudimentary. This has hampered the quantification of prices and costs associated with service delivery for innovative and standard substance abuse services. This is particularly a problem with respect to prevention, in which services often involve costs embedded and expended in other systems, such as schools, law enforcement, community services, or employee assistance programs (EAPs). Treatment costs for other diseases can be increased if patients exhibit a concurrent drug or alcohol abuse disorder, but treating such substance abuse disorders might generate overall cost savings (or cost-offsets ) in integrated health care or community service networks. Conceptualizing and measuring the relationships among accounting and economic cost, marginal cost, incremental cost, average cost, and total cost remain important topics for economic evaluation in prevention and treatment programs and service delivery systems for drug abuse and alcohol abuse problems. Research in these areas is needed so that standardized estimates and methods for measuring the costs and outcomes of prevention and treatment can be generated. Economic research is also sought on the production cost associated with delivering discrete units of services associated with prevention and treatment of drug and/or alcohol abuse disorder.
A comprehensive bibliography on the economics of drug abuse prevention and treatment services can be found on the NIDA web site at: http://www.drugabuse.gov/pdf/despr/EconBiblio2005.pdf.
In May 2003, NIDA convened the Health Services Research Blue Ribbon Task Force to review it's the portfolio of health services research; and to advise the Institute on strategies for increasing its relevance and facilitating the utilization of research-based prevention and treatment interventions into practice and policies. A complete copy of the report can be accessed via the NIDA website at: http://www.drugabuse.gov/about/organization/nacda/CouncilPresentations.html.
In the area of prevention, the Task Force identified a need for an increase in the number of studies fully dedicated to economics issues. The Task Force recommended more studies examining such topics as: financial flows; economic incentives; the level of prevention financing; implementation costs for those programs that have shown promising outcomes; quantifications of cost-benefit, cost-effectiveness, and cost-utility associated with those prevention interventions that emphasize long-term outcomes, particularly for high-risk individuals; financial decision-making about prevention practices; allocation of funds for such services; decision-making processes and how decisions influence program quality and sustainability. In the area of treatment, the Task Force recommended more studies related to: different methods of financing drug abuse treatment services within and outside of conventional health insurance and payment mechanisms; the application of new methods for quantifying cost-benefit, cost-effectiveness, and cost-utility; quantifying changes in quality-of-life associated with successful treatment of drug abuse disorders; performance-contracting models designed to provide payment contingent upon outcomes; and different models of risk adjustment to health plans and providers.
NIDA's Clinical Trials Network (CTN) is an important foundation upon which to conduct economics research sought in this PA. The CTN was established in 1999 to study the impact of evidence-based practices in diverse settings and populations. Economic research is needed to determine the cost-benefit or cost-effectiveness of the interventions under study in CTN. Research in financing and managed care could also be beneficial in the context of the CTN program.
Cross-Cutting Themes: HIV/AIDS and Health Disparities
HIV/AIDS. HIV/AIDS as it relates to the prevention and treatment of drug use, abuse, and dependency continues to represent high public health priorities for these Institutes. The catastrophic medical expenses and premature disability due to AIDS can have a devastating impact on the well being of the afflicted individual. Society also experiences numerous negative consequences from the HIV/AIDS and indeed some nations are experiencing health system failures. Furthermore, persons with HIV/AIDS also face other blood borne infections, and of particular concern, is hepatitis C (HCV).
Public health experts maintain that in order to achieve declines in AIDS incidence and deaths, HIV-infected persons must seek testing earlier in the course of their disease, receive and adhere to treatment, and follow prevention guidelines. Research to achieve these goals must involve an economic component concerned with the economic behavior of consumers, providers, government agencies, and third party payers. Applications are sought that would employ the methods of economic analysis to pressing problems in the financing and delivery of HIV/AIDS services and drug abuse treatment and/or prevention services. For information on grant solicitation on HIV/AIDS, see PA-02-164 at: http://grants.nih.gov/grants/guide/pa-files/PA-02-164.html.
Health Disparities. Substantial disparities exist in the distribution of health services to various populations in the United States. Research on the economics of health disparities is needed to expand the theoretical and conceptual basis as well as improve empirical measurements of health disparities. Considerable work is needed in both health care financing and service distribution and the concept of health equity. Economic research may improve our knowledge about causes of drug abuse, alcohol abuse, and addiction among all racial/ethnic groups, recognizing diversity by gender, socioeconomic status, and other factors affecting racial/ethnic populations. Economic research might also focus on prevention and treatment for racial/ethnic groups at highest risk for abuse or addiction and the medical consequences of drug and/or alcohol abuse.
Research Areas
Researchers are encouraged to develop rigorous designs for studies in the economics of prevention and treatment services for drug and/or alcohol abuse. The following are illustrative problem areas that may be addressed under this announcement. The examples are not exhaustive, and applications that address additional or different research questions are anticipated.
Financing of Prevention and Treatment Services for Drug and/or Alcohol Abuse
Fundamental questions to be examined include: (1) What criteria should be applied in judging budget policies? (2) What are the social, political, economic, and historical forces that have formed the present funding pattern and will determine contemporary and future patterns? (3) What are the interactions between the private and public drug services sectors as various funding plans are devised? Financing issues are complex, and in addition to analytical studies, this area of research requires descriptive studies to identify the sources of funding and their relationship to the organization and delivery of prevention and treatment services. Research topics in this broad area may be refined into two subtopics:
Health Insurance. Private and publicly sponsored health insurance coverage for prevention and treatment services for drug abuse or alcohol abuse affects many participants in the prevention and treatment service delivery systems. Examples of research topics include:
Payment Mechanisms. Payment mechanisms affect the degree of access to, and delivery, utilization, and quality of prevention and treatment services for drug abuse or alcohol abuse. Examples of such studies include:
Alternative Delivery Systems and Managed Care
Substance abuse treatment services are frequently delivered in managed, behavioral health care organizations that combine insurance and delivery functions. Research is needed on access to, and quality, outcomes, and costs of delivering services in alternative or capitated payment environments. Examples of such studies include:
Cost-Benefit, Cost-Effectiveness, and Cost-Utility Analysis
The analysis of the economic costs and benefits associated with prevention and treatment services for drug and alcohol abuse interventions has usually been pursued in conjunction with effectiveness studies. Cost-effectiveness studies are useful in comparing different prevention and treatment interventions, including comparisons of innovative vs. standard interventions. There is a paucity of cost-utility studies reflecting the preference-based assessment of health outcomes associated with treatment for drug abuse or alcohol abuse; more such studies are needed. Examples of such studies include:
Cost and Production of Prevention and Treatment Services for Drug and Alcohol Abuse
A strong conceptualization and measurement of economic costs is needed to support economic evaluations of prevention and treatment programs, as well as studies of the economic costs to society associated with substance abuse and dependency disorders. Additional production function studies are a key complement to drug prevention and treatment cost studies and have not been done. Examples of such cost and production research include:
Methodological Research
Research is encouraged that will develop and test the application of new methods of economic analysis in substance abuse health services research. Examples include:
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Section II. Award Information1. Mechanism(s) of Support
This funding opportunity will use the NIH Research Project Grant (R01), collaborative R01s, Small Grant (R03), and Exploratory/Developmental Grant (R21) award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.
Information on the Collaborative R01 mechanism is available at: http://grants.nih.gov/grants/guide/pa-files/PA-01-123.html
Information on the Small Grant (R03) is available at: http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html
Information on the Exploratory/Developmental Grant (R21) is available at: http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html
This funding opportunity uses just-in-time concepts. It also uses the modular and non modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/modular/modular.htm).
2. Funds Available
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 IC(s) 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 Information1. Eligible Applicants
1.A. Eligible Institutions
You may submit (an) application(s) if your organization has any of the following characteristics:
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.
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
Not applicable
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) 710-0267, Email: [email protected].
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 a unique research opportunity not available in the U.S.
3. Submission Dates and Times
See Section IV.3.A for details.
3.A. Submission, Review and Anticipated Start Dates
Application Submission Dates(s): Standard receipt dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
Peer Review Date(s): June-July, October-November, and February-March: http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): September, February, and May: http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date: October, March, and June: http://grants.nih.gov/grants/funding/submissionschedule.htm
3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.
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 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).
3.C. Application Processing
Applications must be submitted on or before the application receipt dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.
Upon receipt, applications will be evaluated for completeness by CSR. Incomplete 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. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.
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.
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.
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.
Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year
Applicants requesting $500,000 or more in direct costs for any year must carry out the following steps:
1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;
2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and,
3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.
This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
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.
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 Information1. Criteria
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established PHS referral guidelines.
Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.
As part of the initial merit review, all applications will:
The following will be considered in making funding decisions:
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
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)?
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?
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).
Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.
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. Program staff will be responsible for the administrative review of the plan for sharing research data.
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. P rogram 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
Not applicable
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 Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the Notice of Grant Award will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of Grant Award 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 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.
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/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).
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 ContactsWe 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:
Sarah Q. Duffy, Ph.D.
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse
6001 Executive Blvd.
Room 5181, MSC 9589
Bethesda, MD 20892-9589
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 451-4998
Fax: (301) 443-6815
Email: [email protected]
2. Peer Review Contacts:
Not applicable
3. Financial or Grants Management Contacts:
Gary Fleming, J.D.
Chief, Grants Management Branch/OPRM
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Room 270
Bethesda, MD 20892
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: [email protected]
Judy Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3023, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 443-4704
Email: [email protected]
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; NIAAA Guidelines for Data and Safety Monitoring Plans, http://www.niaaa.nih.gov/extramural/guidelines.htm).
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/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.
HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse : Researchers funded by NIDA who are conducting research in community outreach settings, clinical, hospital settings, or clinical laboratories and have ongoing contact with clients at risk for HIV infection, are strongly encouraged to provide HIV risk reduction education and counseling. HIV counseling should include offering HIV testing available on-site or by referral to other HIV testing service for persons at risk for HIV infection including injecting drug users, crack cocaine users, and sexually active drug users and their sexual partners. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html.
National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects : The National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Home Page at http://www.nida.nih.gov under the Funding, or may be obtained by calling (301) 443-2755.
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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