TESTING INTERVENTIONS TO IMPROVE ADHERENCE TO PHARMACOLOGICAL TREATMENT REGIMENS
Release Date: January 19, 2000
RFA: OD-00-006
Office of Behavioral and Social Sciences Research
National Cancer Institute
National Human Genome Research Institute
National Heart, Lung, Blood Institute
National Institute on Aging
National Institute on Alcohol Abuse and Alcoholism
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institute of Child Health and Human Development
National Institute of Dental and Craniofacial Research
National Institute of Diabetes and Digestive Disorders and Kidney
Disease
National Institute on Drug Abuse
National Institute of Mental Health
National Institute of Nursing Research
Letter of Intent Receipt Date: March 6, 2000
Application Receipt Date: April 6, 2000
THIS RFA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT
INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS
THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA
PURPOSE
The Office of Behavioral and Social Sciences Research, National Cancer
Institute, National Human Genome Research Institute, National Heart,
Lung, Blood Institute, National Institute on Aging, National Institute
on Alcohol Abuse and Alcoholism , National Institute of Arthritis and
Musculoskeletal and Skin Diseases, National Institute of Child Health
and Human Development, National Institute of Dental and Craniofacial
Research, National Institute of Diabetes and Digestive Disorders and
Kidney Disease, National Institute on Drug Abuse, National Institute of
Mental Health, and the National Institute of Nursing Research invite
applications for research project (R01) grants in order to encourage
behavioral and social research on the effectiveness of interventions to
improve adherence to therapeutic regimens in various settings.
This RFA is responsive to Congressional Report Language for the FY 2000
Appropriations that urges the Office of Behavioral and Social Sciences
Research [and several NIH Institutes] to stress the need for all
institutions to fund behavioral and social sciences research to improve
adherence to medical regimes, exercise and weight reduction programs.
The RFA is consistent with and based upon recommendations in several
recent reviews of the scientific literature and set forth by advisory
groups to NIH Institutes and Centers.
Applications in response to this RFA must propose research on adherence
to therapeutic treatment regimens where:
1) the therapeutic regimen includes a pharmacological treatment,
2) the therapeutic regimen must be for an existing illness or
condition, whether acute or chronic, as opposed to a health
promotion regimen,
3) the adherence intervention has been (a) demonstrated to be
efficacious in controlled settings (e.g., laboratories, clinical
trials), (b) tested only with limited populations (e.g., small
samples or samples from restricted populations) or with short
periods of follow-up, or (c) researched on a health condition or
treatment regimen different from that in the proposed research,
4) the adherence intervention targets individuals, formal or informal
health-care providers, and/or the social or institutional
environment, and
5) there are measurements of (a) the delivery of the specified
therapeutic regimen and adherence intervention (i.e., treatment
fidelity) and of (b) adherence to the regimen.
In addition, applicants are encouraged to investigate how to adjust
interventions to take into account the characteristics of different
populations as well as people suffering from and receiving treatments
for multiple acute and/or chronic illnesses and conditions. This RFA is
an opportunity to conduct research cutting across the traditional
boundaries of responsibility of the participating NIH Institutes and
Centers (ICs).
HEALTHY PEOPLE 2000
Each NIH RFA addresses one or more of 22 Health Promotion and Disease
Prevention priority areas. These areas can be found at
http://odphp.osophs.dhhs.gov/pubs/hp2000.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic for-profit and non-profit
organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of state and local governments, and
eligible agencies of the Federal government. Foreign organizations are
not eligible. However, foreign organizations may participate if they
are components of domestic, U.S. organizations or via contractual or
consortium agreements with domestic, U.S. organizations. Racial/ethnic
minority individuals, women, and persons with disabilities are
encouraged to apply as principal investigators. Questions about
eligibility may be addressed to the program contacts listed in the
INQUIRIES section.
MECHANISM OF SUPPORT
This RFA will use the National Institutes of Health (NIH) regular
research grant (R01) mechanism. This mechanism supports the full range
of research from basic to clinical intervention studies, as well as
health services, policy and surveillance research. The Principal
Investigator will be responsible for the planning, direction, and
execution of the proposed research project. Awards will be administered
according to the most recent NIH Grants Policy Statement.
Specific application instructions have been modified to reflect
"MODULAR GRANT" and "JUST-IN-TIME" application procedures. Complete and
detailed instructions and information on Modular Grant applications can
be found at http://grants.nih.gov/grants/funding/modular/modular.htm
and in the NIH Guide to Grants and Contracts, December 15, 1998
(http://grants.nih.gov/grants/guide/notice-files/not98-178.html). For
this RFA, the budgetary maximum specified in these general instructions
for Modular Grants should be disregarded. (See FUNDS AVAILABLE.)
FUNDS AVAILABLE
The Office of Behavioral and Social Research is making available
$3,000,000 for the support of approximately six new research grants in
response to this RFA. The total project period for an application may
not exceed five years. Direct costs in the first year of the award may
not exceed $350,000 and the accumulated direct costs over five years
may not exceed $1,750,000. Research projects with costs less than
$350,000 per year are encouraged.
In order to facilitate financial planning of the NIH, applicants are
strongly encouraged to develop budgets with the same number of modules
in each year of the award. That is, it is highly desirable to have
flat or even budgeting across the years of support. Deviations from
even budgeting should be well justified. The anticipated award date for
all applications is September 29, 2000. Funding in response to this RFA
is dependent upon the receipt of a sufficient number of applications of
high scientific merit. At this time, it is not known if this RFA will
be reissued at a future date.
RESEARCH OBJECTIVES
(1) Background
Several recent reports and literature reviews point to the continuing
need for improving adherence to therapeutic regimens. (See REFERENCES.)
Adherence rates vary considerably across diseases and treatments,
measuring instruments, and populations, with rates ranging from 30% to
60% in many instances. Most researchers agree that at least 50% of
persons for whom drugs are prescribed fail to receive the full benefit
through inadequate adherence. As noted by the American Heart
Association (1997), the rationale for enhancing [adherence] is based
on the premise that the patient will get well or stay well if the
physician, other healthcare providers, and the healthcare organization
make appropriate recommendations, providing the patient has the
requisite knowledge, motivation, skills, and resources to follow the
recommendations. Lack of adherence to therapeutic regimens may result
in poorer health for individuals as well as economic costs for their
health-care organizations and the broader society.
The reasons for non-adherence are multifaceted and not fully
understood. Health-care providers, organizational systems, and personal
factors all play a role in adherence to therapeutic regimens. Thus, to
understand and eventually improve adherence, conceptual frameworks and
interventions need to take into account institutional, system,
situational, interpersonal, and personal factors as well as the
characteristics of the illness or condition and of the treatment
regimen.
Research has demonstrated the efficacy of a variety of approaches to
improving adherence to therapeutic regimens in controlled laboratory or
field experimental situations, in small, selected samples, or over
limited periods of time. Less is known about the effectiveness of
interventions when they are moved from controlled research settings to
where health care is actually practiced with individuals of varied
backgrounds over extensive periods of time. How does the success of
interventions to improve adherence vary across types of health-care
providers, settings, and persons of varying educational, economic, and
ethnic backgrounds? What adjustments may be needed to implement
interventions in the real world of health care and under what
circumstances?
In addition to research on effectiveness, opportunities may exist for
research on adapting and assessing the efficacy of promising
intervention strategies that have been used successfully to improve
adherence, but in small, selected (e.g., unrepresentative) samples.
Similarly, behavior-change strategies that have been successful in one
domain may hold promise for improving adherence to therapeutic regimens
for other illnesses or health conditions.
(2) Areas of Emphasis
In order to concentrate available resources, this RFA stipulates five
requirements for research on adherence. Research grant applications
must address all five requirements to be considered responsive to this
RFA. Subsequent funding initiatives may be issued to address other
aspects of adherence. Special emphasis is given to adherence research
in diverse racial/ethnic and socioeconomic status populations.
1. The therapeutic regimen must include a pharmacological treatment.
This treatment may be combined with behavioral or other kinds of
treatments of illnesses or conditions.
2. The therapeutic regimen must be for an existing illness or condition
as opposed to health promotion regimens. See below for examples of
diseases or conditions of interest to the participating NIH
Institutes. While research on changing behaviors to promote health
is important, it lies outside of the purview of this RFA. The NIH
does continue to encourage such research. Most recently, several ICs
joined to solicit such research through the RFA on Innovative
Approaches to Disease Prevention through Behavior Change, NIH Guide
to Grants and Contracts, Volume 26, Number 36, October 24, 1997
(http://grants.nih.gov/grants/guide/rfa-files/RFA-OD-98-002.html).
3. The research must address either (a) the translation of
interventions already demonstrated to be efficacious in controlled
experimental situations to field or practice settings or (b) the
further development of efficacious interventions previously tested
in small, selected samples or with specific diseases and health
conditions. The major emphasis of the RFA is on effectiveness
research as opposed to efficacy research. The research should be
aimed at determining if and how efficacious interventions may be
transported to clinical and community settings. Research on testing
the applicability or generalizability of interventions to broader
groups of individuals (e.g., differing in socioeconomic status,
race, ethnicity, in medical conditions and illnesses) is also
appropriate. However, proposals to develop interventions de novo
(i.e., those without a prior history of development in any treatment
area) fall outside the scope of this RFA.
4. The intervention may target individuals, formal or informal health-
care providers, and/or the social or health-care environments.
Interventions may operate on multiple levels and targets in order to
improve adherence. For example, interventions may attempt to enhance
adherence by increasing people’s knowledge, skills, and motivation,
by instructing health-care providers on how to better provide
information, guidance, or monitoring, by involving the individual’s
social network, or by altering aspects of the health-care system.
5. Explicit conceptualization and measurement of the therapeutic
regimen (i.e., health treatment delivery), the intervention(s) to
improve adherence, and of adherence behaviors are essential.
Research projects should include appropriate measures of the
delivery of the specified therapeutic regimen and adherence
intervention as well as measures of adherence.
In addition to the preceding five emphases, research projects may
address such issues as the following:
o How should the intervention be adjusted to take into account the
characteristics of different populations? Interventions may not work
equally well for all persons depending on their educational, economic,
and cultural backgrounds and circumstances. Are particular groups at
high risk for non-adherence? How should the intervention take this into
account?
o What are the consequences for adherence, if any, of an individual
suffering from and receiving treatments for multiple illnesses and
conditions? An intervention may improve adherence for one treatment
aimed at a specific condition, but it may interfere with adherence to a
regimen for treating another condition. How do interventions to improve
adherence to acute conditions interface with therapeutic regimens for
treating chronic illnesses or conditions (and vice versa)? Research
investigating situations of multiple morbidity cutting across the
traditional boundaries of NIH ICs is particularly encouraged.
o How can the proposed intervention be improved based upon research
results? Research proposals may include provisions making adjustments
to the intervention based upon assessing the effectiveness of the
interventions midway through the grant period. That is, the research
may be divided into two phases. The first phase would consist of a test
of the intervention as originally proposed in the application. During
the second phase, based upon research results obtained during the first
phase, the researchers may fine tune the intervention and assess the
results of this adjustment.
Several NIH Institutes have joined with OBSSR to support this
initiative. Examples of topics of interest to specific NIH Institutes
are given below. These examples are not meant to be an exhaustive list
of the research of interest to the NIH. Additional topical areas and
approaches designed to better understand and increase adherence to
pharmacological therapeutic regimens are welcomed.
NATIONAL CANCER INSTITUTE
NCI is interested in behavioral and social sciences research on
promoting adherence to therapeutic regimens effective in the management
of cancer. ATherapeutic regimens@ are broadly defined to include not
only active anticancer treatments but also post-chemotherapeutic
administration of compounds to prevent/minimize recurrence and prevent
post-treatment toxicities (e.g., steroid and growth factor
administration or reduce sun light exposure post-photodynamic therapy).
Examples of therapeutic regimens that pose particular problems in
adherence include but not limited to interferon treatment for melanoma,
topical application of drugs in mycosis fungoides, oral maintenance
therapy for ALL and oral treatment regimens in CLL. NCI has special
interest in promoting research that may lower barriers to effective
therapy for children and the aged as well as for the underserved.
NATIONAL HUMAN GENOME RESEARCH INSTITUTE
As human genetic research progresses and as more is learned about the
role that genes play in the development of common disorders, it will
become increasingly possible to provide individuals with information
about the genetic contribution to their disorder. Currently, there is
no data on the impact of genetic information on individuals" adherence
to therapeutic regimens. Will individuals who are found to have genes
or genetic markers associated with their own disorder be more, equally,
or less likely to adhere to proposed therapeutic regimens? The NHGRI,
through its Ethical, Legal, and Social Implications Research (ELSI)
program, is interested in supporting research to explore what impact
individualized information about the genetic contribution to particular
disorders, including common complex adult-onset disorders, will have on
an individual"s adherence to therapeutic regimens. For example, women
who are known to be at increased risk to develop breast cancer, due to
familiy history, BRCA mutations, or other factors, may be put on a
regimen of tamoxifen or raloxifen. What impact will knowledge of BRCA1
mutation status have on an individual"s adherence to a tamoxifen or
raloxifen regimen? Special consideration will be given to studies that
examine the impact of this information on individuals from different
socio-cultural and socioeconomic groups.
NATIONAL HEART, LUNG, BLOOD INSTITUTE
The NHLBI supports studies that seek to improve rates of adherence to
medical and behavioral regimens used in preventing and treating heart,
lung, blood and sleep diseases and disorders. The NHLBI is also
interested in studies that investigate how psychological, social,
behavioral, biological, cultural and health care systems factors
influence adherence. Examples of therapies and conditions where
adherence poses special problems include antihypertensive therapies,
cholesterol-lowering medications, medications used to treat myocardial
infarction and congestive heart failure, and treatments for asthma,
tuberculosis and sickle cell disease. Areas of special interest include
effectiveness studies involving development and testing of adherence-
enhancing interventions in health-care and community settings,
investigations of the cultural, social and health care system factors
that affect adherence, research on the determinants of and optimal
approaches to changing provider behavior and practices, and use of new
technologies (e.g., computer-based approaches) in the measurement and
promotion of adherence.
NATIONAL INSTITUTE ON AGING
The NIA seeks research on biological, behavioral, cognitive, social and
economic factors that affect adherence to medications and other
behavioral regimens in the middle and later years. NIA is interested in
adherence behavior to both acute and chronic treatment recommendations
for a broad range of co-morbidities prevalent in old age (e.g.,
Alzheimer’s disease, arthritis, cancer, diabetes, heart disease,
infectious diseases, stroke). Of special interest is an examination of
age-related processes and conditions (e.g., multiple medication use,
multiple morbidities, cognitive changes, transitions in living
arrangements and social supports, and the nature of provider-patient
interactions and clinical decision-making) that affect adherence
behaviors and that are important in the design of appropriate adherence
interventions for older adults. Psychosocial and economic mediators and
outcomes of multi-level intervention approaches should be considered.
For background material and emphasis areas see NIA’s recent program
announcement PA-99-07 on Diversity in Medication Use and Outcomes in
Aging Populations - May 1999 that can be can be found on the Web at
http://www.nih.gov/nia/resfund/bsr.htm.
NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM
The NIAAA is the lead federal agency responsible for research on the
causes, consequences, prevention and treatment of alcohol-related
problems. Research is currently being funded to develop and test
pharmaceutical agents to treat alcoholism. Of interest is the
identification of practical, effective techniques to enhance adherence
to medication regimens, given alone or in combination with psychosocial
therapy, for the treatment of alcohol abuse and alcohol problems.
NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
NIAMS is interested in behavioral and social sciences research on
promoting adherence to therapeutic regimens effective in the management
of arthritis and other rheumatic diseases, muscle diseases,
musculoskeletal disorders, bone diseases including osteoporosis, and
skin diseases. NIAMS has special interest in promoting research which
may lower barriers to effective therapy for underserved populations.
NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
NICHD is interested in research to elucidate behavioral mechanisms
involved in adherence to medical and therapeutic regimens for children
and adolescents with acute and chronic illnesses, injuries, stress and
pain as well as behavioral and attentional disorders. Of interest are
intervention studies examining motivational factors and deterrents to
adherence in children, their parents/caretakers, and health care
providers.
NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
NIDCR is interested in the development and translation of effective
interventions to increase adherence to fluoride, antimicrobial,
antibiotic, analgesic, or other pharmacological regimens used in
treating oral diseases such as dental caries, periodontal diseases,
salivary disorders and xerostomia, TMJ disorders, and trigeminal
neuralgia or other orofacial pain disorders as well as the pain,
swelling, or inflammation associated with dental procedures or with
surgeries to correct craniofacial defects. NIDCR is also interested in
research to increase adherence to treatment regimen involving
pharmacological approaches to reduce oral complications of systemic
diseases, such as diabetes or HIV, or oral complications of medical
interventions, such as chemotherapy or radiation. In addition, research
projects utilizing oral biomarkers, such as salivary measures, to
assess or enhance adherence to pharmacological regimens are of specific
interest to NIDCR.
NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE DISORDERS AND KIDNEY
DISEASE
NIDDK is interested in development and translation of effective
interventions to increase adherence to medical regimens for diabetes,
obesity, genetic metabolic diseases and endocrine, renal, urologic,
hematologic, digestive, and liver diseases. Examples of topics of
interest to NIDDK include: interventions to increase adherence
behaviors affecting glycemic control and other diabetes outcomes,
interventions to improve post-transplant medication compliance,
improved treatment of depression in patients with diabetes or on
dialysis, interventions targeted at increasing compliance in
adolescents, development of interventions in the context of ethnicity,
culture and SES, and studies of interactions between care providers and
patients leading to improved adherence and outcome.
NATIONAL INSTITUTE ON DRUG ABUSE
NIDA is interested in research aimed at improving interventions that
promote adherence to medication in individuals who are addicted to
drugs (including but not limited to cocaine, nicotine, opiates,
marijuana, prescription drugs, etc.). Of particular interest is
research that integrates new developments in basic behavioral,
cognitive, or clinical science to refine, test and improve the
effectiveness of adherence interventions. Adherence to medication for
drug addiction or adherence to medication for a co-morbid physical
and/or mental health problem may be the focus of the research. A
related announcement, delineating a Stage Model for behavioral
intervention research, Behavioral Therapies Development Program, NIDA
PA-99-107, can be found at
http://grants.nih.gov/grants/guide/pa-files/PA-99-107.html.
NATIONAL INSTITUTE OF MENTAL HEALTH
NIMH is interested in expanding research on adherence and behavior
change that integrates findings from the basic behavioral sciences with
interventions for mental disorders, symptoms, or related disability.
Included are studies of mechanisms and processes that enhance and/or
interfere with adherence to preventive, pharmacological, psychosocial,
and rehabilitative treatments. Potential research topics germane to
adherence to interventions for mental disorders are listed in NIMH PA-
00-16 "Research on Adherence to Interventions for Mental Disorders"
which can be can be found on the Web at
http://www.nimh.nih.gov/grants/pamenu.htm.
NATIONAL INSTITUTE OF NURSING RESEARCH
NINR is interested in research studies that involve nursing
interventions or that have a direct impact on client adherence by a
health team. NINR promotes research in health care and outcomes across
all ages, in diverse populations, and for a wide variety of acute and
chronic health conditions. NINR is interested in studies involving
interventions to promote adherence behaviors. In addition to the client
group, interventions may involve health care providers, family members,
or other key individuals or groups involved in the process of promoting
adherence. NINR encourages applications that include both
pharmacological and other adherence interventions.
REFERENCES
American Heart Association, The Multilevel Compliance Challenge:
Recommendations for a Call to Action, Circulation, 1997, 95:1085-1090.
D. L. Roter, J. A. Hall, R. Merisca, B. Nordstrom, D. Cretin, and B.
Svarstad, Effectiveness of interventions to improve patient compliance,
Medical Care, 36, 8, 1998, pp. 1138-1161
Center for the Advancement of Health, Health Care Financing
Administration, and National Institute on Aging, Interventions to
Improve Adherence to Medical Regimens in the Elderly. Washington, DC:
Center for Advancement of Health, 1999
R. B. Haynes, K. A. McKibbon, R. Kanani, M. C. Brouwers, and T. Oliver,
Interventions for helping patients to follow prescriptions for
medications, The Cochrane Library, 1999, Issue 1.
SPECIAL REQUIREMENTS
(a) DATA AND SAFETY MONITORING. A clinical trial entails a relationship
between participants and investigators, both of whom must fulfill
certain obligations for the effort to succeed. Participants must be
fully informed of the study requirements throughout the conduct of the
trial and should comply with the rigors of the research protocol or be
allowed the opportunity to withdraw from participation. The
investigators must protect the health and safety of participants,
inform participants of information relevant to their continued
participation, and pursue the research objectives with scientific
diligence. In 1994, the NIH Office of Extramural Research established
the Committee on Clinical Trial Monitoring to review the oversight and
management practices of the ICs for phase III clinical trials. One of
the outcomes of this Committee"s review was a strong recommendation
that "all trials, even those that pose little likelihood of harm,
should consider an external monitoring body."
Applicants should describe and budget for the organizational structures
and procedures they will employ to ensure the safety of participants
and the validity and integrity of the data. (For a statement of issues
and concerns, see NIH Policy for Data and Safety Monitoring, NIH
Guide to Grants and Contracts, Release Date: June 10, 1998,
http://grants.nih.gov/grants/guide/notice-files/not98-084.html.) At the
time of the award, applicants should be prepared to make adjustments to
their procedures based upon the policies of the NIH Institute/Center
administering their grant.
(b) SAMPLE SIZE/DATA ANALYSIS. Assumptions and steps used to arrive at
the proposed sample size must be described. Discussion should be
devoted to analytic features of the study including primary endpoint
specification, statistical power estimates, randomization procedures,
statistical methods, and use of the intention-to-treat principle (i.e.
whether the primary analysis will be carried out based on the original
treatment assignment versus treatment administered), as applicable.
(c) LEVERAGING. Applicants should consider taking advantage of other
research projects (e.g., clinical trials about to be implemented) that
could be expanded by adding a research component on adherence. Such
projects might provide access to subject populations or settings as
well as reduce the costs of conducting research.
(d) ANNUAL MEETINGS AND COLLABORATION. Successful applicants will be
asked to participate in yearly meetings to report progress, discuss
problems, and share information related to the conduct of their grants.
Previous experience with such meetings has shown that they can provide
opportunities for grantees to work collaboratively in various areas
such as measurement of treatment fidelity and adherence, techniques for
participant recruitment and retention, development and implementation
of interventions, and data archiving and sharing. Cooperation across
funded studies increases their value by facilitating the accumulation
of comparable knowledge and experience. Applicants should include in
their budget funds for two or three investigators to attend the annual
collaborative meetings to be held in Bethesda, MD, at the NIH. The
first of these meetings will be held in November or December 2000.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
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
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
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 research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH
Guide for Grants and Contracts, Volume23, Number 11, March 18, 1994.
Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES. Program staff may also provide additional
relevant information concerning the policy.
NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS
IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of NIH that children (i.e., individuals under the age
of 21) must be included in all human subjects research, conducted or
supported by the NIH, unless there are scientific and ethical reasons
to exclude them. (See NIH Guide to Grants and Contracts, March 6, 1998
or http://grants.nih.gov/grants/guide/notice-files/not98-024.html.)
Investigators also may obtain copies of these policies from the program
staff listed under INQUIRIES. Program staff may also provide additional
relevant information concerning the policy.
LETTER OF INTENT
Prospective applicants are asked to submit, by March 6, 2000, a letter
of intent that includes a descriptive title of the proposed research,
the name, address, and telephone number of the Principal Investigator,
the identities of other key personnel (including research project
collaborators and consultants) and participating institutions, and the
number and title of this RFA. Although a letter of intent is not
binding and does not enter into the review of a subsequent application,
the information that it contains allows NIH staff to estimate the
potential review workload and avoid conflict of interest in the review.
The letter of intent should be sent to:
Dr. Ronald P. Abeles
Office of Behavioral and Social Sciences Research
National Institutes of Health
Gateway Building, Rm. 2C234
7201 Wisconsin Ave., MSC 9205
Bethesda, MD 20892-9205
Telephone: 301-496-7859
Fax: 301-435-8779
E-mail: Abeles@nih.gov
APPLICATION PROCEDURES
The research grant application form PHS 398 (rev. 4/98) must be used in
applying for these grants, with the modifications noted below.
Applications kits are available at most institutional offices of
sponsored research and from the Division of Extramural Outreach and
Information Resources, National Institutes of Health, 6701 Rockledge
Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301-710-0267, E-
mail: GrantsInfo@nih.gov. Applications are also available on the World
Wide Web at http://grants.nih.gov/grants/forms.htm.
The MODULAR GRANT concept establishes specific modules in which direct
costs may be requested as well as a maximum level for requested
budgets. Only limited budgetary information is required under this
approach. The JUST-IN-TIME concept allows applicants to submit certain
information only when there is a possibility for an award. It is
anticipated that these changes will reduce the administrative burden
for the applicants, reviewers and Institute staff.
MODULAR GRANT applications request direct costs in $25,000 modules, up
to a total direct cost request of $350,000 per year. For the purposes
of this RFA, the usual maximum of $250,000 for modular awards does NOT
apply. The total direct costs must be requested in accordance with the
program guidelines and the modifications made to the standard PHS 398
application instructions described below:
(a) PHS 398
o FACE PAGE: Items 7a and 7b should be completed, indicating Direct
Costs (in $25,000 increments up to a maximum of $350,000) and Total
Costs [Modular Total Direct plus Facilities and Administrative (F&A)
costs] for the initial budget period Items 8a and 8b should be
completed indicating the Direct and Total Costs for the entire proposed
period of support.
o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form
Page 4 of the PHS 398. It is not required and will not be accepted with
the application.
o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete
the categorical budget table on Form Page 5 of the PHS 398. It is not
required and will not be accepted with the application.
Applications should include in their budgets funds for attending an
annual meeting of research projects funded under this RFA. For
budgeting purposes, applicants should assume that the meetings would be
for two days in Bethesda, Maryland at the National Institutes of Health
and require the attendance of two or three investigators per funded
project. (See SPECIAL REQUIREMENTS, (d) ANNUAL MEETINGS AND
COLABORATION.)
o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget
Narrative page. (See
http://grants.nih.gov/grants/funding/modular/modular.htm for sample
pages.) At the top of the page, enter the total direct costs requested
for each year. This is not a Form page.
Under Personnel, List key project personnel, including their names,
percent of effort, and roles on the project. No individual salary
information should be provided. However, the applicant should use the
NIH appropriation language salary cap and the NIH policy for graduate
student compensation in developing the budget request.
For Consortium/Contractual costs, provide an estimate of total costs
(direct plus facilities and administrative) for each year, each rounded
to the nearest $1,000. List the individuals/organizations with whom
consortium or contractual arrangements have been made, the percent
effort of key personnel, and the role on the project. Indicate whether
the collaborating institution is foreign or domestic. The total cost
for a consortium/contractual arrangement is included in the overall
requested modular direct cost amount. Include the Letter of Intent to
establish a consortium.
Applicants are strongly encouraged to request the same number of
modules for each year of funding. Provide an additional narrative
budget justification for any variation in the number of modules
requested.
o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information
used by reviewers in the assessment of each individual"s qualifications
for a specific role in the proposed project, as well as to evaluate the
overall qualifications of the research team. A biographical sketch is
required for all key personnel, following the instructions below. No
more than three pages may be used for each person. A sample
biographical sketch may be viewed at
http://grants.nih.gov/grants/funding/modular/modular.htm.
- Complete the educational block at the top of the form page,
- List position(s) and any honors,
- Provide information, including overall goals and responsibilities,
on research projects
ongoing or completed during the last three years.
- List selected peer-reviewed publications, with full citations,
o CHECKLIST - This page should be completed and submitted with the
application. If the F&A rate agreement has been established, indicate
the type of agreement and the date. All appropriate exclusions must be
applied in the calculation of the F&A costs for the initial budget
period and all future budget years.
o The applicant should provide the name and phone number of the
individual to contact concerning fiscal and administrative issues if
additional information is necessary following the initial review.
(b) Mailing Procedures
The RFA label available in the PHS 398 (rev. 4/98) application form
must be affixed to the bottom of the face page of the application.
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 sample RFA label available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been
modified to allow for this change. Please note this is in pdf format.
Submit a signed, original of the application, including the Checklist,
and four (4) signed photocopies of the application in one package to:
CENTER FOR SCIENTIFIC REVIEW (formerly Division of Research Grants)
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)
At the time of submission, send one (1) additional copies of the
application to:
Dr. Ronald P. Abeles
Office of Behavioral and Social Sciences Research
National Institutes of Health
Gateway Building, Rm. 2C234
7201 Wisconsin Ave., MSC 9205
Bethesda, MD 20892-9205
It is important to send this copy at the same time that the original
and four copies are sent to the Center for Scientific Review (CSR).
Applications must be received by April 6, 2000. If an application is
received after that date, it will be returned to the applicant without
review. The Center for Scientific Review (CSR) will not accept any
application in response to this RFA that is essentially the same as one
currently pending initial review, unless the applicant withdraws the
pending application. The CSR will not accept any application that is
essentially the same as one already reviewed. This does not preclude
the submission of substantial revisions of applications already
reviewed, but such applications must include an introduction addressing
the previous critique.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness by CSR and
responsiveness by the participating NIH entities. Incomplete and
nonresponsive applications will be returned to the applicant without
further consideration. 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 CSR in accordance with
the review criteria stated below. As part of the initial merit review,
all applications will receive a written critique and may undergo a
process in which only those applications deemed to have the highest
scientific merit, generally the top half of applications under review,
will be discussed, assigned a priority score, and receive a second
level review by the appropriate national advisory council or board.
Review Criteria
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.
In the written comments reviewers will be asked to discuss the
following aspects of the application 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 the 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.
In addition to the criteria list below, the initial review group will
examine: the appropriateness of proposed project budget and duration,
the adequacy of plans to include both genders, minorities (and their
subgroups), and childen as appropriate for the scientific goals of the
research, and plans for the recruitment and retention of subjects, the
provisions for the protection of human and animal subjects, and the
safety of the research environment.
(1) SIGNIFICANCE: Does this study address an important problem? If the
aims of the application are achieved, how will scientific knowledge be
advanced? What will be the effect of these studies on the concepts or
methods that drive this field? For Pilot Research Projects, what is the
likelihood that the research will contribute to the development of
interdisciplinary programs or more mature research endeavors?
(2) APPROACH: Are the conceptual framework, design, methods, and
analyses adequately developed, well-integrated, and appropriate to the
aims of the project? Does the applicant acknowledge potential problem
areas and consider alternative tactics?
(3) INNOVATION: Does the project employ novel concepts, approaches or
method? Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies?
(4) INVESTIGATORS: Is each investigator 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 (if any)?
(5) ENVIRONMENT: Does the scientific environment in which the work
will be done contribute to the probability of success of the project?
Do the proposed studies take advantage of unique features of the
scientific environment or employ useful collaborative arrangements?
AWARD CRITERIA
Applications will compete for available funds with all other approved
applications submitted in response to this RFA. The following will be
considered in making funding decisions:
The quality of the proposed project as determined by peer review
o Availability of funds
o The research priorities of the participating NIH Institutes.
INQUIRIES
Inquiries concerning this RFA are encouraged. The opportunity to
clarify any issues or questions from potential applicants is welcome.
Applicants may also subscribe to the OBSSR’s automated e-mail service
in order to obtain subsequent information about this RFA. To subscribe,
please send a message addressed to listserv@list.nih.gov. The message
should read SUBscribe RFA-ADHERENCE-L [your full name]. The message is
case sensitive, so capitalize as indicated! Do not include the
brackets. For example, for Robin Smith to subscribe, the message would
read SUBscribe RFA-ADHERENCE-L Robin Smith (omit the quotation
marks). The subject line should be blank. Subscribers will receive a
confirmation of their subscription along with instructions on how to
use the LISTSERV and how to unsubscribe. Information concerning the
RFA, including Frequently Asked Questions and Answers, will be posted
on the OBSSR HomePage at http://www1.od.nih.gov/obssr/adherence.htm.
(a) Direct GENERAL INQUIRIES to:
Dr. Ronald P. Abeles
Office of Behavioral and Social Sciences Research
National Institutes of Health
Gateway Building, Rm. 2C234
7201 Wisconsin Ave., MSC 9205
Bethesda, MD 20892-9205
Telephone: 301-496-7859
Fax: 301-435-8779
E-mail: Abeles@nih.gov
(b) Direct inquiries regarding specific PROGRAMMATIC ISSUES to the
staff of the appropriate Institute/Center:
Dr. Roy S. Wu
Grants Program Director
NCI
6130 Executive Blvd., EPN 734
Bethesda, MD 20892-7432
Cancer Therapy Evaluation Program
Division of Cancer Treatment and Diagnosis
National Cancer Institute
Telephone: 301-496-8866
Fax: 301-480-4663
E-mail: rw51j@nih.gov
Ms. Elizabeth J. Thomson
Program Director, Ethical, Legal, and Social Implications Research
NHGRI
National Institutes of Health
31 Center Drive, MSC 2033, Room B2B07
Bethesda, MD 20892-2033
Telephone: 301-402-4997
Fax: 301-402-1950
E-mail: et22s@nih.gov
Dr. Susan M. Czajkowski
Behavioral Medicine Research Group
NHLBI
Rockledge II, Rm. 8114
6701 Rockledge Dr. MSC 7938
Bethesda, MD 20892-7938
Telephone: 301-435-0406
Fax: 301-480-1773
E-mail: czajkows@nih.gov
Dr. Marcia G. Ory
Behavioral and Social Research
NIA
Gateway Building, Room 533
7201 Wisconsin Avenue MSC 9205
Bethesda, MD 20892-9205
Telephone: 301-402-4156
Fax: 301-402-0051
E-mail: Marcia_Ory@nih.gov
Dr. Margaret E. Mattson
Treatment Research Branch
Division of Clinical and Prevention Research
NIAAA
Willco Building MSC-7003
6000 Executive Blvd.
Bethesda MD 20892-7003
Telephone: 301-443-0796
Fax: 301-443-8774
E-mail: mmattson@willco.niaaa.nih.gov
Dr. Julia B. Freeman
Centers Program, EP
NIAMS
Natcher Building, Room 5AS.19F - MSC 6500
Bethesda, MD 20892-6500
Bethesda, MD 20814 (for express/courier service)
Telephone: 301-594-5052
Fax: 301-480-4543
E-mail: Julia_B_Freeman@nih.gov
Dr. Lynne M. Haverkos
Child Development and Behavior Branch
NICHD
6100 Executive Boulevard, Room 4B05B, MSC 7510
Bethesda, MD 20892-7510
Telephone: 301-435-6881
Fax: 301-480-7773
E-mail: lh179r@nih.gov
Dr. Patricia Bryant
Program Director, Behavioral and Health Promotion Research
Office of Clinical, Behavioral, and Health Promotion Research
NIDCR
Natcher Building, Rm 4AN24E
Bethesda, MD 20892-6402
Telephone: 301-594-2095
Fax: 301-480-8318
E-mail: BryantP@de45.nidr.nih.gov
Dr. Sanford Garfield
Senior Advisor for Biometry and Behavioral Research
NIDDK
Bldg. 45, Rm. 5AN24B
45 Center Drive MSC 6600
Bethesda, MD 20892-6600
Telephone: 301-594-8803
Fax: 301-402-6271
E-mail: garfields@extra.niddk.nih.gov
Dr. Lisa Onken
Behavioral Treatment Development Program
NIDA
6001 Executive Blvd., Room 4227, MSC 9541
Bethesda, MD 20892-9541
Telephone: 301-443-0107
Fax: 301-443-8674
E-mail: lonken@mail.nih.gov
Dr. Robert K. Heinssen
Chief, Adherence and Behavior Change Research Program
Acting Chief, Psychotic Disorders Research Program
Division of Mental Disorders, Behavioral Research and AIDS
NIMH
Room 6190, Mail Stop 9615
6001 Executive Blvd.
Bethesda, MD 20892-9615
Telephone: 301-435-0371
Fax: 301-443-4611
E-mail: rheinsse@mail.nih.gov
Dr. Nell Armstrong
Program Director
NINR
Building 45, Room 3AN12
Bethesda MD 20892-6300
Telephone: 301-594-5973
Fax: 301-480-8260
E-mail: nell_armstrong@nih.gov
(c) Direct inquiries regarding FISCAL MATTERS to the staff of the
appropriate Institute/Center:
Ms. Eileen M. Natoli
Grants Administration Branch
NCI
6120 Executive Blvd.
EPS - 243
Rockville, Md. 20852
Telephone: 301-496-8791
Fax: 301-496-8601
natolie@gab.nci.nih.gov.
Ms. Jean M. Cahill
Chief Grants Management Officer
NHGRI
31 Center Drive Rm. B2B34
MSC 2031
Bethesda, MD 20892-2031
Telephone: 301-435-7858
Fax: 301-402-1951
E-mail: Jean_Cahill@NIH.GOV
Ms. Rhonda Mays
Grants Management Office
NHLBI
Rockledge II, Room 7138
6701 Rockledge Dr. MSC 7938
Bethesda, MD 20892-7938
Telephone: 301-435-0186
Fax :301-480-0422
E-mail: maysr@nih.gov.
Mr. Bob Pike
Grants and Contracts Management Office
NIA
Gateway Building, Suite 2N212
7201 Wisconsin Avenue MSC 9205
Bethesda, MD 20892-9205
Telephone: 301-496-1472
Fax: 301-402-3672
E-mail: Bob_Pike@nih.gov
Ms. Judy Simons
Grants Management Branch
NIAAA
Willco Building MSC-7003
6000 Executive Blvd
Bethesda MD 20892-7003
Telephone: 301-443-2434
Fax: 301-443-3891
E-mail: jsimons@willco.niaaa.nih.gov
Ms. Sally A. Nichols
Grants Management Officer
NIAMS
Natcher Building Room 5AS.49F - MSC 6500
Bethesda, MD 20892-6500
Telephone: 301-594-3535
Fax: 301-480-5450
E-mail: nicholss@exchange.nih.gov
Mr. E. Douglas Shawver
Grants Management Branch
NICHD
6100 Executive Boulevard, Room 8A17, MSC 7510
Bethesda, MD 20892-7510
Telephone: 301-435-6999
Fax: 301-402-0915
E-mail: shawverd@exchange.nih.gov
Mr. Martin Rubinstein
Office of Grants Management
NIDCR
Natcher Building, Rm 4AN-44A
Bethesda, MD 20892-6402
Telephone: 301-594-4800
Fax: 301-480-8301
E-mail: Martin.Rubinstein@nih.gov
Ms. Cheryl Chick
NIDDK
Bldg. 45, Rm. 6AN-38J
45 Center Drive MSC 6600
Bethesda, MD 20892-6600
Telephone: 301-594-8825
Fax: 301-480-4237
E-mail: chickc@extra.niddk.nih.gov
Mr. Gary Fleming
Grants Management Branch
NIDA
6001 Executive Blvd., Room 3131, MSC 9541
Bethesda, MD 20892-9541
Telephone: 301-443-6710
Fax: 301-594-6847
E-mail: gf6s@nih.gov
Ms. Diana S. Trunnell
Grants Management Branch
NIMH
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: 301-443-2805
Fax: 301-443-6885
E-mail: Diana_Trunnell@nih.gov
Mr. Jeff Carow
Grants Management Office
NINR
Building 45, Room 3AN12
45 Center Drive, MSC 6301
Bethesda, MD 20892-6301
Telephone: 301-594-6869
Fax: 301-480-8260
E-mail: jeff_carow@nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance
Nos. 93.395 (NCI), 93.172 (NHGRI), 93.937 (NHLBI), 93.866 (NIA), 93.891
(NIAAA), 93.846 (NIAMS), 93.929 (NICHD), 93.121 (NIDCR), 93.279 (NIDA),
93.847/848/849 (NIDDK), 93.859 (NIGMS), 93.242 (NIMH), and 93.361
(NINR). Awards are made under authorization of the Public Health
Service Act, Title IV, Part A (Public Law 78-410), as amended by Public
Law 99-158, 42 USC 241 and 285) and administered under PHS grants
policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This
program is not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review.
The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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