TRAINING FOR A NEW INTERDISCIPLINARY RESEARCH WORKFORCE
RELEASE DATE: December 16, 2003
RFA Number: RFA-RM-04-015 (This RFA has been reissued, see RFA-RM-06-006)
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
This RFA is developed as a roadmap initiative. All NIH Institutes and
Centers participate in roadmap initiatives.
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.849
LETTER OF INTENT RECEIPT DATE: February 10, 2004
APPLICATION RECEIPT DATE: March 10, 2004
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The purpose of this RFA is to encourage and enable the development of an
interdisciplinary workforce by ensuring that undergraduate, pre-doctoral, and
postdoctoral students receive the didactic and research experiences necessary
to lead and/or engage in integrative and team approaches to solve complex
biomedical and health problems. To accomplish this aim, the National
Institutes of Health invites applications for developing and implementing
novel training programs focused on new interdisciplinary science. These
programs will support a variety of new and innovative didactic and research
activities designed to provide students with the necessary knowledge and
research experience to apply interdisciplinary solutions to complex
biomedical and health problems. Applicants are encouraged to build these new
training programs around existing institutional research programs, whether
formal (e.g., research programs supported by program project, center, or
cooperative agreement mechanisms) or informal (e.g., loose networks of
collaborating R01 grantees).
RESEARCH OBJECTIVES
The National Institutes of Health (NIH) is engaged in a series of activities
collectively known as the NIH Roadmap whose goal, in keeping with the NIH
mission of uncovering new knowledge about the prevention, detection,
diagnosis, and treatment of disease and disability, is to accelerate both the
pace of discovery in these key areas and the translation of therapies from
bench to bedside. In the course of developing the NIH Roadmap, it has become
clear that increasingly, scientific advances are being made at the interfaces
of traditional disciplines, and that approaches to science are becoming more
integrative. This requires a cooperative effort, typically in the form of
investigators from diverse research backgrounds working collectively across
traditional disciplinary boundaries to answer scientific questions and
achieve specific endpoints. This also requires a workforce capable of
crossing disciplinary boundaries and leading and participating in integrative
and team approaches to complex biomedical and health problems. Building
research teams for the future has therefore emerged as one of the major
themes in Roadmap implementation. (Additional information about the NIH
Roadmap can be found on the NIH website at: http://nihroadmap.nih.gov/)
NIH is particularly interested in developing a new interdisciplinary research
workforce. An interdisciplinary approach is distinguished from a
multidisciplinary approach in that a multidisciplinary approach brings
experts from diverse disciplines to address collectively a common complex
problem, each from his or her unique perspective. By contrast, an
interdisciplinary approach is what results from the melding of two or more
disciplines to create a new (interdisciplinary) science. Biophysics,
biostatistics, bioinformatics, bioengineering, social neuroscience, and
psychoneuroimmunology are just some examples of existing interdisciplinary
sciences. NIH recognizes the value and enormous contributions that existing
interdisciplinary approaches have made and are making to our understanding of
health, disease, and disability. However, the Roadmap is focused on
developing new interdisciplinary approaches and therefore the necessary
interdisciplinary workforce.
NIH is announcing a series of initiatives that will provide investigators
with the training to effectively lead and engage in integrative and team
approaches to complex biomedical and health problems. These initiatives fall
into three categories: programs for long-term interdisciplinary research
training; short-term courses and research experiences; and curriculum
development. Collectively, the initiatives provide opportunities for
integration of disciplines at all stages of investigators careers,
facilitate communication among the disciplines, and support the development
of infrastructure to accomplish the building of the workforce for the
research teams for the future. Common features of the proposed initiatives
include having: comprehensive integrative approaches to solving complex
biomedical and health-related problems; developing and implementing new
curricula that integrate disparate disciplines; activities that promote
cohesiveness among training program participants at all levels (faculty-
student, student-student, and faculty-faculty); inclusion of training in the
personal and professional skills necessary to lead and participate in
multidisciplinary teams; outreach to the under-represented minority community
to ensure their participation; monitoring of student progress and outcome;
and self-evaluation of the training program.
NIH recognizes that multidisciplinary approaches may be a necessary step in
the evolution of interdisciplinary research training, and currently offers
many opportunities and mechanisms to support multidisciplinary research
training. However, for the purposes of the Roadmap’s interdisciplinary
research training RFAs, activities that facilitate communication among
different disciplines, promote but perhaps do not completely achieve
integration of different disciplines in the proposed project period, or
propose training in multidisciplinary approaches as a precursor to
interdisciplinary research training, are acceptable only if they include a
detailed plan with appropriate milestones for achieving the Roadmap goal of
developing interdisciplinary research training.
Additional information on initiatives associated with building research teams
of the future can be found on the NIH website at http://nihroadmap.nih.gov/.
Specific Objectives:
The goal of the initiative described below is to enable the development of a
cadre of interdisciplinary research scientists by capitalizing on the
infrastructure of existing multidisciplinary and interdisciplinary research
programs. This announcement is intended to be broad enough to encourage the
building of training programs for students at the undergraduate, pre-
doctoral, and/or postdoctoral levels. Applicants may propose programs that
target one level of student or a combination of them. All programs are
expected to provide to each group of students a comprehensive research
training experience. Special program requirements are outlined below. The
choice of scientific areas to target for interdisciplinary research training
is left to the applicants and may include any combination of the individual
areas encompassed by the NIH mission. Some examples of these include:
behavioral sciences, social sciences, molecular biology, mathematics,
engineering, chemistry, economics, ethics, computer science, and many others.
Programs are expected to combine two or more of these areas and provide a
comprehensive research training experience to the students.
NIH strongly encourages potential applicants to discuss their ideas with
program staff listed in the Where to Send Inquiries section and to send a
letter of intent before submission to ensure that the application will be
responsive to the NIH mission and the intent of this RFA.
MECHANISM OF SUPPORT
This RFA will use the new T90 award mechanism, which combines research and
NRSA authorities in a single mechanism. (See SUPPLEMENTARY INSTRUCTIONS
section for additional information.) Applicants may request a project period
of up to five years. As an applicant you will be responsible for planning,
directing, and executing the proposed training program. This RFA is part of
the NIH Roadmap activities and is a one time solicitation. At the end of the
five year project period, acceptance of applications for competing renewals
or for new programs will be at the discretion of individual NIH institutes
and centers.
The anticipated award date is 09/30/04.
FUNDS AVAILABLE
The NIH intends to commit approximately $6,000,000 in FY 2004 to fund
approximately 10-12 training programs in response to this RFA. An applicant
may request a project period of up five years and a first year budget of
$125,000 total costs for a program focused on undergraduate students and up
to $600,000 total costs for a program focused on pre-doctoral and/or
postdoctoral students. Because the nature and scope of the proposed training
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 RFA are
contingent upon the availability of funds and the receipt of a sufficient
number of meritorious applications.
ELIGIBLE INSTITUTIONS
You may submit an application if your institution has any of the following
characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories
o Eligible agencies of the Federal government
o Domestic or foreign institutions/organizations
o Faith-based or community-based organizations
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
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.
SPECIAL REQUIREMENTS
The NIH recognizes that individual institutions will be positioned to respond
in different ways to the opportunities presented in this RFA. However, all
programs are expected to provide comprehensive interdisciplinary research
training experiences for the students and trainees.
All applications should address the challenges of melding two or more
different fields and their associated cultures at the student, faculty, and
institutional levels. Successful programs will have addressed the following:
o Scientific environment - is expected to be strongly collaborative and
interdisciplinary. Evidence for this infrastructure may include co-authored
publications, collaborative research projects, joint service on dissertation
committees, team teaching of courses, and regular interactions in journal
clubs or seminar series, among other activities.
o Curriculum and degree requirements - for undergraduate and pre-doctoral
students, both curriculum and degree requirements should avoid extending time
to degree; alternatively, a plan for tailoring degree requirements and a
description of milestones for accomplishing the plan should be included. For
undergraduate and postdoctoral students, specific courses and attendance
requirements should be identified.
o Program self-evaluation the program should determine its baseline with
respect to interdisciplinary student training, set measurable goals for
itself, and establish milestones and measures of success for achieving them.
Applications proposing programs still on the evolutionary path from
multidisciplinary to interdisciplinary training should include clear goals
and milestones to mark that path and determine progress.
o Institutional commitment may be indicated via a letter from a high-
ranking institutional official that outlines (1) how the proposed program
fits within the institution’s broader vision with respect to the targeted
interdisciplinary area; and (2) how institutional barriers to
interdisciplinary research will be or are being addressed; and (3) indicates
plans for support of students participating in the training program if the
parent grant fails to compete successfully for renewal.
Trainee and faculty attendance at annual meeting students, trainees and
associated faculty supported by the program will be expected to attend a one
to two day annual meeting to be held in Bethesda or other suitable location
each year. The meeting will highlight the breadth and interdisciplinary
nature of the research being conducted and will be a networking node for
students, associated faculty, and NIH staff.
Trainee reporting requirements programs will be required to submit trainee
appointment forms for all students supported by the program and to track
students who are no longer supported by but are still associated with the
program.
In addition, successful applicants will have addressed the following program
features:
o Applicant pool students in the targeted disciplines who have potential
for participating in the training program should be clearly identified. The
application should also include any recruitment and outreach plans to
increase the depth and ethnic diversity of the student pool. Institutions
that already have one or more NRSA pre-doctoral or postdoctoral training
grants should address how the student pool for the proposed program is
distinct from or relates to that for existing training grants.
o Rotations and internships are highly encouraged and should be of
sufficient duration and rigor to ensure that the students produced by this
program are at a minimum conversant in the two or more targeted fields and
preferably, truly interdisciplinary scientists.
o Mentoring should be substantively shared by faculty members representing
each of the targeted disciplines; formal co-mentoring is strongly encouraged.
o Student interactions must be of sufficient quantity and quality to ensure
that the students and associated faculty develop an internal sense of the
identity of their interdisciplinary field and its rewards and challenges.
Examples of mechanisms for fostering program cohesiveness include seminar
series with presentations from students, faculty, and invited guests;
retreats; and journal clubs.
Leadership and teambuilding skills will be critical to the future success
of the students produced by these programs. Plans should be developed and
put in place to help students and interested faculty develop the leadership
skills and understanding of the challenges of group dynamics necessary to
establish and maintain a genuinely integrated research program.
Responsible conduct of research plans for training in this area must be
included.
Monitoring of students should be an integral part of the program, with
close attention paid to retention in the program and to time to degree (for
undergraduate and pre-doctoral students).
Academic and career advice will be an important factor in the success of
these training programs since they will be producing the first generation of
students in new interdisciplinary sciences. Students should be apprised of
the broad range of career options as well as instructed in how to apply
successfully for research funding.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research/research training, peer review, and financial or
grants management issues:
o Direct your questions about scientific/research issues to:
Terry Rogers Bishop, Ph.D.
Training and Careers Program Director
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 619
Bethesda, MD 20892-5458
Telephone: (301) 594-7726
Fax: (301) 480-3510
Email: tb232j@nih.gov
o Direct your questions about peer review issues to:
Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5456
Telephone: (301) 594-8897
Fax: (301) 480-3505
E-mail: fc15y@nih.gov
o Direct your questions about financial or grants management matters to:
Donna Huggins
Supervisory Grants Management Specialist
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 711
Bethesda, MD 20892-5456
Telephone: (301) 594-8848
Fax: (301) 480-3504
E-mail: dh48v@nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does not
enter into the review of a subsequent application, the information that it
contains allows IC staff to estimate the potential review workload and plan
the review.
The letter of intent is to be sent by the date listed at the beginning of
this document. The letter of intent should be sent to:
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: (301) 594-8897
Fax: (301) 480-3505
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). Pay particular attention to
instructions for INSTITUTIONAL NATIONAL RESEARCH SERVICE AWARD (Section V. in
the PHS 398 instructions). Applications must have a DUN and Bradstreet (D&B)
Data Universal Numbering System (DUNS) number as the Universal Identifier
when applying for Federal grants or cooperative agreements. The DUNS number
can be obtained by calling (866) 705-5711 or through the web site at
http://www.dunandbradstreet.com/. The DUNS number should be entered on line
11 of the face page of the PHS 398 form. The PHS 398 document is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: GrantsInfo@nih.gov.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001)
application form must be affixed to the bottom of the face page of the
application. Type the RFA number on the label. Failure to use this label
could result in delayed processing of the application such that it may not
reach the review committee in time for review. In addition, the RFA title
and number must be typed on line 2 of the face page of the application form
and the YES box must be marked. The RFA label is also available at:
http://grants.nih.gov/grants/funding/phs398/labels.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the Checklist, and three signed, photocopies, in
one package to:
Center For Scientific Review
National Institutes Of Health
6701 Rockledge Drive, Room 1040
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application and all
copies of the appendix material must be sent to:
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
APPLICATION PROCESSING: Applications must be received on or before the
application receipt date listed in the heading of this RFA. If an
application is received after that date, it will be returned to the applicant
without review.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within 8 weeks.
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.
However, when a previously unfunded application, originally submitted as an
investigator-initiated application, is to be submitted in response to an RFA,
it is to be prepared as a NEW application. That is, the application for the
RFA must not include an Introduction describing the changes and improvements
made, and the text must not be marked to indicate the changes from the
previous unfunded version of the application.
SUPPLEMENTARY INSTRUCTIONS:
Allowable costs:
Two budget pages (NRSA SUBSTITUTE FORM PAGE 4, in PHS 398) will be submitted
to distinguish requested funds for NRSA-qualified and non-NRSA-qualified
trainees. Please refer to NRSA Guidelines for eligibility
(http://grants.nih.gov/training/nrsa.htm#policy). Briefly, NRSA-qualified
trainees are either pre-doctoral students or post-doctoral fellows AND either
a U.S. citizen or U.S. permanent resident. Non-NRSA-qualified trainees are
either college students or non-U.S. students or fellows. Also, applications
from foreign institutions will be considered under non-NRSA guidelines.
Funds for NRSA-qualified individuals will be for stipends and funds for non-
NRSA-qualified individuals will be salaries.
PHS2271 (Statement of Activation) has been approved and shall be used to
initiate each trainee or student on the T90 program. Likewise PHS416-7 will
be used for termination notices.
Support for students: Under the T90 mechanism, both foreign and domestic
students at any level may be supported. However, no student may be supported
by the program for more than three years.
Undergraduate students up to NRSA levels in place at the time of award. To
qualify for support by the program, a student must be enrolled full time in a
program that will lead to a BS or BA degree.
Pre-doctoral students up to NRSA levels in place at the time of award. To
qualify for support by the program, a student must be enrolled full time in a
program that will lead to a Ph.D. or equivalent doctoral degree.
Postdoctoral fellows up to NRSA levels in place at the time of award. To
qualify for support by the program, a fellow must be employed full time.
Training related expenses :
o Faculty release time - up to 10 percent salary support for the development
of courses or curricula for the training program.
o Travel, supplies up to $2,000 for undergraduates; $3,000 for pre-doctoral
students and faculty mentors and program director; and $5,000 for
postdoctoral students - to help defray the cost of attending the annual
meeting.
Tuition, Fees, and Health Insurance: The NIH will offset the combined cost
of tuition, fees, and health insurance (either self-only or family as
appropriate) at the following rate: 100 percent of all costs up to $3,000 and
60 percent of costs above $3,000. Costs associated with tuition, fees, and
health insurance are allowable only if they are applied consistently to all
persons in a similar research training status at the institution regardless
of the source of support. A full description of the tuition policy is
contained within the Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2001/part_iib_4.htm#_Toc504812072.
Other Trainee Costs: Trainee travel, including attendance at scientific
meetings that the institution determines to be necessary to the individual's
research training, is an allowable trainee expense. In addition, support for
travel to a research training experience away from the institution may be
permitted. Research training experiences away from the parent institution
must be justified considering the type of opportunities for training
available, the manner in which these opportunities differ from and compliment
those offered at the parent institution, and the relationship of the proposed
experience to the trainee's career stage and goals. This type of research
training requires prior approval from the NIH. Letters requesting such
training may be submitted to the NIH awarding component at any time during
the award period. Under exceptional circumstances, which can include
providing accommodations for a trainee with disabilities, it is
possible to request institutional costs above the standard rate. Requests
for additional trainee costs must be explained in detail and carefully
justified in the application. Consultation with NIH program staff in advance
of such requests is strongly advised.
Training Related Expenses: Institutional costs of $2,200 a year per
predoctoral trainee and $3,850 a year per postdoctoral trainee may be
requested to defray the costs of other research training related expenses,
such as staff salaries, consultant costs, equipment, research supplies, and
travel expenses for the training faculty. Training related expenses may be
adjusted in future fiscal years.
Facilities and Administrative Costs: A facilities and administrative
allowance (indirect cost allowance) based on 8 percent of total allowable
direct costs (this excludes amounts for tuition, fees, health insurance, and
equipment) may be requested. Applications from state and local government
agencies may request full indirect cost reimbursement. Information on
Facilities and Administrative Costs is available in the Grants Policy
Statement at
http://grants.nih.gov/grants/policy/nihgps_2001/part_iib_4.htm#_Toc504812080.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by NIDDK. Incomplete and/or nonresponsive applications will
not be reviewed.
Applications that are complete and responsive to the RFA will be evaluated
for scientific and technical merit by an appropriate peer review group
convened by NIDDK in accordance with the review criteria stated below. As
part of the initial merit review, all applications will:
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications under
review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by an 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 evaluate the application in
order to judge the likelihood that the proposed research will have a
substantial impact on the pursuit of these goals. The scientific review
group will address and consider each of the following criteria in assigning
the application’s overall score, weighting them as appropriate for each
application.
Program direction:
o Research and training leadership and experience of the PI
o Adequacy of the program administration and advisory structure
Participating faculty members:
o Composition of the faculty (by rank and distribution in different fields
and departments)
o Mechanism and criteria for inclusion of the faculty in the program
o Publication records
o Nature and breadth of research in areas pertinent to this announcement
o Evidence of collaboration and cooperation
o Experience in the supervision of research training
Training program:
o Goals of program and rationale for program organization
o Mechanism for the selection and recruitment of students
o Mechanism to monitor and guide the students
o Nature and extent of research opportunities, courses, seminars, etc. in
targeted scientific areas
o Provisions/activities to promote cohesiveness in the program
o Opportunities for collaboration
o Integration of the targeted disciplines or adequacy of plans for
integration
o Flexibility for students to take courses, rotations, and mentorships in
targeted scientific areas
o Appropriateness of training experiences for level of student targeted
o Degree of innovation and potential to impact the research and training
culture at the institution
Student pool:
o Availability of highly qualified candidates (scientific background,
academic credentials)
o Caliber of current (if any) and/or potential students and others identified
with the program (may be demonstrated by grades, standardized test scores,
publication records, and other means)
o Publication records of past and current trainees
Research and training environment:
o Institutional support for the training program
o Adequacy of plans for student support should the parent grant fail to
compete successful for renewal of funding
o Other sources of training support available
o Facilities and resources available to the program
Minority recruitment and retention plan:
o Nature and adequacy of plan
Foreign institutions:
o Justification of a unique setting or availability of unique resources that
are not available in the U.S.
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 criteria included in the
section on Federal Citations, below).
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. Plans for the recruitment and retention of subjects will also be
evaluated. (See Inclusion Criteria in the sections on Federal Citations,
below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to
be used in the project, the five items described under Section f of the PHS
398 research grant application instructions (rev. 5/2001) will be assessed.
BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: February 10, 2004
Application Receipt Date: March 10, 2004
Peer Review Date: June/July 2004
Council Review: September 2004
Earliest Anticipated Start Date: September 30, 2004
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
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). The establishment of data
and safety monitoring boards (DSMBs) is required for multi-site clinical
trials involving interventions that entail potential risk to the
participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for
Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date,
investigators submitting an NIH application seeking more than $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, 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.
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 -
Amended, October, 2001," published in the NIH Guide for Grants and Contracts
on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are 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 RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy 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 not to include
them. This policy applies to all initial (Type 1) applications submitted for
receipt dates after October 1, 1998.
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 that is available at
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 proposals for research involving human
subjects. You will find this policy announcement in the NIH Guide for Grants
and Contracts Announcement, dated June 5, 2000, 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 (see 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). Those who must comply with the Privacy Rule (classified
under the Rule as covered entities ) must do so by April 14, 2003 (with the
exception of small health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule reside
with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including
a complete Regulation Text and a set of decision tools on Am I a covered
entity? Information on the impact of the HIPAA Privacy Rule on NIH
processes involving the review, funding, and progress monitoring of grants,
cooperative agreements, and research contracts can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore,
we caution reviewers that their anonymity may be compromised when they
directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving
the health promotion and disease prevention objectives of "Healthy People
2010," a PHS-led national activity for setting priority areas. This RFA is
related to one or more of the priority areas. Potential applicants may obtain
a copy of "Healthy People 2010" at http://www.healthypeople.gov/.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance at http://www.cfda.gov/ 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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