Research (OER)
9000 Rockville Pike
Bethesda, Maryland 20892
and Human Services (HHS)
ENVIRONMENTAL JUSTICE: PARTNERSHIPS TO ADDRESS ETHICAL CHALLENGES IN
ENVIRONMENTAL HEALTH
Release Date: November 19, 2001
RFA: RFA-ES-02-005
National Institute of Environmental Health Sciences
(http://www.niehs.nih.gov)
National Human Genome Research Institute
(http://www.nhgri.nih.gov)
Letter of Intent Receipt Date: February 22, 2002
Application Receipt Date: March 25, 2002
PURPOSE
The goal of this RFA is to encourage projects that promote public
understanding of the social, ethical, and legal implications of
conducting environmental health research involving human subjects in
areas such as gene-environment interactions (interplay between genetics
and the environment), environmental health hazards, and disease
susceptibility. Specifically, we seek applications that carry out the
following steps: 1) assess a community's level of knowledge regarding
health impacts of hazardous environmental exposures; 2) develop,
implement, and evaluate educational materials and programs that enhance
public awareness and understanding of ethical issues and challenges
related to conducting environmental health research; and 3) establish
an on-going and long-term dialog between scientists and community
members on ethical issues related to environmental health science. All
of these processes must be contained in an application submitted in
response to this RFA and should be arrayed into a concerted,
interdisciplinary approach that addresses one or both of two areas of
focus: 1) gene-environment interactions, i.e., the relationship between
genetics and environment as determinants of health status; and/or 2)
non-therapeutic research in environmental health and the methods for
addressing social, ethical, and legal challenges that arise in those
areas of research. This RFA is specifically intended to incorporate
public participation in developing methodologies and materials that are
culturally and linguistically appropriate. This participatory process
enhances community and individual participation in research, enabling
development of effective strategies for disease prevention and treatment.
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 Request for
Applications (RFA), Environmental Justice: Partnerships To address
ethical challenges in environmental health, 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/.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic, for-profit, and non-profit
organizations, public and private, such as universities, colleges,
hospitals, and laboratories. Faith-based organizations are eligible to
apply for these grants. Racial/ethnic minority individuals, women, and
persons with disabilities are encouraged to apply as Principal
Investigators.
It is important to note that, because of the wide range of
environmental health problems to be addressed and the diversity of
affected communities, applications must be multidisciplinary in nature.
At least one member of each of the following three personnel groups
must have an active and meaningful role in both the development of the
application and conduct of the proposed project:
o A research scientist in environmental health sciences (such as one
at NIEHS Environmental Health Sciences Centers, NIEHS/EPA Centers for
Children's Environmental Health and Disease Prevention Research,
Superfund Basic Research Programs, etc.).
o A behavioral or social scientist (medical sociologist or
anthropologist, community psychologist), a bio-ethicist, or a legal
expert on issues such as stigma or discrimination.
o A representative from a community based organization associated with
or living/working in a community exposed to environmental pollutants.
Additional collaborations may be relevant, such as an expert in the
field of curriculum or educational material development (so that the
materials developed are culturally and linguistically appropriate) or a
government institution such as a local health department or those
responsible for environmental protection. However, such personnel will
not substitute for the three required personnel listed above.
These required personnel must be listed on page two of the PHS 398
application, and biographical sketches must be provided. Applications
lacking the required personnel will be considered non-responsive and
returned to the applicant without review. The role of each member in
developing the application and carrying out the project must be clearly
identified and fully described.
MECHANISM OF SUPPORT
This RFA will use the National Institutes of Health (NIH) R25 award
mechanism. Responsibility for the planning, direction, and execution
of the proposed project will be solely that of the applicant. The
total project period for an application submitted in response to this
RFA may not exceed five years. This RFA is a one-time solicitation.
Future unsolicited competing continuation applications will compete
with all investigator-initiated applications and be reviewed according
to the customary peer review procedures. The anticipated award date is
September 30, 2002.
FUNDS AVAILABLE
The participating institutes intend to commit approximately $1.75
million in FY 2002 to fund approximately five to six new grants in
response to this RFA. An applicant may request a project period of up
to five years and a budget for direct costs of up to $200,000 per year.
Because the nature and scope of the proposed project may vary, it is
anticipated that the size of each award will also vary. Indirect costs
will be paid at eight percent of direct costs less appropriate
exclusions. This is not a modular grant and a detailed budget is
expected. Although the financial plans of the participating institutes
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.
RESEARCH OBJECTIVES
Background
Minimizing and preventing adverse health effects from environmental
exposures requires public outreach and education coupled with
innovative research to develop solutions. Public health research is
the active participation of individuals, the public (community based
organizations, lawyers, policy makers, health care professionals, HMOs,
departments of health, etc), and the research community alike to help
understand the progression of disease, people's exposures and
susceptibilities. Such undertakings lead to methods for prevention and
treatment of disease. Future successful public health research
collaborative endeavors presuppose a well-informed public that is
knowledgeable of the benefits and challenges of participation in
research and at the same time, researchers who are cognizant of the
ethical, legal, and social implications of conducting research,
involving humans. The NIEHS has substantial experience in
translational, environmental genome, and environmental justice
research, which provide the framework for this RFA.
Translational Research: NIEHS focuses much of its efforts on and has
been successful in developing methods for prevention of environmentally
related disease. The Institute accomplishes this task through a
holistic approach to human health and a preventive approach to
medicine. Pursuant to this goal NIEHS developed a series of
translational research programs, beginning in 1993, to bridge the gap
between developments in environmental health science and creating an
informed public. The most basic definition of translational research
is the practical application of biomedical research findings in order
to improve public health. The NIEHS builds upon that definition,
stating that translational research is the conversion of findings from
basic, clinical or epidemiological environmental health science
research into information, resources, or tools that can be applied by
health care providers and community residents to improve public health
outcomes in at-risk neighborhoods. In addition, the NIEHS gives special
attention to insure that the information is culturally and
linguistically appropriate and understandable. For further information
on NIEHS translational research programs, see:
http://www.niehs.nih.gov/dert/programs/translat/home.htm
Environmental Genome Project: The human health/disease condition is
determined by the complex interplay between genetic susceptibility,
environmental exposures and aging. The NIEHS expanded its research
program on genetic susceptibility to environmentally-associated
diseases through the Environmental Genome Project. This project makes
use of technology developed by the Human Genome Project and other
efforts to identify allelic variants (polymorphisms) of environmental
disease susceptibility genes in the U.S. population, developing a
central database of polymorphisms for these genes, and fostering
population-based studies of gene-environment interaction in disease
etiology. Working with genetically susceptible (sub)populations will
allow more precise identification of environmental agents that cause
disease and the true risks of exposure. However, it is of paramount
importance to emphasize that identification of polymorphism(s) in an
individual does not predict that individual's risk to exposure because
of complex, multiple interactions. An individual's complete exposure
risk can only be determined by consideration of additional exposure
history, nutritional status, age and developmental changes, gender, and
other factors. It is our intention that the Environmental Genome
Project will generate data that will be utilized in epidemiological
studies to enhance our understanding of environmental association with
disease. As susceptible (sub)populations are identified, they must be
distinguished from susceptible individuals within that population.
Some individuals within the susceptible population will be at increased
risk for specific exposures while some individuals in that population
will have no increase in exposure risk. For further information, on
the Environmental Genome Project please see:
http://www.niehs.nih.gov/envgenom/home.htm
Environmental Justice: This RFA is located within the NIEHS
Environmental Justice framework so as to develop a comprehensive
program of education on environmental health issues and address the
social, ethical, and legal concerns of the public in such scientific
endeavors. NIEHS recognizes that there is a greater health burden borne
by certain sectors of the society. This increased vulnerability may be
related to a complex interaction of not only genetic but also social
and behavioral conditions confronting such at risk populations. This
understanding led to development of the Environmental Justice Program,
which seeks to remedy the unequal burden, borne by socio-economically
disadvantaged persons, in terms of residential exposure to greater than
acceptable levels of environmental pollution, occupational exposure of
hazardous substances, and fewer civic benefits such as sewage and water
treatment. The primary objective of this program is to establish
methods for linking members of a community, who are directly affected
by adverse environmental conditions, with researchers and health care
providers. Development of community-based strategies to address
environmental health problems requires approaches that are not
typically familiar to the research and medical communities. For further
information on the NIEHS Environmental Justice Program, please see:
http://www.niehs.nih.gov/dert/programs/translat/envjust/envjust.htm
Areas of Focus
The two major foci of this RFA are on interplay between genetics and
the environment (gene-environment interactions) and other non-
therapeutic research in environmental health. The projects will assess
the community's level of knowledge, and develop, implement, and
evaluate educational materials in these two areas. Gene-environment
interaction studies could be those that further our understanding of
genetic susceptibility to environmental agents that cause specific
health problems. Other non-therapeutic research of interest could be
etiological studies of environmental exposures and risk assessment.
Some types of non-therapeutic research may be less intrusive than gene-
environment interaction research, and thus have different ethical,
legal, and social implications. Research of this kind could
potentially pose problems for research on a wide array of environmental
epidemiological studies, for example, asthma, where studies on
indoor/outdoor environmental triggers have yet to be fully explored, or
the effect of pesticides on neurobehavioral deficits.
The application will develop educational materials and support programs
related to either of the two areas of focus. However, if both are
included in the application, they need to be well integrated within the
overall design and conduct of the proposed project. Appropriate topics
for development of educational programs include, but are not limited
to, the following:
1. Interplay between genetics and the environment: Transformation of
the gene-environment vision into reality faces several social, ethical,
and legal concerns. Some general issues to consider in an educational
context are:
o How can we best explain to the public that we may be able to predict
risk for most of the common environmentally related diseases long
before effective and acceptable medical interventions are available?
o What are the ethical and economic implications for individuals who
ignore the known environmental risks after being provided the relevant
information? How can this information be best conveyed to the public?
o How do we protect research participants from discrimination,
stigmatization, and psychological stress? What are the methods to
translate such information to the public?
o How will we educate people to minimize the risk that some people,
upon learning that they carry a predisposing genotype, will develop a
fatalistic attitude and assume that there is nothing they can do to
prevent developing the disease?
o What strategies work best for ensuring informed consent given that
the risks and benefits cannot be fully anticipated at the outset and
what strategies can be adopted to ensure confidentiality?
2. Non-therapeutic Research: A key concept in the protection of human
subjects for most non-clinical or non-therapeutic research endeavors
lies in the concept of "minimal risk." "A risk is minimal where the
probability and magnitude of harm or discomfort anticipated in the
proposed research are not greater, in and of themselves, than those
ordinarily encountered in daily life or during the performance of
routine physical or psychological examinations or tests" [Federal
Policy 46.102(i)]. For example, the risk of drawing a small amount of
blood from a healthy individual for research purposes is no greater the
risk of doing so as part of routine physical examination. There is
then the probability of harm or injury (physical, psychological,
social, or economic) occurring as a result of participation in a
research study. The probability and magnitude of possible harm may
vary from minimal to significant. Though the Federal regulations
define "minimal risk" there is no preset risk-benefit ratio except that
the benefit has to outweigh the risk for the participant.
At the most basic level, if a researcher, in the course of conducting a
non-therapeutic study, finds that children are living in hazardous
environmental conditions some of the dilemmas faced by the researcher
may be:
o What are the social and ethical considerations? How can we best
convey these to the public?
o What are the rights of the individual and the family in being
informed of the risks? How best can we educate the public of their
rights, risks, and benefits?
o Does the researcher have a "greater" responsibility to complete the
research for the "greater good" of the community? How can the concept
of risk-benefit ratio be conveyed to the public?
o Does the researcher refer families at-risk immediately and
consequently jeopardize the results that may have the potential to help
many others in the future? What are some methods of involving the
public in the research and incorporating their concerns and input and
also educating them on the scientific processes of research?
Policies are needed to ensure the appropriate and ethical use of
disease susceptibility and environmental health hazard data.
Developing these safeguards may represent the biggest challenge yet.
The participating institutes through this RFA are promoting educational
projects and on these issues to ensure that the public is adequately
protected.
Scope
As the research horizons on human gene-environment interactions expand,
there are several ethical implications and consequences of such
research. Some of the challenges from these research endeavors,
especially in genetic research, for example, are discrimination
(profiling) and stigmatization, resulting in lack of privacy and
confidentiality and subsequent loss of insurance, jobs, etc. At the
same time, this research is integral to our understanding of
environmental exposures and susceptibility and improving health, the
quality of our lives, and creating an empowered society that is capable
of making health choices, for prevention and treatment.
Current advancements in biotechnology and the capacity to integrate
various databases from research involving human subjects have created
new dilemmas requiring constant vigilance. The benefit of knowledge
gained from research on environmental hazards, gene-environment
interactions, and exposure-disease relationship instills the promise of
prevention of disease and better quality of life. On the other hand,
it is possible that such knowledge may cause deep concerns and schisms
in the community, where people have limited options to move from their
hazardous environment.
The following are some challenges to consider in generating or
developing the proposed education project as it relates to gene-
environment interactions and other non-therapeutic research.
Educational questions related to the following topics fall within the
scope of this RFA:
o Who (insurance companies, employers, family members, other
researchers) is privy to information generated as part of environmental
health studies of disease risk (e.g., the stored data, banked samples)?
o What are the issues relating to follow-up and further testing of the
banked samples?
o What are the limitations and challenges of reusing the data or
information (stored data, banked samples) by other researchers/
communities?
o Should there be a limit on the storage time?
o Who gives consent and are there limitations on proxy consent (as in
the case of children, and mentally challenged or incapacitated people)?
How long and for what is the consent valid? What are the issues in
seeking consent for further testing?
o What are individual rights versus the public's rights in being privy
to the outcome of the research project? What is the role of
certificate of confidentiality and what are their limitations?
o Are there challenges to the existing laws and policies relating to
protection/confidentiality? What are the challenges to advocacy and
changes to the laws in effect currently?
o What are issues relating to discrimination/stigmatization as a
result of development of the field of environmental genomics?
o Are there issues of conflict of interest of the researchers and
other partners (drug companies, industries) in such studies?
o Do inducement (monetary and non-monetary) issues affect rates of
participation and compliance?
o What are the challenges and guidelines for ensuring equal
representation or selection of participants?
o What are the cultural challenges in translation and dissemination of
materials?
o When is the intervention appropriate and beneficial for the
participant? What are the challenges?
o What are the researcher's responsibilities in dissemination of
research findings and providing information ("giving back to the
community")?
It is important to emphasize that applications submitted in response to
this RFA are to be educational and not research projects. Materials
developed in the project should be easily transferable to other
communities. In addition, they should be disseminated through various
methods allowing for an ongoing dialog in the community. Methods of
community dialog can include, but are not limited to, neighborhood-wide
scientific meetings, brochures, information desks, etc. This RFA will
support education projects that are multi-phasic and involve
assessment, development, implementation, and evaluation of curricula
and materials in a culturally and linguistically appropriate manner.
Applications should carry out the following steps: 1) assess the level
of knowledge of the community regarding health effects related to
environmental hazards; 2) develop implement, and evaluate new and
innovative educational intervention strategies addressing ethical
issues and challenges in environmental health research that can produce
successful models for widespread education to diverse communities; and
3) establish an on-going and long-term dialog between scientists and
community members on ethical issues related to environmental health
science. It is critical that the project incorporate within its
framework evaluation of the process of assessment, development and
implementation of the materials and its impact in the community.
SPECIAL REQUIREMENTS
To encourage applicants to share information gained via these grants, a
member of each of the three types of required personnel on each project
will be asked to attend an annual meeting in the Research Triangle Park,
NC area. Applicants should include such travel in their budget
requests.
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
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 AMENDMENT
"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
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a
complete copy of the updated Guidelines are available at
<https://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
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
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 was published in
the NIH Guide for Grants and Contracts, March 6, 1998, and is available
at the following URL address:
https://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.
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. This policy announcement is found
in the NIH Guide for Grants and Contracts Announcement dated June 5,
2000, at the following website:
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.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. Reviewers are cautioned that
their anonymity may be compromised when they directly access an
Internet site.
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:
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this RFA 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.
LETTER OF INTENT
Prospective applicants are asked to submit 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 and participating institutions, and
the number and title of the RFA in response to which the application
may be submitted. 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 NIEHS staff to
estimate the potential review workload and plan the review.
The letter of intent is to be sent to Dr. Linda Bass at the National
Institute of Environmental Health Sciences by the letter of intent
receipt date listed.
Linda Bass, Ph.D.
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-24
111 T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: (919) 541-1307
Fax: (919) 541-2503
Email: bass@niehs.nih.gov
APPLICATION PROCEDURES
The PHS 398 research grant application instructions and forms (rev.
5/2001) at:
https://grants.nih.gov/grants/funding/phs398/phs398.html, must be used
in applying for these grants. This version of the PHS 398 is available
in an interactive, searchable format. For further assistance contact
Grants Info, Telephone 301/710-0267, Email: GrantsInfo@nih.gov.
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: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
Submit a signed, typewritten original of the application, including the
Checklist, and three signed, photocopies, in one package to:
CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application
must be sent to:
Linda Bass, Ph.D.
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-24
111 T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: (919) 541-1307
Fax: (919) 541-2503
Email: bass@niehs.nih.gov
Applications must be received by 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.
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 the CSR
and responsiveness by the National Institute of Environmental Health
Sciences. Incomplete and/or non-responsive 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 National Institute of Environmental Health
Sciences in accordance with the review criteria stated below. As part
of the initial merit review, all applications will receive a written
critique and 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, assigned a priority
score, and receive a second level review by the Advisory Environmental
Health Sciences Council.
Review Criteria
In the written comments reviewers will be asked to discuss the
following aspects of the application. 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 impact and thus deserve a high priority score. For example, an
investigator may propose to carry out important work that by its nature
is not innovative but is essential to move a field forward.
Significance: Does the proposed educational project address an
important ethical, social, or legal issue related to gene-environment
interaction and/or non-therapeutic environmental health research? If
the aims of the application are achieved, to what extent will the
project further the goals of improving understanding of ethical,
social, and legal challenges of gene-environment interactions,
environmental hazards, and disease susceptibility?
Approach: Are the conceptual framework, design and methods adequately
developed, well integrated, and appropriate to the aims of the project?
Specifically, are the following issues addressed?
o Knowledge of the current literature and research, and public
education material development.
o Inclusion of a partnership of personnel who can address scientific,
social, ethical, and community concerns and challenges.
o Provision of a clear and concise plan or method for assessment,
development, implementation and evaluation of educational materials and
programs. It is important that the project include an ongoing
evaluation of the process of implementation and the impact on the
community.
o Definition of a target audience that includes women and under
represented minorities.
o Transportability of educational materials or programs.
o Issues pertaining to cultural and linguistic challenges.
o Evaluation and sustained dissemination of educational materials or
programs.
Innovation: Does the project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies?
Project Team: Are the project leaders and other key personnel
appropriately trained and well suited to carry out this work? Is the
work proposed appropriate to their experience level?
Environment: Does the environment in which the work will be done
contribute to the probability of success? Does the proposed project
take advantage of unique features of the scientific or educational
environment or employ useful collaborative arrangements? Is there
evidence of institutional support?
Evaluation Plan: Will the evaluation plan adequately assess the
effectiveness of the process and outcome of implementation and
dissemination of the materials in achieving its objectives, and the
degree to which the proposed materials are easily transferable and can
be used in other community settings?
In accordance with NIH policy, the applications will also be reviewed
with respect to the following:
o The adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the goals of the project.
o Plans for the recruitment and retention of subjects will also be
evaluated, as appropriate.
o The reasonableness of the proposed budget and duration in relation
to the proposed project.
o The adequacy of the proposed protection for humans, animals or the
environment, to the extent they may be adversely affected by the
project proposed in the application.
SCHEDULE
Letter of Intent Receipt Date: February 25, 2002
Application Receipt Date: March 25, 2002
Peer Review Date: June, 2002
Council Review: September, 2002
Earliest Anticipated Start Date: September 30, 2002
AWARD CRITERIA
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.
INQUIRIES
Inquiries concerning this RFA are encouraged. The opportunity to
clarify any issues or answer questions from potential applicants is
welcome.
Direct inquiries regarding programmatic issues to:
Shobha Srinivasan, Ph.D.
Scientific Program Administrator
Chemical Exposures and Molecular Biology Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-21
111 T.W. Alexander Drive
Research Triangle Park, NC 27709
Phone: (919) 541-2506
Fax: (919) 316-4606
Email: sriniva2@niehs.nih.gov
Jean E. McEwen., J.D., Ph.D.
Program Director
Ethical, Legal, and Social Implications
National Human Genome Research Institute
31 Center Drive, Room B2B07
Bethesda, MD 20892-2033
Phone: (301) 402-4997
Fax: (301) 402-1950
Email: jm522n@nih.gov
Direct inquiries regarding review issues to:
Linda Bass, Ph.D.
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-24
111 T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: (919) 541-1307
Fax: (919) 541-2503
Email: bass@niehs.nih.gov
Direct inquiries regarding fiscal matters to:
Carolyn Winters
Grants Management Officer
Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-24
111 T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: (919) 541-7823
Fax: (919) 541-2860
Email: winters@niehs.nih.gov
Jean Cahill
Grants Administration Branch
Division of Extramural Research
National Human Genome Research Institute
31 Center Drive, Room B2B34
Bethesda, MD 20892-2031
Telephone: (301) 435-7858
Fax: (301) 402-1951
Email: jc166o@nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance
No. 93.113, 93.114, and 93.115 (NIEHS); No. 93.172 (NHGRI). Awards are
made under authorization of Sections 301 and 405 of the Public Health
Service Act as amended (42 USC 241 and 284) and administered under NIH
grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74
and 92. 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 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.
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