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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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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