REDUCING MENTAL ILLNESS STIGMA AND DISCRIMINATION

RELEASE DATE:  June 18, 2004

PA NUMBER:  PAR-04-112

This funding opportunity has been replaced by PAR-07-156,
which now uses the electronic SF424 (R&R) application for 
February 5, 2007 submission dates and beyond.

Expiration Date for R01 Non-AIDS Applications: November 2, 2006 
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
 (http://www.nih.gov)
Substance Abuse and Mental Health Services Administration (SAMHSA)
 (http://www.samhsa.gov/)

COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute of Mental Health (NIMH)
 (http://www.nimh.nih.gov)
Center for Mental Health Services (CMHS)
 (http://www.mentalhealth.samhsa.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.242

THIS PA CONTAINS THE FOLLOWING INFORMATION

o  Purpose of the PA
o  Research Objectives
o  Mechanism(s) of Support
o  Eligible Institutions
o  Individuals Eligible to Become Principal Investigators
o  Special Requirements
o  Where to Send Inquiries
o  Submitting an Application
o  Supplementary Instructions
o  Peer Review Process
o  Review Criteria
o  Award Criteria
o  Required Federal Citations

PURPOSE OF THIS PA

The National Institute of Mental Health (NIMH) invites applications for research
to reduce mental illness stigma and discrimination.  This initiative was
conceived in collaboration with the Center for Mental Health Services (CMHS),
within the Substance Abuse and Mental Health Services Administration (SAMHSA),
and is in response to The President’s New Freedom Commission on Mental Health’s 
call for a national campaign to reduce mental illness stigma.  The CMHS, which 
has a long history of providing support for innovative anti-stigma programs and 
strategies, recently launched the Elimination of Barriers Initiative (EBI).  The 
EBI is a major undertaking to identify effective approaches in addressing mental 
illness stigma and discrimination.  In a parallel effort, the NIMH is taking 
several new steps to encourage research applications to substantially increase 
our knowledge about how to effectively reduce stigma and discrimination and 
their consequences.  This program announcement represents one of these steps 
and its purpose is to provide funding for partnerships between (1) consumer 
and/or advocate organizations, communities, or state and local agencies with 
hands-on expertise in developing and implementing stigma reduction programs and 
strategies, and (2) social, behavioral, and/or communication scientists with 
expertise in stigma research design and methodology.  These partnerships would 
undertake studies that will:  assess the effectiveness of existing stigma and 
discrimination reduction programs and approaches, including media-oriented 
approaches such as public service announcements; examine how, why, and for whom 
existing programs or approaches work; develop innovative new programs and 
approaches; and provide a better understanding of the impact of varied media 
(e.g., television, newspapers, magazines, cinema, direct-to-consumer 
advertising, internet), both positive and negative, on attitudes and beliefs 
about mental illness, and in perpetuating and changing mental illness stigma 
and discrimination.

RESEARCH OBJECTIVES

Background

When the President launched his New Freedom Commission on Mental Health on April 
29, 2002, he declared, “Americans with mental illness deserve our understanding, 
and they deserve excellent care.”  He identified the stigma that surrounds mental 
illnesses as a major obstacle to Americans getting the quality mental health care 
they deserve.  The President’s observation echoes findings of the Report of the 
Surgeon General on Mental Health 
(http://www.surgeongeneral.gov/library/mentalhealth/home.html) and the White House 
Conference on Mental Health (http://www.nimh.nih.gov/whitehouse/accomplish.asp), 
both issued in 1999, that the stigma and discrimination associated with mental 
illness and its treatment have substantial negative impact on the lives of 
individuals, families, and communities.  The Surgeon General’s report concluded 
that despite the existence of effective treatments for mental disorders, the fear 
of stigmatization often deters individuals from acknowledging their illness, 
seeking help, and remaining in treatment.  One of the aims of the Surgeon General’s 
report was to encourage the development and evaluation of fresh approaches to 
changing stigmatizing attitudes and behaviors.  The final report of The President’s 
New Freedom Commission on Mental Health (http://www.mentalhealthcommission.gov) 
gives new impetus to stigma reduction efforts by calling for a national campaign to 
reduce the stigma of seeking care.

Parallel efforts by the NIMH and the CMHS to respond to the call for innovative 
approaches to changing attitudes about mental illness and its treatment first 
issued in the Surgeon General’s report, and compellingly reiterated by the 
President and the final report of The President’s New Freedom Commission on Mental 
Health, provide both an urgency and an exciting opportunity for partnering to 
reduce mental illness stigma and discrimination.

The NIMH established the Stigma Working Group in November 1999.  The charge to the 
working group, comprised of outside experts, was to assist the Institute in 
developing a research agenda aimed at addressing the most pressing issues in 
changing mental illness stigma and discrimination.  The working group identified 
two areas of research in urgent need of further investigation.  The first area is 
research to better understand which strategies and approaches to reduce stigma and 
discrimination are the most effective, for whom, and why.  Models that are found to 
be particularly effective could then be disseminated to other communities or 
tailored to other target groups.  The second area is research to examine media 
influences, both positive and negative, on attitudes and knowledge about mental 
illness and its treatment.

The CMHS launched its Elimination of Barriers Initiative (EBI) in June 2003.  The 
EBI, aimed at identifying effective public education approaches to combat mental 
illness stigma and discrimination, is the most recent in a series of initiatives 
developed by CMHS to encourage and support the development by consumer and 
community groups of demonstration programs to reduce stigma and discrimination – 
including, for example, educational programs and materials, contact-based 
approaches, and public service announcements.  The EBI, as well as other CMHS-
supported programs, provides a natural laboratory for better understanding what 
constitutes effective and transportable models and approaches for changing mental 
illness stigma and discrimination.  (Additional information about the Eliminating 
Barriers Initiative and other CMHS anti-stigma activities can be found at the 
website of the CMHS-supported Resource Center to Address Discrimination and Stigma, 
http://www.adscenter.org.)

These parallel efforts by the NIMH and CMHS provide a platform for identifying 
effective programs and approaches, and building a better understanding of how to 
reduce, or even eliminate, the stigma and discrimination associated with mental 
illness and its treatment.  Although there are many programs and many approaches to 
changing attitudes and behaviors toward mental illness in existence and use, there 
has been little research to assess the effectiveness of these efforts or research 
to understand the mechanisms and processes through which they work.  Research on 
these issues is necessary to provide the critical basis for knowing what works, and 
developing new programs and approaches where needed.  This program announcement 
reflects the opportunity to build the needed research base.  To fully capitalize on 
this opportunity requires the knowledge and expertise of individuals, groups, or 
organizations with hands-on experience in developing anti-stigma and discrimination 
campaigns and researchers with expertise in research design and implementation.  
For this reason, in order to be considered responsive to this program announcement, 
the establishment of a formal collaboration between these two groups of experts is 
required.  It is expected that consumer and/or advocate organizations as a group 
have the most expertise and prior hands-on experience in anti-stigma and 
discrimination programs, and therefore they would be included as collaborating 
partners or they would have substantial roles in all applications submitted for 
this program announcement.

Research Scope

The types of research falling within the purview of this program announcement range 
from full-scale effectiveness studies that are grounded in requisite preliminary 
research, to small-scale pilot, exploratory, and/or developmental studies to, for 
example, develop and test new measures to assess program outcome.  Also of interest 
are public education strategies, personal contact approaches, targeted public 
education, and media-oriented and other types of mental health awareness campaigns, 
and multifaceted campaigns that combine several types of approaches, as well as 
other innovative approaches.  The programs and approaches might also target the 
general public, specific demographic groups (e.g., older adults, children and 
adolescents, racial and ethnic minority groups, and rural Americans), or specific 
stakeholder groups (e.g., mental health service providers, law enforcement 
officers, and employers).  Multi-method studies combining qualitative and 
quantitative approaches are encouraged.

Some illustrative examples of research topics that may be addressed under this 
program announcement are (but are not limited to):

Studies to assess the effectiveness of existing stigma and discrimination reduction 
programs and approaches, including media-oriented approaches such as public service 
announcements:

o  Studies using existing measures and/or to develop pilot test measures to assess 
knowledge, attitudinal, and behavioral outcomes;

o  Studies of the differential effectiveness of programs or approaches across 
gender, age, regional, and/or cultural/ethnic groups;

o  Studies to assess durability of program effects; 

o  Studies to examine the extent to which programs and approaches generalize across 
demographic and stakeholder groups versus the need for programs and approaches 
tailored to specific target groups;

o  Studies to examine the contribution of individual components of multifaceted 
programs to the overall program’s effectiveness.

Studies to examine how and why existing programs or approaches work:

o  Studies to identify the critical elements and/or the conceptual elements of 
effective stigma change strategies targeted at specific groups of individuals 
(e.g., healthcare providers) and to the general public;

o  Studies to identify the operational elements of effective programs and 
approaches targeted at specific groups of individuals (e.g., healthcare providers) 
and to the general public;

o  Studies to examine the social, cognitive, psychological, and/or behavioral 
processes through which effective programs and approaches work to bring about 
reductions in stigma and discrimination.

Studies to develop innovative new programs and approaches:

o  Studies to develop and pilot test program message content and style, and/or 
program format;

o  Studies to adapt existing programs or approaches to another demographic or 
stakeholder group;

o  Studies to develop training protocols for program delivery or implementation.

Studies to examine the role of media (e.g., television, newspapers, magazines, 
cinema, direct-to-consumer advertising, internet) in perpetuating and changing 
mental illness stigma and discrimination:

o  Studies to examine the impact of media content and images on knowledge, 
attitudes, and beliefs about mental illness;

o  Studies of the influence of the media, both positive and negative, on the 
experience and self-beliefs of individuals with mental illness;

o  Studies comparing mediums of message delivery in changing knowledge, attitudes, 
and behaviors towards mental illness;

o  Studies to develop age-appropriate messages to change children’s negative 
attitudes and behaviors toward mental illness.

MECHANISM OF SUPPORT

This PA will use the NIMH collaborative R01 award mechanism 
(http://grants.nih.gov/grants/guide/pa-files/PA-01-123.html) and requires a formal 
collaboration between individuals, groups, or organizations with hands-on 
experience in developing anti-stigma and discrimination campaigns, and researchers 
with expertise in research design and implementation.  As an applicant, you, in 
collaboration with your collaborating partner(s), will be solely responsible for 
planning, directing, and executing the proposed project.

This PA uses just-in-time concepts.  It also uses the modular budgeting as well as 
the non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically, if you 
are submitting an application with direct costs in each year of $250,000 or less, 
use the modular budget format.  Otherwise follow the instructions for non-modular 
budget research grant applications.  This program does not require cost sharing as 
defined in the current NIH Grants Policy Statement at 
http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

ELIGIBLE INSTITUTIONS

You may submit (an) application(s) 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  Units of State and local governments
o  Eligible agencies of the Federal government
o  Foreign institutions are not eligible to apply
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.

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into three areas:  
scientific/research, peer review, and financial or grants management issues:

o  Direct your questions about scientific/research issues to:

Emeline Otey, Ph.D.
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health 
6001 Executive Boulevard, Room 6186
Bethesda, MD 20892-9625
Telephone:  (301) 443-1636
FAX:  (301) 443-4611 
Email:  eotey@mail.nih.gov

o  Direct your questions about the EBI and other CMHS/SAMHSA anti-stigma activities 
to:

Paolo DelVecchio
Office of External Liaison
Substance Abuse and Mental Health Services Administration
5600 Fishers Lane, Room 15-99
Rockville, MD  20857
Telephone:  (301) 443-2619
FAX:  (301) 443-5163
Email:  pdelvecc@samhsa.gov

o  Direct your questions about the NIMH Outreach Partnership Program to:

Timothy Hays, Ph.D.
Office of Constituency Relations and Public Liaison
National Institute of Mental Health
6001 Executive Blvd, Room 7111
Bethesda, MD 20892
Telephone:  (301) 443-3673
FAX:  (301) 443-2578
Email:  thays@mail.nih.gov
http://www.nimh.nih.gov/outreach/partners/

o  Direct your questions about financial or grants management matters to:

Brian Albertini
Grants Management Branch 
National Institute of Mental Health 
6001 Executive Boulevard, Room 6134, MSC 9605
Bethesda, MD  20892-9605
Telephone:  (301) 443-0004
FAX:  (301) 443-6885
Email:  albertib2@mail.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  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 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format.  
For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: 
GrantsInfo@nih.gov.

The title and number of this program announcement must be typed on line 2 of the 
face page of the application form and the YES box must be checked.

SUPPLEMENTARY INSTRUCTIONS:  This program announcement requires the knowledge and 
expertise of (1) individuals, groups, or organizations with hands-on experience in 
developing anti-stigma and discrimination campaigns, and (2) researchers with 
expertise in research design and implementation; and it requires that a formal 
collaboration between two (or more) groups of experts be established.  Each of the 
collaborating partner sites must submit a separate application.  The applications 
must contain an identical ABSTRACT, which identifies the collaborating partner(s) 
site(s) by the name of the Principal Investigator and the name of the applicant 
organization or institution, an identical OVERVIEW, an identical RESEARCH PLAN, 
Section 2 A-D, and an identical Section H, CONSORTIUM/CONTRACTUAL ARRANGEMENTS.

The OVERVIEW must be no longer than 2 pages and must provide an overall rationale 
for applying as collaborative partner sites, the role of each partner site in the 
overall project.  It is expected that consumer and/or advocate organizations as a 
group have the most expertise and prior hands-on experience in anti-stigma and 
discrimination programs, and would therefore, be included as a collaborating 
partner or have a substantial role in all applications submitted under this PA.  If 
none of the collaborating sites is a consumer or advocate organization, the role of 
representatives of the consumer and/or advocate community in developing the 
application and in conducting the research must be explicitly laid out in the 
overview.

The RESEARCH PLAN - Section 2 A-D, must describe the study design, the research 
procedures or protocol, the study population, resources, data analyses, and the 
special expertise and role of each of the collaborating partners in implementing 
each aspect of the research plan.  Since the unique aspects of each site are 
described in both/all collaborating applications, the Collaborative R01 requirement 
of a specific section entitled ELEMENTS UNIQUE TO THIS SITE does not apply to this 
PA. 

Section H, CONSORTIUM/CONTRACTUAL ARRANGEMENTS, must describe a feasible mechanism 
for scientific integration of research procedures, overall managerial and 
administrative responsibilities, and cross-site comparability of training to assure 
reliability and quality control.  The PIs may or may not wish to designate a 
Steering Committee or other decision making body, or identify one individual as the 
contact person for the group as a whole, for purposes of NIMH correspondence.  
Plans for ensuring access to data by all sites, analytic resources, publication and 
authorship rights, the possibility of public use research materials and data, or 
other means of distributing research materials to the wider scientific community, 
and a means of arbitrating disagreements on publication and other issues should be 
discussed in this section of the application.

APPLICATION RECEIPT DATES:  Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which are 
available at http://grants.nih.gov/grants/dates.htm.  Application deadlines are 
also indicated in the PHS 398 application kit.

SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS:  Applications 
requesting up to $250,000 per year in direct costs must be submitted in a modular 
budget grant format.  The modular budget grant format simplifies the preparation of 
the budget in these applications by limiting the level of budgetary detail.  
Applicants request direct costs in $25,000 modules.  Section C of the research 
grant application instructions for the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants.  Additional information on modular grants is 
available at http://grants.nih.gov/grants/funding/modular/modular.htm.

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR:  
Collaborating partners requesting $500,000 or more in direct costs (both/all sites 
combined for any year) must include a cover letter from the NIMH staff member who 
has agreed to accept assignment of the application.

Collaborating partners requesting more than $500,000 for both/all sites combined 
must carry out the following steps:

1) Contact IC program staff at least 6 weeks before submitting the application, 
i.e., as you are developing plans for the study;

2) Obtain agreement from the IC staff that the IC will accept your application for 
consideration for award; and,

3) Identify, in a cover letter sent with the application, the IC staff member who 
agreed to accept assignment of the application.

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised version of 
these grant application types. Additional information on this policy is available 
in the NIH Guide for Grants and Contracts, October 19, 2001 at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.

SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten original of an 
application (each site should submit their individual application), including the 
checklist, and five signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

APPLICATION PROCESSING:  Applications must be mailed on or before the receipt dates 
described at http://grants.nih.gov/grants/funding/submissionschedule.htm.  The CSR 
will not accept any application in response to this PA 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 a substantial 
revision of an unfunded version of an application already reviewed, but such 
application must include an Introduction addressing the previous critique.

Although there is no immediate acknowledgement of the receipt of an application, 
applicants are generally notified of the review and funding assignment within 8 
weeks.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of established PHS 
referral guidelines.  Appropriate scientific review groups convened in accordance 
with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) 
will evaluate applications for scientific and technical merit.

As part of the initial merit review, all applications will:

o  Undergo a selection process in which only those applications deemed to have the 
highest scientific merit, generally the top half of applications under review, will 
be discussed and assigned a priority score
o  Receive a written critique
o  Receive a second level review by the National Advisory Mental Health Council.

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 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.

o  Significance
o  Approach
o  Innovation
o  Investigator
o  Environment

The application does not need to be strong in all categories to be judged likely to 
have major scientific impact and thus deserve a high priority score.  For example, 
an investigator may propose to carry out important work that by its nature is not 
innovative but is essential to move a field forward.

SIGNIFICANCE:  Does this study address an important problem? If the aims of the 
application are achieved, how will scientific knowledge be advanced? What will be 
the effect of these studies on the concepts or methods that drive this field?

APPROACH:  Are the conceptual framework, design, methods, and analyses adequately 
developed, well-integrated, and appropriate to the aims of the project? Does the 
applicant acknowledge potential problem areas and consider alternative tactics?

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?

INVESTIGATOR:  Is the investigator appropriately trained and well suited to carry 
out this work? Is the work proposed appropriate to the experience level of the 
principal investigator and other researchers (if any)?

ENVIRONMENT:  Does the scientific environment in which the work will be done 
contribute to the probability of success? Do the proposed experiments take 
advantage of unique features of the scientific environment or employ useful 
collaborative arrangements? Is there evidence of institutional support?  

ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, the following items 
will be considered in the determination of scientific merit and the priority score:

COLLABORATION:  Is there a feasible mechanism for collaboration to achieve 
scientific integration of research procedures, overall managerial and  
administrative responsibilities, appropriate quality control and reliability  
assurance, and planning for data management, analysis and reporting of results?

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).http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH:  The adequacy of plans to 
include subjects from both genders, all racial and ethnic groups (and subgroups), 
and children as appropriate for the scientific goals of the research will be 
assessed.  Plans for the recruitment and retention of subjects will also be 
evaluated. (See 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.

ADDITIONAL REVIEW CONSIDERATIONS

BUDGET:  The reasonableness of the proposed budget and the requested period of 
support in relation to the proposed research.

AWARD CRITERIA

Applications submitted in response to a PA will compete for available funds with 
all other recommended applications.  The following will be considered in making 
funding decisions:

o  Scientific merit of the proposed project as determined by peer review
o  Availability of funds
o  Relevance to program priorities

REQUIRED FEDERAL CITATIONS

ANIMAL WELFARE PROTECTION:  Recipients of PHS support for activities involving 
live, vertebrate animals must comply with PHS Policy on Humane Care and Use of 
Laboratory Animals 
(http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf),
as mandated by the Health Research Extension Act of 1985 
(http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal 
Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as 
applicable.

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

SHARING RESEARCH DATA:  Investigators submitting an NIH application seeking 
$500,000 or more in direct costs in any single year are expected to include a plan 
for data sharing or state why this is not possible. 
http://grants.nih.gov/grants/policy/data_sharing.  Investigators should seek 
guidance from their institutions, on issues related to institutional policies, 
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. 

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). 

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 PA 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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