HIV/AIDS, SEVERE MENTAL ILLNESS AND HOMELESSNESS

RELEASE DATE:  November 18, 2003

PA NUMBER:  PA-04-024

November 27, 2006 - The R01 portion of this funding opportunity has been replaced by PA-07-090, 
which now uses the electronic SF424 (R&R) application for February 5, 2007 submission dates and beyond.

March 2, 2006 (NOT-OD-06-046) – Effective with the June 1, 2006 submission date, 
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using 
the electronic SF424 (R&R) application. This announcement will stay active for 
only the May 1, 2006 AIDS and AIDS-related application submission date for these 
mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms 
expires on the date indicated below. Other mechanisms relating to this announcement 
will continue to be accepted using paper PHS 398 applications until the stated 
expiration date below, or transition to electronic application submission. Parent 
R03 (PA-06-180) and R21 (PA-06-181) funding opportunity announcements have been 
issued for the submission date of June 1, 2006 and submission dates for AIDS and 
non-AIDS applications thereafter. Applications relating to R33 and R34 activities 
must be in response to NIH Institute/Center (IC)-specific announcements.

EXPIRATION DATE for R03 and R21 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R03 and R21 AIDS and AIDS-Related Applications: May 2, 2006 
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)

COMPONENTS OF PARTICIPATING ORGANIZATION:
National Institute of Mental Health (NIMH)
 (http://www.nimh.nih.gov/)
National Institute on Drug Abuse (NIDA)
 (http://www.nida.nih.gov)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 (http://www.niaaa.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.242, 93.279, 93.273

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  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

This PA replaces PA-98-080.

The overall focus of this Program Announcement (PA), sponsored by the NIMH, 
NIAAA and NIDA, is to refocus research on persons with severe mental illness 
(SMI), either before or after HIV infection, and to expand HIV-related research 
to homeless persons.  This PA solicits studies on the SMI population and/or 
homeless persons with special attention to the development, implementation, and 
evaluation of effective HIV-prevention interventions and their dissemination and 
translation to the community and public health service organizations.  We also 
solicit studies on the SMI population and/or homeless persons that propose 
improved methodologies to study descriptive/analytic epidemiology of HIV 
infection and epidemiology of the behavior associated with risk and the spread 
of HIV infection.  An important objective of this PA is to encourage integration 
both across and within the different research areas by establishing 
multidisciplinary research teams and collaborative alliances.

RESEARCH OBJECTIVES

Over the past decade there have been significant advances in research on the 
U.S. epidemic of HIV infection among people with the most severe and persistent 
mental illnesses.  To date, research has concentrated largely on the following 
areas:  (1) cross sectional studies of regional HIV seroprevalence in SMI in 
predominantly urban sections of the country, (2) studies of risk, transmission, 
and behavioral epidemiology, and (3) research on cognitive behavior and skill-
based risk reduction interventions in adult SMI.  However, research is still 
needed in a number of crucial areas on HIV/AIDS and the SMI, and the links with 
homeless persons have become more obvious, demanding immediate research 
attention (discussed below).  Epidemiological estimates indicate that about 
one-third of all homeless, single adults have severe and persistent mental 
illness and have marked neuropsychological impairments in attention, executive 
functioning, verbal memory, and general intellectual functioning.  Substance use 
and abuse estimates are extremely high for homeless adolescents and adults, 
including alcohol and injection drug use (ranging from 20-80%).  Available data 
suggest that in major urban areas, 10-20% of homeless persons who suffer from 
chronic mental illnesses are infected with HIV.  Nationwide, homeless adults are 
a population at high risk for HIV, due to disproportionate rates of injection 
drug use, unprotected sexual activity, prostitution, and victimization.  
Moreover, those who are often marginalized, such as the homeless, suffer from 
other co-infections (e.g., tuberculosis, hepatitis C virus), multiple 
comorbidities (e.g., substance abuse, mental illness), and a wide range of 
chronic health conditions (e.g., arthritis, heart disease, high blood pressure, 
emphysema/bronchitis, cirrhosis, kidney disorder, seizure disorder).  The 
multiple conditions affecting HIV disease in homeless persons may accelerate HIV 
disease course, add significant complications to the manifestations of HIV 
disease and its CNS sequelae, and challenge the available prevention strategies
and service delivery systems.

Research is needed to better understand the prevalence of HIV and AIDS among 
persons with SMI, with drug abusing behaviors, and/or who are homeless across 
the U.S.  Epidemiological research must look broadly at HIV-related risk 
behavior and examine the extent and social organization of sexual and drug-use 
behavior.  Research efforts might begin by targeting high-risk individuals in 
community samples and then extend into the general population of individuals 
troubled by the most severe mental illnesses.  Epidemiological research needs to 
be broadened to samples of patients with preexisting mental illness, mental 
illness secondary to HIV infection, and to others suffering from mental illness 
within the community.  Research is needed to address: improved methodological 
procedures; longitudinal studies in multiple U.S. regions including incidence 
data; validating self-reported data; increased generalizability to the general 
population; the role of contextual factors; linking risk taking to specific 
aspects of SMI; and longitudinal studies on patterns of risk taking over time;
and connecting between the content of HIV preventive interventions to 
potentially risky situations actually encountered by SMI individuals.  HIV 
research in homeless persons must address: the relative role of co-infections 
and comorbidities; a range of settings including forensic, shelters, new 
admissions and long-stay; developmental trajectories to and out of homelessness 
in youth; risk research in children of homeless adults; and adherence research 
in homeless persons with multiple comorbidities.

In spite of some positive behavior change outcomes of HIV preventive interventions 
for this population, research on risk reduction approaches for mentally ill persons 
is still in its very early stages.  We must develop a “combination” approach to HIV 
prevention in the SMI and homeless that incorporates a range of biomedical, 
behavioral, and social interventions that work on all levels of social organization 
from individuals to whole societies.  We need a broader repertoire of intervention 
models and these models must be assessed at multiple levels including individual, 
system, network, care provider and community.  HIV prevention programs will have to 
be integrated into outreach, transitional living, and community services for the 
SMI by translating effective HIV prevention methods for the SMI to applied mental 
health and public health care systems.  Strategies should be developed for 
sustained long-term effectiveness of HIV preventive programs across multiple care 
and social service systems for the SMI and/or homeless through integration, 
coordination and linkages with psychiatric, alcohol, drug abuse, and medical 
therapies.  Better implementation of effective interventions will require a 
dialogue among researchers, public health practitioners, policymakers, and 
community constituencies as well as an improved science of research dissemination.  
Implementation must be followed by assessment of the extent to which people with 
SMI do in fact actually receive HIV-related medical care.  Interventions will 
succeed only if they are linked to efforts to address the macrosocial conditions 
that contribute to HIV vulnerability and other infectious diseases and their 
consequences.  This is especially important for the SMI and the homeless because of 
the layers of stigma from infection, psychiatric illness, alcohol/drug abuse, life 
style, and inequalities based on race/ ethnicity, discrimination, economic class, 
or sexual identity.

Areas of Research Interest

The following are examples of broad research topics that might be the focus of 
research on HIV/AIDS in persons with SMI and/or homelessness (mentally ill 
populations other than the SMI may sometimes be relevant).  The list of examples is 
not meant to be comprehensive nor exclusive of other topics.

Epidemiology, Risk, and Protective Factors

o  Epidemiological multisite research of population-based samples on at-risk and 
HIV infected individuals with a psychiatric diagnosis and alcohol/drug abuse 
disorders, including all races and ethnic groups, children, adolescents, and adults 
living in multiple urban, suburban, and rural regions of the U.S.

o  Due to the multiple stigmas around mental illness, homelessness, alcohol and 
substance abuse disorders, and HIV/AIDS, research is needed to examine ways in 
which stigma and discrimination or other social, economic cultural and 
environmental conditions contribute to, or create sources of, HIV-related risk and 
develop interventions based on this understanding.

o  Because traditionally underserved populations with mental illness, homelessness, 
alcohol and drug abuse, and HIV/AIDS are skeptical about treatment and care, novel 
recruitment, engagement and retention strategies are  needed to reach and retain 
persons least likely to seek help and to conduct research on effectiveness of 
alternative access methods that may involve either faith-based or other community 
organizations.

o  Increased attention to individually perceived protective factors (e.g., reason 
for living) in the context of known risk factors, trait or state dimensions (such 
as impulsivity or impaired executive functioning), that increase risk of HIV 
infection and the role of cultural factors and acculturative processes that can 
modify risk and its perception as well as influencing protective factors (e.g., 
religiosity).

o  Longitudinal research of HIV-related risk taking at individual and community 
levels in the SMI and homeless.

Comorbidities and Complications

o  Studies of medical or neuropsychiatric manifestations of HIV infection that may 
result in onset of SMI or may co-occur with homelessness (e.g., neurocognitive 
disorders related to HIV with or without Hepatitis-C co-infection, psychotic 
disorders, delirium, CNS opportunistic infections and tumor, systemic 
abnormalities, psychoactive agents, adverse effects of certain medical treatments, 
Hepatitis C Virus).

o  Research to evaluate the effect of co-infection (especially with HBV, HCV or TB) 
on the management of HIV in SMI or homeless persons and to determine the bi-
directional effects of co-infection and treatments on disease progression and drug 
interactions.

o  Evaluation of potential therapies for the prevention and treatment of HIV-
associated infections and co-infections and research on treatment of comorbidities; 
prevention of early comorbid patterns in reducing risk, increasing the efficacy of 
HIV risk-reduction and adherence interventions in the SMI or homeless persons.

o  Studies to determine the impact co-infection with HBV, HCV, or TB on immune 
dysfunction, HIV progression and HIV-therapy associated reconstitution in SMI.

o  Research to discover mechanisms underlying the relationships among co-occurring 
disorders and HIV and potentially modifiable biological substrates that link co-
infections and comorbidites to HIV disease in the SMI and homeless persons.

Multilevel Prevention and Treatment Services

o  Studies of structural, community, social network and societal/cultural level 
interventions to reduce high risk behaviors and prevent HIV infection in the SMI 
and homeless and go beyond the standard individual-level randomized trial 
interventions.

o  Studies to adapt effective HIV preventive interventions to the SMI, homeless, 
and other underserved marginalized populations.

o  Research to address the multiple comorbidities and complications in HIV-infected 
individuals with SMI and/or homelessness through the development of integrated 
treatment and care of mental illness and substance abuse and improved linkages with 
the specialty medical care system.

o  Increased attention to under-developed prevention modalities and sub- 
populations of the SMI and homeless, such as the development of newer methods of 
prevention (e.g., microbicides, vaccines) and HIV prevention among infected 
individuals.

o  Research on mental health and substance abuse service needs or service system 
organization and assessment of the most effective methods for providing and 
financing services to HIV-infected individuals with SMI and homelessness.

Technology Transfer and Information Dissemination

o  Studies that translate research results into community programs for HIV-infected 
persons with SMI and homelessness, moving from research interventions to ongoing 
public health programs and cost effectiveness.

o  Development of outcome measures and suitable methodologies for dissemination and 
dissemination/implementation approaches that accurately assess the success of an 
approach to move evidence into practice.

o  Studies on the fidelity of implementation efforts, including the identification 
of components of implementation that will enable fidelity to be assessed 
meaningfully.

o  Studies on the dissemination of effective HIV-intervention strategies that also 
test the utility of alternative dissemination strategies for service delivery 
systems targeting the SMI, homeless, and/or other related underserved populations.

o  Research to identify factors (system, organizational, individual) necessary to 
enhance an alliance of trust between the provider and client, facilitate treatment 
readiness and  maximize consumer participation and engagement in HIV prevention, 
outreach, transitional living and community services for the homeless and/or 
persons with SMI 

MECHANISMS OF SUPPORT 

This PA will use the NIH Research Project Grant (R01), collaborative R01s, Small 
Grant (R03), Exploratory/Developmental Grant (R21) award mechanism(s).  As an 
applicant, you will be solely responsible for planning, directing, and executing 
the proposed project.

Information on the Collaborative R01 mechanism is available at:  
http://grants.nih.gov/grants/guide/pa-files/PA-01-123.html

Information on the Small Grant (R03) is available at:  
http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html

Information on the Exploratory/Developmental Grant (R21) is available at:  
http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html

This PA uses just-in-time concepts.  It also uses the modular budgeting format. 
(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 format.  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_2001/part_i_1.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  Domestic or foreign institutions/organizations
o  Faith-based or community-based organizations

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry out the 
proposed research is invited to work with their institution to develop an 
application for support.  Individuals from underrepresented racial and ethnic 
groups as well as individuals with disabilities are always encouraged to apply for 
NIH programs.

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 two areas:  
scientific/research and financial or grants management issues:

o  Direct your questions about scientific/research issues to:

David M. Stoff, Ph.D.
Division of Mental Disorders Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6210, MSC 9619
Bethesda, MD  20892-9619
Telephone:  (301) 443-4625
FAX:  (301) 443-9719
Email:  dstoff@nih.gov

Mike Hilton, Ph.D.
Office of Collaborative Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 302
Bethesda, MD 20892-7003
Telephone:  (301) 402-9402
Fax:  (301) 480-2358
Email:  mhilton@niaa.nih.gov

Jerry Flanzer, Ph.D.
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4222, MSC 9565
Bethesda, MD  20892-9565
Telephone:  (301) 443-4060
FAX:  (301) 443-6815
Email:  Jflanzer@nida.nih.gov

Helen Cesari, MSc.
Center of Center on AIDS and Other Medical Consequences of Drug Abuse
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5173
Bethesda, MD  20892
Telephone:  (301) 443-1801
FAX:  (301) 480-4544
Email:  Hcesari@nida.nih.gov

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

Brian Albertini
Division of Mental Disorders, Behavioral Research, and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6135, MSC 9605
Bethesda, MD 20852-9605
Telephone:  (301) 443-0004
FAX:  (301) 443-6885
Email:  albertib2@mail.nih.gov

Judy Fox (formerly Simons)
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 504
Bethesda, MD  20892-7003
Telephone:  (301) 443-4704
FAX:  (301) 443-3891
Email:  jsimons@willco.niaaa.nih.gov

Diana Haikalis, MBA
Office of Extramural Affairs
National Institute on Drug Abuse
6101 Executive Boulevard, Suite 242, MSC 8403
Bethesda, MD  20892-8403 (express/courier service)
Telephone:  (301) 443-6710
FAX:  (301) 443-7595
Email:  dhaikali@nida.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 the PA must be typed in line 2 of the face page of the 
application form and the YES box must be checked.
 
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:  
Applications requesting $500,000 or more in direct costs for any year must include 
a cover letter identifying the NIH staff member within one of NIH institutes or 
centers who has agreed to accept assignment of the application.

Applicants requesting more than $500,000 must carry out the following steps:

1) Contact the 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 staff member and IC 
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 the 
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 appropriate national advisory council or 
board 

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of biological 
systems, improve the control of disease, and enhance health.  In the written 
comments, reviewers will be asked to discuss your 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 
these 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:

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

SHARING RESEARCH DATA:  Applicants requesting more than $500,000 in direct costs in 
any year of the proposed research are expected to include a data sharing plan in 
their application.  The reasonableness of the data sharing plan or the rationale 
for not sharing research data will be assessed by the reviewers.  However, 
reviewers will not factor the proposed data sharing plan into the determination of 
scientific merit or priority score.

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 

HUMAN SUBJECTS PROTECTION:  Federal regulations (45CFR46) require that applications 
and proposals involving human subjects must be evaluated with reference to the 
risks to the subjects, the adequacy of protection against these risks, the 
potential benefits of the research to the subjects and others, and the importance 
of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

DATA AND SAFETY MONITORING PLAN:  Data and safety monitoring is required for all 
types of clinical trials, including physiologic, toxicity, and dose-finding studies 
(phase I); efficacy studies (phase II), efficacy, effectiveness and comparative 
trials (phase III).  The establishment of data and safety monitoring boards (DSMBs) 
is required for multi-site clinical trials involving interventions that entail 
potential risk to the participants.  (NIH Policy for Data and Safety Monitoring, 
NIH Guide for Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

SHARING RESEARCH DATA:  Starting with the October 1, 2003 receipt date, 
investigators submitting an NIH application seeking more than $500,000 or more in 
direct costs in any single year are expected to include a plan for data sharing or 
state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).  
Investigators should seek guidance from their institutions, on issues related to 
institutional policies, local IRB rules, as well as local, state and Federal laws 
and regulations, including the Privacy Rule.  Reviewers will consider the data 
sharing plan but will not factor the plan into the determination of the scientific 
merit or the priority score.

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH:  It is the policy of the 
NIH that women and members of minority groups and their sub-populations must be 
included in all NIH-supported clinical research projects unless a clear and 
compelling justification is provided indicating that inclusion is inappropriate 
with respect to the health of the subjects or the purpose of the research.  This 
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 
103-43).

All investigators proposing clinical research should read the "NIH Guidelines for 
Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, 
October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 
2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.  
The amended policy incorporates:  the use of an NIH definition of clinical research; 
updated racial and ethnic categories in compliance with the new OMB standards; 
clarification of language governing NIH-defined Phase III clinical trials 
consistent with the new PHS Form 398; and updated roles and responsibilities of NIH 
staff and the extramural community.  The policy continues to require for all NIH-
defined Phase III clinical trials that:  a) all applications or proposals and/or 
protocols must provide a description of plans to conduct analyses, as appropriate, 
to address differences by sex/gender and/or racial/ethnic groups, including 
subgroups if applicable; and b) investigators must report annual accrual and 
progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic 
group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:  The 
NIH maintains a policy that children (i.e., individuals under the age of 21) must 
be included in all human subjects research, conducted or supported by the NIH, 
unless there are scientific and ethical reasons not to include them.  This policy 
applies to all initial (Type 1) applications submitted for receipt dates after 
October 1, 1998.

All investigators proposing research involving human subjects should read the "NIH 
Policy and Guidelines" on the inclusion of children as participants in research 
involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS:  NIH policy 
requires education on the protection of human subject participants for all 
investigators submitting NIH proposals for research involving human subjects.  You 
will find this policy announcement in the NIH Guide for Grants and Contracts 
Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC):  Criteria for federal funding of research on 
hESCs can be found at http://stemcells.nih.gov/index.asp and at  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only research 
using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry 
will be eligible for Federal funding (see http://escr.nih.gov).  It is the 
responsibility of the applicant to provide, in the project description and 
elsewhere in the application as appropriate, the official NIH identifier(s)for the 
hESC line(s)to be used in the proposed research.  Applications that do not provide 
this information will be returned without review.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:  The Office 
of Management and Budget (OMB) Circular A-110 has been revised to provide public 
access to research data through the Freedom of Information Act (FOIA) under some 
circumstances.  Data that are (1) first produced in a project that is supported in 
whole or in part with Federal funds and (2) cited publicly and officially by a 
Federal agency in support of an action that has the force and effect of law (i.e., 
a regulation) may be accessed through FOIA.  It is important for applicants to 
understand the basic scope of this amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public archive, 
which can provide protections for the data and manage the distribution for an 
indefinite period of time.  If so, the application should include a description of 
the archiving plan in the study design and include information about this in the 
budget justification section of the application.  In addition, applicants should 
think about how to structure informed consent statements and other human subjects 
procedures given the potential for wider use of data collected under this award.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) issued final modification to the 
“Standards for Privacy of Individually Identifiable Health Information”, the 
“Privacy Rule,” on August 14, 2002.  The Privacy Rule is a federal regulation under 
the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that 
governs the protection of individually identifiable health information, and is 
administered and enforced by the DHHS Office for Civil Rights (OCR).  Those who 
must comply with the Privacy Rule (classified under the Rule as “covered entities”) 
must do so by April 14, 2003  (with the exception of small health plans which have 
an extra year to comply).

Decisions about applicability and implementation of the Privacy Rule reside with 
the researcher and his/her institution.  The OCR website (http://www.hhs.gov/ocr/) 
provides information on the Privacy Rule, including a complete Regulation Text and 
a set of decision tools on “Am I a covered entity?”  Information on the impact of 
the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress 
monitoring of grants, cooperative agreements, and research contracts can be found 
at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES:  All applications and proposals for 
NIH funding must be self-contained within specified page limitations.  Unless 
otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be 
used to provide information necessary to the review because reviewers are under no 
obligation to view the Internet sites.  Furthermore, we caution reviewers that 
their anonymity may be compromised when they directly access an Internet site.

HEALTHY PEOPLE 2010:  The Public Health Service (PHS) is committed to achieving the 
health promotion and disease prevention objectives of "Healthy People 2010," a PHS-
led national activity for setting priority areas.  This PA 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.

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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