HIV/AIDS AND OTHER INFECTIONS AMONG DRUG USERS IN THE CRIMINAL JUSTICE SYSTEM

RELEASE DATE:  December 10, 2003
 
RFA Number:  RFA-DA-04-015

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH) 
 (http://www.nih.gov)

COMPONENT OF PARTICIPATING ORGANIZATION: 
National Institute on Drug Abuse (NIDA)
 (http://www.nida.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.279

LETTER OF INTENT RECEIPT DATE:  February 23, 2004
APPLICATION RECEIPT DATE:       March 23, 2004

THIS REQUEST FOR APPLICATIONS (RFA) CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanisms of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA

This RFA invites epidemiological, prevention, and services research on HIV/AIDS 
and other blood-borne and sexually transmitted infections (STIs) among adult 
and juvenile drug users in the criminal justice system receiving legal 
supervision in community-based settings, such as the drug courts, diversion 
initiatives, or community re-entry programs. Specifically, NIDA seeks 
innovative research to advance knowledge and understanding of the epidemiology, 
prevention, and treatment service needs of drug users in the criminal justice 
system who have or are at high-risk for HIV and other infectious diseases, and 
who receive legal supervision in the community setting. Results from these 
studies are expected to inform future developments in behavioral interventions 
and services to prevent and treat the spread of HIV/AIDS and other diseases 
among individuals in the criminal justice system with substance abuse-related 
problems. Applicants are encouraged to address behavioral, social, medical, 
systems-level, and environmental factors that impact the epidemiology of 
HIV/AIDS and other diseases in this population; to design and pilot test 
behavioral interventions to prevent HIV/AIDS and other comorbid conditions 
associated with the initiation, resumption, or progression of substance abuse 
and unsafe sex; and to develop and test systems-level models for integrating 
strategies to prevent and treat HIV/AIDS and other infectious diseases among 
drug users in the criminal justice system. 

The challenge of achieving long-term HIV risk reduction and behavioral change 
among drug users in the criminal justice system is especially complex given 
the personal, familial, social, environmental, and criminal diversity of the 
population. By improving our knowledge and understanding of the epidemiology, 
prevention, and treatment service needs of criminally-involved drug users who 
may have, or be at high-risk for, HIV and other infections, this initiative 
will advance developments in behavioral interventions and services to prevent 
and treat HIV and other blood-borne and sexually transmitted diseases in this 
population. It will also lead to new developments in systems-level models for 
integrating prevention and treatment services for HIV/AIDS and other 
infectious diseases into the criminal justice system.  

For the purposes of this RFA, the term drug user in the criminal justice 
system refers to any drug user who lives in the community and is receiving 
some form of community-based legal supervision under the auspices of the 
criminal justice system.  Such individuals may be recently released or 
transitioning from a criminal justice institution into the community. Legal 
supervision may include, but is not limited to, drug courts, diversion 
initiatives, probation, parole, or other community re-entry programs. It 
includes supervision during the transitional phase of an inmate's release 
from an institution into the community, but not supervision while the inmate 
is in jails, prisons, or other detention centers. 

RESEARCH OBJECTIVES 

Background

Drug users are disproportionately involved in criminal activity.  According to 
data from the National Institute of Justice's Arrestee Drug Abuse Monitoring 
(ADAM), about 66% of adult and more than 50% of juvenile arrestees tested positive 
for one or more illicit drugs in 1999. In 1998, approximately 36% of jail inmates 
were under the influence of drugs at the time of their offense. In 1999, an 
estimated 24% of property offenses and 11% of violent offenses were committed for 
money to buy drugs. Today, over 6.6 million adults (one of every 32 persons) in 
the U.S. are on probation, in jail/prison, or on parole. In 1999, 61% of Federal 
inmates were sentenced for drug offenses, up from 53% in 1990. Among individuals 
in state prisons, the increase from 1990 to 1999 for drug offenses was even larger 
at 69%. The proportion of juvenile justice-involved youth has increased 31% from 
1989 to 1998 (National Center of Juvenile Justice, 2001). Recent estimates suggest 
that 60% or more of juveniles in the criminal justice system have substance abuse 
problems (U.S. Department of Justice, 2000). Since 1999, approximately 600,000 
inmates per year have been released from institutional facilities back into the 
community, and an estimated 33% of these individuals have drug abuse problems, as 
well as other medical and mental health disorders. Upon release, few have 
connections in the community to help them access local drug treatment services or 
HIV/AIDS prevention and treatment programs.  Individuals who do have access to 
community-based drug treatment programs often are or have been involved in the 
criminal justice system, however. Findings from the Drug Abuse Treatment Outcome 
Study (DATOS) suggest that more than 50% of cocaine and opioid addicts seeking 
community-based drug treatment reported involvement in the criminal justice 
system.

Data suggest that the prevalence of HIV and other infectious diseases is high 
among drug users in the criminal justice system. Cooper (1999) estimated that HIV 
seropositivity rates in U.S. correctional settings were roughly 8-10 times higher 
than the general population. Data synthesized from surveys, surveillance, and 
other reports by Hammett et al (2002) indicate that, during 1997, 20% to 26% of 
all people living with HIV in the U.S., 29% to 43% of all those infected with HCV, 
and 40% of all those who had tuberculosis (TB) in that year passed through a 
correctional facility. While only 3% of the U.S. population spent time in a 
correctional facility in 1997, between 16% to 43% of the burden of HIV/AIDS, HCV, 
and TB was found in this relatively small segment of the population, making AIDS 
about 5 times more prevalent among prisoners, and HCV about 9 times more prevalent 
(Hammett et al, 2002). The findings for juvenile detainees are equally alarming. 
For example, Teplin et al (2003) examined HIV/AIDS risk behaviors in a 
longitudinal study of 1,829 males and females ages 10-18 years in Chicago, and 
found that 95% of the sample had engaged in 3 or more high-risk behaviors, and 65% 
had engaged in 10 or more (e.g., alcohol and other substance use, unprotected sex 
with multiple partners).

These and other findings highlight the need for better understanding of the 
epidemiology, prevention, and treatment service needs of drug users in the 
community who are involved in the criminal justice system. Applicants are 
encouraged to consider multidisciplinary approaches, as appropriate, in their 
study designs, drawing from the behavioral, biomedical, and social sciences, 
and utilizing both qualitative and quantitative measures and methods. Topics 
of research interest include, but are not limited, to the following:

o Identify behavioral, social, cultural, environmental, and systems-level 
factors in the epidemiology of substance abuse and behavioral risks for HIV 
and other infectious diseases among drug users in the criminal justice system 
receiving legal supervision in community-based setting;

o Identify gender-based differences in trajectories of HIV and other health 
consequences of drug use (including relapse, HBV, HCV, mental health 
outcomes, and violence) among persons newly released from prisons and jails, 
and their implications for prevention, treatment, and re-entry and 
integration into the community setting;  

o Determine the types, accessibility, availability, and effectiveness of 
community-based HIV prevention programs and treatment services for men and/or 
women newly released from prison or jail, on probation or parole, or those 
receiving some form of legal supervision in community-based settings for 
substance abuse-related problems (e.g., through drug courts, diversion 
initiatives, or community re-entry programs);

o Design innovative behavioral prevention and intervention strategies for 
pilot testing with community-based drug users in the criminal justice system 
to reduce HIV/AIDS and other comorbid conditions (including hepatitis B, 
hepatitis C, and other sexually transmitted diseases) associated with drug 
abuse and unsafe sex;

o Develop and test effective community-based outreach strategies to drug 
users in the criminal justice system that utilize referrals and improve 
access to HIV/AIDS and other health-related prevention and treatment 
services;

o Develop, pilot test, and refine novel HIV prevention messages and 
strategies to reduce high-risk drug use and sexual behaviors associated with 
the spread of HIV and other infectious diseases among adult and juvenile drug 
users involved with the criminal justice system who live in community 
settings; 

o Develop improved methods to assess adherence to therapeutic regimens among 
HIV-infected drug users involved in the criminal justice system, including 
studies to compare and validate adherence measures in the context of linked 
community-based treatment programs and services (e.g., community-based 
medical care for HIV, HBV, HCV and drug abuse treatment);

o Identify contextual, social, and gender-related factors associated with 
risks of drug use, HIV, and other blood-borne infections and STIs among drug 
users in the criminal justice system who live in the community (e.g., health 
disparities, norms and attitudes about gender roles, and peer influences 
related to HIV-related risk behaviors, including injecting drug use and 
unsafe sex), and design and pilot test community-based risk reduction 
interventions that take these factors into account;

o Utilize operational and health services research methods to identify and 
understand issues related to barriers/facilitators and the implementation/ 
integration of community-based HIV/AIDS interventions for drug users in the 
criminal justice system;

o Identify characteristics of community-based services (e.g., organizational, 
financing, management, access, delivery, cost-effectiveness, linkage, and 
coordination) that can be augmented, enhanced, or modified to improve 
outreach, HIV/AIDS prevention, and treatment programs and services for drug 
users in the criminal justice system who live in the community.

Applications solicited under this RFA should be conceptually clear and 
theoretically driven, and should address the purposes and objectives of this 
RFA. In addition, applications should be sensitive to issues of cost, cost-
effectiveness, and the integration of public health and public safety 
outcomes.  

MECHANISMS OF SUPPORT
 
This RFA will use the National Institutes of Health (NIH) exploratory grant 
(R21) and the small grant program (R03) award mechanisms.  As an applicant, 
you will be solely responsible for planning, directing, and executing the 
proposed project. Applicants must clearly specify in the application which 
mechanism is being requested. 

Applications for R21 awards should describe projects distinct from those 
supported through the traditional R01 mechanism.  For example, long-term 
projects, or projects designed to increase knowledge in a well-established 
area will not be considered for R21 awards. Applications submitted under the 
R21 mechanism should be exploratory and novel. These studies should break new 
ground or extend previous discoveries toward new directions or applications.  
Projects of limited cost or scope that use widely accepted approaches and 
methods within well-established fields are better suited for the R03 small 
grant mechanism.  This RFA is a one-time solicitation.  Future unsolicited, 
competing-continuation applications based on this project will compete with 
all investigator-initiated applications and will be reviewed according to the 
customary peer review procedures.  The anticipated award date is September 
30, 2004. 

This RFA uses just-in-time concepts.  It also uses the modular budgeting 
format. (see http://grants.nih.gov/grants/funding/modular/modular.htm).  All 
applications submitted in response to this announcement must use the modular 
budget 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.  

Exploratory/developmental grant support is for new projects only; competing 
continuation applications will not be accepted.   Two revisions of a 
previously reviewed exploratory/developmental grant application may be 
submitted as defined in NIH Policy at 
http://grants.nih.gov/grants/policy/amendedapps.htm.  It also uses the 
modular budgeting format (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).   

FUNDS AVAILABLE
 
NIDA intends to commit approximately $1.5 million in FY 2004 to fund a 
combination of 6-8 R21s and R03s in response to this RFA. For an R21, an 
applicant may request a project period of 2 years and a budget for up to 
$275,000 total.  For an R03, an applicant may request up to $50,000 in direct 
costs for each of the 2 years, and the application research plan (items a-d) 
cannot exceed 10 pages.  Because the nature and scope of the proposed 
research will vary from application to application, it is anticipated that 
the size and duration of each award will also vary. Although the financial 
plans of NIDA provides support for this program, awards pursuant to this RFA 
are contingent upon the availability of funds and the receipt of a sufficient 
number of meritorious applications. 

ELIGIBLE INSTITUTIONS
 
You may submit (an) application(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 inquiries concerning this RFA 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:

Elizabeth Y. Lambert, M.Sc.
Center on AIDS and Other Medical Consequences of Drug Abuse (CAMCODA)
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 5198, MSC 9593
Bethesda, MD 20892-9593
Telephone: 301-402-1933
Email: EL46i@nih.gov

o Direct your questions about peer review matters to:

Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD 20892-8401
Telephone: 301-443-2755
Email: tlevitin@mail.nih.gov

Direct your questions about financial or grants management matters to:

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 242, MSC 8403
Bethesda, MD 20892-8403
Telephone:  301-443-6710
E-mail:  gfleming@mail.nih.gov

LETTER OF INTENT
 
Prospective applicants are asked to submit a letter of intent that includes 
the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this RFA 

Although a letter of intent is not required, is not binding, and does not 
enter into the review of a subsequent application, the information that it 
contains allows NIDA staff to estimate the potential review workload and plan 
the review.
 
The letter of intent is to be sent by the date listed at the beginning of 
this document.  The letter of intent should be sent to:
 
Director
Office of Extramural Program Review
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401  
Bethesda, MD 20892-8401
Rockville, MD  20852 (for express/courier service)
Telephone:  301-443-2755
Fax:  301-443-0538
Email:  tlevitin@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 document 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.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting 
up to $250,000 per year in direct costs must be submitted in a modular grant 
format.  The modular 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.

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  Failure to use this label 
could result in delayed processing of the application such that it may not 
reach the review committee in time for review.  In addition, the RFA title 
and number must be typed on line 2 of the face page of the application form 
and the YES box must be marked. The RFA label is also available at: 
http://grants1.nih.gov/grants/funding/phs398/label-bk.pdf.
 
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the Checklist, and three signed, photocopies, in 
one package to:
 
Center For Scientific Review
National Institutes Of Health/DHHS
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 and all 
copies of the appendix material must be sent to:

Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 234, MSC 8401
Bethesda, MD  20892-8401
Rockville, MD  20852 (for express/courier service)

APPLICATION PROCESSING: Applications must be received on or before the 
application receipt date listed in the heading of this RFA.  If an 
application is received after that date, it will be returned to the applicant 
without review.

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignments within 8 weeks.
 
The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  
However, when a previously unfunded application, originally submitted as an 
investigator-initiated application, is to be submitted in response to an RFA, 
it is to be prepared as a NEW application.  That is, the application for the 
RFA must not include an Introduction describing the changes and improvements 
made, and the text must not be marked to indicate the changes from the 
previous unfunded version of the application.  

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by NIDA.  Incomplete applications will not be reviewed.  If 
the application is not responsive to the RFA, NIH staff may contact the 
applicant to determine whether to return the application to the applicant or 
submit it for review in competition with unsolicited applications at the next 
appropriate NIH review cycle.
 
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 NIDA in accordance with the review criteria stated below.  As 
part of the initial merit review, all applications will:

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

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to evaluate the application in 
order to judge the likelihood that the proposed research will have a 
substantial impact on the pursuit of these goals.  The scientific review 
group will address and consider each of the following criteria in assigning 
the application's overall score, weighting them as appropriate for each 
application. 

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.

(1) SIGNIFICANCE:  Please assess the extent to which the study aims are 
consistent with the goals of the RFA.  Does the study address an important 
problem consistent with the goals of this RFA?  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?  

(2) 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?

(3) 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?

(4) 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)?

(5) 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).

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

ADDITIONAL REVIEW CONSIDERATIONS

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

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:    February 23, 2004 
Application Receipt Date:         March 23, 2004
Peer Review Date:                 July/August 2004
Council Review:                   September 2004
Earliest Anticipated Start Date:  September 30, 2004

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
 
REQUIRED FEDERAL CITATIONS 

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

DATA SAFETY AND 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 Safety and Monitoring, NIH Guide for 
Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

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 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 
(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.

HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON DRUG 
ABUSE:  Researchers funded by NIDA who are conducting research in community 
outreach settings, clinical, hospital settings, or clinical laboratories and 
have ongoing contact with clients at risk for HIV infection, are strongly 
encouraged to provide HIV risk reduction education and counseling.  HIV 
counseling should include offering HIV testing available on-site or by 
referral to other HIV testing service for persons at risk for HIV infection 
including injecting drug users, crack cocaine users, and sexually active drug 
users and their sexual partners.  For more information see 
http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html.

NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE 
ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS:  The National Advisory Council on 
Drug Abuse recognizes the importance of research involving the administration 
of drugs to human subjects and has developed guidelines relevant to such 
research.   Potential applicants are encouraged to obtain and review these 
recommendations of Council before submitting an application that will 
administer compounds to human subjects.  The guidelines are available on 
NIDA's Home Page at http://www.nida.nih.gov under the Funding, or may be obtained by 
calling (301) 443-2755.

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

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of "Healthy 
People 2010," a PHS-led national activity for setting priority areas. This 
RFA is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at 
http://www.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.


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