DRUG ABUSE AND HIV PREVENTION IN YOUTH
RELEASE DATE: January 14, 2003
RFA NUMBER: DA-03-012
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov)
National Institute of Mental Health (NIMH)
(http://www.nimh.nih.gov)
LETTER OF INTENT RECEIPT DATE: March 14, 2003
APPLICATION RECEIPT DATE: April 14, 2003
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
The National Institute on Drug Abuse (NIDA) and the National Institute of
Mental Health (NIMH) invite grant applications for the conduct of research on
drug abuse and HIV prevention in youth. The major purpose of this RFA is to
fill the need for theory-driven and research-based drug abuse-related HIV
prevention interventions that will be effective in decreasing the incidence
of HIV infection and AIDS in youth. There is a great need for drug abuse HIV
prevention interventions in youth that are efficacious and effective in the
short-term and that maintain efficacy and effectiveness in the long-term.
Thus, this RFA will support studies on the prevention of HIV and maintenance
of effects of prior prevention interventions on youth. Youth is defined as
persons under the age of 21 years. The specific purposes of this RFA are:
1) to document the prevalence, nature, and effectiveness of existing HIV
prevention programs; 2) to test new drug abuse-related HIV prevention
interventions in randomized control group or equivalent study designs; 3) to
determine context-specific features that influence maintenance of behavior
change following intervention; 4) to examine enhancers and barriers to
implementing HIV prevention programs in different populations and settings;
and 5) to examine long-term impact of childhood and/or adolescent drug abuse
prevention interventions on subsequent HIV-related risk behaviors. Potential
implementation contexts include, but are not limited to: schools and
universities, health care organizations, workplaces, families, community and
faith-based organizations, and media. Proposed research can test single
interventions alone or combinations of interventions (e.g., school- plus
peer-based interventions). Also, proposed research may capitalize on
existing studies, designs and infrastructure to investigate maintenance of
drug abuse and HIV-associated behavior change following prevention
intervention.
RESEARCH OBJECTIVES
Background
In the United States, data indicate that women, youth, and minorities account
for a growing proportion of new AIDS cases, that increasing numbers of cases
are emerging in rural and smaller urban areas, and that an increasing
proportion of AIDS cases are linked to heterosexual exposure (CDC, 2000b).
Further, given the extended latency period for demonstrable infection, it is
likely that most young adults diagnosed with HIV contracted the infection in
the adolescent years. AIDS was the ninth leading cause of death in 1998
among youth ages 15 to 24 years, and the fifth leading cause of death for
individuals ages 25 to 44 years, many of whom were infected as teenagers
(Murphy, 2000). Young women and racial and ethnic minorities have been
disproportionately affected (IOM, 2000). Females accounted for 58 percent of
reported AIDS cases in 1999 among 13- to 19-year olds and 38 percent of cases
among 20- to 24-year olds. Forty-three percent of new AIDS cases in the 13-
to 24-year age group were among African-Americans, and 21 percent were among
Hispanics (CDC, 2000b). Although African-Americans and Hispanics combined
accounted for 66 percent of all new AIDS cases in 1999, they comprised only
23 percent of the total U.S. population. Sexual exposure is the primary
route of infection for youth among the known sources of risk. Most young
males are infected through sex with other men, while most young females are
infected through heterosexual exposure.
It is well known that the period of adolescence and early adulthood is a time
for experimentation and exploration, particularly for sexual and drug use
behaviors. The use of alcohol and illicit drugs place individuals at risk
for engaging in risky sexual behaviors because inhibitions are lowered and
cognitive functioning is impaired. Moreover, adolescence is a period of
cognitive development typically characterized by perceptions of
invulnerability from harm. This can reinforce the use and effects of
substances that result in risky behaviors, including risky sexual behaviors.
In addition, adolescents who are involved in other risky behaviors (e.g.,
dating older persons, inconsistent use of condoms) are at increased risk of
engaging in risky sexual behavior.
A number of demographic and lifestyle characteristics have been identified
that affect adolescents' reproductive health; they include gender, age, and
race/ethnicity, as well as attitudes, involvement in activities, and academic
performance. Other examples include early initiation of sexual behavior,
sexual trauma, violence, SES and community norms. Also, early puberty and
early menstruation and teens appearing older or more physically developed
than their actual age increase the likelihood of being sexually experienced.
Adolescents who are informed about reproductive health are more likely to use
contraception than those without information. Interpersonal relationship
quality, both perceived and real, play a role in adolescents' reproductive
health. Family dynamics including parental monitoring of youth behavior,
attachment of parent and child, and stated family values and expectations
about sexual behavior all positively influence the choice to abstain.
Adolescents with peers who drink and use drugs, and teens who think their
peers engage in these activities, are more likely to have sex than same aged
youth who do not engage in these risky behaviors or have these perceptions.
Teens engaging in risky behaviors (e.g., drugs and alcohol use, delinquency)
are more likely to have multiple sexual partners, putting themselves at
increased risk for pregnancy and STDs. Adolescents who have experienced rape
or sexual abuse and youth with much older sex partners also are at greater
risk for engaging in risky sexual behavior. These are just some of the
factors that play a role in youth being at risk or protected from HIV risk-
associated sexual behaviors.
To date, the majority of science-based HIV prevention interventions have been
developed for high-risk youth (e.g., runaways, abused, homosexual, low-
income, minority). Thus, whereas the general youth population is both at-
risk for HIV infection and an important target for HIV prevention
interventions, little is known about the prevalence of adolescent-focused HIV
prevention programs currently offered through general population settings
(e.g., primary care and other health care organizations, school health,
university programs) or the nature of these programs (e.g., abstinence, safe
sex, coping skills). Therefore, it is important to determine what is
currently being used and to develop and test developmentally and contextually
appropriate drug abuse-related HIV prevention interventions or intervention
components to reach the broad youth population. As with all general
population interventions, a subpopulation of individuals or groups of
individuals will be at heightened risk. Including these individuals and
subgroups in a general population intervention may provide the intervention
necessary without the exposure to the stigma attached to programming or
services for those at higher risk.
A review of prevention interventions found some common approaches to reducing
adolescent unprotected sex: sex and HIV education, clinic protocols, service
learning programs, and multi-component programs. Sex and HIV education
programs and clinic protocols focus on sexual antecedents of risk-taking
(e.g., sexual beliefs, attitudes, norms, and self-efficacy related to sexual
behaviors). Service learning programs address nonsexual antecedents (such as
volunteer work that facilitates connection to adults or positive future
beliefs). Multi-component programs address both sexual and nonsexual
antecedents. The latter approach appears to have the greater impact, however
a few studies have demonstrated the effectiveness of brief, modest
interventions on the topics of HIV, STD risk behaviors or sexual behavior.
It has also been shown that prevention programs for young children and their
families have a positive impact many years later on their reproductive
health. Thus, findings to date are inconclusive, suggesting that no one
approach is more effective than another. Rather, some youth may have the
knowledge and skills needed regarding contraception but lack the motivation
to avoid unprotected sex, whereas others may lack the knowledge, attitudes,
or skills, but have the attachment to adults and the motivation to avoid
unprotected sex. Thus, determining the underlying reasons for sexual risk-
taking is an important factor in developing program strategies to be tested.
Research Goals and Scope
The goal of this RFA is to generate drug abuse-related HIV risk-associated
prevention interventions that are efficacious and effective and will maintain
long-term behavior change in youth and ultimately reduce the rate of HIV
infection and AIDS in youth. It is important that all adolescents be
screened for drug abuse and HIV risk behavior and, if indicated, assessed and
provided tailored interventions because adolescence is a critical phase
during which youth make conscious or de facto decisions about engaging in
sexual and substance abuse behaviors. Thus, applications are encouraged that
target general population youth and/or high-risk youth. Research goals may
include drug abuse-related HIV prevention interventions that help adolescents
abstain from intercourse, delay intercourse, develop safer sexual practices,
and reduce sexual risk-taking connected with substance abuse. Populations of
particular interest include females, communities of color, and
gay/lesbian/bisexual/transgender and questioning youth. Research proposals
for international settings are also welcome. Examples of groups of youth who
are at very high-risk for HIV include those engaging in a variety of risky
behaviors, e.g., out-of-school youth, street youth, and youth in the juvenile
justice system. Other very high-risk groups include youth in foster care and
youth who have been physically or sexually abused.
Youth who have already dropped out of school and other high-risk groups
(e.g., youth on in-school suspension, youth in gangs, young men having sex
with men, street youth, those using drugs or have parents or siblings abusing
drugs, prostitution rings, etc.) may be particularly hard to reach.
Moreover, because of the transient nature of many of these subgroups,
developing and testing strategies that address their prevention needs and
retaining these youth in programming is an important research focus.
Other factors may make certain populations less likely to receive prevention
services. For example, there is much controversy regarding sex education,
including HIV prevention, in schools. Further, both general population and
at-risk adolescents residing in rural and frontier areas are faced with the
lack of availability of health care services and the stigma of seeking
services when available. Females are at a particular disadvantage with
regard to HIV prevention when they lack power and in some cases suffer abuse
in interpersonal relationships. Many subpopulation groups may be less
responsive to prevention efforts that are not sensitive to group attitudes,
norms, beliefs, and context. Issues around HIV, sexuality, and substance
abuse must be recognized as potentially sensitive issues in minority
communities. Research that takes a novel approach to advancing the science
of prevention in high-risk and special populations is of special interest.
Applications must justify the need of the population being targeted for drug-
related HIV prevention interventions (i.e., students in high school health
classes, all adolescent patients in primary care, youth who have been raped),
level of risk of the population (i.e., universal, selective, indicated or
tiered), and the type of intervention to be used (i.e., brief versus more
intensive, single- or multi-component interventions, sexual versus nonsexual
antecedents). Interventions can: (1) be focused on risk and protective
factors or mediators for HIV exposure/infection that are nonsexual in nature
and examine sexual behaviors as outcomes, (2) be focused on sexual behaviors
(e.g., delaying initiation of sex, increasing condom use, decreasing number
of partners), or (3) constitute a combination of nonsexual and sexual
behaviors. HIV prevention components can also be integrated into existing
drug abuse prevention programs or drug abuse prevention can be integrated
into existing HIV prevention programs.
RESEARCH AREAS
This initiative will support research that examines existing strategies, and
designs and tests new strategies for drug abuse-related HIV prevention for
youth. Please note that applications which address HIV prevention
interventions for HIV-positive youth and youth in drug abuse treatment will
not be accepted under this RFA. These areas of intervention are outside the
scope of this RFA. Examples of types of applications that would be of
interest include:
New Interventions
Development and testing interventions to prevent or reduce drug abuse and
sexual risk behavior among uninfected youth.
Determination of whether and which strategies utilized in drug abuse
prevention interventions influence HIV outcomes.
Examination of the potential additive effects of programming through
combining an HIV prevention component with an existing drug abuse prevention
program or adding a drug abuse prevention component to an existing HIV
prevention program.
Development of brief HIV and drug abuse prevention interventions in
adolescent clinical and primary care settings that focus on HIV and drug
abuse prevention.
Application of effective HIV prevention programs or program components in a
variety of drug abuse-related prevention contexts, such as health clinics,
primary care, school health programs, faith-based programs, social
organizations and community settings, to determine equivalent or differential
effectiveness by setting, delivery characteristics and financial and human
resources.
Incorporation of technology (e.g., internet-based, personal digital assistant
(PDA), two-way pager, CD-ROM, etc.) in order to enhance access, feasibility,
efficacy, and dissemination of innovative, theory-driven, empirically based
interventions for adolescents.
Development and testing of community-based interventions, including mass
media approaches that focus on HIV prevention in the context of drug abuse
prevention.
Development and testing of prevention programming dealing with both drug
abuse and HIV tailored to the needs of special, at-risk subpopulations of
youth, including ethnic minority MSM, marginalized youth, street youth, youth
in foster care, etc.
Risk and Protective Factors
Development and testing of drug abuse interventions focused on sexual
antecedents, nonsexual antecedents, and/or the combination of both on
adolescent HIV risk behaviors.
Examination of the impact of targeting mediators of drug abuse, HIV, and
STDs, and examining subsequent sexual activity and HIV and other STD
infection.
Follow-Up Studies
Addressing the maintenance of HIV prevention effects through examination of
follow-up data from randomized control group design prevention interventions
related to drug abuse.
Follow-up studies of existing drug abuse and drug abuse-related HIV
prevention programs to examine long-term impact on delaying initiation of
intercourse and reducing adolescent unprotected sex and HIV infection.
Address contextual factors influencing maintenance of behavior change
following randomized control trials of preventive interventions.
MECHANISMS OF SUPPORT
This RFA will use the NIH research project grant (R01), the NIDA small grant
(R03), and the developmental/exploratory grant (R21) award mechanisms, as
well as competitive supplements. As an applicant you will be solely
responsible for planning, directing, and executing the proposed project.
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, 2003.
This RFA uses just-in-time concepts. It also uses the modular budgeting
format. (see https://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.
FUNDS AVAILABLE
NIDA intends to commit approximately $2,000,000 and NIMH intends to commit
$400,000 in FY 2003 to fund six to eight new and/or competitive continuation
grants as well as competitive supplements in response to this RFA. An
applicant may request a project period for the R01 of up to five years and a
budget for direct costs of up to $350,000 per year. For the R21, three years
and a budget for direct costs of up to $100,000. For the R03, two years and
a budget for direct costs of up to $50,000. 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 and NIMH provide support for this
program, awards pursuant to this RFA are contingent upon the availability of
funds and the receipt of a sufficient number of meritorious applications.
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
o Faith-based or community-based organizations
Foreign applicants are not eligible for the small grant award (R03).
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:
NIDA:
Eve E. Reider, Ph.D.
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 5153, MSC 9589
Bethesda, Maryland 20892-9589
Telephone: (301) 402-1719
FAX: (301) 480-2542
Email: ereider@mail.nih.gov
NIMH:
Andrew Forsyth, Ph.D.
Center for Mental Health Research on AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6201, MSC 9619
Bethesda, Maryland 20892-9619
Telephone: (301) 443-6100
FAX: (301) 443-9719
Email: aforsyth@mail.nih.gov
o Direct your questions about peer review issues to:
Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, Maryland 20892-9547
Telephone: (301) 443-2755
Email: tlevitin@mail.nih.gov
o Direct your questions about financial or grants management matters to:
NIDA:
Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3131 MSC 9541
Bethesda, Maryland 20892-9541
Telephone: (301) 443-6710
E-mail: gfleming@mail.nih.gov
NIMH:
Brian Albertini
Grants Management Branch
National Institute of Mental Health
National Institutes of Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: 301-443-0004
Fax: 301-443-0219
Email: albertinib2@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 Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, Maryland 20892-9547
Rockville, Maryland 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). The PHS 398 is available at
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
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
https://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
https://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:
https://grants.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 must be
sent to:
Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, Maryland 20892-9547
Rockville, Maryland 20852 (for express/courier service)
Telephone: (301) 443-2755
APPLICATION PROCESSING: Applications must be received by the application
receipt date listed in the heading of this RFA. If an application is
received after that date, it will be returned to the applicant without
review.
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application. The
CSR will not accept any application that is essentially the same as one
already reviewed. This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications must
include an Introduction addressing the previous critique.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by NIDA. Incomplete and/or non-responsive applications will
be returned to the applicant without further consideration.
Applications that are complete and responsive to the RFA will be evaluated
for scientific and technical merit by an appropriate peer review group
convened by NIDA accordance with the review criteria stated below. As part
of the initial merit review, all applications will:
o Receive a written critique
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 second level review by the National Advisory Council on Drug
Abuse or 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 discuss the following
aspects of your application in order to judge the likelihood that the
proposed research will have a substantial impact on the pursuit of these
goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these criteria
in assigning your application's overall score, weighting them as appropriate
for each application. Your 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, you may propose to carry out
important work that by its nature is not innovative but is essential to move
a field forward.
(1) SIGNIFICANCE: Does your study address an important problem consistent
with the goals of this RFA? If the aims of your application are achieved, how
do they advance scientific knowledge? 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? Do you acknowledge potential problem areas and consider alternative
tactics?
(3) INNOVATION: Does your project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does your project challenge
existing paradigms or develop new methodologies or technologies?
(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out
this work? Is the work proposed appropriate to your experience level as the
principal investigator and to that of other researchers (if any)?
(5) ENVIRONMENT: Does the scientific environment in which your 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, your
application will also be reviewed with respect to the following:
o PROTECTIONS: The adequacy of the proposed protection for humans, animals,
or the environment, to the extent they may be adversely affected by the
project proposed in the application.
o INCLUSION: 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
included in the section on Federal Citations, below)
o 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: March 14, 2003
Application Receipt Date: April 14, 2003
Peer Review Date: June/July 2003
Council Review: September 2003
Earliest Anticipated Start Date: September 30, 2003
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
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components
involving Phase I and II clinical trials must include provisions for
assessment of patient eligibility and status, rigorous data management,
quality assurance, and auditing procedures. In addition, it is NIH policy
that all clinical trials require data and safety monitoring, with the method
and degree of monitoring being commensurate with the risks (NIH Policy for
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12,
1998: https://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
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable;
and b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN
SUBJECTS: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
https://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
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.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
https://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 www.nida.nih.gov under the Funding, or may be obtained by
calling (301) 443-2755.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research
on hESCs can be found at https://grants.nih.gov/grants/stem_cells.htm and at
https://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 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
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this RFA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
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 No. 93.279 (NIDA) and 93.242 (NIMH), and is not
subject to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review. Awards are made under authorization of
Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241
and 284) and administered under NIH grants policies described at
https://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations
42 CFR 52 and 45 CFR Parts 74 and 92.
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.