HEPATITIS C DIAGNOSIS, TREATMENT AND INTERACTION WITH HIV/AIDS
RELEASE DATE: January 23, 2002
RFA: RFA-DA-02-008
PARTICIPATING INSTITUTES AND CENTERS (ICs):
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov)
LETTER OF INTENT RECEIPT DATE: March 18, 2002
APPLICATION RECEIPT DATE: April 16, 2002
THIS REQUEST FOR APPLICATIONS (RFA) CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism(s) 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
The NIDA plans to support a new National Drug Abuse Research Initiative for
accelerating research on the diagnosis and treatment of Hepatitis C in drug
abusing populations, especially those at risk for or infected with HIV/AIDS,
including such areas as the development of (1) innovative minimally invasive
methods for early diagnosis, (2) improved minimally invasive techniques to
predict clinical course, (3) studies elucidating factors that influence
clinical course, e.g. patterns of abuse of alcohol and other drugs,
nutrition, stress, re-infection, (4) studies of the interaction of hepatitis
C with co-morbid conditions, e.g. hepatitis B, HIV/AIDS, (5) treatment
regimens for hepatitis C and its co-morbid conditions that are effective and
deliverable in drug abusing populations both within and outside of drug abuse
treatment, (6) studies that address hepatitis C diagnosis and treatment in
special populations of drug abusers, e.g., minorities, women versus men,
pregnant women, women with childcare responsibilities, (7) interventions that
promote the prevention of medical consequences of hepatitis C, (8) models of
delivery of diagnostic and treatment services that address issues of access,
cost, organization and management and effectiveness, and (9) interventions
for the prevention of transmission by infected drug abusers. These research
efforts should involve interdisciplinary collaborations including such areas
as basic virological and biological science, immunology, behavioral science,
prevention science, epidemiology and clinical trials. It is the intent for
this RFA to support research that can demonstrate reciprocal interactions
between basic and applied research components to facilitate creative and
innovative research along the continuum of disciplines. However, the primary
intent of this RFA is to support studies that relate directly to the
development and testing of protocols for hepatitis C diagnosis and treatment
in drug abusing populations, so as to provide data essential to the
formulation of clinical guidelines in these areas.
RESEARCH OBJECTIVES
Background
Previous research has identified the high prevalence of hepatitis C in drug
abusing populations and has related that prevalence to injection drug use.
However, a previous NIH sponsored Consensus Conference on Hepatitis C
recommended that treatment for hepatitis C not be initiated in drug abusing
populations prior to the achievement of a full year of sobriety. This
recommendation, in the absence of significant data and in the absence of
treatment alternatives currently available, expressed concerns that the level
of adherence to treatment among injection drug users would not reach the
level that would allow treatment to be effective and, that the resulting
abbreviated and/or intermittent treatment would promote the development and
transmission of resistant viral strains and exhaust the limited resources
available to provide treatment to those infected with hepatitis C. Thus,
despite a demonstrated high level of early infection with hepatitis C and the
known potential of hepatitis C to result in chronic progressive liver disease
leading from fibrosis to cirrhosis and liver failure, research on the
diagnosis and development and implementation of effective treatment of
hepatitis C in drug abusing populations remains an underdeveloped area. The
objective of this RFA is to proceed as rapidly as possible towards the
developed of data-based clinical guidelines for the diagnosis and treatment
of hepatitis C in drug abusing populations and thus minimize the influence of
institutionalized pessimism with respect to the possibility of effective,
deliverable treatment for drug abusers.
Research Goals and Scope
The NIDA recognizes the need to encourage the development of new, innovative
interventions in the diagnosis and treatment of the medical consequences of
drug abuse, including hepatitis C and co-morbid conditions, with a particular
emphasis on HIV/AIDS. The overall goal for this RFA is to stimulate the
development and testing of diagnostic and treatment interventions, including
the possibility of early diagnosis and treatment, that can ultimately be
demonstrated to be effective in drug abusing populations, and, hence to
prevent the development of the medical consequences of hepatitis C and its
co-morbid conditions, especially HIV/AIDS. Intrinsic to this effort is the
need to elucidate the underlying mechanisms that determine the effectiveness
of these interventions, including factors ranging from the basic biology and
virology to those related to adherence and the organization and delivery of
health services. The results of these studies should promote the development
of diagnostic and treatment interventions that target critical mechanisms in
the cycle of transmission, development of infection and progression of
hepatitis C in drug abusers at risk for or infected with HIV. Additionally,
it is recognized that even the most effective diagnostic and treatment
interventions have not benefited all who have been exposed to those
interventions. Thus, current challenges in diagnostic and treatment research
include the need to better characterize subgroups or individuals who are
refractory to existing interventions and develop new paradigms for targeting
these resistant populations.
It is the intent of this RFA to support interdisciplinary collaborations
along a continuum of research, ranging from basic science that can inform or
guide the development of novel hepatitis C diagnostic and treatment
interventions, through clinical trials and the development of guidelines for
clinicians in the area of the diagnosis and treatment of hepatitis C in drug
abusing populations at risk for or infected with HIV. Preliminary diagnostic
and treatment development, efficacy testing, and effectiveness trials of
promising new diagnostic methods and treatment interventions are encouraged.
Studies at the following levels of analysis are appropriate and applicants
should incorporate more than one level of analysis in the interdisciplinary
proposal: (a) Basic research studies, with potential application to the
development of innovative diagnostic methods and comprehensive treatment
interventions,(b) Research on the development, refinement and pilot testing
of new diagnostic methods and treatment interventions, including studies
aimed at translating discoveries from basic virological, immunological,
behavioral, cognitive, social or health services research into novel or
improved diagnostic methods or treatment interventions, (c) Efficacy testing
of diagnostic methods or treatment interventions that show promise, including
research on the hypothesized mechanisms through which these interventions
produce their effects, (d) Effectiveness and cost-effectiveness trials of
diagnostic methods and treatment interventions.
Applications are encouraged to include the study of racial, ethnic minority
group membership, sexual orientation, and effects of gender and culture
whenever possible and appropriate.
The following provide examples of scientific themes in the area of diagnosis
and treatment of hepatitis C in drug abusing populations that might benefit
from interdisciplinary collaborations within the context of this RFA.
However, the list is not intended to be all-inclusive, and many other
significant topics of scientific inquiry may be appropriate:
o Studies of the effects of drug and alcohol abuse patterns, including drug
abuse history, continued drug abuse, and relapse to drug abuse in, for
example, dropouts from drug abuse treatment, on (1) the onset and progression
of hepatitis C, including basic studies of effects of drugs of abuse on the
viral replication and/or the development of unique viral isolates, (2) immune
processes related to disease transmission and course, and (3) response to
treatment regimens. Studies examining the possible effects of repeated or re-
infection among drug abusers in treatment for hepatitis C may be included.
o Studies of the effects/side effects of treatment of hepatitis C, e.g., the
development and treatment of depression during the course of treatment with
interferon, and development of ways of dealing with such side effects so as
to minimize dropouts from treatment or other forms of non-adherence.
o Development of minimally invasive ways of predicting the course of
hepatitis C and monitoring the effectiveness of treatment intervention, e.g.,
ways of ascertaining levels of fibrosis of the liver that do not involve the
need for liver biopsy.
o Development and testing of minimally invasive diagnostic methods that allow
the very early identification of infection so as to facilitate tests of early
treatment intervention, since at least one study suggests that such early
treatment may lead to higher rates of treatment success.
o Effects of metabolic, endocrine and gastrointestinal factors, including
macro and micro nutrient deficiency in the course and treatment of hepatitis C.
o Elucidation of the basic mechanisms at the cellular and sub-cellular, e.g.,
mitochondrial, levels of the pathogenesis of hepatitis C infection in drug
abusing populations, emphasizing the influences of factors unique or
predominant in drug abusers and including mechanisms effecting response to
treatment.
o Studies of the influence of alcohol as a cofactor in processes related to
the acquisition and treatment of hepatitis C in drug abusing populations.
o Studies of the drug-abuse-related factors and mechanisms that influence the
pathogenesis of hepatitis C disease. Examples include studies of (1) effects
of host and viral genetics on resistance, course of hepatitis C infection and
response to treatment and (2) proteomic issues related to the aforementioned.
o Research elucidating factors important in addressing diagnostic and
treatment issues for hepatitis C and its co-morbid conditions among special
populations, e.g., minorities, gender differences, pregnant women. For
example, questions of why African Americans seem to do worse than Caucasians
in results of treatment for hepatitis C may be explored.
o Examination of co-factors that increase the risk of acquisition of
hepatitis C in non-injection drug users, e.g., some data indicates a
prevalence of up to 20-35%.
o Examination of the influence of co-infection with other forms of hepatitis,
e.g., hepatitis B, hepatitis G, and other infectious diseases, e.g., HIV, on
the disease course and treatment of hepatitis C.
o Study of drug interactions among medications used to treat hepatitis C and
those used to treat (1) drug abuse, e.g., methadone, buprenorphine/naloxone,
(2) co-morbid mental disorders, e.g., antidepressants, and (3) co-morbid
infectious diseases, e.g., HIV, hepatitis B, tuberculosis.
o Development of methods to maximize adherence to treatment in drug abusing
populations both in and out of drug abuse treatment and study of the effects
of degrees of non-adherence on the effectiveness of treatment.
o Research on the most effective ways of organizing, delivering, (e.g.,
linkage to primary care and/or drug abuse treatment, other outpatient models
for care delivery), and financing health service systems to maximize ability
to deliver effective treatment for hepatitis C and it co-morbid conditions to
drug abusing populations, including special populations as minorities, women
versus men, pregnant women, injection versus non-injection drug users.
MECHANISM OF SUPPORT
This RFA will use the National Institutes of Health (NIH) research project
(R01), small grant (R03)
(https://grants.nih.gov/grants/guide/pa-files/PAR-00-059.html),
and exploratory/developmental grant (R21)
(https://grants.nih.gov/grants/guide/pa-files/PA-01-012.html) award
mechanisms. Responsibility for the planning, direction, and execution of the
proposed project will be solely that of the applicant. The RFA is a one-time
solicitation. Future unsolicited competing continuation applications will
compete with all investigator-initiated applications and be reviewed
according to the customary peer review procedures. The anticipated award
date is September 30, 2002.
The exploratory/developmental (R21) grants are limited to 3 years and small
grants (R03) are limited to 2 years. Both are non-renewable and limited in
direct cost amount per year (R03, $50,000, R21, $100,000). The R03 mechanism
is intended for newer, less experienced investigators, for investigators at
institutions without well-developed research traditions and resources, or for
experienced investigators wishing to change research directions or test new
methods or techniques. The R21 mechanism is intended to encourage
exploratory research projects with sound methodology and strong rationales in
underdeveloped research areas of drug abuse, such as the areas covered in
this RFA. Investigators may also choose to include methods development as
one component within any of the other mechanisms. Responsibility for the
planning, direction, and execution of the proposed project will be solely
that of the applicant.
This RFA uses just-in-time concepts. It also uses the modular as well as the
non-modular budgeting formats (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. Otherwise follow the instructions for non-
modular research grant applications.
FUNDS AVAILABLE
NIDA intends to commit approximately $2 million in FY 2002. Because the
nature and scope of the research proposed may vary, it is anticipated that
the size of each award will also vary. It is anticipated that approximately
3-6 awards will be made under this announcement. Although the financial plans
of NIDA 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.
ELIGIBILITY 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
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:
Sander Genser, M.D., M.P.H.
Center on AIDS and Other Medical Consequences of Drug Abuse
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5198, MSC 9593
Bethesda, MD 20892-9593
Telephone: (301) 443-1801
FAX: (301) 594-6566
Email: SG73F@NIH.GOV
o Direct your questions about peer review issues to:
Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, Maryland 20892-9547
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: tl25u@nih.gov
o Direct your questions about financial or grants management matters to:
Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD 20892-9541
Telephone: (301) 443-6710
FAX: (301) 594-6847
Email: gf6s@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 IC 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
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, Maryland 20892-9547
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: tl25u@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
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
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, Maryland 20892-9547
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: tl25u@nih.gov
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 the (IC) in 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.
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 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?
(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
method? 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?
(6) RELEVANCE: The relevance of the proposed work to the purpose of the RFA.
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 (including
data safety monitoring plans), 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 18, 2002
Application Receipt Date: April 16, 2002
Peer Review Date: June/July 2002
Council Review: September 2002
Earliest Anticipated Start Date: September 30, 2002
AWARD CRITIERIA
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 biomedical and behavioral research
projects involving human subjects, unless a clear and compelling rationale
and justification are 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 is available at
https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research, updated racial and ethnic categories in compliance with the new OMB
standards, clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398, and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable,
and b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by
the NIH, unless there are scientific and ethical reasons not to include them.
This policy applies to all initial (Type 1) applications submitted for
receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the Inclusion of Children as Participants in
Research Involving Human Subjects that was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: https://grants.nih.gov/grants/guide/notice-files/not98-024.html.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH proposals for research involving human
subjects. This policy announcement is found in the NIH Guide for Grants and
Contracts Announcement dated June 5, 2000, at the following website:
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
URLS IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Reviewers are
cautioned that their anonymity may be compromised when they directly access
an Internet site.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2)
cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at:
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this RFA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
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.
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 services. 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.
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. Awards are made under authorization
of Sections 301 and 405 of the Public Health Service Act as amended (42 USC
241 and 284) and administered under NIH grants policies and Federal
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not
subject to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and promote the non-use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.