Release Date: April 26, 2005
Application Receipt Dates(s): Standard receipt dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
Peer Review Date(s): June-July, October-November, and February-March: http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): September, February, and May: http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date: October, March, and June: http://grants.nih.gov/grants/funding/submissionschedule.htm
Additional Information To Be Available Date (Url Activation Date):
Expiration Date for R03 and R21 Non-AIDS Applications: March 2, 2006
Expiration Date for R03 and R21 AIDS and AIDS-Related Applications: May 2, 2006
Expiration Date for R01 Non-AIDS Applications: November 2, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007
Due Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
NIDA and NIAAA invite clinical research grant applications to the PA entitled Complementary and Alternative Medicine for Substance- and Alcohol-Related Disorders . An important goal of this program is to identify, evaluate and develop safe and effective Complementary and Alternative Medicine therapies for the treatment of substance use disorders (SUD) and alcohol use disorders (AUD), including abuse or dependence on licit (alcohol and tobacco) and illicit drugs, and for the treatment of neurological, psychiatric and medical consequences of drug and alcohol addiction. An applicant may use the R01, R03, and R21 award mechanisms. This PA uses just-in-time concepts. It also uses the modular budgeting as well as the non-modular budgeting formats. The investigators/institutions with one of the following characteristics are eligible to apply: for-profit or non-profit organizations; public or private institutions (universities, colleges, hospitals, and laboratories); units of State and local governments; eligible agencies of the Federal government; domestic or foreign institutions/organizations; faith-based or community-based organizations. 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. There is no limit to the number of scientifically different applications an applicant may submit under this announcement. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. The application materials are available at (http://grants.nih.gov/grants/oer.htm). Telecommunications for the hearing impaired is available at: TTY 301-451-5936.
Table of ContentsPart II Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information - Required Federal Citations
Part II - Full Text of AnnouncementSection I. Funding Opportunity Description
1. Research Objectives
Clinical studies are needed to critically evaluate the therapeutic effects of different CAM therapies in treating various aspects of SUD and AUD, alone or in combination with conventional treatments. In cases where issues of safety arise, the clinical study protocol may be accompanied by an adjunct preclinical study protocol examining safety of the proposed therapy in an animal model. Studies involving subjects from various ethnic populations, ages, and genders are encouraged, although not necessarily in a single study, depending upon the research questions. Identification, evaluation and development of safe and effective CAM therapies for the treatment of children, adolescents and pregnant women with SUD and AUD are especially encouraged. For these vulnerable populations safety is a major concern, hence the treatments proposed should have proven safety for developing organisms.
Purpose
The National Institute on Drug Abuse (NIDA) and the National Institute on Alcohol Abuse and Alcoholism (NIAAA) are seeking high quality clinical research grant applications focusing on the identification, evaluation and development of safe and effective Complementary and Alternative Medical (CAM) therapies for the treatment of substance use disorder (SUD) and alcohol use disorder (AUD), as defined by DSM-IV, including abuse or dependence on all licit (alcohol and tobacco) and illicit drugs/medications. Studies may also focus on treatments of neurological, psychiatric or medical consequences of drug abuse, e.g., acute and chronic drug and alcohol toxicities, psychoses, mood disorders, neurological and cognitive impairments, and brain atrophy.
There is a growing popularity in the United States of CAM for the treatment of various disorders and diseases. The recent report prepared by the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention (CDC) National Center for Health Statistics (NCHS), based on data from 2002 National Health Interview Survey (NHIS) obtained from interviews of 31,044 adult U.S. residents, shows that 62% of them used some kind of CAM during the past 12 months, while 75% have ever used CAM, (http://www.cdc.gov/nchs/data/ad/ad343.pdf). CAM interventions appear also popular among drug addicts. A recently published survey of 548 persons with a history of intravenous drug use recruited from a methadone maintenance clinic revealed that 45% of them reported use of at least one type of CAM therapy, usually supplemental to conventional treatments, (http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12765213&dopt=Abstract). However, the effects of many CAM therapies in treating SUD and AUD have not been systematically examined, and the effectiveness of most CAM treatments in aiding recovery from drug and alcohol addictions is unknown. Such therapies need to be studied. For the purpose of this PA, CAM therapies are defined as those therapies that are outside of the realm of conventional medicine and consist of a broad spectrum of therapeutic modalities (their classification and examples are given further in the text). According to the National Center for Complementary and Alternative Medicine (NCCAM) of NIH, conventional medicine is medicine as practiced by holders of M.D. (medical doctor) or D.O. (doctor of osteopathy) degrees and by their allied health professionals, such as physical therapists, psychologists, and registered nurses. Other terms for conventional medicine include allopathy, Western, mainstream, orthodox, and regular medicine, and biomedicine. Other terms for CAM include but are not limited to: unconventional, non-conventional, folkloric, nutritional, herbal, naturopathic, homeopathic, and non-Western medicine or health care. Some conventional medical practitioners are also practitioners of CAM.
Background and Rationale
Substance abuse continues to be a grave threat to public health in the United States. According to the National Survey on Drug Use and Health (NSDUH) conducted by SAMHSA, based on interviews of approximately 67,500 persons, in 2002 an estimated 19.5 million Americans, or 8.3% of the population age 12 and older were current users of illicit drugs. Among 12- to 17-year-olds, current use of illicit drugs was 11.6%, and among pregnant women it was 3.3%. In addition, 6.2 million persons, or 2.6% of the population aged 12 or older, were current users of psychotropic medications taken nonmedically. http://www.drugabusestatistics.samhsa.gov/nhsda/2k2nsduh/Overview/2k2Overview.htm#highlights. A publication of the Executive Office of the President, Office of National Drug Control Policy (2001), reports that in 1998 the estimated total cost to the society due to illicit drug use was $143.4 billion. This cost has been increasing 5.9% annually between 1992 and 1998, giving an extrapolated value for 2004 (if similar trends continues) about $200 billion. (http://www.whitehousedrugpolicy.gov/publications/pdf/economic_costs98.pdf)
These numbers stress the urgency and importance of identifying, evaluating and developing effective therapies for treating substance dependence and abuse.
Acute or chronic abuse of drugs and alcohol can cause serious health and social problems. It may lead to life threatening health consequences, various neuropathologies, psychiatric disorders and addictions or dependencies that might require immediate medical interventions, specialized treatments employing pharmacotherapies, behavioral therapies, or combinations thereof. Clinical and preclinical research has documented drug-and alcohol-induced alterations of brain chemistry and function in chronic drug and alcohol abusers, which are believed to contribute to persistent drug and alcohol dependencies. Drug and alcohol abuse by children and adolescents may lead to serious developmental consequences and is associated with various medical problems, poor school performance and antisocial behaviors. Acute and chronic use of inhalants and stimulants seems to have particularly devastating effects on the brain. Substance and alcohol abuse or dependence is often comorbid with other psychiatric disorders, which may precede drug and alcohol abuse or follow as a consequence of it, and may contribute to poor treatment outcomes. Whereas many SUD and AUD can be effectively treated with pharmacotherapies, behavioral treatments, or combinations thereof, there is an ongoing need for treatments with long-term efficacy in maintaining abstinence and preventing relapse to drug and alcohol abuse.
The National Center for Complementary and Alternative Medicine (NCCAM) at the National Institutes of Health, classifies CAM therapies into 5 major categories: 1) Alternative Medical Systems e.g. homeopathic and naturopathic medicine, non-western medicine systems such as Ayurveda or traditional Chinese medicine (acupuncture, acupressure); 2) Mind-Body interventions such as meditation, yoga, spiritual and mental healing, art, music, dance therapy; 3) Biologically Based Therapies such as use of herbs, special macronutrient diets, megadoses of vitamins, minerals and other dietary supplements; 4) Manipulative and Body-Based Therapies such as chiropractic or osteopathic manipulations, therapeutic massage, balneotherapy, hyperbaric pressure therapy; and 5) Energy Therapies which utilize energy fields including unconventional use of electromagnetic fields, e.g. pulsed electromagnetic fields, alternating current or direct current fields [transcranial magnetic stimulation (TMS), transcranial direct current stimulation (TDCS)], or use biofield manipulations, such as qi gong, Reiki, and therapeutic touch, (http://www.nccam.nih.gov/health/whatiscam/). Research in all 5 NCAAM categories of therapies is encouraged, as it relates to the potential treatment of SUD and AUD.
Some CAM therapies have been evaluated in clinical studies for their potential in the treatment of SUD and AUD. Regarding alternative medical systems, acupuncture has received the greatest empirical attention as a potential treatment for substance and alcohol abuse and dependence, yielding equivocal results. In several clinical trials, acupuncture has been found to produce better cocaine abstinence rates (Avants et al, 2000), to reduce craving for cocaine (Avants et al, 1995), to improve mood, sleep, and appetite among substance abusers (Gurevich et al, 1996). However, other clinical trials have found no significant differences between active acupuncture conditions and comparison conditions in reducing cocaine use (Margolin et al, 2002), reducing use of or craving for crack-cocaine (Lipton et al, 1994), or reducing drug use in a prison population (Berman et al, 2004) and a population with chronic arrest histories (Russell et al, 2000). Studies that help to refine the treatment approach (e.g., duration and frequency of needle insertion, type of needle insertion, evaluation of different systems of acupuncture, etc.), the comparison condition (e.g., invasive versus non-invasive, more tightly-controlled delivery and assessment of concurrently offered psychotherapy, etc.) may help to clarify these mixed results. Applications seeking to develop, adapt, or test acupuncture or other non-biologically-based therapies for SUD or AUD based on alternative medical systems, please refer to the Behavioral Therapies Development Program Announcement (PA-03-126, http://grants.nih.gov/grants/guide/pa-files/PA-03-126.html) for a detailed description of NIDA's conceptualization of therapy development research.
Another category of NCCAM's complementary and alternative approaches is mind-body interventions, that is those interventions designed to enhance the mind's capacity to affect bodily function and symptoms (NCCAM website, http://nccam.nih.gov/health/whatiscam/#1). Most often, the mind-body interventions are used to complement other treatments for substance abuse, rather than to serve as an alternative to treatment. While meditation, relaxation, and mindfulness-based approaches are included in NCCAM's framework as mind-body approaches, these approaches have been well integrated into current behavioral treatment research for substance abuse. Applicants wishing to develop, adapt, or test behavioral treatments emphasizing meditation or mindfulness are encouraged to respond to the Behavioral Therapies Development Program Announcement (PA-03-126).
Other types of behavioral therapies, while not typically integrated into current behavioral treatment research, are utilized fairly widely in community settings. These include faith-based interventions such as prison ministries and community outreach, exercise therapies, and therapies incorporating dance, art, and music. Research activities in which existing interventions are described in reproducible manuals, and these manualized interventions are pilot-tested for efficacy, (i.e., reverse-engineering ) may be most appropriate for these approaches. Studies testing these therapies, and other types of therapies which could be viewed as mind-body interventions, are also encouraged under PA-03-126.
Studies proposing to develop, adapt, or test mind-body interventions for SUD and AUD populations are encouraged to follow a three-stage model of therapy development. In Stage I therapy development research, activities include creating a well-specified treatment manual, designing psychometrically-sound measures of treatment fidelity and competence, and conducting a small pilot test of the treatment. In Stage 2 research, activities include larger-scale tests of the treatment through randomized designs, or other scientifically-appropriate research designs. In Stage 3 research, activities include preparing the treatment for dissemination to community settings, including developing and testing methods of training therapists and approaches to clinical supervision in the treatment. At all stages of therapy research, activities related to clarifying the mechanisms of action (i.e., how and why a therapy works) are relevant, and research is especially encouraged that clarifies the treatment of special populations such as racial and ethnic minorities, the elderly, pregnant women, adolescents, drug-abusers with co-morbid psychiatric conditions, etc. (For a more detailed description of a guiding framework to approaching behavioral therapy research, please refer to the Behavioral Therapies Development Program Announcement, PA-03-126, http://grants.nih.gov/grants/guide/pa-files/PA-03-126.html.)
Regarding biologically based therapies: a preliminary small placebo-controlled trial demonstrated that supplemental magnesium may reduce illicit opiate use in methadone-maintained cocaine abusing patients and decrease cocaine craving (Margolin et al., J. Addict. Dis. 22:49-61, 2003). Because magnesium ion is an endogenous blocker of the NMDA receptor complex, which is implicated in stimulant and opiate dependence, further testing of this supplement is needed in controlled studies for treating opiate and stimulant dependence. In small controlled clinical studies melatonin was shown to attenuate symptoms of nicotine and benzodiazepine withdrawal, and animal studies suggest that it reverses opiate tolerance. Controlled studies evaluating effectiveness of melatonin in the treatment of nicotine, opiate and sedative dependence are needed. Preclinical studies also suggest that melatonin and L-carnitine may be protective against methamphetamine-induced neuronal toxicities. Clinical studies, using psychological and brain imaging evaluation are needed to confirm, or not, such effects in methamphetamine addicts. Some clinical studies documented that extracts of Valeriana have anxiolytic and sedative effects with fewer motor-impairing effects than benzodiazepines. Studies are needed to evaluate Valeriana's utility in the treatment of benzodiazepine/sedative abuse/dependence. Because extracts of Valeriana have GABA-ergic properties and medications from this class have shown efficacy in the treatment of cocaine dependence, it is possible that Valeriana might be effective as well. Likewise, a GABA-ergic aminoacid, taurine, might be effective in the treatment of benzodiazepine and stimulant dependence. Clinical and preclinical studies suggest that fat-enriched diets may reverse hepatotoxic and neurotoxic effects of inhalant solvents. Such diets or specific fatty supplements (e.g. fatty acids, phoshatidylcholine) may have utility in reversing toxic effects of solvents and in the treatment of solvent addicted children and adolescents.
Kudzu ( Pueraria lobata) is a medicinal plant used in traditional Chinese medicine to treat alcoholism. Kudzu extracts have been shown to decrease alcohol intake in several animal models (Keung and Vallee, Proc Natl Acad Sci 90:1008-10012, 1993; Overstreet et al., Alcohol Clin Exp Res 20:221-227, 996). Several active components of kudzu, including puerarin, daidzin and daidzein, have also reduced drinking in animals. Silymarin, the active constituent of Milk Thistle, is an herbal remedy that has shown efficacy in treating alcoholic liver disease (Saller, Drugs 61:2035-2063, 2001). This Program Announcement invites studies of these and other biologically-based therapies for their potential use in treating AUD.
Regarding energy therapies: a small double-blind crossover trial showed that high frequency repeated TMS of left dorsolateral prefrontal cortex significantly reduced cigarette smoking (Eichhammer et al., J. Clin Psychiatry, 64:8, 2003). TMS is a non-invasive neurotechnique, which offers a unique tool to selectively and regionally alter brain cortical activity. It has been reported to reduce symptoms of depression, post traumatic stress disorder (PTSD), obsessive compulsive disorder (OCD), epilepsy, migraine, Parkinson's disease, hallucination in schizophrenic patients, and to alter cognition. Repetitive TMS may alleviate drug craving by transient deactivation of certain brain regions or may stimulate hypoactive brain regions in addicts, thus promoting better control of drug-use compulsions and other behaviors. It may improve mood and enhance cognition, thus facilitating abstinence from drugs of abuse and increasing effectiveness of cognitive therapies. Preclinical studies showed that TMS induced neuronal sprouting and produced lasting plastic changes in the brain, which may aid recovery from drug dependence by promoting neuroregenerative processes and by restoring brain homeostasis. Studies are needed to evaluate effects of TMS on different psychological, physiological, neurobiological and behavioral aspects of drug abuse.
Another neurotechnique that may be utilized to bidirectionally, regionally change brain activity is TDCS, which involves transcranial application of a weak current. It has been used in neurology and psychiatry to control pain and seizures, and to alter perception or cognition. Like TMS, it may have utility in the treatment of drug use disorders by reducing drug craving, improving cognitive therapy and promoting brain plasticity, necessary for restoration of CNS homeostasis in recovering drug addicts.
Also unilateral visual field stimulation using goggles that allow vision only through one eye was shown to alter mood and anxiety in psychiatric patients, which suggests its potential utility in treating drug abuse/dependence. Kundalini yoga is another technique, which allows for lateral hemispheric control of brain activity through one nostral breathing. Applicants interested in manipulative and body-based therapies, energy therapies, and the development of treatments based upon neuroscience are also referred to PA-03-126.
The therapeutic effects of many other CAM therapies in the treatment of SUD have not been scientifically examined. Such research is needed and timely in view of the apparent popularity of CAM therapies among some drug abusing populations.
Given the high prevalence of psychiatric comorbidities such as depression, attention deficit hyperactivity disorder (ADHD), PTSD, OCD and conduct disorders with SUD and AUD, and the potential for common origins or pathways of SUD and AUD and these comorbidities, it seems reasonable to predict that CAM therapies intended for the treatment of psychiatric and neurological disorders might be beneficial in the treatment of SUD and AUD. In the case of biologically-based therapies, for example, several controlled studies showed that omega-3 fatty acids and Hypericum can be are beneficial in the treatment of depression; melatonin and Valerian for anxiety and insomnia; Ginkgo biloba, phosphatidylserine and L-carnitine for memory impairments; mega doses of vitamin E for slowing down the progression of Alzheimer's dementia. Mind-body therapies such as biofeedback or meditation are effective for treating anxiety and for stress management. Novel neurotechnologies such as TMS have shown beneficial effects in the treatment of depression, and a potential in the treatment of OCD, PTSD, epilepsy, Parkinson's disease, memory impairments, and hallucinations. Some of these disorders, such as depression, OCD, PTSD, cognitive deficits, are comorbid with drug dependence, hypodopaminergia is common for Parkinson's disease and stimulant dependence, and hallucinations are common for schizophrenia and for intoxications with certain drugs. By alleviating these neuropsychiatric disorders/symptoms, such neurotechnologies may also aid drug abuse therapies.
Research topics of interest include, but are not limited to:
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Hypotheses supported human laboratory studies that address different aspects of CAM therapies for SUD and AUD. For example, they may examine physiological, neuropsychological, and subjective effects of a CAM therapy on drug and alcohol craving, discrimination, self-administration, sensitization, reward, tolerance, withdrawal and psychological and physiological signs of drug dependence. They may also concentrate on reversing or compensating the neurobiological deficits observed in substance and alcohol abusing populations, or preventing acute and chronic effects of abused substances and alcohol on the brain.
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Brain imaging studies evaluating effects of CAM therapies on CNS substrates of SUD and AUD. Studies may focus on examination of CAM therapy effects on acute neuropharmacological actions of abused drugs and alcohol (e.g. brain metabolism, neurotransmission) or on neurochemical, neurophysiological, psychological and medical manifestations of chronic drug and alcohol abuse, including craving, drug- and alcohol-related memories and other cognitive aspects, neuroadaptations, or neuropathologies. Of particular interest are studies imaging the neurochemical-neurophysiological effects of novel neurotechnologies such as transcranial magnetic stimulation (TMS) or transcranial direct current stimulation (TDCS) in SUD and AUD populations, that might affect different neurobiological substrates of drug and alcohol abuse/dependence, such as arousal, craving or metabolic deficits.
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Exploratory/developmental pilot studies evaluating the safety, tolerability and therapeutic potential of biologically based CAM therapies on selected outcomes of treatment for SUD and AUD e.g., decrease of drug/alcohol use or craving, initiation or prolongation of abstinence, prevention of relapse, reversal of drug-and alcohol-induced neuroadaptations or neuropathologies, treatment of psychiatric comorbidities associated with SUD and AUD, improvement of cognitive functions, or enhancement of effectiveness of behavioral therapies.
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Randomized Phase II clinical trials evaluating the efficacy of promising biologically based CAM therapies in treating SUD and AUD or their clinical manifestations. Studies may focus on the treatment of toxic effects of abused substances, reversal of long-term medical/psychiatric consequences of drug and alcohol abuse, and different aspects of SUD and AUD, such as abstinence, withdrawal and relapse.
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Studies evaluating the effects of biologically based CAM therapies in the treatment of psychiatric disorders comorbid with SUD and AUD (e.g., depression, anxiety, ADHD, PTSD, ASP) and their correlation with efficacy in the treatment of the clinical manifestations.
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Designing specialized biologically based CAM therapies (primarily those based on neuroscience) to diminish drug-related emotional memories, reverse neuroadaptations, or compensate for cognitive deficiencies, which impair recovery from drug and alcohol dependencies and contribute to relapse to drug and alcohol addiction.
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Clinical studies testing the efficacy of biologically based CAM therapies in preventing or reducing medical consequences of drug and alcohol abuse, including the risk of HIV and other infections, or improving adherence to established pharmacotherapies for these diseases.
- Evaluation and development of safe biologically based treatments, e.g., specialized macro-nutrient enriched diets, nutritional supplements, or botanicals to reverse or compensate for some long-term medical and psychiatric consequences of drug and alcohol abuse, and to treat SUD and AUD that could be suitable for treating children, adolescents and pregnant women. Because some botanicals might interact with abused drugs, alcohol, or with medications used by addicts to treat their comorbid disorders, there is a need to establish safety of some biologically based treatments for developing organisms and in interactions with abused drugs, alcohol, or used medications.
Combinations of different CAM therapies with each other, or with conventional treatments for SUD and AUD that are expected to enhance their efficacy, may also be tested. Such combinations may target simultaneously several biological and clinical aspects of SUD and AUD. Because treatment of SUD and AUD usually requires a multidisciplinary approach, it is expected that proposals, which assess effects of biologically based CAM therapies will use - when appropriate - some behavioral intervention platform (i.e., psychotherapy).
Certain CAM therapies may require INDs and FDA approval. With biologicals and natural products quality certificates will be required. For information and guidance on NIH policy on the quality of natural products, please refer to NCCAM instructions. (http://nccam.nih.gov/research/policies/naturalproducts.htm) For guidance on designing clinical trials of NCCAM therapies determining dose ranges, please refer to the NCAM site. (http://nccam.nih.gov/research/policies/guideonct.htm)
For studies developing, adapting, reverse-engineering, and/or testing behavioral therapies and other non-biologically-based therapies for the treatment of SUD and AUD drawing from CAM therapies traditions such as mindfulness, meditation, martial arts, tai chi, yoga, dance and others, or using virtual reality as a way to help improve the efficacy of a therapy, applicants should refer to the Behavioral Therapies Development Program Announcement, which can be found at: http://grants.nih.gov/grants/guide/pa-files/PA-03-126.html.
Because clinical and preclinical studies have documented that males and females respond differently to drugs of abuse, alcohol, and to various pharmacological and behavioral treatments, the investigators are encouraged to evaluate, if feasible, sex/gender differences in response to their selected CAM therapies.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
1. Mechanism(s) of Support
This PA will use the NIH Research Project Grant mechanism (R01) (http://grants.nih.gov/grants/funding/r01.htm), the Small Grant award (R03) (http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html) and the Exploratory/Developmental Grant (R21) mechanism (http://grants.nih.gov/grants/funding/r21.htm). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project, http://grants.nih.gov/grants/funding/funding_program.htm.
This PA uses just-in-time concepts. It also uses the modular budgeting as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format. Otherwise follow the instructions for non-modular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm.
2. Funds Available
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 the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.
Section III. Eligibility Information1. Eligible Applicants
1.A. Eligible Institutions
You may submit (an) application(s) if your organization has any of the following characteristics:
- For-profit organizations
- Non-profit organizations
- Public or private institutions, such as universities, colleges, hospitals, and laboratories
- Units of State government
- Units of local government
- Eligible agencies of the Federal government
- Foreign Institutions
- Domestic Institutions
- Faith-based or community-based organizations
Foreign Institutions are eligible only as partners/collaborators of eligible US institutions, preferably from academia (universities, colleges, hospitals, and laboratories).
1.B. Eligible Individuals
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.
2. Cost Sharing or Matching
Cost sharing is not required.
The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.
3. Other-Special Eligibility Criteria
Not applicable
1. Address to Request Application Information
The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.
The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.
3. Submission Dates and Times
Applications must be mailed on or before the receipt date described below (Section IV.3.A). Submission times N/A.
3.A. Receipt, Review and Anticipated Start Dates
Application Receipt Dates: Standard receipt dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm.
Peer Review Date(s): June-July, October-November, and February-March.Council Review Date(s): September, February, and May.
Earliest Anticipated Start Date: October, March, and June
3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.
3.B. Sending an Application to the NIH
Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
3.C. Application Processing
Applications must be submitted on or before the application receipt dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm. Upon receipt, applications will be evaluated for completeness by CSR.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.
Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.
4. Intergovernmental Review
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (see also Section VI.3. Reporting).
Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.
The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
Applicants submitting proposals for clinical studies must document that they possess the necessary expertise and resources to conduct the proposed research, including having appropriate research facilities, access to the target population of drug addicts, capacity to recruit the specified number of patients, infrastructure to assure the ethical treatment of subjects, etc.
Specific Instructions for Modular Grant applications:
Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget 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 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm. (See also Section II.1. Mechanisms of Support).
Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year.
Applicants requesting $500,000 or more in direct costs for any year must carry out the following steps:
1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;
2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and,
3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.
This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. (See also Section VIII-Other Information).
Plan for Sharing Research Data
The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.
Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).
The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.
Sharing Research Resources
NIH policy requires that grant award recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.
Section V. Application Review Information1. Criteria
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established PHS referral guidelines.
Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.
As part of the initial merit review, all applications will:
- Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
- Receive a written critique
- Receive a second level of review by the appropriate National Advisory Council or Board.
The following will be considered in making funding decisions:
- Scientific merit of the proposed project as determined by peer review
- Availability of funds
- Relevance of program priorities
The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an 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. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
2. Approach. Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?
3. Innovation. Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
4. Investigators. Are the investigators 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? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?
5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?
2.A. Additional Review Criteria:
In addition to the above criteria, the following items will continue to 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 the Research Plan, Section E on Human Subjects in the PHS Form 398).
Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.
2.B. Additional Review Considerations
Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.
2.C. Sharing Research Data
Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.
2.D. Sharing Research Resources
NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.
The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.
3. Anticipated Announcement and Award Dates
Not applicable
1. Award Notices
After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document. If the grantee organization is set up to receive e-mailed awards from NIH, the award will be e-mailed to the authorized business official of the grantee institution. If the organization is not e-mailed enabled, one copy of the Notice of Award will be mailed to the authorized business official. The business official's office is responsible for sending a copy of the award to the Principal Investigator.
Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.
Section VII. Agency ContactsWe encourage your inquiries concerning this funding opportunity 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:
1. Scientific/Research Contacts:
Melissa Racioppo, Ph.D.
Behavioral and Integrative Treatment Branch
Division of Clinical Neuroscience, Development, and Behavioral Treatment
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Blvd., Room 4230
Bethesda, MD 20892-9551
Phone: 301-443-0107
Fax: 301-443-6814
Email: [email protected]
Raye Z. Litten, Ph.D.
Associate Director
Division of Treatment and Recovery Research
National Institute on Alcohol Abuse and Alcoholism/NIH/DHHS
5635 Fishers Lane, Room 2041
Bethesda, MD 20892-9304
Phone : 301-443-0636
Fax : 301-443-8774
Email : [email protected]
2. Peer Review Contacts:
Not applicable
3. Financial or Grants Management Contacts:
Gary Fleming, J.D.
Chief, Grants Management Branch/OPRM
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Room 270
Bethesda, MD 20892
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: [email protected]
Judy Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3023
Bethesda, MD 20892-9304
Telephone: (301) 443-4704
Email: [email protected]
Required Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.
Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html). For NIAAA specific DSMB guidelines see http://www.niaaa.nih.gov/extramural/guidelines.htm.
Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.
Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is 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 Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.
All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (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 applications for research involving human subjects and individuals designated as key personnel. The policy is available 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 (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.
Public Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.
Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
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 PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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