DRUG ABUSE ASPECTS OF HIV/AIDS AND OTHER INFECTIONS RELEASE DATE: October 10, 2003 PA NUMBER: PA-04-007 January 17, 2007 - The R01 portion of this funding opportunity has been replaced by PA-07-307, which now uses the electronic SF424 (R&R) application for February 5, 2007 submission dates and beyond. March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. This announcement will stay active for only the May 1, 2006 AIDS and AIDS-related application submission date for these mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms expires on the date indicated below. Other mechanisms relating to this announcement will continue to be accepted using paper PHS 398 applications until the stated expiration date below, or transition to electronic application submission. Replacement R03 (PA-06-310) and R21 (PA-06-309) funding opportunity announcements have been issued for the submission date of June 1, 2006 and submission dates for AIDS and non-AIDS applications thereafter. 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 All R01 Applications: October 10, 2006 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATIONS: National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.279 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanisms of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The National Institute on Drug Abuse (NIDA) supports research on the natural history, epidemiology, etiology, virology and pathogenesis, prevention, and treatment of drug abuse and drug abuse aspects of HIV/AIDS and other infectious agents [e.g., hepatitis B virus (HBV), hepatitis C virus (HCV), other sexually transmitted infections (STIs), and tuberculosis (TB)]. AIDS was first recognized as a growing epidemic among men who have sex with men (MSM) and injection drug users (IDUs) and their sexual partners in the early 1980s. While considerable scientific progress has been made since then in understanding, preventing, and treating the intertwined epidemics of drug abuse and HIV/AIDS, much remains unknown or poorly understood today. Emerging drugs of abuse, such as the club drugs ecstasy (MDMA), GHB, ketamine, and methamphetamine, as well as more potent supplies of heroin, cocaine, and marijuana, are continually changing the profiles of populations at risk. Moreover, these drugs often contain adulterants, and are used in risky social contexts in combination with alcohol and other drugs, including Viagra, poppers, and tobacco. In the United States today, over 77,000 women have been diagnosed with AIDS attributed to injection drug use or sex with an IDU, and nearly a third of AIDS cases in adult/adolescent women diagnosed in 2001 reported injection drug use or sex with an IDU as their primary risks. Racial and ethnic minority populations of both genders have been deeply affected by drug abuse, HIV/AIDS, and other infectious diseases in recent years, with new HIV infections continuing at an alarming rate in the U.S. and in other nations. There are an estimated 800,000 to 900,000 people living with HIV in the U.S., with approximately 40,000 new HIV infections occurring every year. By race, more than half of new HIV infections in 2001 and deaths attributable to AIDS in 2000 occurred among African Americans, although they represent only 13% of the U.S. population. This PA seeks to stimulate a range of investigator-initiated studies to advance the scientific knowledge base on drug abuse aspects of HIV/AIDS and other serious infections. Researchers are invited to address diverse and cross-cutting issues in multiple disciplines, including, among others: virology, bacteriology, molecular epidemiology, etiology, therapeutics and vaccines, ethnography and behavioral epidemiology, mathematical modeling and simulations, and the behavioral and social sciences. RESEARCH OBJECTIVES Background and Significance In the early 1980s, HIV and AIDS were first identified in the U.S. among MSM, IDUs, and the sexual partners of IDUs. It later became clear that the same risk behaviors for HIV (i.e., injecting drug use and unprotected sex) are associated with other blood-borne and sexually transmitted infections, such as HBV and HCV, and with the spread of TB. Sharing syringes and other equipment for drug injection is a primary route of HIV transmission, yet injection drug use contributes to the spread of HIV/AIDS beyond the circle of those who inject; e.g., to persons who have sex with an IDU and to children born to HIV- infected mothers who acquired the infection from sharing needles or having sex with an infected IDU. IDU-associated AIDS accounts for a larger proportion of cases among women than among men. Since the epidemic began, 55% of all AIDS cases among women have been attributed to injection drug use or sex with partners who inject drugs, compared with 19% of cases among men. Racial and ethnic minority populations in the U.S. have experienced a disproportionate burden of HIV/AIDS cases, most profoundly from IDU-associated AIDS. In 2000, IDU-associated AIDS accounted for 26% of all AIDS cases among African American and 31% among Hispanic adults and adolescents, compared with 19% of all cases among White adults/adolescents. Since the start of the epidemic, injection drug use has directly or indirectly accounted for more than a third (36%) of the AIDS cases in the U.S., and the trend continues today. The Centers for Disease Control and Prevention (CDC) reports that 11,635 (28%) of the 42,156 new cases of AIDS in the U.S. in 2000 were associated with injection drug use. IDUs also have one of the highest HBV seroincidence rates compared to other risk groups, and at least 60% of incident HCV cases are among IDUs. Acquisition of HBV and HCV can occur rapidly following initiation of injection, with reported prevalence rates of 50% for HBV and 65% for HCV among persons injecting for less than one year. Co-infections of HBV, HCV, and HIV often cluster in IDUs and are endemic among experienced IDUs. IDUs are at very high risk for pneumonia, septic pulmonary emboli, and TB as well. As with HIV, TB disproportionately affects minorities; 54% of active TB cases in 1999 were among African-Americans and Hispanics. Conditions that increase vulnerability to TB include injection drug use and poverty, as well HIV/AIDS. TB transmission is rampant in crowded shelters and prisons where people weakened by poor nutrition, drug addiction, and alcoholism are exposed to M. tuberculosis. Other infectious diseases pose major risks to IDUs, including Human T- Lymphotropic Viruses (HTLV) and hepatitis D virus (HDV). Combined HBV and HDV infection is associated with hepatitis outbreaks and high mortality among IDUs. IDUs are at risk for other serious health complications, such as rhabdomyolysis and delirium, as well as a variety of bacterial infections, including endocarditis, skin/soft tissue infection, mycotic aneurysm, septic arthritis, septic thrombophlebitis, respiratory infections, and osteomyelitis. Risks for these infections are particularly high among IDUs exposed to infected blood from multi-person use of syringes and other injecting equipment. Noninjecting drug use, particularly the use of crack cocaine, methamphetamine, and club drugs such as ecstasy or MDMA, GHB, and ketamine, is another major transmission risk for HIV and other infectious diseases. For example, research has shown that crack smokers may be three or more times more likely to be infected with HIV than nonsmokers. The context of risk, including crack and other drug use and drug-for-sex exchanges or risky, unprotected sex with multiple partners, is significantly associated with the rapid spread of HIV and other STIs through drug and sex networks. Age-discrepant relations also have implications for HIV transmission; young women and adolescents who use crack and other drugs are at high risk for HIV infection at an early age, especially when they use drugs and have sex with older, HIV-infected partners. Largely because of substantial gains in early diagnosis and therapeutic care, there are now more people living with HIV in the U.S. than ever before. Moreover, today's HIV prevention programs have benefited considerably from the empirical knowledge accrued over nearly two decades of NIDA-supported research on preventing the spread of HIV and other infections among drug users. While the number of new HIV infections in the U.S. has declined significantly from the 150,000 a year in the late 1980s, there are still an estimated 40,000 new infections every year. In addition, the CDC estimates that, of the 900,000 people currently living with HIV in the U.S., up to a third are unaware that they have the infection. Today, the profile of the individual at risk in the U.S. is largely urban and involves multiple and simultaneous risk-taking behaviors, including injecting and no injecting drug use (particularly use of crack cocaine and other drugs), unprotected sex with multiple partners, and exchange of sex for drugs or money. The intertwined epidemics of drug abuse, HIV/AIDS, and other infectious diseases have evolved over time. HBV and HCV have become more prevalent in injecting and non-injecting drug-using populations, as have drug-resistant strains of gonorrhea and TB. HCV is now considered an opportunistic infection in HIV-positive persons, according to the U.S. Public Health Service (1999). An estimated 80% of HIV-infected persons in the U.S. today are co-infected with HCV. Although no vaccine is available for HIV or HCV, epidemiological data on the HBV vaccine indicate that successful immunization of injecting and non-injecting drug users is possible. Multidisciplinary, biomedical, and behavioral research is critically needed today to keep abreast of these continually changing and intertwined epidemics, as they affect all ethnic and racial groups, adolescents and young adults, and persons of all sexual orientations. Areas of Interest NIDA seeks multidisciplinary, cross-cultural, domestic and international research on drug abuse aspects of HIV/AIDS, other blood-borne and sexually transmitted infections, and TB. Research of interest will inform our understanding of the causes, consequences, and differences in HIV-associated risks, morbidity, and mortality in men and women, adolescents and adults, and in majority and minority populations. Researchers are encouraged to utilize and integrate complementary methodological approaches in their study designs, including molecular epidemiology, ethnography and behavioral epidemiology, mathematical modeling and simulations, behavioral and prevention science, virology, bacteriology, and clinical medicine. This PA envisions a range of national and international research projects within and across the priority areas for NIH research on HIV/AIDS (http://www.nih.gov/od/oar/index.htm), including but not limited to the types of studies and issues described below. Natural History and Epidemiology o Studies to characterize the risk factors and mechanisms of transmission of HIV, other blood-borne infections, STIs, and TB, and to guide strategies for prevention of transmission among injecting and non-injecting drug users, their sexual partners, and their risk, peer, and social networks, and among specific groups and subpopulations (e.g., racial/ethnic minority groups; adolescents, runaways, and street youth; drug-using women; drug-using MSM; drug abuse treatment clients; rural populations; and migrant drug users who follow circuit parties, are homeless, who move in and out of jails/prisons, or move to other geographical regions for work). o Studies to identify and understand potential cofactors, mediators, and interactions of HIV and other diseases, their progression, and their outcomes in diverse groups (e.g., by HIV subtype, by socio-demographic factors) of active drug users. Researchers are encouraged to identify and understand how antiretroviral therapies, adherence interventions, health disparities, and other biologic and behavioral factors influence HIV progression among drug users, as shown by virologic, immunologic, and clinical outcomes. o Studies of new and improved approaches to access and recruit hard-to-reach cohorts of active drug users to participate in biomedical and behavioral interventions to reduce drug use-related risk behaviors, disease transmission, comorbidity, including drug-associated psychosis, and mortality. Researchers are encouraged to develop or refine study protocols, sampling and survey methods, and strategies to link community-based outreach to drug users with referrals and access to services for HIV counseling and testing, diagnostic screening for other diseases, drug treatment, and medical care. Etiology and Pathogenesis o Studies of viral and host mechanisms involved in the transmission, establishment, and spread of HIV in drug users and their sexual partners, including research on the mechanisms by which viral hepatitis, STIs, and other bacteriological and virological infections may influence HIV transmission in these populations. Research is encouraged to identify the etiologic and interactive biologic, behavioral, environmental, sociocultural, and race- and gender-related factors that determine the relative transmission efficiency of HIV and other diseases in diverse groups of drug users and others at risk. o Studies that define the role of drugs of abuse and related compounds (including adulterants and contaminants of drugs of abuse) or drug abuse treatment medications on susceptibility, onset, and progression of HIV disease, latent HIV infection, pharmacotherapy-resistant HIV strains, AIDS- associated opportunistic infections, TB, other blood-borne and sexually transmitted diseases, and drug-associated mental health disorders in drug- abusing populations. o Research on drug abuse-related risk factors associated with nutritional, metabolic, endocrine, and gastrointestinal disorders and their underlying pathophysiology in persons infected/co-infected with HIV, HIV/AIDS-associated opportunistic infections, TB, viral hepatitis, and other blood-borne and sexually transmitted infections. o Basic and clinical research on the neuropathogenesis of HIV and the relationship of nervous system infection to disease progression in drug users, including studies of the relationship(s) of virologic, host, pharmacologic, and environmental factors to HIV-associated central nervous system dysfunction and AIDS dementia complex. Therapeutics o Clinical trials research which reflects the changing demographics of drug abuse, HIV/AIDS, TB, viral hepatitis, and other blood-borne and sexually transmitted infections, including studies that recruit and retain multi- ethnic/racial populations of drug users, their sexual partners, and their children in the evaluation of potential therapies for the treatment of drug abuse, HIV infection, serious HIV-associated complications, and other diseases. o Basic and applied research to advance therapeutic entities and strategies to prevent and treat HIV, HIV/AIDS-related complications, and potential co- infections in drug users and their sexual partners. Of interest are studies of drug interactions among commonly used treatments for HIV and HIV-related disease and other substances that may be used by HIV-infected drug users (such as drug addiction treatment medications and over-the-counter drugs). Investigators are encouraged to evaluate the acceptability and use of new compounds (e.g., topical microbicides and other agents) to reduce and prevent sexual transmission of HIV and other infectious diseases in high-risk, sexually active, drug-using populations. o Studies that select and investigate biologic markers, surrogates, and/or other outcomes to evaluate the safety and clinical efficacy of new agents and approaches in the treatment of HIV-associated opportunistic infections and neurologic complications of HIV disease in drug users. In particular, clinical trials research is needed to identify optimal and appropriate treatment modalities and interventions that facilitate therapeutic adherence among traditionally underrepresented populations, i.e., ethnic/racial minorities and hard-to-reach drug users infected with HIV and other diseases. o Studies of antiretroviral adherence among drug users infected or co- infected with HIV and other diseases, including research to develop improved methods to assess adherence to therapeutic regimens; to compare and validate adherence measures in the context of linked services (e.g., medical care for HIV, HBV, HCV and drug abuse treatment) for infected drug users; and to evaluate the impact of antiretroviral therapy in the setting of viral hepatitis/STI and drug treatment. Vaccines o Basic research to advance the design and development of candidate vaccines and other biomedical interventions to prevent the spread of HIV in drug users, including studies that, for example, monitor and model effects on immune activation from drug abuse and STIs in HIV-infected and uninfected drug users and their sexual partners. o Basic virologic and immunologic research to model, develop, and evaluate safe and effective HIV vaccine strategies and passive immune interventions to interrupt HIV transmission from mother to infant, with special focus on high- risk, sexually active and/or pregnant women who use drugs or are the sexual partners of IDUs. o Epidemiologic and behavioral research to monitor changes in the risk behaviors and HIV seroincidence rates of drug users participating in vaccine clinical trials and to improve methods for identifying and evaluating emerging risk groups likely to participate in HIV vaccine efficacy trials. Behavioral and biomedical intervention studies are also needed to improve the recruitment, adherence, and retention of traditionally underrepresented populations (e.g., racial/ethnic minorities, women) in HIV vaccine efficacy trials and to minimize potential adverse social, economic, behavioral, and legal consequences of participation. o Multidisciplinary research to improve the design and efficiency of HIV vaccine efficacy studies involving drug users, including studies that establish and strengthen linkages between HIV vaccine preparedness and other prevention and treatment research activities (e.g., community-based HIV outreach and education interventions that integrate counseling and testing for HIV with screening, counseling, medical services for viral hepatitis and other STIs, and referrals and access to drug abuse treatment). Behavioral and Social Sciences Research o Behavioral intervention research that addresses the initiation, sustainability, and renewal of HIV/AIDS risk reduction and prevention among drug users and their sex partners, including studies of the effectiveness, cost-effectiveness, and durability of intervention outcomes among demographically and culturally diverse populations and communities. Studies are encouraged to design and test new community-based outreach interventions that are linked to a variety of ancillary services (e.g., rapid diagnostic assays, HIV counseling and testing, medical care for viral hepatitis/STIs, and drug treatment) or that are adapted to traditionally underrepresented or hard- to-reach populations, such as racial/ethnic minorities, drug injecting women, the sex partners of drug injectors, and drug-using MSM. o Multidisciplinary research on behavioral, cultural, social, and economic risk factors and consequences of injection drug use, risky sex, and HIV and other infections among drug-using groups and populations that differ by socioeconomic status, geographic location (domestic/ international, urban/rural), gender, sexual orientation, age, and race/ethnicity. Such studies may address, for example, contextual factors associated with risks of drug use, HIV, and other blood-borne infections and STIs, including health disparities, norms and attitudes about gender roles, the composition and stability of social networks, and peer and other influences related to transitions from noninjecting to injecting drug use or from safe to unsafe sex. o Studies to improve outreach, recruitment, and retention of HIV-infected drug users, especially hard-to-reach IDUs, in clinical trials on HIV/AIDS and drug abuse prevention and treatment. Of particular interest are studies that identify and address determinants and complications of antiretroviral adherence; drug use relapse prevention; the co-occurrence of HIV and other infectious and co-morbid conditions (drug addiction, alcoholism, viral hepatitis, STIs, mental illness, homelessness); the stigmatization so often associated with these diseases; and the social and cultural contexts within which HIV-related risks, protective behaviors, and behavioral changes occur. o Research that advances qualitative and quantitative methodologies in behavioral and social science investigations of drug abuse, HIV/AIDS, and other infectious diseases. Included are studies to: improve measurement instruments for hard-to-reach and special populations (e.g., racial/ethnic minorities, drug-using women and MSM, prisoners, adolescents, and migrant drug users); advance understanding of the social, structural, and cultural factors that influence risk behaviors, behavioral norms, social mixing, and high-risk networks; model, simulate and forecast the epidemiology of HIV/STIs and drug abuse, and guide the development of new interventions that target vulnerable groups to address health disparities and avert new infections; develop new outcome measures and indicators for evaluating the costs, benefits, and social impact of HIV prevention interventions; and formulate new strategies that facilitate multisite, intercultural, and international research projects. o Operational and health services research to understand and improve barriers to, and facilitators of, the implementation of science-based HIV/AIDS interventions in drug abuse prevention and treatment settings. Included are studies of the organization, financing, management, access, delivery, cost-effectiveness, linkage, and coordination of services to prevent and treat HIV/AIDS and other medical consequences of drug abuse, as well as the quality, outcomes, and costs of those services. MECHANISMS OF SUPPORT This PA will use the NIH research project (R01), the small grant (R03), and the exploratory/developmental (R21) award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The total project period for an application submitted in response to this PA may not exceed five years for the R01 and two years for the R03 and R21. 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_2001/part_i_1.htm. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign institutions/organizations o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct your questions about scientific/research issues to: Elizabeth Lambert, M.Sc. Center on AIDS and Other Medical Consequences of Drug Abuse National Institute on Drug Abuse, NIH, DHHS 6001 Executive Boulevard, Room 5198, MSC 9593 Bethesda, MD 20892-9593 Telephone: (301) 402-1933 FAX: (301) 480-4544 Email: EL46i@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, NIH, DHHS 6101 Executive Boulevard, Suite 242, MSC 8403 Bethesda, MD 20892-8403 Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: gf6s@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. The title, "Drug Abuse Aspects of HIV/AIDS and Other Infections," and number of the program announcement (PA-04-007) must be typed on line 2 of the face page of the application form and the YES box must be marked. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget grant format. The modular budget grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from IC staff that the IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an unfunded version of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by an appropriate advisory council or board REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to evaluate application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application's overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS Sharing Research Data Applicants requesting more than $500,000 in direct costs in any year of the proposed research are expected to include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. (See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm.) BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose- finding studies (phase I); efficacy studies (phase II), efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking more than $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. (http://grants.nih.gov/grants/policy/data_sharing) Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants1.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.healthypeople.gov/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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