WOMEN, GENDER DIFFERENCES AND DRUG ABUSE RELEASE DATE: June 16, 2003 PA NUMBER: PA-03-139 ( March 15, 2007 - This PA has been replaced by PA-07-329 (R01), PA-07-331(R21) and PA-07-330 (R03) See NOT-DA-06-015 for NIDA’s Intent to Reissue PA-03-139. 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-06-332) and R21 (PA-06-331) 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: June 30, 2006 National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.279 THIS PROGRAM ANNOUNCEMENT (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 This PA encourages gender-based drug abuse research that explores the mechanisms, origins, and consequences of drug abuse, and that develops and assesses gender-based prevention and treatment interventions and services. It also encourages the study of female-specific issues in all areas of drug abuse. RESEARCH OBJECTIVES Background and Significance Historically, in drug abuse research, as in other fields of public health research, subjects have largely been male. Findings emerging in the past few years, however, clearly are establishing the importance of studying issues specific to women and studying male-female differences in all areas of drug abuse research. From basic studies on genetics and neurotransmitters to studies on etiology and interventions, evidence for the importance of analyzing data separately for males and females is emerging. Accumulating epidemiological and clinical research indicates that the predictors and progression to drug abuse and dependence are often gender- specific or are gender-sensitive. Depression, conduct disorder, physical and sexual abuse, prenatal drug exposure and family dysfunction are among the variables differentially predictive of drug use, abuse, and dependence in males and females. In some cases, predictors are stronger for either males or females, i.e., gender-sensitive. In other cases, predictors apply only to males or to females, i.e., they are gender-specific. The implications of gender-based differences in risk factors for prevention and treatment interventions are largely unexplored; however, these differences raise the possibility that interventions that are designed to target gender-sensitive and gender-specific risk factors and that are guided by well-established gender differences in psychosocial and cognitive development could improve outcomes for both males and females. Animal and human laboratory research has shown that males and females often differ in their biological responses to drugs. Animal studies, for example, have found male-female differences in the motor-activating effects of stimulants, speed in acquisition of drug self-administration, the amount of drug self-administered, the percentage of subjects that acquire self- administration, motivation for self-administration, and the tendency to relapse following drug cessation. Human and animal pharmacokinetic studies often report male and female differences, as do studies of adverse effects of abused drugs. Both human and animal studies have established that the menstrual/estrous cycle is a determinant of drug action, both pharmacokinetic and behavioral. Despite the important progress made in laboratory-based gender research, the work is just beginning and many questions remain un- addressed. Numerous male-female differences in nicotine have been reported, including differences in the use patterns and dependence susceptibility, cessation rates and relapse rates, effectiveness of nicotine replacement therapies and other pharmacotherapies, control of smoking by non-nicotine factors, and the genetics of nicotine addiction including the genetic basis of nicotine metabolism. Indeed, research on gender differences in nicotine dependence appears to exceed that of other drugs of abuse and thus may serve to guide research on other abused drugs. Nevertheless, many gaps remain in our understanding of gender differences in the nature of nicotine addiction and its prevention and treatment, including issues specific to females such as the menstrual cycle and weight control issues. According to the Centers for Disease Control and Prevention, among HIV cases that progress to a diagnosis of AIDS, drug abuse is associated with a greater percentage of cases among women than among men. Nearly half (41 percent) of all women diagnosed with AIDS are injecting drug users (IDUs), whereas among men 22 percent of AIDS cases are IDUs. An additional 16 percent of women with AIDS, compared with one percent of men with AIDS, report having sex with users who inject drugs. Thus, in all, drug abuse is over twice as likely to be directly or indirectly associated with AIDS in women (57 percent) as in men (23 percent). Additionally, current research suggests that gender-related differences exist in some fundamental aspects of the HIV/AIDS disease process; for example, an HIV-infected woman with half the amount of virus circulating in the bloodstream as an infected man will progress to a diagnosis of AIDS in about the same time. There is also evidence that HIV risk reduction interventions may impact men and women differently. Although drug abuse plays a greater role in HIV in women than in men, major gaps remain in knowledge regarding gender differences in the role of drug abuse in HIV/AIDS and the unique needs of women. Gender differences are emerging in various aspects of treatment research including treatment entry characteristics, treatment and services needs, barriers to treatment, treatment engagement and retention, treatment outcomes, and relapse. Such research points to the need to address the possibility that treatment for both males and females could be improved by the development of gender-based approaches. The extant literature on gender differences in drug abuse strongly suggests that males and females are likely to differ in many aspects of drug abuse yet to be explored and that in the long run, identifying and understanding such differences can improve our understanding of the nature and etiology of drug abuse and have implications for tailoring prevention and treatment interventions to maximize outcomes for both males and females. Although progress has been made in knowledge of gender differences in drug abuse and issues unique to women, noteworthy gaps remain. Often, studies fail to include gender analyses, and only a small proportion of animal research includes female subjects or analysis of data by gender. Thus, in all areas of drug abuse, research is needed that examines gender differences and issues specific to females. In referring to differences between males and females, distinctions are often made in the use of the terms 'sex-difference' and 'gender-difference.' In this program announcement, for brevity and because it is often not known a priori whether a difference is sex-based or gender-based, the term 'gender- difference' will be used to refer to both types of differences. Additionally, researchers are encouraged to recognize that a gender difference is often a proxy for an unidentified independent variable (or variables) and that finding a gender difference often should be regarded as a first step in a search for such variables. Areas of Research Interest Research of interest includes, but is not limited to, the following: I. Mechanisms and Origins: Gender differences in the basic behavioral, biological, and genetic mechanisms underlying drug abuse and dependence; and preclinical, clinical, and epidemiological studies of gender differences in the determinants of initiation, progression, and maintenance of drug use and dependence. o Studies of the genetic basis of sex differences in drug abuse and dependence using a variety of methodologies, including, but not limited to, the following: statistical or epidemiological studies to ascertain heritability; identification of genetic variants through linkage, linkage disequilibrium, or association studies; studies of candidate genes using knockout or over-expression technologies in model organisms; gene expression studies. o Gender differences in the biological substrates of drug abuse, including molecular, cellular, neurochemical, neuromodulatory, neuroendocrine. o Gender differences in the pharmacokinetics and pharmacodynamics of abused drugs. o Gender differences in the role of hormonal (e.g., menstrual and estrous cycle, stress hormones), psychosocial, and cognitive factors in modulating drug effects and drug use. o Gender differences in the developmental-organizing and activating influences of sex steroids on brain and behavior and interactions with neurotransmitter systems and the HPA axis. o Gender differences in the effects of stress on the response to drugs of abuse. o Gender differences in the abuse liability of drugs. o Gender differences in vulnerability to drug initiation, acquisition, escalation, dependence, and relapse. o Laboratory behavioral studies of male-female differences in the role of tolerance, sensitization, habituation, drug discrimination, behavioral alternatives, impulsivity, delay discounting, stress, learning, memory, and cognition in the development and maintenance of drug abuse. o Field studies of gender differences in the antecedents and pathways to drug abuse and dependence, including study of psychosocial and environmental risk and protective factors associated with initiation, progression, and maintenance of drug use. o Gender differences in the role of psychiatric disorders (e.g. depression, PTSD, anxiety, eating disorders, borderline personality disorder, and antisocial personality) in the development and maintenance of drug abuse. o Gender differences in the roles played by the timing of puberty, the transition to puberty (e.g., onset of menarche), adolescent physique characteristics, and body image distortion in the onset and progression of drug abuse. o Family studies of gender differences in the intergenerational transmission of drug abuse. o Gender differences in the impact of violence, victimization, and stress on psychosocial development and functioning as it relates to the development and maintenance of drug abuse and dependence. o Gender differences in opportunity to use drugs, access to drugs, patterns of drugs of use and abuse, and factors affecting these differences. II. Consequences and Impact: Laboratory (both human and animal), field, and clinical research aimed at (1) identifying gender differences in the consequences of drug use, abuse, and addiction following acute use, chronic use, as well as residual effects following prolonged abstinence, and (2) examining drug-related consequences that are unique to females. o Gender-specific differences in the effects of abused drugs on the nervous system, endocrine system, immune system, cardiovascular system, and other physiological systems. o Laboratory-based studies of gender differences in the behavioral effects of abused drugs ranging from effects on sensation, perception, and unlearned behavior (e.g., affiliative, reproductive, defensive, aggressive, ingestive) to effects on learning, conditioning, and cognition. Studies of the biological substrates of these gender differences. o Gender differences in the perception of pain and in efficacy of both pharmacological and non-pharmacological pain treatments. o Gender differences in the acquisition and transmission of infection among drug users, and its clinical course and consequences. o Gender-specific medical consequences associated with drug abuse. o Gender differences in the precipitation and/or exacerbation of psychiatric disorders following drug use/abuse. o Gender differences in the effects of drug abuse on the response to stress. o The effects of drugs of abuse on the menstrual/estrous cycle as well as effects in the postmenopausal female. o The impact of drug abuse during pregnancy on medical conditions, both physiological and psychological, in the mother. o Gender differences in offspring prenatally exposed to abused drugs. o Gender difference in the effect of drug use on the development and maintenance of interpersonal relationships, e.g. empathy, conflict, hostility, attachment, friendships, marriage. o Gender differences in the effect of drugs on attainment of age-appropriate developmental levels, both physiologically and psychologically. o Gender differences in the impact of abused drugs on aggressive, hostile and violent behavior including child abuse, sexual assault, victimization, elder abuse, and school and workplace violence. o The effects of drugs of abuse on maternal and paternal functioning (e.g., maternal/paternal infant and child bonding, child abuse and neglect, role modeling behaviors) and differential impact on male and female offspring. o Gender differences in the socioeconomic and legal consequences of drug abuse, including the effects on education, employment, poverty, homelessness, gang activities, drug trafficking and distribution systems, and family functioning; (e.g., disruption, dislocation, violence, divorce and child custody.) III. Prevention and Prevention Services: The application of gender-specific theories and empirical findings on the origins, pathways, and risk and protective factors related to drug use, progression/transition, and maintenance, to the design, development, and testing of gender-based prevention strategies and interventions to determine efficacy and effectiveness. o In universal, selective and indicated prevention programs shown to be effective, conduct gender analysis and identify the intervention features and/or components that account for gender differences in outcomes. o Develop developmentally-appropriate gender-based universal, selective and indicated prevention strategies that are guided by etiologic research findings on gender differences in risk and protective factors and by gender differences in psychosocial and cognitive development. o In family-based prevention strategies, examine the effect of gender congruence between the participating parent and child on prevention outcomes. o Develop gender-based screening and assessment tools aimed at the identification of both risk and protective factors for use at the individual, family and community levels and in health care settings. o Develop interventions that consider the role of childhood and adulthood violence and victimization in perpetuating drug abuse in females with attention to environmental, psychosocial and cultural factors that keep women in the cycle of violence. o Conduct prevention studies on the role of effective gender-specific communication in media and interpersonal interventions. o Assess the effectiveness of gender-specific prevention services and the factors that affect their availability, adoption, adaptation, sustainability, cost benefit, and cost effectiveness. IV. Treatment and Treatment Services: The development and testing of theoretically-based drug treatment approaches (including behavioral treatment and pharmacotherapies) that address gender-specific issues, and the examination of gender-specific issues related to the effective and efficient delivery of drug abuse treatment services. o Assess the differential effectiveness of current drug abuse treatments in males and females. o Develop and evaluate gender-based behavioral therapies and pharmacotherapies, alone and in combination in a variety of treatment settings, including traditional community-based drug treatment programs, criminal and juvenile justice settings, and primary care settings such as office-based practices and primary care clinics. o Develop and test alternative or complementary therapies for drug abusers (e.g. biofeedback, acupuncture, herbal therapies) and compare their effectiveness in males and females. o Examine gender differences in therapies that target comorbid psychopathology. o Examine the role of gender in pharmacogenetic studies. o Examine the efficacy and effectiveness of gender-based approaches for treatment and relapse prevention, e.g., same-sex vs. mixed-sex treatment approaches, same-sex vs. opposite-sex therapist. o Examine gender-based treatment approaches and delivery of services for individuals having experienced violence and victimization and for those individuals with co-occurring drug abuse and mental disorders (e.g. depression, eating disorders, PTSD), and/or physical disorders (e.g. STD, HIV/AIDS, HCV). o Develop and test family-oriented treatment approaches that are gender- specific with respect to both parents and children. o Develop and test treatment approaches aimed at the role of partner drug use and drug treatment status in treatment outcomes. o Identify gender-specific needs for and use of services ancillary to drug abuse treatment (e.g., childcare, transportation, housing, skills training, assertiveness training, and vocational training) and their differential impact on males and females with respect to access, utilization, retention, outcomes and cost-benefit. o Identify effective pharmacotherapy for females of all ages including adolescence and pre-, peri- and postmenopausal women with consideration for issues such as developmental status, use of contraceptives, and use of hormone therapy. o Determine best treatment practices for the use of pharmacotherapy in the treatment of pregnant women and mothers who breastfeed, in terms of both the mother's health and the infant's. o Identify gender-based factors affecting drug abuse treatment access, treatment entry, readiness for treatment, retention in treatment, compliance with treatment, and treatment outcomes; and develop gender-based strategies to reduce or eliminate gender disparities. o Identify organizational, management, and treatment financing practices that impede or facilitate access, utilization, retention and outcomes for female clients and assess the structure and role of organization in the development of linkages to other relevant treatment services (e.g., medical services, prenatal clinics, psychiatric services) to ensure retention and continuity of care for females, including pregnant and postpartum females. o Develop or enhance and evaluate gender-based instruments for matching drug-abusing clients to appropriate services, and for identifying, diagnosing and assessing substance abusers in a variety of treatment settings especially primary care settings. V. HIV/AIDS and Related Infectious Diseases: Develop and evaluate gender- specific interventions directed at preventing and treating HIV/AIDS and related infectious diseases among drug using populations at every age level. o Examine gender differences in the viral, immunologic, genetic, and drug use factors that may influence susceptibility, recovery and persistence, and progression of viral diseases associated with drug use. o Examine gender differences in factors influencing long-term therapeutic effectiveness, development of viral resistance, disease progression, and medical outcomes. o Examine gender differences in the interactions/effects of antiretrovirals when used in combination with drugs of abuse and/or medication to treat drug abuse and/or medication to treat co-occurring disorders. o Develop gender-based strategies, including behavioral and cognitive approaches, to improve access, utilization and adherence to HIV/AIDS medication regimens for drug-abusing populations both in and out of treatment. o Develop gender-based strategies to improve clinical care and outcome with respect to antiretroviral therapy, including interventions to improve the clinical management of individuals on multiple medical therapies for HIV and associated infectious diseases. o Develop valid, reliable HIV/STD risk-of-exposure screening instruments with gender and age-group-specific, empirically-based normative data. o Examine gender differences in the behavioral dynamics and drug use-related processes associated with the acquisition and transmission of HIV and other infectious diseases, including factors that influence transitions from non- injection to injection drug use and their implications for the development of prevention interventions. o Develop gender-based interventions to prevent HIV and other infectious diseases, including research that explores the dynamics of social networks and the identification of factors that sustain positive behavioral changes. o Develop community-level intervention strategies aimed at preventing HIV/AIDS in women whose drug and sex practices put them at high risk of HIV infection. CROSS-CUTTING ISSUES In addition to the above areas of research on gender differences and issues unique to women, several research considerations and topic areas apply to many areas of research. They include, but are not limited to, the following: o Research that addresses and compares stages of the life cycle, from infancy, childhood, adolescence, adulthood, to late adulthood. o Research that examines the role of race, ethnicity, culture, and SES in drug abuse. o Research that examines health disparity issues in drug abuse and associated infectious diseases. o Research on women in hidden and underserved populations, e.g., incarcerated, lesbians, transgender individuals, homeless, victims of violence, sex workers, migrant workers, school dropouts, truants, runaways, street youth, latchkey children. o Research on all drugs of abuse, including the nonmedical use of prescription drugs, over-the-counter drugs with abuse potential, nicotine, club drugs, and polydrug use. o Use of a wide range of methodological approaches including longitudinal studies, secondary analyses of current data sets, descriptive and ethnographic studies, use of and development of novel measurement tools, and interdisciplinary approaches. o Research that addresses gender-specific recruitment and retention issues. MECHANISMS OF SUPPORT This PA will use the National Institutes of Health (NIH) research project grant (R01), small grant (R03), and exploratory/developmental (R21) award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This PA uses just-in-time concepts. It also uses the modular budgeting format. (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 format. Otherwise follow the instructions for non-modular 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 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: Cora Lee Wetherington, Ph.D. Women & Gender Research Coordinator National Institute on Drug Abuse, NIH, DHHS 6001 Executive Boulevard, Room 4282, MSC 9555 Bethesda, MD 20892-9555 Telephone: 301-435-1319 FAX: 301-594-6043 Email: wetherington@nih.gov o Direct your questions about financial or grants management matters to: Gary Fleming, J.D., M.A. Chief, Grants Management Branch National Institute on Drug Abuse, NIH, DHHS 6001 Executive Boulevard, Room 3131 Bethesda, Maryland 20892-9541 Telephone: 301-443-6710 Fax: 301-594-6849 E-mail: GF6S@NIH.GOV SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at 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. 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 GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. 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 NIDA program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from NIDA staff that NIDA will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and NIDA 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 received by or 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 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. An appropriate scientific review group 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 Receive a written critique 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 second level review by the National Advisory Council on Drug Abuse. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: Does this study address an important problem? If the aims of your 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 to that of 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 priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research 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). ADDITIONAL CONSIDERATIONS 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 MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phases I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice -files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended _10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. 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 www.nida.nih.gov under the Funding, or may be obtained by calling (301) 443-2755. 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 the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. 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 No. 93.279, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284)(or other authorizations) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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