RFA-GM-05-006: SHORT COURSE: INTEGRATIVE AND ORGAN SYSTEMS PHARMACOLOGY

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SHORT COURSE: INTEGRATIVE AND ORGAN SYSTEMS PHARMACOLOGY RELEASE DATE: April 26, 2004 RFA Number: RFA-GM-05-006 (Reissued as RFA-GM-08-010) EXPIRATION DATE: June 26, 2004 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATION: National Institute of General Medical Sciences (NIGMS) (http://www.nigms.nih.gov) Office of Dietary Supplements (ODS) (http://dietary-supplements.info.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S) 93.859 APPLICATION RECEIPT DATE: June 25, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The purpose of this RFA is to solicit proposals for a Short Course(s) in Integrative and Organ Systems Pharmacology. The National Institute of General Medical Sciences (NIGMS) recognizes the importance of studies using intact organ system and in vivo animal models in the conduct of research. There is a growing need for functional analysis of biological systems to connect results at molecular and cellular levels to the expression of genetic and environmental determinants in the whole organism. This RFA solicits proposals for Education Projects that will introduce students to the knowledge and skills needed for studies of integrative organ system and whole organism biological responses to drugs and other physiological perturbations. The project should develop an appropriate, innovative curriculum to teach basic concepts and experimental techniques during a brief, but intensive short course, to be offered during the summer. Inclusion of independently funded follow-up experiences at either the home institution or through industrial internships is encouraged. Interested students will likely be drawn from graduate programs in pharmacology, physiology, toxicology, and related disciplines. However, the course should be open to participation of other students at advanced levels of training and career stages, and to students from industry and government as well as from academia. The training should foster their ability to assume leadership roles in all three sectors. The goal of these Education Projects will be to strengthen the research personnel base in the United States by broadening the exposure of students to training in integrative and organ systems sciences. RESEARCH OBJECTIVES Background: The definition of Integrative and Organ Systems Pharmacology for the purpose of this RFA is as follows: "Pharmacological research using in vivo animal models or substantially intact organ systems that are able to display the integrated responses characteristic of the living organism that result from complex interactions between molecules, cells, and tissues." Such studies are important because isolated molecules and cells in vitro do not accurately display all of the properties that they possess in vivo. Isolated molecules and cells do not adequately reflect the function of intact tissues, organs, and organ systems. Normal physiology, pathology, and pharmacology reflect not only interactions between molecules and cells, but interactions of multiple tissues, organs, and organ systems as well. Concerns have been raised by academic and industrial scientists about the training of current students in the area of integrative and organ systems sciences. Most graduate students in the basic biomedical sciences receive limited training in physiology and integrative pharmacology. Even within the discipline of pharmacology, not all students gain sufficient hands-on experience with in vivo animal models and organ systems. Graduates need to have sufficient understanding of how to choose and use models that appropriately reflect the human condition under study. Furthermore, students need the skills to communicate with other scientists across the breadth of science from isolated molecule to whole animal and human clinical research that is required for translation of research results into health benefits. Several factors suggest an increasing need for students trained in integrative and organ systems sciences. Bioinformatics and genomic approaches are suggesting new targets for study. Hypotheses generated by in vitro studies or by computational biology and systems approaches to the integrative behavior of living systems need to be tested in the actual living organism. The ability to develop genetically modified organisms has outstripped the ability to characterize the phenotypic changes in these organisms. Interest is growing in behavioral and neurobiological phenomena that can only be studied in relatively intact systems and living organisms. Discoveries in the areas of chemistry, genomics, and pharmacogenetics have accelerated the rate of research and have increased the demand for integrative and organ systems pharmacologists in the pharmaceutical industry. Pharmacologists, experienced with in vivo models, form an integral part of every drug discovery and development project and are essential to assuring that only safe and efficacious lead compounds go forward to clinical trials. New tools, such as microdialysis and imaging methods, have become available that enhance the collection efficiency and value of pharmacological data obtained in vivo. Academic infrastructure at many institutions may not be able to meet the demand for appropriate training in this area. The success of reductionist approaches based on molecular and cellular methods has resulted in the displacement of many of the researchers formerly engaged in integrative and organ systems studies. The cost of animal subjects research has increased and the use of animal subjects in basic medical and graduate instruction has been significantly curtailed. The training to be provided by the solicited Education Projects will help restore the balance between in vitro and in vivo approaches to science. The above analysis is based on input that NIGMS staff has gleaned from several sources: 1. Concerns in this area were raised by Jobe, et al., "The essential role of integrative biomedical sciences in protecting and contributing to the health and well being of our nation," in the Physiologist 37, 79-86 (1994), reprinted in the Pharmacologist 40, 31-37, 1998. Similar concerns at the international level are raised in "The fall and rise of in vivo pharmacology," Trends in Pharmacological Sciences 23, 12-18, 2002. 2. Public affairs briefing materials on the issues are available from the American Society for Pharmacology and Experimental Therapeutics and the American Physiological Society through their respective websites: http://www.aspet.org and http://www.the-aps.org. A broad coalition of scientists, represented by organizations including the American Association of Anatomists, the American Physiological Society, the American Society for Clinical Pharmacology and Therapeutics, the American Society for Nutritional Sciences, the American Society for Pharmacology and Experimental Therapeutics, the PHARMA Foundation, the Safety Pharmacology Society, and the Society of Toxicology, have endorsed a joint statement of support for increased research and training in Systems and Integrative Biology. Input from other societies has included the American Association of Veterinary Medical Colleges, the Institute for Laboratory Animal Research, and several international pharmacological societies. 3. Meetings between NIGMS staff and representatives of academia and industry have occurred on multiple occasions, including but not limited to a meeting organized by NIGMS titled, "What IS training in the Pharmacological Sciences?" held on the NIH campus, August 8-9, 2002. Details of the meeting and an Executive Summary Report are available at the following URL: http://www.nigms.nih.gov/news/meetings/pharmscitraining/. Additional summary reports were published in the journals, Molecular Interventions 2(5), 270-275, 2002 and Pharmaceutical Research 19(12), 1773-1774, 2002. NIGMS staff also participated in a workshop organized by the Life Sciences Research Office (LSRO), "The Status and Future of Integrative & Organ Systems Sciences," held on October 20-21, 2002. See: http://lsro.org/ioss/frames_ioss_home.html. GOALS FOR THE PROPOSED EDUCATION PROJECT(S): o Establish a strong connection between in vitro, organ function in situ, and in vivo results. o Introduce students to the role of in vivo methods in translational research and safety and efficacy in drug discovery and development. o Expose students to multiple animal models and reasons for selecting a given model for a particular purpose. o Provide significant hands-on experience with small animal models and at least some exposure to larger animal models. o Provide reinforced training in responsible conduct of research, including improved ability to articulate the need for such work in health research. o Improve the ability of students to communicate with other scientists across a broad spectrum of research activities. o Stimulate development at institutions through the return of interested students and the encouragement of institutional commitment. The project should develop an appropriate and innovative program of instruction in Systems and Integrative Pharmacology to be conducted during an intensive short course (e.g., 2-3 weeks) to be offered in the summer. Other course durations and offering times may be suggested. This program should satisfy the needs of the students for the introduction of basic concepts as well as the acquisition of initial hands-on skills with a number of organ system and intact animal model methods. A combination of lectures, laboratories, demonstrations, and seminars may be employed. The development of novel educational tools and approaches is encouraged. This program embraces physiology and other related areas of integrative and organ systems sciences as they form the underpinnings of in vivo pharmacology. The target audience for the Education Project(s) includes scientists at all advanced levels of training and career development, although a concentration on students at the graduate level may be appropriate. These projects will not support K-12 or undergraduate education. Graduating seniors who expect to enter graduate school in the near future may be included. Participation of students supported by NIH predoctoral training grants in the Pharmacological Sciences is highly encouraged, but the training should be available to other students as well. Inclusion of students pursuing MD, PharmD, DVM, and other advanced degrees, as well as PhD degree students, is encouraged. Inclusion of postdoctoral fellows and established researchers who are seeking new directions is also appropriate. The course should be open to students from industry and government as well as academia. The project should develop plans for recruiting and selecting students to participate in the project. These plans should be structured in a way that encourages integration of the proposed short course experience into the program of training of students at their home institutions. Agreements with a number of home institutions might be developed to encourage participation of their students, but the course should not be limited to institutions with whom such agreements exist. Projects may (but are not required to) include components that provide matching of students to follow-up academic or industrial experiences that will provide additional training in integrative and organ systems pharmacology. It would be useful to establish collaborations with a number of industrial organizations expressing willingness to accept the number of students to be placed. It would be useful to obtain commitments from academic mentors indicating how the student will be able to utilize their training after the course. Projects should include plans to evaluate the effectiveness of short course and other activities and to further refine the program in subsequent years of the project period. Projects should describe plans to disseminate the educational tools and approaches developed by this project to additional institutions. Provision of handout materials via websites and access to lectures via streaming video or other technologies is highly encouraged. Access to archival video material is desirable. SUGGESTED SHORT COURSE TOPICS: The following list of topics for inclusion in a short course is suggestive only, not inclusive or prescriptive: o Care and use of animals o Responsible conduct of research involving animal subjects o Role of animal subjects in translational research o Selection of appropriate models for human diseases o Routes of drug administration and sampling o Pharmacokinetics and pharmacodynamics, including ADME studies o Small animal surgery and tissue sample recovery for histology o Cardiovascular, renal, and pulmonary function monitoring in restrained and unrestrained live animals o Small animal reproduction and characterization of genetically modified organisms o Small animal neuropharmacology and behavioral monitoring o Large animal laboratories, demonstrations, videos, and simulations o Primate model lectures, videos, remote data, and simulations o Imaging applications in pharmacology o Toxicological methodology o Integration of cellular and molecular information with organ systems and whole organisms data The short course should not merely cover the necessary techniques to execute a particular protocol. Rather, it should provide an understanding of the strengths and weaknesses of particular models and the important concepts needed to design meaningful experiments. The course should provide not only familiarity with systems that are inherently integrative in their function, but should enhance the ability of the scientist to integrate information about systems. Although much attention may be focused on mouse and rat models, inclusion of other species in some capacity is required. MECHANISM OF SUPPORT This RFA will use the NIH Education Project (R25) award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. (It may or may not be reissued at a future date.) Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is April 1, 2005, for short courses that will be first offered in the summer, 2005. This RFA does not use the modular budgeting format. A detailed categorical budget should be proposed. 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. FUNDS AVAILABLE The NIGMS intends to commit approximately $500,000 in FY 2005 to fund 2 to 3 new grants in response to this RFA. An applicant may request a project period of up to 3 years and a budget for direct costs of up to $200,000 per year. Because the nature and scope of the proposed project 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 NIGMS provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic institutions/organizations o Foreign institutions are not eligible to apply; however, foreign scientists may participate as instructors. Foreign organizations may participate as sponsors for follow-on experiences, such as industrial internships, outside of the scope of the funded project. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed Education Project is invited to work with their organization 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. SPECIAL REQUIREMENTS o Requirement for Commitment of Principal Investigator The Principal Investigator is expected to commit a substantial effort to the organization, oversight, development of materials, and instruction of the short course. o Requirement for Involvement of Multiple Participating Organizations These Education Project awards will not support curriculum development projects focused on a single institution. For administrative purposes, only one organization may serve as the applicant organization and should coordinate all activities of the project. However, multiple organizations must be committed to the Education Project. It is recommended that the course be run by an organizing committee and that multiple organizations be represented on the organizing committee. The short course may make use of the facilities at multiple organization sites, but this is not essential--appropriate academic, government, independent laboratory, or industrial research facilities should be proposed. Faculty should be drawn from multiple organizations. Inclusion of faculty members representing academia, industry, and government, is encouraged. The participation of individual industrial sponsors or industrial organization sponsors is encouraged. The inclusion of letters indicating commitment of the target community to the project is recommended. o Recruitment of Students Advertising, application procedures, and selection of students will be a grantee responsibility. The students should be drawn from multiple institutions, not just the grantee institution, and efforts should be made to insure recruitment of a diverse student pool. Recruitment plans must address inclusion of disadvantaged students, including under-represented minorities. o Animal Welfare Assurances The applicant organization must provide assurance that all students receive appropriate training in the Responsible Conduct of Research involving Animal Subjects prior to beginning any work with animal subjects. If students have received such training at their home institutions, the organization must obtain appropriate documentation of this fact. If students have not received such training at their home institutions, the organization must provide this training. In either case, the organization should provide any additional training necessary for students to meet assurance requirements for use of animals at the host site. Plans to meet assurance requirements should be described in the application. Documentation of assurance will be requested at the time of award. o Reporting Requirements The Application for Continuation of a Grant (PHS 2590, rev. 5/01, http://grants.nih.gov/grants/forms.htm) or equivalent documentation must be submitted to, and be approved by, NIH to noncompetitively fund each additional budget period within a previously approved project period. The PHS 2590 application should include in the progress report a list of students who participated in the Education Project, their home institutions, department or degree program, and mentor or sponsor, and research project title at the home institution. Statistical data should be included on the representation of disadvantaged student groups. The report should indicate any known follow-on activities in which the students are participating. If the coordination of such activities is a formal part of the Education Project, then a detailed summary, including information about follow-on host site, mentor, and specific project, should be provided. The annual progress report must also include information on any changes in the Education Project curriculum and other activities, progress toward assessing the impact of the project, and activities undertaken to disseminate instructional methods and materials developed. (Reference: NIH Grants Policy Statement, NIH Publication No. 99-8, October 1998.) o Evaluation: In carrying out its stewardship of human resource- related programs, the NIGMS may request information essential to an assessment of the effectiveness of this program. Accordingly, the grantee should notify the Principal Investigator and participating students that they may be contacted after the completion of this award for periodic updates on various aspects of student employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program. o Allowable Costs: Items must be consistent with PHS policy and must be reasonable, allowable, and well justified for specific application to the proposed Education Project. Support will be provided for a combination of curriculum development and short course implementation. Support will not be provided for curriculum development projects alone. Funds may be requested for principal investigator, faculty, and administrative staff salaries; laboratory equipment, animals, supplies, and other educational materials; production and dissemination of course content; program evaluation; travel and per diem (see below). It is recommended that part of the cost be borne by the student's home institution, mentor, or employer as a way to assure commitment to the student's training. Co-sponsorship of the course by other organizations, such as non-profit and industrial sponsors, should be mentioned in the application. Co-funding through individual student registration fees and differential fee structures is permitted. Funds for travel expenses to other sites that may participate in follow-on industrial internships and other follow-on activities should not be requested, but may be mentioned as industrial or other types of matching contributions. Such matching contributions should be documented. Student stipends, tuition, and fees (other than as mentioned above) should not be requested. Facilities and Administration costs will be paid at 8% of the direct costs, exclusive of equipment. Awards will be administered according to the NIH Grants Policy Statement: http://grants.nih.gov/grants/policy/nihgps_2003/index.htm Travel and per diem expenses: Funds may be used for the travel of staff, speakers, participants, and attendees, if identified in the application and approved at the time of award. Travel expenses for employees of the grantee organization are governed by the grantee’s travel policies, consistently applied regardless of the source of funds. Any U.S. foreign travel restrictions that are in effect at the time of the award will be followed, such as: o limitations or restrictions on countries to which travel will be supported or o budgetary or other limitations on availability of funds for foreign travel. Proposed per diem or subsistence allowances must be reasonable and limited to the days of attendance at the conference plus the actual travel time to reach the conference location by the most direct route. Local mileage costs only may be paid for local participants. Where meals and/or lodgings are furnished without charge or at a nominal cost (e.g., as part of the registration fee), the proposed per diem or subsistence allowance must take this into consideration. Transportation costs for attendees and participants at the conference may not exceed coach class fares. In all cases, U.S. flag carriers will be used where possible (see: NIH Grants Policy Statement in Subpart B. Cost Considerations Allowability of Costs/Activities Selected Items of Cost Travel ). WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about programmatic issues to: Peter C. Preusch, Ph.D. Division of Pharmacology, Physiology, and Biological Chemistry National Institute of General Medical Sciences Building 45, Room 2AS.55E, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-5938 FAX: (301) 480-2802 Email: preuschp@nigms.nih.gov o Direct your questions about peer review issues to: Dr. Helen R. Sunshine, Chief Office of Scientific Review National Institute of General Medical Sciences Building 45, Room 3AN.12F, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-2881 FAX: (301) 480-8506 Email: sunshinh@nigms.nih.gov o Direct your questions about financial or grants management matters to: Ms. Antoinette Holland Grants Management Branch Division of Extramural Activities National Institute of General Medical Sciences Building 45, Room 2AN.50B, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-5132 FAX: (301) 480-2554 Email: hollanda@nigms.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 document 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. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to: Chief, Office of Scientific Review National Institute of General Medical Sciences Building 45, Room 3AN.12, MSC 6200 Bethesda, MD 20892-6200 APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. 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. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIGMS. Incomplete and/or nonresponsive applications will not be reviewed. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIGMS in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the NIGMS Advisory Council. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to evaluate the 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. (1) Innovation, appropriateness, and merit of the proposed Education Project curriculum, including short course and any proposed follow-on activities, in meeting the needs of the targeted students. (2) Appropriateness of proposed follow-on experiences, if proposed, adequacy of commitment from follow-on sponsors, and adequacy of plans for student placements. (3) Adequacy of plans to recruit and select students for participation in the project, including plans to encourage a diverse student population. (4) Adequacy of inclusion of institutions representing the broad target community and the commitment of multiple institutions to the participation of their students in the project. (5) Administrative experience, scientific expertise, and leadership of the principal investigator, appropriateness of faculty and other staff. (6) Availability and adequacy of laboratory and other resources necessary for the project, contribution of the environment to the probability of success, evidence of institutional commitment. (7) Merit of the measurable objectives and adequacy of the plans to evaluate the effectiveness of the Education Project and refine the program in subsequent years. (8) Adequacy of plans for dissemination of educational materials and methods developed by the project. 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. The only expected human subjects involvement in the Education Project(s) would be the collection of survey data for the evaluation of the educational tools to be developed. Such activity may be exempt from human subjects regulations, but this should be described and Exemption E1 and/or E2 should be noted and justified. (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. 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: The five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Application Receipt Date: June 25, 2004 Peer Review Date: November, 2004 Council Review: January, 2005 Earliest Anticipated Start Date: March 1, 2005 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities REQUIRED FEDERAL CITATIONS 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: 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, 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. 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). 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 RFA 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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