EXPIRED
DISSERTATION RESEARCH GRANTS FOR UNDERREPRESENTED MINORITIES IN THE ETHICAL, LEGAL, AND SOCIAL IMPLICATIONS (ELSI) OF GENETICS RESEARCH RELEASE DATE: January 22, 2002 PA NUMBER: PA-02-048 EXPIRATION DATE: January 2, 2005, unless reissued PARTICIPATING INSTITUTES AND CENTERS (ICs): National Human Genome Research Institute (NHGRI) (http://www.nhgri.nih.gov) National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidr.nih.gov/) National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov/) National Institute on Aging (NIA) (http://www.nia.nih.gov/) National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov/) THIS PA CONTAINS THE FOLLOWING INFORMATION: o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements 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 THE PA The purpose of this program announcement (PA) is to stimulate and encourage underrepresented minority doctoral candidates from a variety of academic disciplines and programs (See INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS) to conduct research related to the ethical, legal, and social implications (ELSI) of genetics, genomics, and gene-environment interaction research. It is hoped that this program will facilitate the entry of promising new minority investigators into the field of ELSI research. A dissertation represents the most extensive research experience formulated and carried out by a doctoral candidate, with the advice and guidance of a mentor. Dissertation research involves a major investment of the doctoral student"s time, energy, and interest and its substance is often the basis for launching a research career. The usual mechanisms used for the support of doctoral dissertation research have not attracted significant numbers of underrepresented minority students to the field of ELSI research. The intent of these dissertation research grants is to attract larger numbers of underrepresented minority students as ELSI investigators and to assist in providing a positive and constructive research experience that will stimulate them to pursue research careers in this field. RESEARCH OBJECTIVES Background and Significance As the Human Genome Project draws closer to completion of the final "finished" human DNA sequence, researchers are focusing increasing attention on the discovery of variations found in the DNA sequences among individuals. The identification, classification, quantification and analysis of these genetic sequence variations is expected to constitute one of the most powerful, and direct, approaches to the study of a wide range of important biological questions. It will allow researchers to identify genetic contributions to, and the role of environmental factors in, many common diseases and disorders, such as diabetes, heart disease, depression and other forms of mental illness, deafness and hearing impairment, Alzheimer"s disease and neurodegenerative illness, addiction and substance abuse, as well as some forms of cancer. It will also provide the basis for studying how genetic variation influences gene function and individual differences in human growth, development, and behavior, and will increase our understanding of gene-environment interactions affecting these phenotypes. Knowing the entire sequence of the human genome and understanding more about genetic variation among individuals and groups will, however, raise a number of ethical, legal, and social issues. These include: how to design and conduct genetic, genomic, and gene-environment interaction research, not only in a scientifically sound, but also an ethical manner, how to interpret and use this information, whether and how to integrate this information into clinical settings, and what impact this information will have in non-clinical and research settings. Many of these issues may be of special concern to individuals from diverse communities who traditionally have not been involved in genetics, genomics, and gene-environment interaction research, may have been adversely affected in the past by certain types of research, or fear that advances in diagnosis or treatment stemming from such research may not be equally accessible to all members of society. On the one hand, the exclusion of certain groups from research studies has contributed to disparities in the diagnostic and treatment options available to members of these groups. On the other hand, the inclusion of members of these populations in some early genetic studies may have led to an increase in stigmatization and to the potential for discrimination in employment, health care, insurance, or society more broadly. These issues may become even more pressing if ongoing research reveals data on the interactions among genotype, diseases or traits, and traditional, socially constructed concepts of race, ethnicity and culture. To anticipate, analyze and address these issues, input will be needed from a wide array of academic disciplines. In addition, because genetic information affects not only individuals and families, but also communities and large population groups, it is essential that researchers are well trained in their disciplines and are also cognizant of and sensitive to the concerns of members of diverse racial, ethnic and socioeconomic groups. Individuals from populations that are currently underrepresented in ELSI research and who have received training in disciplines that are relevant to this research will be essential to the success of the next phase of the Human Genome Project. The number of individuals who are identified as members of underrepresented minority groups and who are engaged in ELSI research is currently small. There is a clear need to develop new ways to assist and encourage minority researchers to become active in the conduct of studies that can advance the rapidly growing knowledge base in ELSI research. This research initiative is aimed at providing underrepresented minority students with assistance to complete their dissertation research on an ELSI-related topic and thereby increase their representation in ELSI research. Research Scope Applications may be made for support of research in any area relevant to the ethical, legal and social implications of genetic and genomic research. Proposed projects can range from large clinical studies of the impact of genetic information and technologies in health care settings to smaller analytical studies of how this information affects individuals or how communities view themselves or are viewed by others. General areas of programmatic interest are set out on the NHGRI ELSI Research website at http://www.nhgri.nih.gov:80/About_NHGRI/Der/Elsi/. The following five specific research goals have been developed for the NHGRI ELSI program through the year 2003 (a list of examples of research questions associated with each of these goals is available online at: http://www.nhgri.nih.gov:80/98plan/elsi/: 1. Examine the issues surrounding the completion of the human DNA sequence and the study of human genetic variation. 2. Examine issues raised by the integration of genetic technologies and information into health care and public health activities. 3. Examine issues raised by the integration of knowledge about genomics and gene-environment interactions into non-clinical settings. 4. Explore ways in which new genetic knowledge may interact with a variety of philosophical, theological, and ethical perspectives. 5. Explore how the social environment, including socioeconomic factors, age, gender and concepts of race and ethnicity influence the use, understanding, and interpretation of genetic information, the utilization of genetic services, and the development of policy. For additional information on the types of research funded by the NHGRI ELSI program, a list of all the grants supported by the NHGRI ELSI program since 1990 may be found at: http://www.nhgri.nih.gov:80/About_NHGRI/Der/Elsi/elsiabs.html. Information on other initiatives supported by the NHGRI ELSI Program may be found at: http://www.nhgri.nih.gov/About_NHGRI/Der/Elsi/#PA. Each of the sponsoring institutes has a particular interest in ELSI research relevant to its own mission. NIEHS is particularly interested in understanding the impact of environmental exposures on human health and disease. The NIEHS expanded its research program on genetic susceptibility to environmentally associated diseases through the Environmental Genome Project. Understanding genetic susceptibility to environmental agents will allow more precise identification of the environmental agents that cause disease and the true risks of exposures. This can lead to more effective disease prevention and improved public health. Further information on the Environmental Genome Project can be found at: http://www.niehs.nih.gov/envgenom/home.htm. Questions on the relevance of a particular topic to the objectives of this PA may be addressed to the program contact listed under INQUIRIES. MECHANISM OF SUPPORT This PA will use the NIH small grant (R03) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Grants to support dissertation research will provide no more than $25,000 (one module) in direct costs. An application that exceeds this limit will be returned to the applicant without review. Grants are normally awarded for twelve months, but may be extended without additional funds for up to a total of 24 months. This PA uses just-in-time concepts. It also uses the modular budgeting format. (see http://grants.nih.gov/grants/funding/modular/modular.htm). ELIGIBLE INSTITUTIONS You may submit an application if your institution is a public or private institution such as a university or college that supports doctoral level training. The performance site may be foreign or domestic. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS The applicant must be a full time student in good standing enrolled in an accredited doctoral degree program in a relevant social science or humanities discipline, such as anthropology, economics, health policy, public health, history, philosophy, political science, psychology, religious studies, or sociology. The applicant must be conducting or intending to conduct research in one of the areas described in this PA (see RESEARCH OBJECTIVES). The applicant must have obtained approval of the dissertation proposal by the dissertation committee by the time of application. All requirements for the doctoral degree other than the dissertation (and clinical internship, if applicable) must also be completed by the time of application. The applicant"s eligibility must be verified in a letter of certification from the mentor (the chair of the dissertation committee or other academic advisor) and submitted with the grant application (see SPECIAL REQUIREMENTS). Priority will be given to applicants who belong to ethnic or racial groups that are currently underrepresented in ELSI research. Within this group, persons with disabilities are particularly encouraged to apply. Academic institutions are encouraged to facilitate applications from qualified applicants. SPECIAL REQUIREMENTS Additional Material In addition to the completed PHS 398 application form (see SUBMITTING AN APPLICATION), the applicant must also submit the following materials, attached to the application as Appendices: o A letter from the applicant"s mentor which: (1) fully identifies the members of the dissertation committee and certifies their approval of the dissertation proposal, (b) certifies that all requirements for the doctoral degree, except the dissertation (and clinical internship, if applicable), are completed, (c) certifies that the mentor has read the application and believes that it reflects the work to be completed in the dissertation, and (d) certifies that the institution"s facilities and general environment are adequate to conduct the proposed research. o A tentative timeline for completion of the research, the dissertation, and the dissertation defense. o An official transcript of the applicant"s graduate school record. o A statement of the applicant"s career goals and intended career trajectory. o A biography of the mentor, limited to two pages (use the Biographical Sketch page in application form PHS 398). Page Length of Application The narrative portion of the application that describes the Research Plan of the dissertation may not exceed ten pages. Allowable Costs and Concurrent Support Costs requested may not exceed $25,000 (one module) in direct costs for the total (one year) project period. Allowable costs include: (1) the applicant"s salary (not to exceed $20,000) and (2) direct research project expenses, such as data processing, payments to subjects, statistical consultant services, supplies, and dissertation printing costs, and (3) travel to scientific meetings, if adequately justified. No tuition support is allowed. An applicant who receives a dissertation research grant under this PA may not at the same time receive support under a predoctoral training grant or individual fellowship grant awarded by any Federal agency, or by any other dissertation grant. Other Special Conditions for Dissertation Research Grants o The doctoral candidate must be the designated Principal Investigator and must be the only individual named in the application for whom salary support is requested. o The responsible Program Official for the institute awarding the grant must be informed if there is a change of mentor. A Biographical Sketch of the new mentor must be provided for approval by the responsible Program Official. o A dissertation research grant may not be transferred to another institution, except under unusual and compelling circumstances (such as if the mentor moves to a new institution and both the mentor and the student wish to move together). o Two copies of the dissertation, including abstract, must be submitted to the responsible Program Official and will constitute the final report of the grant. The dissertation must be officially accepted by the dissertation committee or university official responsible for the candidate"s dissertation and must be signed by the responsible official. o Any publications directly resulting from the grant should be reported to the responsible Program Official. The grantee also should cite receiving support from the appropriate institute(s) both in the dissertation and any publications directly resulting from the dissertation grant. 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 three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Jean E. McEwen, J.D., Ph.D. ELSI Research Program National Human Genome Research Institute Building 31, Room B2B07 31 Center Drive, MSC 2033 National Institutes of Health Bethesda, MD 20892-2033 TEL: (301) 402-4997 FAX: (301) 402-1950 E-mail: [email protected] James A. Lipton, D.D.S., Ph.D. Division of Population and Health Promotion Sciences National Institute of Dental and Craniofacial Research Building 45, Room 4AS-37J Bethesda, MD 20892-6402 TEL: (301) 594-2618 FAX: (301) 480-8318 Email: [email protected] Shobha Srinivasan, Ph.D. National Institute of Environmental Health Sciences Chemical Exposures and Molecular Biology Branch Division of Extramural Research and Training P.O. Box 12233, MD EC-21 111 T.W. Alexander Drive RTP, NC 277709 TEL: (919) 541-2506 FAX: (919) 316-4606 E-mail: [email protected] Jennifer Harris, Ph.D. Behavioral and Social Research Program National Institute on Aging 7201 Wisconsin Avenue, Suite 533, MSC 9205 Bethesda, MD 20892-9205 TEL: (301) 496-3138 FAX: (301) 402-0051 Email: [email protected] Jonathan D. Pollock, Ph.D. Division of Neuroscience and Behavioral Research National Institute on Drug Abuse 6001 Executive Boulevard, Room 4284, MSC 9555 Bethesda, MD 20892-9555 TEL: (301) 443-6300 FAX: (301) 594-6043 Email: [email protected] o Direct your questions about financial or grants management matters to: Jean Cahill Grants Administration Branch Division of Extramural Research National Human Genome Research Institute Building 31, Room B2B34 31 Center Drive, MSC 2031 Bethesda, MD 20892-2031 TEL: (301) 435-7858 FAX: (301) 402-1951 E-mail: [email protected] Martin R. Rubinstein Grants Management Officer Division of Extramural Activities National Institute of Dental and Craniofacial Research Building 45, Room 4AS-55 Bethesda, MD 20892-6402 TEL: (301) 594-4800 FAX: (301) 480-8301 Email: [email protected] Jackie Russell Grants Management Officer Grants Management Branch Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD EC-24 111 T.W. Alexander Drive Research Triangle Park, NC 27709 TEL: (919) 541-0751 FAX: (919) 541-2860 Email: [email protected] Linda Whipp Grants and Contracts Management Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2N212, MSC 9205 Bethesda, MD 20892 TEL: (301) 496-1472 FAX: (301) 402-3672 Email: [email protected] Gary Fleming, J.D., M.A. Grants Management Branch Office of Planning and Resource Management National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 TEL: (301) 443-6710 FAX: (301) 594-6847 Email: [email protected] 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: [email protected]. APPLICATION RECEIPT DATES: Applications submitted in response to this PA 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. 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 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. 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 appropriate national 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 discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application"s overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your 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, your application will also be reviewed with respect to the following: PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. OTHER REVIEW CRITERIA: In the context of this PA, the investigator"s academic record, career goals, and other information in the Additional Materials will inform consideration of the above criteria. Strong emphasis will be placed on the reviewers" assessment of the applicant"s potential as a future contributor to ELSI research. Emphasis will also be placed on: (1) whether the proposed research is appropriate to the experience level of the applicant, and (2) whether the mentor has the qualifications (based on the mentor"s research and research training experience, particularly, but not exclusively, in ELSI research) to provide the necessary guidance to the applicant. 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 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. 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. 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. 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. 93.172 (NHGRI), No. 93.121 (NIDCR), Nos. 93.113, 93.115 (NIEHS), No. 93.866 (NIA), and No. 93-279 (NIDA) 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) 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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