RESEARCH ON RESEARCH INTEGRITY Release Date: August 14, 2000 RFA: NS-01-008 Office of Research Integrity National Institute of Neurological Disorders and Stroke Letter of Intent Receipt Date: November 17, 2000 Application Receipt Date: December 15, 2000 THIS RFA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA. PURPOSE The Office of Research Integrity (ORI, DHHS) and the National Institute of Neurological Disorders and Stroke (NINDS, NIH) invite applications (R01) to support research on research integrity. "Integrity in this context is understood as adherence to rules, regulations, guidelines, and commonly accepted professional codes or norms. Research integrity is a vital component of both the trustworthiness of the research record and of the trust that underlies public support for research. Therefore the responsible expenditure of public funds for research must include attention to research integrity. The purpose of the proposed grant program is to foster empirical research on the institutions, processes, and values that positively and/or negatively influence integrity in research. The sponsoring agencies are particularly interested in studies that will inform policy making at DHHS, NIH, and research institutions, with the goal of fostering appropriate attention to integrity in publicly funded research programs. RESEARCH OBJECTIVES Background In the early 1980s, research integrity became a major national concern as a consequence of a number of well-publicized cases of research misconduct. Since that time, thousands of publications have in one way or another reported on, analyzed, and/or expressed opinions about integrity in publicly funded research. However, only limited attention has been directed toward research on research integrity. Little is known about the causes and significance of or remedies for practices that fall short of professional standards for conducting research. There is not enough empirical evidence to determine whether intentional misconduct in research is rare or widespread. The impact of compromises in integrity on the public and on the research record has not been assessed. No systematic effort has been made to evaluate different approaches to transmitting high standards for integrity in research, making it difficult to know which ones, if any, are effective. The lack of research on research integrity presents a significant problem for government, research institutions, researchers and their professional societies. If integrity is defined as being truthful and living up to professional standards that researchers and research institutions set for themselves, there is ample evidence to suggest that publicly funded research can fall short of this standard. Some researchers have engaged in practices that clearly constitute research misconduct. Research results can be inappropriately influenced by bias, conflicts of interest, and carelessness, and personal ambitions can obscure the objectivity of the research process. However, the lack of generalizable empirical evidence relating to research integrity makes it difficult to develop rational policies for these problems or to assess the potential harm to the public health caused when standards for good practice are compromised. Areas of interest This RFA seeks to address the need for more and better information on the factors that encourage and/or discourage integrity in publicly funded research. For the purposes of this RFA, research is defined broadly to include societal, institutional and individual aspects of the enterprise. Integrity is understood as adherence to rules, regulations, guidelines, and commonly accepted professional codes or norms. Proposals are encouraged that will provide generalizable empirical knowledge about the ways in which researchers and research institutions meet or fail to meet their professional responsibilities in the conduct, evaluation, and reporting of research. Particular areas of interest include but are not limited to: o Research norms and/or practices, such as: How do researchers make decisions about what they should and should not do as professionals? Do workplace conditions and career pressures affect their decisions? What responsibilities do they accept or reject and why? How do they learn about these responsibilities? How do they define and deal with conflicting responsibilities? o Institutional climate and responsibility, such as: What responsibilities do research institutions and scientific societies accept for maintaining the integrity of their research programs? How do they meet these responsibilities? Do research institutions or professional societies promote values that effectively encourage high standards for integrity? What impact does institutional climate have on the attitudes and practices of individual researchers? o Education on the responsible conduct of research (RCR), such as: What impact, if any, does RCR education have on research integrity? Are some approaches (e.g., mentoring, case study, class-room lectures) to RCR education more effective than others? What methods or instruments are best suited for assessing the effectiveness of RCR education? o Integrity of publication practices and the research record, such as: Are research results quickly, fairly, and accurately disseminated? Is research effectively self-correcting? How effective are different approaches (e.g., peer review, data audits, or detailed research and publication guidelines) to encouraging and ensuring the integrity of the research record? o Conflict of interest, such as: How do conflicting interests impact the conduct and results of research? How do individuals, research institutions, and professional societies recognize and manage conflicts of interest? Are financial conflicts of interest a growing concern in research, and if so, what impact do they have? Are existing conflict of interest policies known and effective? o Research policies, such as: How well are current federal and institutional policies known and understood by researchers? How effective are those policies in promoting responsible research conduct or in pursuing allegations of research misconduct? Are humans and animals adequately protected when serving as participants in research projects? Relevant research perspectives and disciplines include, but are not limited to: anthropology, applied philosophy, business, economics, education, information studies, law, organizational studies, political science, psychology, sociology, and survey and evaluation research, plus the physical, biomedical, and clinical sciences. SPECIAL REQUIREMENTS Successful applicants will be asked to participate in future ORI sponsored conferences on research on research integrity to report progress, discuss problems, and share information related to the conduct of their grants. It is recommended that costs associated with attendance of the principal investigator at one meeting per year in Bethesda, Maryland be included as part of the budget proposal. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research project grant (R01) award mechanism. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed two years. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The anticipated award date is July 2001. FUNDS AVAILABLE The ORI intends to commit approximately $500,000 in FY 2001 to fund three to five new grants in response to this RFA. An applicant may request a project period of up to two years and a budget for direct costs of up to $100,000 per year. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plans of the ORI 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. Pending approval, ORI is planning to commit approximately $1,000,000 in FY 2002 to continue support for the first-year proposals, plus to fund an additional three to five new proposals. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or answer questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Mary D. Scheetz, Ph.D. Office of Research Integrity Division of Education & Integrity 5515 Security Lane, Suite 700 Rockville, MD 20852 (301) 443-5302 Email: MScheetz@osophs.dhhs.gov Mary Ellen Cheung, Ph.D. NINDS/NIH Neuroscience Center, Room 2209, MSC 9525 6001 Executive Boulevard Bethesda, MD 20892-9525 (301) 496-1447 Email: mm108w@nih.gov Direct inquiries regarding review issues to: Lillian M. Pubols, Ph.D. Chief, Scientific Review Branch National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard, Suite 3208 Rockville, Maryland 208512 Telephone: (301) 496-9223 Email: lp28e@nih.gov Direct inquiries regarding fiscal matters to: Ms. Sheila Simmons Grants Management Branch National Institute of Neurological Disorders and Stroke Neuroscience Center, Room 3254 6001 Executive Boulevard Bethesda, Maryland 20892-9537 Telephone: (301) 496-8084 Email: ss433y@nih.gov LETTER OF INTENT Prospective applicants are asked to submit by November 17, 2000, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NINDS staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to: Mary Ellen Cheung, Ph.D. NINDS/NIH Neuroscience Center, Room 2209, MSC 9525 6001 Executive Boulevard Bethesda, MD 20892-9525 Rockville, MD 20852 (for courier service) SCHEDULE SUMMARY Letter of Intent Receipt Date: November 17, 2000 Application Receipt Date: December 15, 2000 Peer Review Date: March 2001 Council Review: May 2001 Earliest Anticipated Start Date: July 2001 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: GrantsInfo@nih.gov. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $100,000 per year. The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $100,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form page. o Under Personnel, list all project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm - Complete the educational block at the top of the form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. - List selected peer-reviewed publications, with full citations, o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. (Note: Grants to unaffiliated individuals are not eligible for facilities and administrative cost re-imbursement.) o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. The RFA label available in the PHS 398 (rev. 4/98) 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. There is a sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Please note this is in pdf format. 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 must be sent to: Dr. Lillian Pubols Chief, Scientific Review Branch National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard, Suite 3208 Rockville, Maryland 20852 (for express/courier service) Applications must be received by 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. 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. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the ORI and NINDS staff. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. 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 NINDS in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and 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, assigned a priority score, and receive a second level review by the NINDS National Advisory Council. REVIEW CRITERIA The goal of this grant program is to foster empirical research on the institutions, processes, and values that positively and/or negatively shape integrity in research. The sponsoring agencies are particularly interested in studies that will inform policy making at DHHS, NIH, and research institutions, with the goal of fostering appropriate attention to integrity in their research programs. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of this goal. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will the understanding of research integrity be advanced? What will be the effect of these studies on the concepts or methods that drive RRI and policy making more broadly? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Will the study result in significant generalizable empirical information? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed investigations take advantage of unique features of the intellectual environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research. o 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. o The adequacy of the proposed plan to share data, if appropriate. 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 o program balance among similarly meritorious applications. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided 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 research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which was published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994, and is available on the web at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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. Reviewers are cautioned 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 Request for Applications (RFA), "Research on Research Integrity", 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. 93.853. 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 and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices



NIH Office of Extramural Research Logo
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®



Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.