RESEARCH ON RESEARCH INTEGRITY RELEASE DATE: August 6, 2004 RFA Number: RFA-NS-05-003 (This RFA has been reissued, see RFA-NR-06-001) EXPIRATION DATE: November 23, 2004 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS: National Institutes of Health (NIH) ( Agency for Healthcare Research and Quality (AHRQ) ( COMPONENTS OF PARTICIPATING ORGANIZATIONS: Office of Research Integrity (ORI/DHHS) ( National Institute of Neurological Disorders and Stroke (NINDS/NIH) ( National Institute of Nursing Research (NINR/NIH) ( National Institute on Drug Abuse (NIDA/NIH) ( CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.853 (NINDS), 93.361 (NINR), 93.279 (NIDA), 93.226 (AHRQ) LETTER OF INTENT RECEIPT DATE: October 22, 2004 APPLICATION RECEIPT DATE: November 22, 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 Letter of Intent 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 Office of Research Integrity (ORI, DHHS), the National Institute of Neurological Disorders and Stroke (NINDS, NIH), the National Institute of Nursing Research (NINR, NIH), the National Institute on Drug Abuse (NIDA, NIH), and the Agency for Healthcare Research and Quality (AHRQ, DHHS) invite applications to support research on research integrity. The purpose of the proposed grant program is to foster empirical research on societal, organizational, group, and individual factors that affect, both positively and negatively, integrity in research. Proposals must have clear relevance to biomedical, behavioral health sciences, and health services research. Applicants are strongly encouraged to take into consideration problems or issues that are relevant to the missions of DHHS, NIH, AHRQ, or specific NIH institutes and programs. For the purposes of this RFA, "research" is interpreted broadly to include societal, organizational, group, and individual aspects of the enterprise. "Integrity" is understood as "the use of honest and verifiable methods in proposing, performing, and evaluating research and reporting research results with particular attention to adherence to rules, regulations, guidelines, and commonly accepted professional codes or norms." RESEARCH OBJECTIVES Background Integrity requires acting correctly or properly. In research, integrity requires adhering to responsible research practices or, following the definition above, "the use of honest and verifiable methods in proposing, performing, and evaluating research and reporting research results, with particular attention to adherence to rules, regulations, guidelines, and commonly accepted professional codes or norms." While much is written about integrity in research and its importance, three key questions remain largely unanswered: 1. What standards guide responsible practice and how are they set? 2. To what extent is research, as a profession, effectively self- regulating? 3. What are the key factors that influence the way researchers and research institutions conduct research and how can these factors be enhanced or mitigated as appropriate? This RFA seeks applications for empirical research that will provide answers to these questions, with particular interest in quantifiable information that is relevant to particular PHS research communities and/or research interests. Projects that are relevant to the current NIH Roadmap Initiatives (New Pathways to Discovery, Research Teams of the Future, and Re-engineering the Clinical Research Enterprise) are also encouraged. Areas of Interest 1. Standards for responsible conduct. The standards for responsible conduct in research are complex and not always apparent. Some (e.g. Federal regulations for human and animal research or for handling misconduct) are clearly described and must be followed. Others (e.g. Federal guidelines and professional codes) are clearly described but have no compelling authority. Still others (e.g. for designing experiments; recording, storing, and interpreting data; or assigning authorship) are more customs than clearly defined standards and can vary from field to field or research setting to research setting. The participating Institutes and Agencies are interested in knowing how standards for responsible conduct in research are formulated and the practices these standards endorse or discourage. In proposing studies in this area, researchers should pay attention to and clearly distinguish ideal from actual practices. What practices are ideally recommended? What practices do researchers routinely accept and, by implication, assume are responsible? There is particular interest in knowing more about the standards for: o data collection, storage, and sharing; o data selection, interpretation and reporting; o the use of statistics in data interpretation and reporting significant results; o assigning authorship; and o collaboration with other researchers and laboratories, particularly in clinical trials and international research. 2. Self-regulation. Self-regulation plays a vital role in maintaining integrity in research and for ensuring the reliability of the research record. Even in areas that are subject to Federal and local regulation (e.g. misconduct policies), regulators/administrators rely heavily on the research community to follow the rules and to report problems when observed. The participating Institutes and Agencies are interested in knowing how self-regulation operates in different research areas and its effectiveness. Studies proposed in this area should explore both ideals and real practices. What responsibilities for self-regulation do researchers recommend? Are researchers accepting their responsibilities for self-regulation? How effective is self- regulation? There is particular interest in knowing more about self- regulation as it pertains to: o responding to/preventing research misconduct and questionable research practices; o responding to/preventing inadvertent and careless errors; o correcting the research literature; and o promoting responsible mentoring and laboratory practices. 3. Factors that enhance or undermine integrity. Integrity is primarily a personal responsibility, but it can be and often is influenced by other factors, such as the attitudes of mentors, colleagues, and institutional leaders; institutional priorities; the availability of different types of research funding; local, national and/or world events; and personal obligations. The participating Institutes and Agencies are interested in knowing which factors play primary roles in either encouraging or discouraging the adoption of high standards for integrity in research. Studies proposed in this area should not only explore what these factors are but also how they can be influenced or changed. Does education about responsible research practices make a difference, and if so what approaches to education have the most impact? Are institutional factors important and if so how can they be changed? How do different incentives (interests) promote or undermine integrity? There is particular interest in knowing more about factors that enhance integrity in relation to: o RCR (responsible conduct of research) education; o mentoring; o conflicts of interest, particularly those that involve financial gain; o the effectiveness of research regulations; o the organization of individual laboratories and clinical research settings; and o the organization of large research collaborations (clinical trials, multi-site research, international research). 4. Relevant Research Perspectives and Disciplines. Relevant research perspectives and disciplines include, but are not limited to: anthropology, applied philosophy, business, economics, education, information studies, law, organizational studies, health services, political science, psychology, public health, sociology, and survey and evaluation research, plus the physical, biomedical, and clinical sciences, including nursing. The NINR is particularly interested in research done by nurses on these areas of interest. The AHRQ is particularly interested in research done by health services researchers on these areas of interest. MECHANISM OF SUPPORT This RFA will use NIH R01 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. 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 July 2005. This RFA uses just-in-time concepts. It also uses the modular budgeting format. (see Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at FUNDS AVAILABLE The ORI intends to commit approximately $1,500,000 in FY 2005 to fund new grants in response to this RFA. NINDS, NINR, NIDA, and AHRQ may provide additional funding for projects relevant to their research programs. Awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. An applicant may request a project period of up to 2 years and a budget for direct costs of up to $175,000 per year excluding Fiscal and Administrative costs ( Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will vary. Applicants developing new research areas or assembling new, interdisciplinary project teams should consider proposing limited, short-term projects to establish the methods for and validity of the work they propose to do (e.g., $75,000-100,000/year for one or two years). Larger, longer-term applications should be limited to major data collection efforts that involve multiple institutions, phased surveys, detailed direct or on site analysis, or other major research work that cannot be accomplished in smaller studies. In addition to new applications, amended applications for unfunded projects previously submitted to NIH in response to preceding RFAs from NIH/ORI will be accepted. Competitive continuations of existing projects are not eligible under this RFA. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign institutions/organizations o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Successful applicants should plan 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 therefore strongly recommended that costs associated with attendance of the principal investigator at one conference each year be included as part of the budget proposal. Applicants are also encouraged to include funds for at least one additional professional presentation of research results over the course of the grant period. 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 scientific/research issues to: Mary D. Scheetz, Ph.D. Office of Research Integrity 1101 Wootton Parkway, Suite 750 Rockville, MD 20852 (301) 443-5302 Email: Claudia S. Moy, Ph.D. NINDS/NIH Neuroscience Center, Room 2214 6001 Executive Boulevard, MSC 9520 Bethesda, MD 20892-9520 (301) 496-2789 Email: Alexis D. Bakos, Ph.D., M.P.H., R.N. Program Director Office of Extramural Programs National Institute of Nursing Research One Democracy Plaza 6701 Democracy Boulevard, Room 710, MSC 4870 Bethesda, MD 20892-4870 (301) 594-2542 Email: Noble Jones, M.Ed. Center for AIDS and Other Medical Consequences NSC, Suite 5198, MSC 9593 National Institute on Drug Abuse Bethesda, MD 20892-9593 (301) 402-0807 Email: Sally Flanzer, Ph.D. Agency for Health Care Research and Quality Office of Extramural Research, Education and Priority Populations 540 Gaither Road, Room 2-2042 Rockville, Maryland 20850 (301) 427-1538 Email: o Direct your questions about peer review issues to: Philip F. Wiethorn, Ph.D. Scientific Review Branch National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard, Suite 3208 Bethesda, MD 20892-9529 Telephone: (301) 496-9223 Email: o Direct your questions about financial or grants management matters to: Ms. Sheila Simmons Grants Management Branch National Institute of Neurological Disorders and Stroke Neuroscience Center, Room 3290 6001 Executive Boulevard Bethesda, Maryland 20892-9537 Telephone: (301) 496-9231 Email: LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA 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 IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Claudia S. Moy, Ph.D. NINDS/NIH, Neuroscience Center, Room 2214 6001 Executive Boulevard Bethesda, MD 20892-9520 (for courier, use Rockville, MD 20852) (301) 496-2789 Email: 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 D&B number can be obtained by calling (866) 705-5711 or through the web site at The D&B number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: 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 includes step- by-step guidance for preparing modular grants. Additional information on modular grants is available at 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: 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, Scientific Review Branch, NINDS 6001 Executive Blvd, Suite 3208 Bethesda, MD 20892-9529 Rockville, MD 20852 (for express/courier service) 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. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NINDS and ORI. Incomplete applications will not be reviewed. If the application is not responsive to the RFA, NIH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle. 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: 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 appropriate National Advisory Council or Board. REVIEW CRITERIA The purpose of the proposed grant program is to foster empirical research on societal, organizational, group, and individual factors that affect, both positively and negatively, integrity in research. Studies will be evaluated on their relevance to one or more of the identified areas of interest (above), to biomedical and behavioral research, and to the missions of DHHS and NIH. Successful applications do not need to address all three areas. Projects that provide carefully controlled and substantive answers to specific questions are encouraged. 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. SIGNIFICANCE: Does this study address an important problem? Will it enhance understandings of how standards are set and function in research? Will it further understandings of self-regulation? Will it make a significant contribution to understandings of research behaviors that adversely affect the research record and on the effect of efforts to change these behaviors through education and/or institutional reform? METHOD: 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? Has the applicant conducted a thorough review of the existing literature? Does the applicant acknowledge potential problem areas and consider alternative tactics? INNOVATION: Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? Does the project employ novel concepts, approaches or methods? INVESTIGATORS: Is the principal 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)? Are appropriate or necessary collaborations in place? Does the research team include appropriate expertise for the scope of the project? 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? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). 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: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: October 22, 2004 Application Receipt Date: November 22, 2004 Peer Review Date: March 2005 Council Review: May 2005 Earliest Anticipated Start Date: July 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 ANIMAL WELFARE PROTECTION: Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (, as mandated by the Health Research Extension Act of 1985 (, and the USDA Animal Welfare Regulations (, as applicable. 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. 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: 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 (; a complete copy of the updated Guidelines are available at 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 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 HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at and at Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see 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 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 ( 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 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 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance at 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 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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