RESEARCH ON RESEARCH INTEGRITY Release Date: May 9, 2002 RFA: NS-03-001 Office of Research Integrity National Institute of Neurological Disorders and Stroke National Institute of Nursing Research National Institute on Drug Abuse Letter of Intent Receipt Date: October 15, 2002 Application Receipt Date: November 15, 2002 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism 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 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 on Drug Abuse (NIDA, NIH), and the National Institute of Nursing Research (NINR, NIH) invite applications 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 both of the reliability 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 affect 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? How do professional societies establish norms for acceptable research practices? 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 (i.e., 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 Mentor/trainee relationships, such as: What are the responsibilities of mentors and trainees in pre-doctoral and post-doctoral research programs (i.e., role or responsibilities of a mentor, conflicts between mentor and trainee, collaboration and competition, selection of a mentor, and abusing the mentor/trainee relationship)? o Data acquisition, management, sharing, and ownership. What are the accepted practices for acquiring and maintaining research data? What are the proper methods for record keeping and electronic data collection and storage in scientific research (i.e., defining what constitutes data; keeping data notebooks or electronic files; data privacy and confidentiality; data selection, retention, sharing, ownership, and analysis; data as legal documents and intellectual property, including copyright laws)? o Responsible authorship, such as: What is the level of accountability among authors? How pervasive are problems associated with collaborative work and assigning appropriate credit, acknowledgments, appropriate citations, repetitive publications, fragmentary publication, sufficient description of methods, corrections and retractions, conventions for deciding upon authors, author responsibilities, and the pressure to publish? 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 Integrity of peer review in determining merit for research funding, such as: How do reviewers recognize and manage potential biases in the peer review process? What are the responsibilities reviewers have to privileged information and confidentiality? o Research collaborations and issues that may arise from such collaborations, such as: setting ground rules early in the collaboration, avoiding authorship disputes, and the sharing of materials and information with internal and external collaborating scientists. 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 The meaning of research misconduct and the regulations, policies, and guidelines that govern research misconduct in PHS-funded institutions, such as: How pervasive is fabrication, falsification, and plagiarism; error vs. intentional misconduct? How effective are institutional misconduct policies? How effective are institutional structures in identifying misconduct? How effective are the procedures for reporting misconduct; protection of whistleblowers; and outcomes of investigations, including institutional and Federal actions. 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, including nursing. The NINR is particularly interested in research done by nurses on these topics. Proposals that address research integrity issues that are relevant to specific NIH institutes, including the NIDA and NINDS, are appropriate. MECHANISM OF SUPPORT This RFA will use the 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 2003. This RFA uses just-in-time concepts. It also uses the modular budgeting format. (See http://grants.nih.gov/grants/funding/modular/modular.htm) Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. FUNDS AVAILABLE The ORI intends to commit approximately $750,000 in FY 2003 to fund new grants in response to this RFA. (In addition to new applications, amended applications for unfunded projects previously submitted to NIH will be accepted.) Competitive continuations of existing projects are not eligible under this RFA. An applicant may request a project period of up to 2 years and a budget for direct costs of up to $100,000 per year. 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 also vary. Although the financial plans of 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. ELIGIBLE INSTITUTIONS You may submit an application 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 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 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. 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 Division of Education & Integrity 5515 Security Lane, Suite 700 Rockville, MD 20852 (301) 443-5302 Email: MScheetz@osophs.dhhs.gov Mary Ellen Michel, Ph.D. NINDS/NIH Neuroscience Center, Room 2209, MSC 9525 6001 Executive Boulevard Bethesda, MD 20892-9525 (301) 496-1447 Email: mm108w@nih.gov Karin Helmers, Ph.D. Office of Extramural Programs National Institute of Nursing Research Building 45, Room Number 3AN12, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-2177 FAX: (301) 480-8260 Email: Karin_helmers@nih.gov Joseph Frascella, Ph.D. Clinical Neurobiology Branch Division of Treatment Research and Development National Institute on Drug Abuse 6001 Executive Boulevard, Room 4123, MSC 9559 Bethesda, MD 20892-9559 Telephone: 301-443-4877 Email: jfrascel@mail.nih.gov 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 Rockville, Maryland 208512 Telephone: (301) 496-9223 Email: pw73q@nih.gov 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 20892-9231 Telephone: (301) 496-9231 Email: ss433y@nih.gov 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: Mary Ellen Michel, Ph.D. NINDS/NIH Neuroscience Center, Room 2209, MSC 9525 6001 Executive Boulevard Bethesda, MD 20892-9525 Rockville, MD 20852 (for courier service) FAX: (301) 480-1080 Email: mm108w@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. 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. 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/label-bk.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 must be sent to: Chief, Scientific Review Branch National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard, Suite 3208 Rockville, Maryland 20852 (for express/courier service) APPLICATION PROCESSING: 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. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NINDS. 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 the NINDS in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique 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 second level review by the appropriate National Advisory Council or Board. 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 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 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? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o 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. o 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) o 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 15, 2002 Application Receipt Date: November 15, 2002 Peer Review Date: March 2003 Council Review: May 2003 Earliest Anticipated Start Date: July 2003 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. 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 RFA 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, 93.279, and 93.361 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) 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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