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Funding & Research

Program Description
Specialized Centers of Clinically
Oriented Research (SCCOR)

National Heart, Lung, and Blood Institute

August 2004

A.  INTRODUCTION

The National Heart, Lung, and Blood Institute (NHLBI) has revised the Specialized Centers of Research (SCOR) program, based primarily on recommendations from the National Heart, Lung, and Blood Advisory Council. The new program is called the Specialized Centers of Clinically Oriented Research (SCCOR) program. This program has been described by the Institute Director, NHLBI in an editorial in the January 29, 2002 issue of Circulation. The original SCOR program required both basic and clinical research, but the preponderance of funded projects were in the basic science arena. The newly developed SCCOR program mechanism still requires clinical and basic scientists with a broad range of skills to work together on a unified theme, but more emphasis is placed on the clinical research projects. The new title and the revisions to the program reflect the NHLBI’s desire to capitalize on basic research advances by encouraging their translation to the clinical arena. The guiding principle of the new SCCOR program is the central focus on clinically relevant research, and the key change to achieve this goal is the new requirement that at least one-half of funded projects be clinical.

The specific requirements of the new SCCOR program are detailed in this document. Guidance for preparing an application is available on the NHLBI Special Instructions for Specialized Centers of Clinically Oriented Research (SCCOR) Grant Applications and questions and answers about the program can be found on the NHLBI Specialized Centers of Clinically Oriented Research (SCCOR) Frequently Asked Questions Page. NHLBI Links to current and future solicitations for SCCORs can be found on the NHLBI Grants and Contracts Page.

NOTE: This program is not an investigator-initiated grant mechanism. SCCOR programs specific for certain research areas will be published as individual RFAs which will appear in the NIH Guide.

B.  PURPOSE

The primary objective of the SCCOR program is to foster multidisciplinary research on clinically relevant questions enabling basic science findings to be more rapidly applied to clinical problems. It is expected that results from these SCCOR grants will have a positive effect on the prevention, diagnosis, and treatment of the particular disease under study.

C.  SCCOR REQUIREMENTS

  1. The overall concept of a SCCOR program focuses on clinical and basic scientific issues related to diseases and disorders relevant to the mission of the NHLBI. All applications must include both clinical and basic research and at least 50 percent of the funded projects must be clinical. For example, if an application has a total of three projects, two of the projects must be clinical. In addition, interactions between clinical and basic scientists are expected to strengthen the research, enhance the translation of fundamental research findings to the clinical setting, and identify new research directions. Translation of findings from basic to clinical studies is an important focus of the SCCOR program.
  1. In order for a project to be considered clinical, the research must fit the definition of clinical research in the PHS 398 (parts 1 and 2, but not part 3). That is, the research must be either patient-oriented research, or an epidemiologic or behavioral study.

Patient-oriented research is "research conducted with human subjects (or material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects." Clinical investigations may include studies of subjects with the disease of interest as well as normal healthy subjects. In studies involving the use of human specimens, e.g., blood, bronchoalveolar lavage, or biopsy, the investigators must have direct interaction with the subject or patient and relate the research results to the patient status or outcome for this to be considered a clinical project. It is intended that the requirement for investigator interaction with the study participants will not include research involving archived tissue.

Human biomedical and behavioral studies of etiology, pathogenesis, prevention and prevention strategies, diagnostic approaches, and treatment of diseases, disorders or conditions may be proposed. Small population-based epidemiologic studies, where the research can be completed within 5 years, may also be proposed. However, clinical research projects focused on large epidemiologic studies or Phase III clinical trials will not be considered.

All clinical research projects, whether on human subjects or human specimens, will be subject to the standard NHLBI policies and procedures regarding human subjects monitoring.

  1. The number of clinical projects in each NHLBI SCCOR must be equal to or greater than the number of basic science projects at the time of submission, award, and throughout the 5-year project period. Neither a clinical component in a basic science project nor a clinical core fulfills the requirement for a clinical project. Because a SCCOR grant is a 5-year program, an applicant should submit a 5-year plan for all the projects. If a project can be completed in less than 5 years, it should not be included in the application.
  1. Each awarded SCCOR must consist of three or more projects all of which are directly related to the SCCOR program topic. At least 50 percent of the projects and 50 percent of the cores must be located at the applicant institution and at least one of the clinical projects must be at the applicant institution. All basic research projects must be related to the overall clinical focus of the SCCOR. Each component project, whether clinical or basic, requires a well-described clinically relevant hypothesis, preliminary data, and a timetable for conducting the proposed investigations.
  1. The relationship of each core to each component project should be described. A core must provide services to two or more projects.
  1. Applicants are encouraged to establish links with existing resources including General Clinical Research Centers, the NHLBI Program in Genomic Applications, and NHLBI clinical research networks, as appropriate.
  1. Each SCCOR must have a well-delineated organizational structure and administrative mechanism that foster interactions between investigators, accelerate the pace of research, accelerate translation of basic research findings to clinical applications, and ensure a productive research effort.
  1. Applicants should provide a detailed data and safety monitoring plan for the clinical research proposed; the monitoring plan will be considered as part of the application and will be peer reviewed. This plan should address informed consent, recruitment, reporting of adverse events, patient safety, oversight of clinical issues in the protocols, storage and analysis of confidential data, and dissemination of any research results. There may be isolated cases when the NHLBI may wish to convene a DSMB to oversee the clinical projects in a SCCOR program. This will be determined after review and selection of the SCCOR centers. 

D. PRINCIPAL INVESTIGATORS

The principal investigator should be an established research scientist with the ability to ensure quality control and the experience to administer both clinical and basic research effectively and integrate all components of the program. A minimum time commitment of 25 percent is required for this individual. The principal investigator must be the project leader of one of the component research projects. If this project is not recommended by peer review, the overall SCCOR application will not be considered further. If this project is judged by peer review to be of low scientific merit, this will markedly reduce the overall scientific merit ranking assigned to the entire application.

Project leaders should have significant research experience and must agree to commit at least 20 percent effort to each project for which they are responsible. Investigators with minimal research experience but promising credentials may participate; however, it is expected that most of the project leaders will be investigators with significant research experience.

E. CONSORTIUM ARRANGEMENTS

If a grant application includes research activities that involve institutions other than the grantee institution, the application will be considered a consortium effort. Such applications are permitted, but it is imperative that they are prepared so that the programmatic, fiscal, and administrative considerations are explained fully. In addition, at least 50 percent of the projects (including at least one clinical project) and 50 percent of the cores must be located at the applicant institution. The published policy governing consortia is available in the business offices of institutions that are eligible to receive Federal grants-in-aid and should be consulted before developing the application. Applicants for SCCOR grants should exercise great care in preserving the interactions of the participants and the integration of the consortium projects with those of the parent institution, because synergism and cohesiveness can be diminished when projects are located outside the group at the parent institution. Indirect costs paid as part of a consortium agreement are excluded from the limit on the amount of direct costs that can be requested.

F. CHANGE OF INSTITUTION

If a project leader in a funded SCCOR program moves to another institution, the project is not normally allowed to continue under a consortium relationship with the new institution. Therefore, in such situations, the SCCOR program director should plan to justify the continuation of the component project based on its role in the overall program. Furthermore, a SCCOR program may normally not be transferred administratively to another institution.

G. REQUIRED FEDERAL CITATIONS

  1. MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks.
  1. 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 October 9, 2001 amendment to the NIH Guidelines for Inclusion of Women and Minorities; a complete copy of the updated Guidelines are also available. 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.

  1. 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.

  1. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS: NIH policy requires education on the protection of human research 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.
  1. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs were published in the NIH Guide and frequently asked questions and answers regarding the use of hESC are available and should be consulted by investigators proposing to use hESC. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding. It is the responsibility of the applicant to provide the official NIH identifiers for the hESC lines to be used in the proposed research. Applications that do not provide this information will be returned without review.
  1. 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 and should consult guidance provided by the NIH.

Data may be collected 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.

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