Frequently Asked Questions (FAQ)
SPECIALIZED CENTERS OF CLINICALLY ORIENTED RESEARCH (SCCOR) PROGRAMS

National Heart, Lung, and Blood Institute

Revised October 13, 2005

Q: Where can I read about the SCCOR programs?
A. A description of the SCCOR program is available on the NHLBI Specialized Centers of Clinically Oriented Research (SCCOR) Program Description Page and guidance for preparing an application is on the NHLBI Special Instructions for Specialized Centers of Clinically Oriented Research (SCCOR) Grant Applications. NHLBI Links to current and future solicitations for SCCORs can be found on the NHLBI Grants and Contracts Page.

Q: What is a SCCOR?
A: A SCCOR is a multi-project grant to enable multidisciplinary basic and clinical research that is focused on clinically-relevant questions. The key new requirement in the SCCOR is that at least one-half of funded projects must be clinical. As always, there must be at least three fundable projects, the Principal Investigator (PI) should be an established research scientist who will commit at least 25% of his/her time to the SCCOR, and the PI must have a fundable project. All proposed projects must be designed to be completed within the five-year duration of a SCCOR award.

Q: Must an overall PI of a SCCOR be a physician?
A: No. However, the PI should be experienced and knowledgeable in clinical research, including human subject recruitment and all rules and regulations governing the participation of human subjects in research.

Q: What is a clinical project?
A. A clinical project is one in which the project investigators have direct contact with patients having the disease or condition of interest. Normal healthy subjects may be included, but only in combination with patients. In studies involving the use of human specimens, the investigators must have direct interaction with the patient from whom the specimen is obtained 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 eliminate research involving archived tissue.

Q: An investigator can obtain samples from patients enrolled in a clinical treatment trial being conducted by industry in order to measure pathogenic markers that will be evaluated with respect to individual patient outcome. Does this qualify as a clinical project?
A: No. If the investigators are not involved as a site in the clinical study, this would not be considered a clinical project. The SCCOR investigators must interact directly with the participants in a study.

Q: Can a project involving studies of non-human primates and/or other animals AND patients qualify as a clinical project?
A: Yes, but the primary focus of the project must be clinical.

Q: Can an institution collaborate with other institution(s) in order to obtain sufficient patients to perform meaningful clinical studies?
A: Yes; the usual subcontracting requirements apply.

Q: Do indirect costs of institutions under a subcontract count toward the $2.5 million direct cost cap?
A: No, Indirect costs for subcontracts are considered direct costs, but do not count toward the direct cost cap.

Q: Can an investigator be the PI for more than two projects?
A: Yes, but the investigator must devote the required effort (20% for each project; 25% for the overall PI).

Q. What is a Skills Development Core?
A: This is a new optional Core to support activities to assist in the development of the research skills of new clinical investigators. It provides up to $100,000 in direct costs in addition to the cap.

Q: Do I have to apply for a Skills Development Core?
A: No.

Q: Will I be penalized if my application does not include a Skills Development Core?
A: No, the priority score of the Skills Development Core will not be entered into the calculation of the overall SCCOR priority score.

Q: Can the leader of the Skills Development Core be the SCCOR PI?
A: Yes, but the individual must devote 5% effort to the Core as well as 25% effort as the PI of the SCCOR.

Q: Can my institution submit two applications for the same SCCOR program?
A: Yes, but reviewers are likely to be skeptical about the viability of two complete SCCORs from one institution, especially with the increased requirement for clinically-oriented research. Each application must have a different PI.

Q: Can an institution outside of the United States apply?
A: No, but an individual project or parts of a project could be from a non-US institution.

Q: Is a letter of intent required?
A: No, but it helps the Institute staff to plan the review. If you intend to submit an application, check the information in the RFAs for the due dates and addresses.

Q: Can I personally deliver the application on the due date at NIH?
A: No, NIH no longer accepts applications in person; they must be either mailed or sent by one of the overnight delivery services.

Q: Are these initiatives open to non-USA centers?
A: These initiatives are not open to non-USA centers. Please refer to section 1-A and 3-4 of the RFAs.

Q: Can a Clinical Core contain pilot clinical studies?
A: No. The purpose of a Core is to provide services to two or more research projects. All research studies must be included in the projects.

Q: May one person apply as a collaborator/co-investigator on two independent SCCOR applications?
A: NHLBI has no problem with your agreeing to participate in both SCCOR programs as long as there is no administrative, scientific, or budgetary overlap and the projects are not interdependent.

Q: Can a SCCOR project contain both basic and clinical research?
A: The spirit and intent of the SCCOR, as you know, is that at least half of the funded research is clinical. Please be aware that if a program contains more basic than clinical research when it is received, it will be considered as being non-responsive. The announcement states that a single project may integrate basic and clinical research. Keep in mind, however, that to be counted as "clinical,” a project must be predominately clinical (i.e., a major portion of the work involves direct interaction with human subjects.)

Q: If I submit 2 projects that are mostly clinical research, but do contain some basic research, and one project that is all clinical research, how many basic research projects may I submit- two or three?
A: If you were to have 2 projects that are predominately clinical but also include basic research, plus one purely clinical project, we recommend that you plan for just 2 additional basic research projects, as opposed to 3. It would be very helpful to us if you would include in the application for each of the combined clinical/basic research projects your estimate of the percentage of the project that is clinical research.

Q: Can a basic scientist be the PI of a clinical project?
A: A clinical project may have a basic scientist as the PI and a clinician as Co-Investigator, e.g., this arrangement is appropriate for a project concerning the evaluation of noninvasive technology to detect pulmonary hypertension. Please note, however, that the announcement (Section III, 3. Other-Special Eligibility Criteria, Item 10) indicates that leaders of clinical projects should have experience in clinical research as defined above.

Q: Is there a minimum or maximum number of clinical projects that must be submitted?
A: A SCCOR program must have a minimum of 3 projects, and the number of clinical projects must be equal to or greater than the number of basic research projects. A 3 project application would need to have 2 clinical projects; that would be the minimum number of clinical projects a group would have to submit. There is no maximum, but remember that the SCCOR must also have some basic research projects.

Q: What is the required effort commitment from a Core Leader?
A: There is no specified minimum requirement for Core Leaders (other than the Leader of the Skills Development Core.) An effort of 5 or 10% would be appropriate. It depends upon how much of a commitment is required to oversee the work. A percent effort below 5% is not recommended.

Q: Would research into improved methods of patient education, recruitment, and retention be appropriate for a SCCOR program?
A: Behavioral studies related to treatment adherence are considered to be clinical research projects by the NHLBI and would be eligible for inclusion in a SCCOR program. However, an important characteristic of SCCOR's is the integration of the various projects. You should consider carefully and should describe in the application how the behavioral project would be synergistic with other clinical and basic science projects that you propose.