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K23 Awards
The K23, offered by the National Institutes of Health, provides the physician-investigator the opportunity to obtain both the knowledge and the research skills necessary to compete for independent support in patient-oriented research. Funding is granted competitively on the basis of scientific merit. The three-to-five-year awards support at least 75% of the research effort (up to $75,000 per year) of a young physician developing a career in clinical investigation, with $25,000 annually for career development, equipment, supplies and travel.

Although K23 awards are granted by all of the institutes at the NIH, one third come from the National Center for Research Resources (NCRR) . The NCRR, which also funds the General Clinical Research Centers program nationwide, is receptive to human subjects studies that explore questions above and beyond the conventional clinical trial. Furthermore, the NCRR review committees are comprised completely of clinicians.

While individual investigators may apply for a K23 award on their own, there are distinct advantages to applying through the CRC for those who have CRC-based projects. The CRC has been supporting the applications and projects of K23 awardees (formerly Clinical Associate Physicians or CAPs), for fifteen years. The CRC administration and directorship are thoroughly familiar with the application process and likewise, the NCRR is familiar with the legacy of excellent clinical research, mentorship and training that comes from the University of Chicago CRC.

In order to qualify, candidates must have completed their clinical training, including subspecialty training, but they may apply during their final year of fellowship with an institutional commitment for an academic position to follow. Applicants who are already independent investigators (i.e., serve as principal investigators on projects with peer-reviewed sources of funding) are not eligible. K23 candidates are usually U.S. citizens, but may be foreign nationals with a permanent immigration visa.

The candidate should be well-trained, have notable research accomplishments in relation to career stage, relevant experience, and must be associated with one or more senior investigators able to provide scientific mentorship. Although the associated projects often include a laboratory component, in order for the CRC to sponsor the applicant, the clinical portions must utilize the CRC and the mentor must be a CRC-based investigator. In general, biologically-oriented research, rather than epidemiological or survey research, is most likely to be able to use the CRC's resources appropriately. The CRC also provides statistical expertise and informatics support.

For more detailed application instructions, please visit the NIH's K23 Web page, or call the CRC Administrative Office at 702-6980.

Clinical Research Training Program
The Clinical Research Training Program (CRTP) at the University of Chicago is funded through grant number K30 HL04093 from the National Institutes of Health. The CRTP is a three-track training program in the practice of clinical research for clinical fellows or postdoctoral researchers as well as other interested professionals. The first track consists of a three-quarter lecture series on patient-oriented research titled, The Essentials of Patient Oriented Research (EPOR). The second track will culminate in a certificate, and the third track will culminate in a Master's of Science degree. Because the curriculum is intended to be taken in conjunction with a program or primary clinical training, scheduling of the core components is intended to be accessible for trainees who also have clinical responsibilities.

Track I - The Essentials of Patient-Oriented Research is a three-quarter series of integrated lectures on how patient-oriented research can be safely and effectively planned, conducted, reported, and funded. This course is intended primarily for fellowship trainees, but others interested in clinical research are welcome as space permits. This course is presented at no charge. Although no application is needed, registration with the program office is required.

Track II - Trainees will participate in a core curriculum consisting of three graduate-level courses in statistical and epidemiologic methods, the year-long Essentials of Patient Oriented Research course described above, and a two-year seminar series on the design and analysis of clinical investigations. Applications should be received by June 1 and consist of:

  • A letter of nomination from the fellow's program director indicating how this program will promote the student's training.
  • A letter from the candidate detailing how this program will support his/ her career goals.
  • A letter of endorsement from the Department Chair/Section Chief supporting the candidate's participation and insuring that sufficient protected time will be provided.
  • CRTP Applicant Information Sheet.

Track III - This track offers the most comprehensive curriculum of the CRTP. Students will complete all of the core requirements of the Certificate Program (Track II), together with specific additional formal courses designed to provide in-depth knowledge of the methods of biostatistics, epidemiology, patient-outcomes assessment, and health-services research.

Students who have been admitted to Track II must apply to Track III through the established BSD/Health Studies admissions process. Applications should consist of:

  • Sealed official transcript(s)
  • A career statement detailing how this program will support the candidate's career goals
  • A letter of support from the fellow's program director indicating how this program will promote the student's training
  • MCAT or GRE scores
  • BSD application (including three letters of recommendation)
  • Applicant Information Sheet

Application packets and application deadlines are available from the Department of Health Studies CRTP website.

Fundamentals in Clinical Research
This unique course has been designed to provide undergraduate and graduate students in different stages of education and career development with the background necessary to plan, manage, and communicate within the world of clinical (human subjects) research.

The course introduces students to the basics of the clinical laboratory and includes the tools, techniques, and skills required to assist in human research protocols. Topics emphasized are lab safety, instrumentation, quality control and assurance, immunological assays, DNA preparation, and the ethics and logistics of research protocol development. The class includes hands-on lab participation, informal lectures, and open discussion.

Please consult Courses and Programs of Study, The University of Chicago College, available from the University Registrar's Office.

Statistics for Biomedical Researchers
The CRC no longer offers a "mini-course" on statistics for medical researchers, formerly taught as a stand-alone class by Theodore Karrison, Ph.D., of our Biostatistical Unit. This series, still free and open to anyone in the University community, has been incorporated into the Essentials of Patient Oriented Research course offered as part of the Biological Sciences Division's Clinical Research Training Program.

Please check their website for details.

Required Education in the Protection of Human Research Participants
As of October 1, 2000, the National Institutes of Health requires that grantees, such as the CRC, document that all investigators and co-investigators conducting clinical research have undergone an accepted educational program on the protection of human participants from research risks. The CRC complies fully with this requirement. Investigators and co-investigators on all protocols conducted under our auspices, regardless of whether the study is investigator-initiated or industry-initiated, must provide certification that they have successfully completed training through any of several possible programs at the University of Chicago. These programs include:

For detailed information on this requirement, please see the June 5, 2000, issue of the NIH Guide to Grants and Contracts.