Oregon Human Investigations Program

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DESCRIPTION: State the application's broad, long-term objectives and specific aims, making reference to the health relatedness of the project. Describe concisely the research design and methods for achieving these goals. Avoid summaries of past accomplishmentsand the use of the first person. This abstract is meant to serve as a succinct and accurate descdption of the proposed work when separated from the application, If the application is funded, this description, as is, will become public information. Therefore, do not include proprietary/confidential information. DO NOT EXCEED THE SPACE PROVIDED. The complexities of clinical research and translational research over the past 10 years have placed additional demands for mastery of a new set of research skills for clinical investigators. The K30-funded Human Investigations Program (HIP) was established four years ago to meet the needs of OHSU faculty and fellows, and community affiliates. The program consists of a didactic component coupled with a mentored research experience; we propose to add an experiential component in the next grant period. The didactic courses were developed around the accepted core competencies for research: clinical research study design, biostatistics, medical informatics, ethics of human research, and scientific writing and communication. To these, we add translational research and health services research. Elective courses in the HIP program include data management, randomized clinical trials, evidence-based medicine and effective clinical teaching. All residency and fellowship research courses have been consolidated into this program. The HIP courses are created and taught by senior, experienced educators using principles of adult education. In the mentored research experience, each student is works with a mentor to write either an NIH-style grant or to design, implement, and write a manuscript on a clinical research project. In the proposed experiential learning, HIP trainees will have opportunities to participate in grant review, IRB meetings, or molecular biology lab work, as examples. All trainees evaluate the courses in the curriculum and the entire program is evaluated in a focus group setting at the end of each year. Completion of the HIP program results in awarding a Certificate of Training in Human Investigation; a Master of Clinical Research has been approved at OHSU and is pending approval by the Oregon University System. At present, HIP has enrolled 86 into the degree cohort and 48 into the non-degree cohort. Of the initial cohort of 31 who matriculated in the degree track, 78% have graduated or remain active in the program; of the second cohort of 29, 90% remain active; of the third cohort, of 26, 96% remain enrolled. In the first cohort to complete the program, 80 % have submitted at least one research grant, and 73% currently have research support. PERFORMANCE SITE(S) (organization, city, state) Oregon Health & Science University, Portland, Oregon KEY PERSONNEL. See instructions. Use continuagon pages as needed to provide the required information in the format shown below. Start with Principal Investigator. List all other key personnel in alphabetical order, last name first. Name Organization Role on Project Morris, Cynthia D., PhD, MPH OHSU Program director Assael, Leon, DMD OHSU Course director Bagby, Grover C. Jr., MD OHSU Course director Becker, Thomas, MD, PhD OHSU Course director Beemsterboer, Phyllis, MS, EdD OHSU Program evaluator Berlin, Michelle, MD, MPH OHSU Course director Bowen, Judith, MD OHSU Course director Brandon, David D., PhD OHSU Course director Chan, Benjamin, MS OHSU Statistical consultant Chiodo, Gary, DMD, FACD OHSU Course director Helfand, Mark, MD, MPH OHSU Course director Disclosure Permission Statement. Applicable to SBIR/STTR Only. See instructions. [] Yes [] No PHS 398 (Rev. 05/01 ) Page 2 Numberpagesconsecutivelyatthe bottomthroughout Form Page 2 theapplication,Do notuse suffixesuchas 2a, 2b. Principal InvestigatodProgram Director (Last, First, Middle): Morris, Cynthia D. Name Organization Hersh, William, MD OHSU Lapidus, Jodi, PhD OHSU McCracken, Karen, BA, BSN OHSU Mori, Motomi, PhD OHSU Orwoll, Eric S, MD OHSU Samuels, Mary, MD OHSU Schuff, Robert, MS OHSU PHS 398/2590 (Rev. 05/01) Page 3 Role on Project Course director Course director Program Coordinator Course director Course director Course director Course director Continuation Format Page PrincipInavelstigator/Program Director (Last, First, Middle): Morris, Cynthia D. The name of the principal investigator/program director must be provided at the top of each printed page and each continuation page. RESEARCH GRANT