K12 Eligibility

1.Career Advancement Program for Clinical Research Scholars (CAPS) ORIENTATION TBS

Difficulty recruiting and retaining clinical researchers

Rising overhead costs and regulatory demands

Limitations due to NIH funding mechanisms, review, and program structure

Lack of a viable career pathway deters investigators from conducting clinical and translational research impedes basic research results from entering into clinical practice

The current system of academic advancement favors the independent investigator

Most institutions house scientists in discrete departments

Interdisciplinary science requires interdisciplinary peer-review

Project management and oversight is currently performed by discrete ICs

Interdisciplinary research teams take time to assemble and require unique resources

Roadmap K12 Program is designed to increase the national pool of clinician-scientists from many disciplines

The program differs in its goal by supporting career development of the clinical research team

The clinical research team includes:nurses, sociologists, pharmacologists, biostatisticians, and epidemiologists, in addition to physicians, dentists, and other scientists.

Funding for up to 5 years includes didactic and practical training in design, conduct, and analysis of clinical research

Each clinical research scholar may be recruited from within a grantee institution or externally and has two mentors

CAPS is more than a training program.

Goals:

to train clinical researchers

to launch Scholars careers

to increase the number of interdisciplinary researchers who are working together

Minnesotas Approach

Core Competencies

Training Program

Expectations

Scholars & Mentoring Teams

Shared Resources

Ombudsman

Faculty Career DevelopmentProgram

Executive Committee

Multidisciplinary Scholars

Mentoring Teams

Infrastructure Support

Research Support

Evaluation

Upper Midwest Consortium

Study concepts

Study designs

Multidisciplinary collaboration

Research funding

Planning and managing research studies

Human Subjects Protection and Responsible Conduct of Research

Data collection, management, & analysis

Data interpretation

Reporting study findings (publications)

Professional presentation of study results

MS in Clinical Research or related field

Additional CAPS courses and seminars

Career Development seminar (PubH 6309)

AHC Clinical Research Conference

Management for Clinical Research (PubH 6572)

NIH CTSA KL2/K12 Annual Meeting

Midwest Consortium

Fundamentals of Clinical Research (3 cr)

Epidemiologic Methods I & II (3 cr each)

Biostatistics I & II (4 cr each)

Clinical Trials (3 cr)

Clinical Research Project Seminar (2 cr)

Writing Research Grants (2 cr)

Ethics in Public Health: Res & Policy (1 cr)

Thesis Credits: Masters (10 cr)

Electives (3 cr)

MS in Health Services Research and Policy

MS in Clinical Investigation

MS in Social, Administrative, and Clinical Pharmacy - Experimental and Clinical Pharmacology Track

MPH in Epidemiology

Commit 75% effort to CAPS-related training, research, and career development activities (50% effort for surgical scholars).

Commit no more than 25% total effort to clinical duties, teaching, and departmental administrative duties.

Post and update Career Development Plan, Ground rules, Confidentiality Agreement, and Mentoring Team interactions on mentor team website.

Meet regularly with mentoring team.

Participate in all CAPS-specific activities (seminar, conferences, workshops, etc).

Complete MS degree program (if not completed prior to CAPS).

Register for additional CAPS-specific courses.

Submit one peer-review article for publication per year (exceptions granted for full-time MS program students in first K12 year)

Presentations

Grant proposal (by end of CAPS period)

Scholar: Aviva Abosch, MD, PhD, Assistant Professor, Neurosurgery

Mentors: Apostolos P. Georgopoulos, MD, PhD, Professor, Neuroscience; Jon E. Grant, MD, MPH, Associate Professor, Psychiatry; Kamil Ugurbil, PhD, Professor, Center for Magnetic Resonance Research; Lynn E. Eberly, PhD, Associate Professor, Biostatistics

Project Title: Compulsive Behavior in Patients with Parkinsons Disease before and after Deep Brain Stimulation

Scholar: Jason Baker, MD, MS, Assistant Professor, Infectious Diseases & International Medicine, HCMC

Mentors: James D. Neaton, PhD, Professor, Biostatistics; W. Keith Henry, MD, Professor, UMN AIDS Clinical Trials Unit, HCMC; Richard Grimm, MD, PhD, MPH, Professor, Cardiology/ Epidemiology; Daniel A. Duprez, MD, PhD, Professor, Cardiology

Project Title: Small and Large Arterial Elasticity and HIV Infection:a pilot study

Scholar: Monica Colvin-Adams, MD, Assistant Professor, Cardiology

Mentors: Daniel J. Garry, MD, PhD, Professor, Cardiology;

Daniel A. Duprez, MD, PhD, Professor, Cardiology; Robert F. Wilson, MD, Professor, Cardiology; John E. Connett, PhD, Professor and Head, Biostatistics; Robert Bache, MD, Professor, Cardiology

Project Title: Phosphodiesterase-5 Inhibition and Cardiac Allograft Vasculopathy

Scholar: Sean Elliott, MD, Assistant Professor, Urologic Surgery

Mentors: Timothy J. Wilt, MD, MPH, Professor, Internal Medicine; Beth A. Virnig, PhD, MPH, Associate Professor, Health Services Research, Policy, and Administration; Robert L. Kane, MD, Professor, Health Policy and Management; Roger Feldman, PhD, Professor, Health Policy and Management; Bradley P. Carlin, PhD, MS, Mayo Professor, Biostatistics

Project Title: The influence of financial incentives on practice patterns and outcomes in prostate cancer therapy

Scholar: Lynda Polgreen, MD, MS, Fellow, Pediatric Endocrinology

Mentors: Anna Petryk, MD, Assistant Professor, Pediatric Endocrinology; Antoinette M. Moran, MD, Professor, Pediatrics; Chester B. Whitley, MD, PhD, Professor, Pediatrics; William Thomas, PhD, MS, Associate Professor, Biostatistics

Research Project :To study bone health in two related populations: children after hematopoietic cell transplantation (HCT) and children with Mucopolysac-charidosis (MPS) diseases with and without HCT and/or enzyme replacement therapy (ERT)

Scholar: Steven Stovitz, MD, Assistant Professor, Family Medicine and Community Health; Adjunct Faculty, Kinesiology

Mentors: Robert W. Jeffrey, PhD, Professor, Epidemiology and Community Health; John H. Himes, PhD, Professor, Epidemiology and Community Health; Mark A. Pereira, PhD, Associate Professor, Epidemiology and Community Health; Peter J. Hannan, MStat, Senior Research Fellow, Epidemiology and Community Health

Research Project: To study childhood growth features which predict adult obesity utilizing the CATCH and SOLAR databases

Scholar: Fareed Suri, MD, Fellow, Neurology

Mentors: Aaron R. Folsom, MD, MPH, Professor, Epidemiology and Community Health; Adnan I. Qureshi, MD, Professor, Neurology; Cavan S. Reilly, PhD, MS, Associate Professor, Biostatistics

Project Title: Renin-Angiotensin System Polymorphisms and Risk of Small Vessel Ischemic Stroke Analysis from a Cardiovascular Cohort

Scholar: Lisa Chow, MD, Assistant Professor, Endocrinology

Mentors:Elizabeth R. Seaquist, MD, Professor, Medicine;

Michael Garwood, PhD, Professor, Radiology;

Lynn E. Eberly, PhD, Associate Professor, Biostatistics

Project Title: Evaluation of Intramyocellular Lipid Content (IMCL) in Skeletal Muscle by Magnetic Resonance Spectroscopy

Scholar: Sarah A. Cooley, MD, Assistant Professor, Adult Hematology, Oncology and Transplantation

Mentors: Jeffrey S. Miller, MD, Professor, Medicine;

Daniel J. Weisdorf, MD, Professor, Hematology, Oncology and Transplantation; Chap T. Le, PhD ,Distinguished Professor, Biostatistics

Project Title: Natural Killer Cell Receptors

Scholar:Kamakshi Lakshminarayan, MD, Assistant Professor, Neurology

Mentors: David C. Anderson, MD, Professor, Neurology;

Russell V. Luepker, MD, MS, Mayo Professor, Epidemiology & Community Health; Beth A. Virnig, PhD, MPH, Associate Professor, Health Services Research, Policy, and Administration;

David R. Jacobs, Jr., PhD, Professor, Epidemiology & Community Health

Project Title:Improving Evidence-Based Quality of Care in Acute Stroke

Scholar: Peter Milev, MD, PhD, Assistant Professor, Psychiatry

Mentors: Kelvin O. Lim, MD, Professor, Psychiatry;

Angus W. MacDonald III, PhD, Assistant Professor, Psychology; Susanne S. Lee, PhD, Assistant Professor and Statistician, Psychiatry

Project Title:Deficits in perceptual organization and thought disorder in schizophrenia: relationships with fMRI functional anatomy

Scholar: Melissa A. Geller, MD, Assistant Professor, Obstetrics, Gynecology and Women's Health

Mentors: Amy P. N. Skubitz, PhD, Associate Professor, Laboratory Medicine and Pathology; Sundaram Ramakrishnan, PhD, Professor, Pharmacology; Douglas Yee, MD, Professor, Hematology, Oncology and Transplantation;Chap T. Le, PhD, Professor, Biostatistics

Project Title:Neoadjuvant Chemotherapy in Ovarian Cancer: Predicting Tumor Response

Scholar: LAurelle A. Johnson, PhD, Assistant Professor, Experimental & Clinical Pharmacology

Mentors: Timothy S. Tracy, PhD, Professor, Pharmacy;

Pamala A. Jacobson, PharmD, Associate Professor, Pharmacy;

Julie A. Ross, PhD, Professor, Pediatrics; Antoinette M. Moran, MD, Professor, Pediatrics; Melanie M. Wall, PhD, MS, Associate Professor, Biostatistics

Project Title:The effect of childhood obesity on phase 1 and phase 2 drug metabolism enzymes

Scholar: Ken M. Kunisaki, MD, MS, Assistant Professor, Pulmonary, Allergy, Critical Care, and Sleep Medicine

Mentors: Dennis E. Niewoehner, MD, Professor, Pulmonary Section, VAMC; Allen S. Levine, PhD, Professor and Dean, College of Food, Agricultural and Natural Resources Sciences; John E. Connett, PhD, Professor and Head, Biostatistics

Project Title:Micronutrients and Exacerbations of COPD

Scholar: Donald R. Nixdorf, DDS, MS, Assistant Professor, Diagnostic & Biological Sciences, Dentistry

Mentors: Eric L. Schiffman, DDS, MS, Associate Professor, Dentistry; David A. Bereiter, PhD, Professor, Dentistry; Kamil Ugurbil, PhD, Professor, Center for Magnetic Resonance Research; Noam Harel, PhD, Assistant Professor, Medicine; James S. Hodges, PhD, MA, Associate Professor, Biostatistics

Project Title: Functional Imaging of Trigeminal Neuropathic Pain

Scholar: Jeffrey R. Wozniak, PhD, LP, Assistant Professor, Psychiatry

Mentors: Kelvin O. Lim, MD, Professor, Psychiatry; Monica A. Luciana, PhD, Associate Professor, Psychology; Pi-Nian Chang, PhD, Associate Professor, Pediatrics/Psychiatry; Paul M. Thuras, PhD, Research Associate, Psychiatry

Project Title: Cerebral white matter effects of fetal alcohol exposure: A Diffusion Tensor Imaging (DTI) study of microstructural brain abnormalities and their neurocognitive correlates

Scholar: Fang Yu, PhD, RN, Assistant Professor, Adult and Gerontological Health Co-operative Unit, Nursing

Mentors: Jean F. Wyman, PhD, RN, FAAN, FGSA, Professor, Nursing Research/Community Health and Family Practice;

Maurice W. Dysken, MD, Professor, Psychiatry; Wei Pan, PhD, Associate Professor, Biostatistics

Project Title:The FIT-AD Study / Preserving Cognition and Function Through Aerobic Training in Alzheimer's Disease

Russell V. Luepker, MD, MS (Chair)

Linda H. Bearinger, PhD, MS, RN, FAAN

David M. Brown, MD, Ombudsman

Barbara A. Elliott, PhD

Frank A. Lederle, MD

Bryan S. Michalowicz, DDS, MS

James D. Neaton, PhD

Nancy C. Raymond, MD

Timothy W. Schacker, MD

S. Charles Schulz, MD

Elizabeth R. Seaquist, MD

William Thomas, PhD, MS

Timothy S. Tracy, PhD

Todd M. Tuttle, MD, MS

Anne Marie Weber-Main, PhD

Daniel J. Weisdorf, MD

David M. Brown, MD, Professor Emeritus, Pediatrics/Laboratory Medicine and Pathology

Role of Ombudsman

to provide scholars with feedback and advice

from outside the program

to facilitate resolution of program-related difficulties and challenges

Why the emphasis on mentoring in this program

What do we know abouteffectivementoring

How the CAPS program facilitates aneffectivementoring approach

How the CAPS program evaluated

Faculty with mentors demonstrate higher levels of success on the following factors:

Research productivity (Bland and Schmitz 1986, Byrne and Keefe 2002)

Professional socialization and interactions with colleagues (Corcoran and Clark 1984)

Salary levels; and satisfaction with salary and promotion (Melicher 2000)

Teaching effectiveness, evidenced by declines in teaching anxiety and improved student ratings of teaching effectiveness (Williams 1991).

Effective faculty mentoring is a result of:

Clarity of purpose

Systematic tasks and activities that the mentor and mentee do together not personal chemistry

Early and enduring mentoring is most beneficial

Regular meetings of the mentoring pairs/teams- which may require nudging

Using mentors from outside the mentees department is very effective

(Boyle and Boice, 1998)

Mentoring teams include experienced clinical investigators

Teams are multidisciplinary and include a biostatistician

Mentors responsibilities are clearly delineated

Mentoring process and development of mentees is reviewed regularly

Mentors and mentees participate in training workshops

Online tracking of mentoring process (meetings and progress) is provided

Mentoring Workshop:

Scholars attend an initial mentoring workshop with their senior mentors and, preferably, one or more associate mentors.

Mentor-to-Mentor Workshop:

Senior Mentors attend a mentors-only workshop to provide feedback on the mentoring experience.

Dates are posted on the CAPS Website as workshops are scheduled.

Next Mentoring Workshop (new Scholars & Mentors):

Friday, June 6, 2008 from 1:00-4:00 p.m.

at 142 WBOB

Working session to review:

Mentees career vision, goals, next years objectives, and activities

Mentees incoming strengths and improvement areas

Mentoring ground rules and confidentiality agreements

Mentoring schedule (team is expected to meet as a group at least quarterly)

Role of each mentor on the team

Working session

to review highlights of Scholars progress

to review Scholars time distribution

to discuss mentoring team roles (individual and group as a whole)

to review Scholars satisfaction with mentoring behaviors

to review adequacy of mentoring interactions

to discuss purpose of multidisciplinary mentoring and how best to achieve it

to share strategies for successful mentoring

to assess reasonableness of Scholars next years goals and timelines

to identify ways CAPS can better support mentoring activities.

Post career vision, goals, planned strategies, and timeline

Post ground rules and confidentiality agreement documents

Document mentor team meetings

Document use of Shared Clinical Research Support Group (SCRSG)

Note decisions from meetings, assignments before next meeting, and goals for next meeting

Maintain drafts of projects accessible by whole team

Ease mentor tracking burden

Aid evaluation without duplication of effort

Requirement:

75% effort on CAPS-related training, research, and career development activities (50% surgical scholars)

Expectations:

Career development plan (post on team website within 2 wks of Mentoring Workshop; update 2 wks prior to scheduled MAC review meetings)

Ground rules and confidentiality agreements (post on team website w/in 2 wks of Mentoring Workshop)

Regularly scheduled mentoring team meetings (post schedule and interactions on mentor team website - post meetings and action items w/in 2 wks of each interaction)

Expectations (continued):

Participate in all CAPS-specific activities

Complete MS degree program (if notcompleted prior to CAPS) - 9-14 cr in first year; maintain 3.5 GPA

Register for additional CAPS-specific courses (all scholars)

Peer-review articles (1 per yr - exceptions granted to full-time students in first year)

Presentations

Grant proposal (by end of CAPS period)

Requirement:

Assure that scholars spend 75% effort on CAPS-related training, research, and career development activities (50% effort for surgical scholars)

Expectations:

Attend CAPS Orientation and mentoring workshops

Participate in regularly scheduled mentoring teammeetings

Senior Mentor provides accountability for scholars work and coordination of team - plans meeting agendas with Scholar to address research and career mentoring topics

Complete written mentoring ground rules and confidentiality agreements with scholar

Assist scholar with career development plan components including annual goals and objectives with specific strategies and timeline

Expectations (continued):

Approve career development plan components and subsequent changes (posted on mentor team website)

Monitor scholars career development, CAPS activities, and mentoring interactions - review team website entries monthly

Assure that scholar is receiving support and resources from home department

Provide information for semi-annual program evaluation of mentoring activities

Develop plans for grant submission

Benefits:

Mentor funds for CAPS-related activities including travel, continuing education, CAPS research project support, or salary redistribution

Evaluation

Data collection at the beginning of the program and abbreviated follow-up at the end of each year as well as ongoing mentoring tracking:

Scholar Clinical Research Appraisal Inventory

Scholar Department/Division Culture

Scholar Discipline Identification

Mentor Discipline Identification

Scholar and Mentor Consent form

Evaluation is a CAPS requirement

Baseline forms - complete and return to CAPS Administrative Specialist (forms are posted on CAPS website)

Consent form - grants permission to use evaluation data for research purposes

At 6 months, 1 year, and then annually, a MAC Evaluation Subcommittee reviews:

Clinical Schedule (protected time)

Overall Weekly Schedule (time management)

MS Degree Program

Current Research

Career Development

Mentoring Team Interactions

Connections in Professional Field

Use of Shared Resources

Overall CAPS Satisfaction

Completion of Evaluation Forms

Clinical Research Skills Development

Work with you and the other mentors as part of a multi-disciplinary team

Learn about your field and area of research

Advise/teach biostatistical topics relevant to your research

Convey the value of early biostats mentor involvement re project design, data collection, and problem resolution

Discuss potential role of biostatistician mentors on future grants

Formulate study questions

Develop study implementation plans

Interpret data

Determine the next question

Salary and Benefits - commensurate with rank and position (75% effort; 50% for surgical scholars)

Tuition and program application fee for up to 14 cr/sem and 6 cr/summer session

Travel funds for annual NIH-sponsoredCTSA/K12 Meeting for Scholars , Upper Midwest Consortium meeting, and professional meetings (up to $2,500/year)

Research funds (up to $25,000 per year)

Mentor funds (up to $10,000 per year/team)

CAPS Award is renewable annually (3-5 years)

Salary

Salary is paid through scholars departments

(departments cross charge K12 grant)

Tuition

Full tuition coverage for scholars in MS programs (e-mail Student Accts Receivable page to CAPS Coordinator each semester)

Scholars not in MS program apply for Regents Scholarship (non-degree student information and form are posted on CAPS website)

Required course textbooks and software are covered by CAPS (SAS forms on CAPS website)

Travel

Complete CAPS Travel Authorization (TA) form (on CAPS website) & submit to CAPS Coordinator prior to travel

Check GSA per diem when completing TA (link posted on CAPS website)

Complete Employee Expense Worksheet (on CAPS website) and submit with original receipts after travel (internet charges are not allowed by K12 grant)

Research Funds

Complete Research Funding Application (on CAPS website)

Complete NIH budget and justification

Contact Coordinator re equipment order forms

Submit forms electronically to the CAPS Coordinator with IRB approval/renewal letter

Include electronic signatures or send a signed hard copy to CAPS Coordinator at EpiCH, 300 WBOB

For subsequent year renewal requests, submit NIH budget and justification electronically and the most recent IRB approval/renewal letter

Mentor Funds

Review policy re use of mentor funds (on Mentoring page of CAPS website)

Each Scholars team decides how to divide funds

Mentor funds may be used for professional travel, continuing education, CAPS research project, or salary redistribution

Submit forms to the CAPS Coordinator as early in each budget year as possible

Submit choice of MS program to CAPS Program Director for approval

Apply to program (see SPH website and Graduate Studies Coordinator for information)

Attend the SPH Orientation

Maintain contact with Major Coordinator and Advisor

Refer to Student Guidebook throughout program

Register for course load as outlined in plan

Maintain cumulative GPA of 3.5

Scholars name

Biosketch

Area of study and research interest

Disclosed in press releases, program reports, web pages, and similar documents

Scholars are required to immediately notify

CAPS Director in writing of:

Changes that preclude meeting award requirements

Acceptance of similar award with duplicate benefits

Changes in course load

Changes in clinical responsibilities

Changes in teaching load

Withdrawal from degree program

Requires written request to CAPS Program Director

Requires approval of CAPS Program Director

Maximum, if approved, is 2 months of unpaid absence

K12 Eligibility

Documents