The purpose of the Clinical and Translational Science Institute’s Clinical Research Scholars Program is to provide didactic training and individual mentoring in career development and clinical research to junior faculty who are pursuing careers in academic medicine as independently funded, clinical and translational investigators. The training sessions promote collaborative research education through the provision of didactic speakers, skills-based activities, and manuscript/grant review groups. There are barriers to clinical investigators engaging in research and the number of clinical investigators nationally has declined, as has the capacity of clinical investigators to compete for federal grant funding . Documented barriers to engaging in clinical research include lack of resources or limited access to resources, limited opportunities to network and collaborate with investigators from diverse backgrounds, and a lack of direction about how to proceed (e.g., guidance in grant writing; guidance in clinical research design) . NIH established the “NIH Roadmap” to address these barriers, enhance clinical research workforce training, and reengineer the clinical research enterprise . In 2015, the Medical College was awarded a Clinical & Translational Science Award (NIH UL1TR001436) to provide infrastructure supporting efforts to enhance the translation of research findings from bench to bedside and from beside into clinical practice. This grant supports the efforts of the MCW Clinical and Translational Science Institute (CTSI). The expanded training of clinical investigators is a critical part of the CTSI’s mission.
ACCME Accreditation Statement:
The Medical College of Wisconsin is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
AMA Credit Designation Statement:
The Medical College of Wisconsin designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Hours of Participation for Allied Health Care Professionals:
The Medical College of Wisconsin designates this activity for up to 1.0 hours of participation for continuing education for allied health professionals.
Physicians
Allied Health Care Professionals
1. Provide knowledge and skills that will enhance the participant’s ability to engage in clinical research.
The following are examples of competencies that will be obtained by participants:
• Formulate a well-defined clinical or translational research question to be studied in human or animal models.
• Propose study designs for addressing a clinical or translational research question.
• Assess the strengths and weaknesses of possible study designs for a given clinical or translational research question.
• Design a research study protocol.
• Identify measures to be applied to a clinical or translational research project.
• Design a research data analysis plan.
• Write research grants.
2. Networking and collaborate with other investigators from diverse backgrounds which will enhance the participant’s ability to engage in and translate clinical research into scholarship, advocacy and practice.
The following are examples of competencies that will be obtained by participants:
• Communicate with scientists from diverse backgrounds.
• Build inter- /intra-/multi-disciplinary team that expands the scope of one’s research.
• Translate the implications of clinical and translational research findings for clinical practice, advocacy, and governmental groups.
• Translate clinical and translational research findings into national health strategies or guidelines for use by the general public.
• Explain the utility and mechanism of commercialization for clinical and translational research findings, the patent process, and technology transfer.
3. Apply ethical principles to one’s own research and translation to clinical practice.
The following are examples of competencies that will be obtained by participants:
• Critique a clinical or translational research proposal for risks to human subjects.
• Explain the special issues that arise in research with vulnerable participants and the need for additional safeguards.
• Determine the need for a risk-benefit ratio that is in balance with the outcomes in clinical and translational research.
• Describe the elements of voluntary informed consent, including increasing knowledge about research, avoiding undue influence or coercion, and assuring the decision-making capacity of participants.
• Explain the need for fairness in recruiting participants and distributing the benefits and burdens of clinical research.
• Assure the need for privacy protection throughout all phases of a study.
• Adhere to IRB application procedures.
• Explain how the structural arrangement of science and the research industry may influence the behavior of scientists and the production of scientific knowledge.
4. Use cutting edge technologies to enhance one’s own research.
The following are examples of competencies that will be obtained by participants:
• Develop protocols utilizing technologies such as information access and management techniques (including the electronic medical record), proteomics, genotypic and phenotypic genomics, imaging, etc.
• Collaborate with technological specialists in the design, development, and implementation of research projects.
• Describe the effects of technology on medical research, education, and patient care.
• Access patient information using quality checks via electronic health record systems.
• Retrieve medical knowledge through literature searches using advanced electronic techniques to advance patient care.
Activity Director: Ryan Spellecy, PhD
Planning Committee:
Theodore Kotchen, MD
David Gutterman, MD
Laurens Holmes, MD DrPH
Terri deRoon Cassini, PhD