VCUHS HEMATOLOGY/ONCOLOGY FELLOWSHIP CURRICULUM Research/Scholarship Curriculum Description of Rotation or Educational Experience The VCU Hematology-Oncology fellowship program research curriculum is designed to foster the scholarly interests of the individual fellow and to provide a basic skill set by which to appreciate the scientific process and the regulatory aspects of conducting clinical investigation. All of this occurs under the supervision of the Division of Hematology, Oncology, and Palliative Care faculty members or other suitable mentor determined based on the needs of a fellow’s specific project(s). Location: Various Length of Experience: Longitudinal experience with dedicated time concurrent with the many clinical rotations throughout the fellowship training program. Dedicated research block time additionally varies according to training track and individual fellow’s academic pursuits. Educational Goals All fellows should upon completion of their training are expected to Demonstrate the ability to critically review current bio-medical and oncology literature and to accurately assess the validity of the information reviewed Interpret accurately results of clinical trials and the statistical methodology used in generating data and appropriately apply the results to clinical practice Demonstrate an understanding of the molecular correlates of prognosis; a knowledge of cellular and molecular biological techniques used in examining biological correlates; and the ability to integrate these correlates in the design of a clinical trial Understand and apply the appropriate statistical and correlative tests to use in different clinical situations and also the limitations and drawbacks of such techniques. Collect, organize and analyze clinical data using appropriate statistical tests and laboratory based correlative techniques to use in different clinical situations and be familiar with the limitations and drawbacks of such technique The trainees in the clinical-translational research track are expected to Develop an innovative research study designed to expand on the current body of medical knowledge, to test novel therapies, to improve systems-based practice, to enhance quality health care delivery, to advance educational innovation, or other similar scholarly endeavors pertinent to the field of hematology-oncology The trainee interested in basic science-translational research track are expected to Develop an innovative experimental approach to elucidate the biology of disease and/or to develop new therapies. Demonstrate knowledge of cellular and molecular biological techniques used in examining biological systems as well as be able to interpret results of clinical trials and the statistical methodology used in examining data. Perform common laboratory based assays relevant to the fellow’s chosen area of inquiry and be able to apply them in different systems and be familiar with the limitations and drawbacks of such techniques. 1 YEAR 1 Progressive Responsibilities by Fellow Year The first year fellow is expected to focus on primary knowledge acquisition pertaining to the scientific process and the regulatory aspects of conducting clinical investigation. This includes, but is not limited to, mandatory participation by all fellows in the VCUHS GME research course with successful completion of all related class work necessary to fulfill course requirements. Additionally, the fellow is expected to identify at least one specific scholarly project including an appropriate mentor. By the completion of the first year of training, the project design should be completed and any necessary IRB or other regulatory body approval should be in progress. All fellows are expected to complete annual CITI certification training. YEAR 2 By the end of the first year, the fellow is expected to present and discuss in 10 minutes their choice of mentor; main area of scholarly interest; and, to the extent developed their preliminary project concepts. The second year fellow is expected work further develop their knowledge of the scientific process of conducting clinical investigation but, additionally, the project specific skills and knowledge acquisition to fully understand the background, rationale, design and conduct of their project(s). The fellow is expected to initiate the project and make steady progress throughout the year of training toward its completion. The fellow should identify early in the project the targeted venue and method for dissemination of the product of the project. All fellows are expected to complete annual CITI certification training. By the end of the second year, the fellow is expected to present and discuss in 35-40 minutes an update on their scholarly project(s). YEAR 3 The third year fellow is expected to achieve independent proficiency in the project specific skills and knowledge base necessary to develop a scholarly project and to fully understand the background, the rationale and the design of their work develop. Additionally, the fellow is expected to acquire the knowledge and skills needed for the presentation of scholarly work in oral, poster, published, or new-media forms. The fellow is to complete at least one scholarly project and to disseminate the product of the effort at the institutional level and to have submitted the effort to a regional, national or international venue. All fellows are expected to complete annual CITI certification training. By the end of the third year, the fellow is expected (1) to present the background, design, and product of their scholarly effort to the faculty of the division of hematology-oncology (for which they will be allocated one hour inclusive of questions).and (2) to submit for presentation the product of their scholarly effort at the VCUHS GME Resident-Fellow Research Day. Additionally, submission of the product of their scholarly effort for possible publication or presentation at a regional, national, or international meeting is strongly encouraged. Funding to offset the costs associated with the publication or presentation of scholarly work at regional, national or international meetings is made available through the Department of Internal Medicine and the Division of Hematology, Oncology, and Palliative Care. Patient Care Goal Fellows must be able to provide patient care that is compassionate, appropriate, and effective for the treatment of health problems and the promotion of health. Please refer to overview of the fellowship curriculum for competencies/objectives for patient care. Specifically, fellows should show respect of the vulnerability of the patient involved in clinical research and the safeguards in place to protect their rights and minimize the potential for harm. The fellow is expected to develop the skills needed to fully inform the patients and obtain consent for clinical research participation. Competencies Fellows are expected to: Gather appropriate clinical information Synthesize information into a care plan 2 Perform the procedures necessary for the effective diagnosis and management of acute hematologic and oncologic disorders Partner with patients/families in the implementation of the plan Coordinate care plans with a multi-disciplinary research team of health professionals Objectives Fellows are expected to: Develop skills in history/physical examination of the patient with hematologic and oncologic disorders with sensitivity to the patient’s rights and vulnerability as a subject. Develop skills necessary to fully inform the patients and obtain consent for clinical research participation. Document properly in the research record in accordance with the research requirements and maintain records in accordance with regulatory requirements Provide compassionate, appropriate, and comprehensive patient care Medical Knowledge Goal Fellows must demonstrate knowledge of established and evolving biomedical, clinical, epidemiological, and social-behavioral sciences, as well as the application of this knowledge to patient care. Competencies Fellows are expected to demonstrate skills in: Acquisition of knowledge Analysis of information Application of knowledge Dissemination of knowledge Objectives The first year fellow is expected to: Develop knowledge of the scientific process and the regulatory aspects of conducting clinical investigation. Discuss the rights of the subject in human research and the legal body of work establishing these rights Identify vulnerable and special patient populations and discuss the special protections afforded them in the conduct of human research Describe the various study designs for clinical and epidemiologic investigation Recall and calculate the basic biomedical statistics Compare/contrast the various study designs with an understanding of their relative strengths and weaknesses. Discuss the responsibilities and role of the institutional review board (IRB) Discuss the various requirements and processes of obtaining approval for studies based on study design Discuss the role and responsibilities of the principle investigator Discuss the role and responsibilities of the study monitor Discuss the role and responsibilities of the study sponsor Determine a patient’s functional performance score Access and identify the NCI toxicity grades The second year fellow is expected to: Refine the objectives defined for the first year fellow Develop the specific skills, laboratory techniques, and knowledge acquisition to fully understand the background, rationale, design, and conduct of their specific project(s). The third year fellow is expected to: Refine the objectives defined for the first year fellow 3 Acquire the knowledge and skills needed for the presentation of scholarly work in oral, poster, published, or newmedia forms. Practice- Based Learning and Improvement Goal Fellows must demonstrate the ability to investigate and evaluate their scholarly efforts, to appraise and assimilate scientific evidence, and to continuously improve their scientific skills on constant self-evaluation and lifelong learning. The fellow is expected to present primary scientific and medical evidence to support their conclusions. Moreover, the fellow should demonstrate the skills and knowledge needed to independently assess the validity of the evidence being reviewed and/or presented. The fellow is expected to recognize their areas of deficiency. The fellow is expected to be able to effectively utilize their resources to arrive at necessary information and to apply the information to their scholarly effort. Systems Based Practice Goal Fellows must demonstrate an awareness of and responsiveness to the larger context and system of the local and global scientific community, as well as the ability to call effectively on other resources. Fellows will learn to work within a multidisciplinary team of research professionals. Professionalism Goal Fellows must demonstrate a commitment to carrying out professional responsibilities and an adherence to ethical principles. The fellow is expected to model professional and courteous behavior in the treatment of the patient engaged in research and in working with the entire research team. The fellow is expected to complete documentation of their patient care, of their communications with the patient and health care providers, and of their procedures in a timely fashion within the medical (and where additionally necessary the research) record. The fellow is also expected to recognize the critical importance of their own education and the importance of life-long learning as part of their professional responsibility. As such, it is the obligation of the fellow to themselves, their profession, and their patients to attend and complete in a timely fashion all of fellowship training program’s expected educational activities. Please refer to overview of the fellowship curriculum for competencies/objectives for professionalism. Interpersonal and Communication Skills Goal Fellows must demonstrate interpersonal and communication skills that result in the effective exchange of information and teaming with patients, their families, and professional associates. Please refer to overview of the fellowship curriculum for competencies/objectives for interpersonal and communication skills. Teaching Methods Clinical and/or laboratory research experience Modeling of observed behaviors of mentors Formal classwork with completion of all required assignments Didactic sessions Performance feedback Self-directed learning CITI training online modules for investigators 4 Assessment of Fellow Performance Periodic (generally quarterly) evaluation of the fellow by the project mentor Quarterly self-assessment by the fellow Assessment of Rotation Periodic (generally quarterly) evaluation of the mentor by the fellow Annual program review Discussions with fellows during biannual review Level of Supervision Indirect supervision with the mentor and suitable laboratory staff (direct supervision by the mentor or suitable laboratory staff where necessary depending upon the nature of the activity being performed relative to the residents proven level of independent competence). Educational Resources Research for Residents: A Primer--VCUHS GME research course material CITI online training modules PubMed 5