Section 1: Mount Sinai Clinical Research Education Program Description
The Clinical/Translational Research Training Programs (CLR programs) of The Mount Sinai Graduate School of Biomedical Sciences are designed to foster the development of future leaders in patient oriented research. These training opportunities are intended to encourage the development of critical thinking necessary to conduct innovative hypothesis driven, independent and collaborative clinical/translational scientific research, in an effort to improve patient care and the wellbeing of society. In particular, we hope to enhance the research opportunities of clinical scientists as well as enhance the ability of basic scientists to better position themselves to translate the promise of their respective discoveries into the clinical arena, in a meaningful way with significant impact.
A rigorous curricular foundation designed to promote an in depth understanding of research methodologies and processes essential to translating the promise of scientific discovery into solving problems of disease is central to these educational initiatives, and forms the basis of our Certificate Program, Masters of Science in Clinical Research, and Ph.D. in Clinical Research.
The Clinical Research Training Program (CRTP) is an introductory, 1 year, part-time certificate version of the MSCR program which includes the core coursework without a Masters Thesis requirement or 2nd year research seminars and journal club.
The Masters of Science in Clinical Research (MSCR) is a 2 year program that provides an exceptional educational experience to outstanding health professionals, such as clinical / post-doctoral fellows, junior faculty, veterinarians, nurse Ph.D.s, allied health professionals, and other trainees (M.D., M.D./Ph.D., and ‘basic science’ Ph.D. students) with the knowledge, skills, and experience to successfully launch clinical and/or translational research-intensive careers. The MSCR has two main components: 1) graduate courses including biostatistics, epidemiology, research design, data analysis, informatics, bioethics and grant writing; and 2) a mentored clinical research project leading to a Masters thesis. The program is designed to be completed in 2 years. However, coursework can be taken over a longer period of time.
The Ph.D. in Clinical Research is designed for those outstanding candidates who are health professionals that desire a more intense educational experience to prepare them for a career in clinical or translational research. The program provides a strong didactic foundation combined with a mentored clinical research experience leading to a doctoral degree in Clinical Research.
Four tracks/training areas are offered within the Ph.D. in Clinical Research Program:
1) Translational Research: Bench to Bedside
2) Clinical Trials Research
3) Population, Outcomes and Implementation Research
4) Molecular Epidemiology (this track is currently being finalized)
Within the context of these specific tracks, students may choose to develop an area of concentration or focus, developing specific expertise in:
General Clinical Research
Health Services Research & Health Policy Research
Behavioral Research & Cognitive Tools
Biostatistics: Quantitative and Qualitative Methods
Epidemiology: Basic, Molecular and Clinical
Informatics & Bioinformatics
Genomics & Personalized Medicine
Clinical Trials Research
These areas of special focus build upon strengths reflective of the Icahn School of Medicine at Mount Sinai, Graduate School of Biomedical Sciences, and Mount Sinai’s Institutes and Departments.
Having trained over 100 outstanding candidates for successful careers in clinical/translational research, these various programs prepare individuals to be active facilitators in “Team Science” designed to solve problems of disease and facilitate the growth of individuals who will conduct well conceived and relevant clinical/translational research that leads to improved health and health care.
The mission of the Clinical Research Education Program is to 1) provide rigorous academic training and mentorship in patient-oriented clinical and translational research to outstanding candidates from the health professions; 2) stimulate the acquisition of specific research skills and methodologies, the development of critical thinking skills; and 3) conduct better translational research that is relevant and leads to improved health and health care.
- Enhance appreciation for the spectrum and promise of clinical/translational research
- Foster knowledge regarding basic principles fundamental to the conduct of clinical research
- Promote the ability to develop and refine a good research question
- Encourage the development of an efficient, effective & ethical study design
- Highlight the importance of mentorship
Statement of Values
The Clinical Research Education Program, of Icahn School of Medicine at Mount Sinai and Graduate School of Biomedical Sciences, is dedicated to improving the health of individuals and communities. The Program is based on the following core values:
Sound Science: We value the use of the scientific method to solve problems of disease and improve the health of individuals and the society at large.
Community: We value joint program-community participation in identifying and improving the health status of communities by enabling them to identify and address their unique public health problems
Diversity: We value the recognition of the cultural context of individuals and populations and work to educate clinical investigators with the cultural competencies necessary to understand and respect diverse populations.
Social Justice: We value fostering and advocating for policies that reduce or eliminate health disparities
Teamwork: We value working with others through cooperation and collaboration using interdisciplinary, multidisciplinary and trans-disciplinary teams in education and research.
Professionalism & Responsible Conduct: The Clinical Research Education Program Adheres to the Medical Educator code of conduct and the (medicinal & graduate) Code of Conduct outlined in the Icahn School of Medicine of Mount Sinai Medical Student Handbook, which applies to all students at Icahn School of Medicine at Mount Sinai and Mount Sinai Graduate School of Biomedical Sciences.
Responsible Conduct of Research
Requirements for Coursework on Responsible Conduct in Research (RCR)
The requirement by NIH, for investigators to have “face to face” training in Responsible Conduct of Research (RCR) can currently be met by means of: 1) enrolling and completing the entire 8 hour RCR course directed by Charles Mobbs or can be fulfilled by a combination of opportunities totaling 8 hours in which one can receive such instruction including:
1. Charles Mobbs’ course (1-2 select sessions (Each session counts as 2 hours)
2. CLR0016 (counts as 2 hours of face time)
3. CLR0017, 0018, and 0019 (participation in all 3 courses counts as 2 hours of face time)
4. CLR0700 (counts as 2hours of face time)
All of the CLR courses utilize case based discussions as does the Charles Mobbs’ course, strongly encouraged by NIH.
Although it currently does not satisfy the NIH requirements, we will include whether a student has or has not completed the Collaborative Institutional Training Initiative (CITI) course in:
Basic Courses in the Protection of Human Research Subjects.
o Biomedical Focus (Investigators/Research Staff)
o Good Clinical Practice (GCP)
Please refer to your program checklist to ensure that you have met the RCR requirement.
The Clinical Research Education Program supports the advancement of integrated and interdisciplinary education, training, and career development in Clinical and Translational Science. NCRR, in collaboration with the CTSA Education and Career Development Key Function Committee, formed the Education Core Competency Work Group to define the training standards for core competencies in clinical and translational research. The work group’s final recommendations for core competencies include 14 thematic areas that should shape the training experiences of junior investigators by defining the skills, attributes, and knowledge that can be shared across multidisciplinary teams of clinician-scientist. The Clinical Research Education Program has recently adopted these program competencies for all students.
The Program uses these thematic competencies to guide overall program learning objectives, overall curriculum development, and course specific learning objectives. Students will be expected to achieve proficiency in these thematic areas in the course of class work, the, seminars, journal club, independent study and through the Master’s Thesis and/or PhD dissertation. Attainment of these respective competencies will be assessed through the satisfactory completion of course work
Core Competencies in Clinical and Translational Research Core Thematic Areas Competencies are outlined as follows:
I. CLINICAL AND TRANSLATIONAL RESEARCH QUESTIONS
- Identify basic and preclinical studies that are potential testable clinical research hypotheses.
- Identify research observations that could be the bases of large clinical trials.
- Define the data that formulate research hypotheses.
- Derive translational questions from clinical research data.
- Prepare the background and significance sections of a research proposal.
- Critique clinical and translational research questions using data-based literature searches.
- Extract information from the scientific literature that yields scientific insight for research innovation.
II. LITERATURE CRITIQUE
- Conduct a comprehensive and systematic search of the literature using informatics techniques.
- Summarize evidence from the literature on a clinical problem.
- Describe the mechanism of a clinical problem reviewed in a manuscript.
- Use evidence as the basis of the critique and interpretation of results of published studies.
- Identify potential sources of bias and variations in published studies.
- Interpret published literature in a causal framework.
- Identify gaps in knowledge within a research problem.
III. STUDY DESIGN
- 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 a target population for a clinical or translational research project.
- Identify measures to be applied to a clinical or translational research project.
- Design a research data analysis plan.
- Determine resources needed to implement a clinical or translational research plan.
- Prepare an application to an IRB.
IV. RESEARCH IMPLEMENTATION
- Compare the feasibility, efficiency, and ability to derive unbiased inferences from different clinical and translational research study designs.
- Assess threats to internal validity in any planned or completed clinical or translational study, including selection bias, misclassification, and confounding.
- Incorporate regulatory precepts into the design of any clinical or translational study.
- Integrate elements of translational research into given study designs that could provide the bases for future research, such as the collection of Biomedical specimens nested studies and the development of community-based interventions.
V. SOURCES OF ERROR
- Describe the concepts and implications of reliability and validity of study measurements.
- Evaluate the reliability and validity of measures.
- Assess threats to study validity (bias) including problems with sampling, recruitment, randomization, and comparability of study groups.
- Differentiate between the analytic problems that can be addressed with standard methods and those requiring input from biostatisticians and other scientific experts.
- Implement quality assurance systems with control procedures for data intake, management, and monitoring for different study designs.
- Assess data sources and data quality to answer specific clinical or translational research questions.
- Implement quality assurance and control procedures for different study designs and analysis.
VI. STATISTICAL APPROACHES
- Describe the role that biostatistics serves in biomedical and public health research.
- Describe the basic principles and practical importance of random variation, systematic error, sampling error, measurement error, hypothesis testing, type I and type II errors, and confidence limits.
- Scrutinize the assumptions behind different statistical methods and their corresponding limitations.
- Generate simple descriptive and inferential statistics that fit the study design chosen and answer research question.
- Compute sample size, power, and precision for comparisons of two independent samples with respect to continuous and binary outcomes.
- Describe the uses of meta-analytic methods.
- Defend the significance of data and safety monitoring plans.
- Collaborate with biostatisticians in the design, conduct, and analyses of clinical and translational research.
- Evaluate computer output containing the results of statistical procedures and graphics.
- Explain the uses, importance, and limitations of early stopping rules in clinical trials.
VII. BIOMEDICAL INFORMATICS
- Describe trends and best practices in informatics for the organization of biomedical and health information.
- Develop protocols utilizing management of information using computer technology.
- Describe the effects of technology on medical research, education, and patient care.
- Describe the essential functions of the electronic health record (EHR) and the barriers to its use.
- Explain the role that health information technology standards have on the interoperability of clinical systems, including health IT messaging.
- Access patient information using quality checks via electronic health record systems.
- Retrieve medical knowledge through literature searches using advanced electronic techniques.
- Discuss the role of bioinformatics in the study design and analyses of high dimensional data in areas, such as genotypic and phenotypic genomics.
- Collaborate with bioinformatics specialists in the design, development, and implementation of research projects.
VIII. RESPONSIBLE CONDUCT OF RESEARCH
VIII.a. Clinical Research Ethics Competencies
- Summarize the history of research abuses and the rationale for creating codes, regulations, and systems for protecting participants in clinical research that requires community input.
- 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.
- Assure the need for privacy protection throughout all phases of a study.
- Assure the need for fairness in recruiting participants and in distributing the benefits and burdens of clinical research.
- 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.
VIII.b. Responsible Conduct of Research Competencies
- Apply the main rules, guidelines, codes, and professional standards for the conduct of clinical and translational research.
- Adhere to the procedures to report unprofessional behavior by colleagues who engage in misconduct in research.
- Implement procedures for the identification, prevention, and management of financial, intellectual, and employment conflicts of interests.
- Apply the rules and professional standards that govern the data collection, sharing, and protection throughout all phases of clinical and translational research.
- Apply elements of voluntary informed consent, of fostering understanding of information about clinical research, and for avoiding undue influence or coercion, and taking into consideration the decision-making capacity of participants.
- Explain the need for privacy protection and best practices for protecting privacy throughout all phases of a study.
- Explain the need for fairness in recruiting participants and in distributing the benefits and burdens of clinical research.
- Explain the function of the IRB.
IX. SCIENTIFIC COMMUNICATION
- Communicate clinical and translational research findings to different groups of individuals, including colleagues, students, the lay public, and the media.
- Translate the implications of clinical and translational research findings for clinical practice, advocacy, and governmental groups.
- Write summaries of scientific information for use in the development of clinical health care policy.
- 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.
X. CULTURAL DIVERSITY
- Differentiate between cultural competency and cultural sensitivity principles.
- Recognize the demographic, geographic, and ethnographic features within communities and populations when designing a clinical study.
- Describe the relevance of cultural and population diversity in clinical research design.
- Describe cultural and social variation in standards of research integrity.
- Critique studies for evidence of health disparities, such as disproportional health effects on select populations (e.g., gender, age, ethnicity, race).
XI. TRANSLATIONAL TEAMWORK
- Build an interdisciplinary/ intradisciplinary/ multidisciplinary team that matches the objectives of the research problem.
- Manage an interdisciplinary team of scientists.
- Advocate for multiple points of view.
- Clarify language differences across disciplines.
- Demonstrate group decision-making techniques.
- Manage conflict.
- Manage a clinical and/or translational research study.
- Work as a leader of a multidisciplinary research team.
- Manage a multidisciplinary team across its fiscal, personnel, regulatory compliance and problem solving requirements.
- Maintain skills as mentor and mentee.
- Validate others as a mentor.
- Foster innovation and creativity.
XIII. CROSS DISCIPLINARY TRAINING
- Apply principles of adult learning and competency-based instruction to educational activities.
- Provide clinical and translational science instruction to beginning scientists.
- Incorporate adult learning principles and mentoring strategies into interactions with beginning scientists and scholars in order to engage them in clinical and translational research.
- Develop strategies for overcoming the unique curricular challenges associated with merging scholars from diverse backgrounds.
XIV. COMMUNITY ENGAGEMENT
- Examine the characteristics that bind people together as a community, including social ties, common perspectives or interests, and geography.
- Appraise the role of community engagement as a strategy for identifying community health issues, translating health research to communities and reducing health disparities.
- Summarize the principles and practices of the spectrum of community-engaged research.
- Analyze the ethical complexities of conducting community-engaged research.
- Specify how cultural and linguistic competence and health literacy have an impact on the conduct of community engaged research.