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Mentoring, Education, and Career Development Core

CLINICAL AND TRANSLATIONAL RESEARCH CORE COMPETENCIES AND COURSES

Competency Area Host Institution Course Description

I. CLINICAL AND TRANSLATIONAL RESEARCH QUESTIONS

MUSC MCR 736: Clinical Epidemiology

An emphasis will be placed on the concepts, study designs and procedures used in the implementation of clinical epidemiological research studies. The methodology and process used to access and analyze data as well as the collection of data will be described.

MUSCMCR 724: Introduction to Clinical Trials

This is a comprehensive course in the design and conduct of clinical trials. The course covers the types of clinical trials; study design (including sample size estimation); randomization methods and implementation; project and data management; ethics; and issues in data analysis (e.g., intent-to-treat; missing data analysis). Both clinical and basic science investigators can benefit from this course provided they have the required background in statistics.

MUSC

MCR-732: Comparative Effectiveness Research

This course is focused on design and measurement issues for three of the four types of study designs: 1) Systematic Review; 2) Database Review; 3) Prospective Observational Study. (The issue of design of the Randomized Clinical Trial is covered in a separate course.) This course will also cover the approaches used for interpretation and translation of CER data through decision models to compare the cost effectiveness of treatments. Decision analysis models are predictive mathematical models that are used to structure CER and cost data to help inform evidence-based decision choices. The following topics are include in the course: 1) a review of research designs and statistical methods for outcomes research, 2) measurement of efficacy, effectiveness, opportunity cost, and quality of life, 3) benchmarks for economic value, cost effectiveness, cost utility, and budget impact, 4) mathematical approaches for estimating expected outcomes: decision trees, Markov and simulation/estimation with regression. The course is designed for clinical researchers who have an identified area of interest in medical condition or a treatment approach. Most course assignments require the student to have a clinical focus area to which they can apply the course topics and designs. The design and construction of a decision model in an area of interest to the individual student is required.

MUSC MCR789-07: Industry

Input from the pharmaceutical industry will guide course content as to the roles, responsibilities, and expectations for a successful collaboration between industry and the




/Regulatory

principal investigator. There will be considerable attention on developing budgets, managing research coordinators, reporting events, and participation in FDA monitored trials, Phase I trials, Phase II trials, Phase III trials, Investigational New Drug, and Orphan drug studies. In addition, this new course will cover the regulatory oversight of clinical trials and the guidance as outlined in Good Clinical Practice as provided for from the International Conference on Harmonization.

MUSC MCR 789-20 Grants Overview

The course will function as an interactive description of the research grant mechanisms, application process, review process and implementation. The different types of grants will be presented and the details of the application and peer review. The source of funding will be described. Students will learn on overview of the types of grants, potential funding sources, how to get started and resources available at MUSC.

UDPSYC380010 Psychopathology

Exploration of research on diagnosis, etiology and treatment of major pathological disorders. Emphasis on original research articles, class discussion and assessment instruments, in addition to analysis of video-taped interviews with patients used to illustrate the disorders.

UD

PSYC490010 Social Interdependence

Presents theoretical and empirical approaches of social psychology to the study of conflict versus cooperation between mutually dependent people. Cooperation/conflict is analyzed in terms of effects of environmental influence, reward structure of the relationship, and interpersonal values of participants.

UDNURS609 Nursing Science: Theory and Research

Examines the science of nursing from theoretical and research perspectives and emphasizes theory as the foundation for research and practice.

UD NURS814 Advanced Qualitative Research in Nursing Science

In-depth analysis of quantitative research methodology within the context of research studies or existing data bases. Provides practical experience in collecting, analyzing and interpreting quantitative data. Topics include: formulation of research questions and hypotheses that are




supported by a critical review of the literature and conceptual or theoretical frameworks; examination of quantitative research designs, sampling strategies and sample size estimation; data collection methods and planning for data analysis.

UD

BHAN326010 Research Methods and Statistics for Behavioral Science

Overview of types of research and statistical techniques commonly used in health behavior science, including research proposal development.

UDBHAN332010 Health Behavior Theory and Assessment

Provides understanding and application of health behavior theory to program development and evaluation. Emphasis placed on skills and competencies necessary for programming and evaluation including needs assessments, research, communication and team process.

CCHSResearch Fundamentals

This course provides an overview of research strategies and methods as well as an understanding of statistical reasoning and analysis as applied to clinical research studies. (The Value Institute)

II. LITERATURE CRITIQUE

MUSC MCR 731: Critical Review

This course is required for the Master of Science in Clinical Research. It is assumed that students in this class have a solid foundation in research design and both parametric and nonparametric statistics. An emphasis will be placed on the competencies and processes necessary to review the scientific literature. In particular, the students will review the published and unpublished literature associated with clinical research results. The focus of the class will be the review of the types of scientific and clinical research manuscripts papers and reports produced from different study approaches. The course will identify resources for the critical review of the scientific literature. The considerations and criteria for critical review of the literature will be addressed in the course. Students will prepare written critiques of selected literature and manuscripts.




UDPSYC380010 Psychopathology

Exploration of research on diagnosis, etiology and treatment of major pathological disorders. Emphasis on original research articles, class discussion and assessment instruments, in addition to analysis of video-taped interviews with patients used to illustrate the disorders.

UD

BISC602010 Molecular Biology of Animal Cells

Examination of eucaryotic genes, synthesis and processing of messenger RNA and control of protein synthesis with emphasis on regulation of normal cellular growth and differentiation and the process of cancer cell transformation. Emphasis on recombinant DNA technology, monoclonal antibody production and tissue culture.

UD

BISC605010 and BISC606, Advanced Mammalian Physiology

Systemic mammalian physiology: cellular mechanisms, muscle, cardiovascular, respiratory, renal, digestive and endocrine systems. Emphasizes human physiology and includes discussions of primary literature in the field of physiology research. Second semester: respiratory, renal, gastrointestinal, and reproductive systems and metabolism.

UDBISC612010 Advanced Cell Biology

Four major sections: (1) cell structure/function; (2) signaling mechanisms and cell fate; (3) protein biosynthesis and trafficking and (4) integrative cell biology. Requires interpreting and evaluating data from primary scientific literature.

UD

BISC625010 Cancer Biology

Provides an integrated lecture series summarizing current knowledge in cancer biology. Topics include: statistics of incidence/survival, pathology, the process of chemical carcinogenesis and sources of carcinogens, genetic and epigenetic mechanisms and consequences, viral and hormonal carcinogenesis as well as current treatment options. Written NIH proposal is a requirement.

UD BISC671010 Cellular and Molecular Immunology

Introduces the basic concepts of immunology and describes how different immune responses can either protect the body from infection or lead to immunological based diseases. Focuses on cellular interactions and the resultant molecular responses that lead to immune




protection.

UD

BISC690010 Fundamentals of Pharmacology

Focus on basic principles of drug/receptor interactions, mechanisms of drug action, and pharmacokinetics. Emphasis on pharmacological problems in the current experimental literature. Goals are to understand drug-receptor theory, interpret agonist/antagonist dose-reponse relationships, and interpret results from experimental literature in written and oral formats.

UD

BISC639010 Developmental Neurobiology

Developmental biology of the nervous system, including cellular components, neural induction, neurogenesis and neuronal migration, cellular determination, axon outgrowth and pathfinding, synapse formation, programmed cell death, neurotrophic factors, neurodevelopmental disorders, and early critical periods.

UD

BISC654010 Biochemical Genetics

Covers the use of genetic model organisms to answer biological questions, including mapping and cloning of human disease genes and the creation of animal models for human genetic diseases. There is an emphasis on examples from the recent scientific literature and building scientific writing skills.

UD

BISC682010 Bacterial Pathogens

Molecular Mechanisms: Explore the molecular mechanisms of infectious diseases. Disease transmission and infection, horizontal gene transfer and pathogenomics are reviewed using primary research literature. Topics include water and food borne, airborne, vector borne and human borne pathogens, their molecular mechanisms of invasion, colonization, virulence and immune avoidance.

UD BISC693010 Human Genetics

Emphasis on the medical and social implications of our knowledge of human genetics. Discusses theoretical and practical principles of genetics useful in studying human variation such as cytogenetics and cell genetics, biochemical genetics, developmental genetics and




teratology, principles of genetic counseling, multi-factoral inheritance and the genetics of cancer.

UD

CHEG595 Intellectual property for engineers and scientists (Methods of protecting intellectual property. Patents, trademarks, copyrights, trade secrets and unfair methods of competition, including analyses of significant court decisions in each area. Directed to innovators in all fields interested in legal protection of their ideas.)

UDHLPR823 Human Response to Stress

Provides an overview of current models and theories of stress, a review of multidisciplinary approaches to the study of stress in applied settings, and a reading knowledge of selected research findings in the field of stress.

UD

NTDT610 Overweight and Obesity Prevention and Management

Pathophysiology and therapies for overweight/obesity. Tools to assess and manage weight. Examination of diet/exercise, pharmacotherapy and surgery as treatment options. Treatment and prevention resources for client education. Review of popular weight loss regimens. Related legislative and policy issues. Analysis and synthesis of current scientific literature on obesity-related topics.

CCHSConducting a Literature Search; Finding the Evidence

Attendees will learn how to formulate a searchable question, identify key steps in a literature search, navigate OVID and MEDLINE search tools, and apply limits to identify evidence based medicine literature. (The Value Institute)

CCHS

Advanced Literature Search

Attendees will learn how to take using searchable questions to the next level by using the PICO method; use subject headings to represent concepts; apply limits to identify evidence-based literature; and develop strategies and navigate MEDLINE search tools. (The Value Institute)




III. STUDY DESIGN MUSC MCR 736: Clinical Epidemiology




MUSC








/Regulatory


UD BISC600 Biotechnology and Molecular Medicine

UDUAPP333010 Research Methods for Policy Analysis

Examines research methods and their applications in policy analysis. Demographic analysis, survey research and geographic information systems are applied to policies in such areas as transportation, health, energy and economic development.

UD

BHAN326010 Research Methods and Statistics for Behavioral Science

Overview of types of research and statistical techniques commonly used in health behavior science, including research proposal development.

UDBHAN609050 Survey Research Methods

Emphasis on procedures for designing survey-based research studies, including choice of subjects, development of proper instrumentation, statistical design and analysis, and formulation of proposals appropriate for publication.

UD

HDFS615010 Research Methods

Evaluation of existing research reports, articles and monographs, development of data collection techniques, analysis and presentation of data pertaining to child, family and community populations, elements of statistical analysis, evaluation and selection of research designs, preparation of a research project proposal.




IV. RESEARCH IMPLEMENTATION

MUSC MCR 736: Clinical Epidemiology




MUSC








/Regulatory


UD

NURS687 Nursing Science: Research Application (Evidence Based Practice)

Focuses on the application of research to nursing practice. Includes critical analysis of research through an organized critique process, examination of data, and examination of facilitators and barriers to research/research utilization, models of research utilization, and methods of quality management.

CCHS

Institutional Review Board (IRB) Processes and Regulations

Learners identify standard operating procedures for IRB processes, review policies for conduct of research and regulatory compliance, and apply principles to their research projects. (The Value Institute)

CCHS Current Issues in Research Series

Provides continuing updates of established and revised ethical principles, applicable federal, state, and local/institutional regulations, and relevant policies and procedures related to the performance of research. (The Value Institute)

CITI Good Clinical Practice (GCP)

GCP content includes three distinct courses tailored to the different types of clinical research, suitable for research teams involved in clinical trials of drugs, biologics, and devices.

CITI

Human Subjects Research (HSR)

HSR content includes two tracks, one with a biomedical focus, and another designed for the social, behavioral, and educational disciplines, each of which covers the historical development of human subjects protections as well as current information on regulatory and ethical issues.

CITI Information Privacy and Security (IPS)

IPS materials cover the principles of data protection, focusing on the healthcare-related privacy and information security protections of the Health Insurance Portability and Accountabiility Act (HIPAA).




CITIResponsible Conduct of Research (RCR)

RCR content includes disciplinary courses for the biomedical sciences, engineering, the humanities, the physical sciences, and the social, behavioral and education sciences. A course on financial conflicts of interest is also available.

V. SOURCES OF ERROR

VI. STATISTICAL APPROACHES

MUSC MCR 700: Clinical Biostatistics

An introduction to basic and intermediate statistical techniques used to analyze and interpret data in health sciences and related fields. Emphasis is on applications of these methods, with just enough derivation to understand the procedures. Topics include descriptive statistics, graphical methods, probability with applications to epidemiology, discrete and continuous distributions, inference on means, nonparametric methods, inference on proportions, contingency tables, correlation, analysis of variance, linear regression, logistic regression, and survival analysis. Students will not be expected to run computer programs, but will learn how to read printout in order to interpret analytical results.

MUSC MCR 789-03: Special Topic - Regression

This course covers regression analysis, a method for investigating functional relationships among variables. You will learn to evaluate the fit using statistics such as t, F, and R2, but you will also learn informal analysis based on uncovering patterns in the data. The emphasis is on exploratory data analysis rather than on statistical theory or formula derivation. We will rely heavily on graphical representations of the data and make use of plots of regression residuals. Concepts and techniques of regression analysis will be taught based on carefully developed examples. This course is intended for anyone involved in analyzing data, but who do not specialize in statistics. We will use computer software (mainly SAS) to examine data output, but you will only be required to read and understand the output. You are not responsible for computer programming.

MUSC MCR 789-31: Intro to Basic Analytics

This course is not a standalone course in statistics, but is meant to be used in conjunction with a statistics course. This course will provide means for students to do computing in a




statistics course and acquire an appreciation for data analysis. You will learn about the SAS programming language. You will know enough of the SAS “basics “to be able to find your way around other SAS reference manuals, or even the internet. And, you will have an invaluable skill to use in the industry or research fields.

UD

UAPP222010 Introduction to Epidemiology

Introduces the basic concepts of epidemiology and biostatistics as applied to public health problems. Emphasis is placed on the principles and methods of epidemiologic investigation, appropriate summaries and displays of data, and the use of classic statistical approaches to describe the health of populations.

UD

STAT200010 Basic Statistical Practice

Uses real data from a variety of disciplines to explore topics in data analysis, estimation and inference such as graphical displays, estimation of and hypothesis tests on means and proportions, sampling distributions, confidence intervals, analysis of variance, simple linear regression, chi-square tests for independence.

UD

MATH201010 Introduction to Statistical Methods I

Exploratory data analysis, basic probability, discrete and continuous distributions, sampling distributions and confidence intervals, and one- and two-sample hypothesis tests on means and proportions. Emphasis on applications in business and economics. Statistical computing is an integral part of this course. PREREQ= College algebra.

UDBISC643010 Biological data analysis

Introduction to the numerical analysis of biological data in fields such as molecular and cellular biology. Emphasis on choosing and using the correct analysis method for each experiment by using small number of relatively simple statistical tests.

UDSOCI614010 Advanced Data Analysis

Methods of analyzing data in sociological research focusing on multivariate approaches

UDSOCI647010 Disparities in Heath & Healthcare

The HRSA define health disparities as population-specific differences in presence of disease, health outcomes, or access to health care, and we will explore these issues as they relate to race, gender, and age.

UD BHAN609 Survey Research

Emphasis on procedures for designing survey-based research studies, including choice of subjects, development of proper instrumentation, statistical design and analysis, and




Methods formulation of proposals appropriate for publication.

UD

HLPR632 Health Science Data Analysis

An overview of the descriptive and inferential statistics needed to analyze and interpret health data and evaluate health-related literature in the core disciplines of public health including: epidemiology, biomedical science, social and behavioral science, health policy and management, and environmental health.

CCHS Epidemiology and Statistics Lectures

The Core Lecture Series has a clinical and epidemiology focus. (The Value Institute)

CCHSStatistics 2 General and Generalized Linear Models

Learners analyze clinical research data, interpret the output from common statistical computer software, using SPSS software. (The Value Institute)

VII. BIOMEDICAL INFORMATICS

MUSCMCR 746: Data Management for Clinical Research

This course is intended to introduce clinical researchers to research oriented data management and related basic topics in Informatics. Students taking this course will learn about basic concepts in: relational database design, modern research data capture tools, clinical data warehousing, security risks and mitigations, privacy issues in electronic data, data standards, data mining and other related topics. Students will get hands-on experience with using modern database tools to solve specific scientific problems by attending the course labs.

UDCISC844010 Computational Biomedicine

Survey methods and approaches in algorithms, statistics and machine learning, along with their current applications in bio- and medical- informatics.

VIII. CLINICAL RESEARCH INTERACTIONS

MUSC MCR 750-01: Ethical Issues in Clinical Research I

An emphasis will be placed on the ethical issues associated with clinical research and practice. The focus of the class will be the review of the competencies involved in the conduct of ethically responsible research. The process of assessing ethical issues in research and study will be described. The ethical considerations in study design; study implementation, data management, data analysis, data interpretation and results




presentation and publication will be described. As future educators, the students will be presented with the honor council process, assessment process for unethical classroom and study behavior, and the process for behavior modification and remediation. The ethical considerations involved with collaborative research will be presented. The course will consider evolving ethical issues in clinical research including the human subjects and conflict of interest. The course will include the use of a class participation system where each student will be able to express their opinion in “real-time”.

UDNURS812 Responsible Conduct of Research

Critically examines scientific integrity and responsible conduct in biomedical, clinical and translational research within the theoretical and social context of research ethics using case examples and previous experience. Topics include: individual and institutional responsibilities for promoting scientific integrity, protection of the rights of researchers and human and animal subjects, data issues, collaboration, authorship practices, intellectual property, and impact of future developments in science.

IX. SCIENTIFIC COMMUNICATION

MUSC MCR 725: Grant Development

This course is required for participants in the Clinical Masters program. The objective of the course is to prepare the student to develop a draft grant application by teaching them about grantsmanship, helping them to develop the sections of a grant, teaching them about IRB regulations and procedures, what reviewers look for and how to think like a reviewer, about ethics, and about developing a research budget. Students will be given examples of successful grants and grants that have not been funded to discuss and critique.

MUSC MCR 789-20 Grants Overview

The course will function as an interactive description of the research grant mechanisms, application process, review process and implementation. The different types of grants will be presented and the details of the application and peer review. The source of funding will be described. Students will learn on overview of the types of grants, potential funding sources, how to get started and resources available at MUSC.

UD HLPR610 Health and the Media

Explores the relationships between health behavior and cognition, and media communications and messages. Specific attention placed on culturally influenced health outcomes, channels of communication, and personal and demographic influences. Health




promotion programmatic considerations and interventions related to media factors will be emphasized.

UD

NURS816 Advanced Qualitative Research in Nursing Science

The naturalistic paradigm and qualitative approaches, such as ethnography, phenomenology, grounded theory and/or others, are explored. The appropriateness of each approach for exploration, description and explanation of phenomena encountered in clinical, organizational and educational settings is emphasized. Development of a qualitative research proposal.

UD

NURS833 Nurse Scientist: Special Topics Seminar I

Students share scholarly discourse with experts in nursing science and health-related research to develop their dissertation research and advance their knowledge of theoretical, methodological and practical aspects of research and grant writing. The expected behavior and responsibilities of the nurse scientist and academician are integrated.

UDUAPP333010 Research Methods for Policy Analysis

Examines research methods and their applications in policy analysis. Demographic analysis, survey research and geographic information systems are applied to policies in such areas as transportation, health, energy and economic development.

UDUAPP457010 Health Policy

Provides students with a basic understanding of the U.S. health system and gives them practical experience in analyzing how healthcare reform and health policy more generally affect various sectors of the economy.

UDBHAN390010 Principles of Coaching

Introduces students to the general philosophy and methods of coaching. Covers communication skills, teaching skills, sport psychology and managing team related responsibilities and relationships, including risk management.

UDUAPP657010 Health Policy

Provides students with a basic understanding of the U.S. health system and gives them practical experience in analyzing how healthcare reform and health policy more generally affect various sectors of the economy.

UDX. CULTURAL DIVERSITY

UDPSYC432010 Advanced Health Psychology

This course is an introduction to the field of clinical health psychology, focusing on the biopsychosocial model of health. The topics include stress and coping, cancer, diabetes, and cardiovascular disease.

UD PSYC390010 Social An analysis of theory and research in social psychology including the topics of social




Psychology cognition, attitudes, interpersonal, group and intergroup relations.

UD

PSYC394010 Cultural Psychology

Introduction to how culture shapes psychological experience, including social behavior, cognition, motivation, and the experience of the self. Covers psychological theory and research on human cultural variation and focuses on different national populations (especially North Americans and East Asians), with some attention to the psychological experience of multicultural populations within the United States.

UD



UDSOCI311010 Sociology of Health & Illness

Overview of the many contributions medical sociologists have made to our understanding of the determinants of health, the organization and implications of medical care, the roles of doctors and patients, and the intersections between social change in society and in medicine.

UDSOCI433010 Gender and Health

Why are women sicker, but men die younger? In this course we will critically examine the relationship between gender and health. In doing so, we will also consider the contribution of race, class and sexuality in shaping that relationship.

UD

HDFS270010 Families and Developmental Disabilities

Focuses on people with developmental disabilities in the context of their family and culture from a multidisciplinary perspective. Covers disabilities and their causes; changing needs across the lifespan, gender, cross-cultural and legal issues; and information about prevention/intervention, employment, inclusion, and empowerment.

UDBAMS415010 Race, Class, and Gender

Analysis of current American social issues that show interrelationship of race, class and gender. Readings from sociology, Afro-American studies, feminist studies, history and literature.

UDNURS834 Nurse Scientist: Special Topics Seminar II

Students share scholarly discourse on current topics in nursing science and health-related research, advance their ideas for dissertation, and incorporate behavior needed by the nurse scientist for engaging with the local and global scientific community

UD UAPP233010 Introduces key diseases and conditions which affect the health of different populations




Introduction to Global Health

including basic biological and varying social aspects which cause major global health issues. Emphasis on the developing world, the health of the poor, and possible solutions.

XI.

TRANSLATIONAL TEAMWORK

UDLEAD341010 Decision-Making and Leadership

The application of different decision-making tools and models for making effective decisions in a leadership context.

UD

BUAD309 Management and Organizational Behavior

Discusses the processes and procedures used to manage individual performance effectively in organizational settings

UDBUAD422 Designing Effective Organizations

Concepts of administration at the individual, group and organizational level of analysis. Emphasis on organizational level of analysis with topics including job design, organization structure and design, and inter- and intra-organizational processes

UDBUAD429 Selected Topics in Management

Topical seminar on such management issues as organizational socialization, work motivation, and organization-environment relations. Development of an individual research project is stressed.

UDBUAD306 Operations Management

Analysis of major problems faced by operations managers at different levels of management. Topics include scheduling, forecasting, process design, inventory management and quality management.

UD BUAD346 Analysis of Operations Problems

(Follows BAUD306) To include the investigation and development of the decision making process in an operations environment. Emphasis on practical applications.

UDBUAD448 Decision Support Systems for Operations

Effective design and implementation of decision support for operations. Selection of appropriate models for decision support. Emphasis on project work in which an actual decision support system is designed and implemented.

UD

HLPR631 Health Coaching

Course develops patient and client centered coaching skills, techniques and knowledge to facilitate positive behavior change to improve health and reduce chronic disease. Emphasis is placed on individual as well as group-oriented coaching skills within the context of health care through personal practice and observation.




UD

HLPR664 Health Coaching Practicum

Course provides 120 hours of coaching practice within a supervised clinical environment. Students work with patients and clients in clinical and community settings to hone their skills, knowledge and expertise in health coaching. This course serves as final preparation for the Health Coaching exit exam.

UD

NURS604 Advanced Practice Roles for Health Care Providers

Focuses on roles and issues affecting healthcare providers engaged in advanced practice. Roles are analyzed in relation to current issues and concepts of advanced practice.

UDNURS635 Health Administration Theories

Theories of administration, organization and management, their interaction with other health discipline theories and their influence on management of healthcare agencies. Includes the interaction of theories with attainment of institutional goals.

UD

NURS637 Health Planning Strategies

Analyzes organizational systems and roles of managers and administrators. Students identify organizational needs, formulate goals and objectives appropriate to healthcare agencies and identify strategies appropriate to accomplishing goal attainment with ethical constraints of healthcare.

UDNURS638 Health Services Evaluation

Emphasizes the role of managers and administrators in personnel development, promotion of research in clinical settings and development and implementation of quality improvement initiatives and their implications for healthcare.

XII. LEADERSHIP

MUSC MCR 789-32: Leadership

This course introduces the major historical and contemporary theories of organization and human behavior in the workplace with emphasis on the principles and application of leadership skills. The course will include the study of organization structures, principles, techniques and processes as they relate to the management of health services and research organizations. Opportunities to gain a better understanding of organizational behavior issues such as motivation, leadership, communication, interpersonal conflict, and group dynamics are provided in case analyses and skill building exercises.

UD LEAD200010 The Leadership ChallengeUD BUAD870 Leadership Develops a knowledge base and requisite skills for managing individual, group, and




and Organizational Behavior

organizational processes through the use of diagnostic models, cases, and/or simulated exercises.

CCHS

IHI Open School Modules - Quality Improvement (QI101) and Leadership (L101)

The IHI Open School for Health Professions is an interprofessional educational community that gives learners the skills to become change agents in health care improvement. The IHI Open School currently offers a range of online courses in the areas of quality improvement, patient safety, patient- and family-centered care, managing health care operations, and leadership. IHI course numbers = Quality Improvement, QI 101-106; Leadership, L101.

XIII. CROSS DISCIPLINARY TRAINING

UD

BISC816

Systems Biology of Cells in Engineered Environments

Provides a technical review of systems biology approaches including genomics, transcriptomics, proteomics, metabolomics, and bioinformatics as well as applications in tissue engineering, stem cell differentiation, and drug delivery.

UDBISC815

Ethics, Business and Communication

Provides professional development in ethics, business and communication related to systems biology research applications in stem cell, tissue engineering, and drug delivery technologies.

XIV. COMMUNITY ENGAGEMENT

MUSC MCR 789-04 Community Engagement Research

Community engagement is an important element of the successful translation of research from bench to bedside and community. “Community-engaged research” (CEnR) is an approach to conducting research that requires partnership development, cooperation and negotiation, and commitment to addressing local health issues of the community of interest. At the heart of all CEnR is the understanding that community members will be involved in some meaningful way in the research process. This course provides a foundation for incorporating the principles of community engagement in the development of community-academic research partnerships and implementing best practices of CEnR. Topics include community interaction, partnership development, ethics and responsible conduct in




community-engaged research, strategies to engage communities across all phases of the research process, and community-based dissemination.

UD

PHIL241010 Ethical Issues in Healthcare

Interdisciplinary study of ethical thought and its application to contemporary medicine, with a focus on ethical challenges in the provision and distribution of healthcare. Consideration of such issues as whether there is a right to health care, personal responsibility for ill health, and healthcare rationing.

UD PHIL444010 Medical Ethics

Seminar focuses on such topics as experimentation with human subjects, genetic engineering and the moral problems of health care.

UD

HDFS346010 Counseling in human services

Presents approaches to interviewing and counseling individuals and families in a variety of community-based human service settings. Includes case management, advocacy and empowerment strategies of intervention. Explores professional and ethical issues in providing individual and family services.

UD

HDFS333010 Development of Human Relationships

Developmental theory and research related to intrapersonal and interpersonal conditions, characteristics, attitudes and behaviors necessary for effective human relationships. Basic focus on the psychology of the individual, relationship skills, conflict management and intimacy.

UD



UD BHAN335010 Health and Aging

Aging process addressed from biopsychosocial perspective. Particular emphasis placed on developing understanding of complex interrelations among aging, health and social structure.

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UAPP639010 Community Development Theory, Concepts and Practice

Explores the evolution of core principles and concepts associated with community development, examines various models of practice, and identifies and assesses current challenges and issues confronting the field in the United States.




UD

HLPR630 Behavior Change Strategies and Tactics

Emphasis on skills to assist individuals in making health behavior changes including weight management, physical activity, medication compliance, smoking cessation, and stress management. Students will develop plans and courses of action to assist individuals in making health behavior changes.

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HLPR803 Advanced Health Promotion Programming and Evaluation

Prepares the student with the skills for planning, developing, implementing and evaluating health promotion programs in a variety of settings and populations. Emphasis on the behavioral, epidemiological and socio-ecological issues that impact programming and the skills required to evaluate a program.

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HLPR809 Health Behavior

Health and behavioral science theory and research provide a framework for the analysis of health-related behaviors across the lifespan. Emphasis on the psychological and social determinants of health-related behaviors of individuals. Examines the roles of health professionals in facilitating behavior change.



Competency Area Specific Competencies

I. CLINICAL AND TRANSLATIONAL RESEARCH QUESTIONS

1. Identify basic and preclinical studies that are potential testable clinical research hypotheses.

2. Identify research observations that could be the bases of large clinical trials.

3. Define the data that formulate research hypotheses.

4. Derive translational questions from clinical research data.

5. Prepare the background and significance sections of a research proposal.

6. Critique clinical and translational research questions using data-based literature searches.

7. Extract information from the scientific literature that yields scientific insight for research innovation.

Pediatric 1. Describe how a translational research hypothesis might be modified to be testable in a pediatric population. (e.g., pediatric rare diseases, small numbers of patients; see also below under Study Design)

T1 Research1. Understanding mechanistic approaches to disease and disease processes within their area of expertise. Specific examples of such competencies include physiology, pathophysiology, the genetics of human disease, and pharmacology

II. LITERATURE 1. Conduct a comprehensive and systematic search of the literature using informatics techniques.



CRITIQUE

2. Summarize evidence from the literature on a clinical problem.

3. Describe the mechanism of a clinical problem reviewed in a manuscript.

4. Use evidence as the basis of the critique and interpretation of results of published studies.

5. Identify potential sources of bias and variations in published studies.

6. Interpret published literature in a causal framework.

7. Identify gaps in knowledge within a research problem.

III. STUDY DESIGN 1. Formulate a well-defined clinical or translational research question to be studied in human or animal model.

2. Propose study designs for addressing a clinical or translational research question.

3. Assess the strengths and weaknesses of possible study designs for a given clinical or translational research question.

4. Design a research study protocol.

5. Identify a target population for a clinical or translational research project.

6. Identify measures to be applied to a clinical or translational research project.

7. Design a research data analysis plan.

8. Determine resources needed to implement a clinical or translational research plan.



9. Prepare an application to an IRB.

Pediatric1. Describe study design modifications and methods appropriate for small sample sizes.

Pediatric2. Describe study design modifications or controls that would be appropriate for a vulnerable population.

Pediatric3. Describe special considerations for biospecimen collection from children (e.g., age-appropriate sampling techniques, quantity/volume of specimen, subject assent/ informed consent).

T1 Research1. Understanding the methodologies in which clinical and basic science findings are initially evaluated in terms of their relevance to human disease. This area would also encompass familiarity with animal models and the technical tools used for the phenotyping and analysis of those models (imaging, gene expression, proteomics, metabolomics, etc.).

IV. RESEARCH IMPLEMENTATION

1. Compare the feasibility, efficiency, and ability to derive unbiased inferences from different clinical and translational research study designs.

2. Assess threats to internal validity in any planned or completed clinical or translational study, including selection bias, misclassification, and confounding.

3. Incorporate regulatory precepts into the design of any clinical or translational study.

4. Integrate elements of translational research into given study designs that could provide the bases for future research, such as the collection of biological specimens nested studies and the development of community-based interventions.

V. SOURCES OF 1. Describe the concepts and implications of reliability and validity of study measurements.



ERROR

2. Evaluate the reliability and validity of measures.

3. Assess threats to study validity (bias) including problems with sampling, recruitment, randomization, and comparability of study groups.

4. Differentiate between the analytic problems that can be addressed with standard methods and those requiring input from biostatisticians and other scientific experts.

5. Implement quality assurance systems with control procedures for data intake, management, and monitoring for different study designs.

6. Assess data sources and data quality to answer specific clinical or translational research questions.

7. Implement quality assurance and control procedures for different study designs and analysis.

VI. STATISTICAL APPROACHES

1. Describe the role that biostatistics serves in biomedical and public health research.

2. 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.

3. Scrutinize the assumptions behind different statistical methods and their corresponding limitations.

4. Generate simple descriptive and inferential statistics that fit the study design chosen and answer research question.

5. Compute sample size, power, and precision for comparisons of two independent samples with respect to continuous and binary outcomes.



6. Describe the uses of meta-analytic methods.

7. Defend the significance of data and safety monitoring plans.

8. Collaborate with biostatisticians in the design, conduct, and analyses of clinical and translational research.

9. Evaluate computer output containing the results of statistical procedures and graphics.

10. Explain the uses, importance, and limitations of early stopping rules in clinical trials.

VII. BIOMEDICAL INFORMATICS

1. Describe trends and best practices in informatics for the organization of biomedical and health information.

2. Develop protocols utilizing management of information using computer technology.

3. Describe the effects of technology on medical research, education, and patient care.

4. Describe the essential functions of the electronic health record (EHR) and the barriers to its use.

5. Explain the role that health information technology standards have on the interoperability of clinical systems, including health IT messaging.

6 Access patient information using quality checks via electronic health record systems.

7. Retrieve medical knowledge through literature searches using advanced electronic techniques.

8. Discuss the role of bioinformatics in the study design and analyses of high dimensional data in areas, such as genotypic



and phenotypic genomics.

9. Collaborate with bioinformatics specialists in the design, development, and implementation of research projects.

Pediatric1. Identify unique or describe age-appropriate modifications to data fields for the conduct of studies involving children.

Pediatric2. Describe how quality control/quality assurance standards for data entry might be modified for studies involving children (e.g., height/weight data fields appropriate for a 3 year old).

T1 Research1. Understanding the more distal steps in the translation process. These include many of the competencies listed in Areas I-XIV. Areas of particular relevance to T1 investigators include being familiar with technology transfer and other matters connected with working with the private sector, and understanding the steps leading to the ultimate application of research

VIII. CLINICAL RESEARCH INTERACTIONS

A. REGULATORY SUPPORT AND KNOWLEDGE COMPETENCIES

1. Describe the fundamental principles of the protection of human subjects, the main authoritative bodies, key codes, and scope of enforcement.

2. Describe the Food and Drug Administration requirements for drug biologic products

3. Prepare an application for IRB approval.

4. Critique a proposal for risks to human subjects and protections of vulnerable populations.

5. Describe the essential elements of voluntary informed consent.



6. Describe the principles of research documentation, validation and audit.

B. RESPONSIBLE CONDUCT OF RESEARCH COMPETENCIES

1. Explain the ways in which the principles of research ethics are integrated into the design, conduct, oversight and dissemination of research.

2. Describe the authority for and professional standards for the responsible conduct o research.

3. Explain the procedures for reporting and investigating misconduct in research.

4. Explain conflict of interest management in research.

5. Outline criteria for determination of authorship.

6. Describe the role of peer review in funding and publication.

7. Explain the purpose, policies and procedures to ensure ethical use, care, and animal safety in research.

Pediatric1. Summarize the US regulatory and historical framework to the conduct of clinical research involving children and how it differs from adults (e.g., section 407 and minimal risk; age appropriate ascent procedures ).

IX. SCIENTIFIC COMMUNICATION

1. Communicate clinical and translational research findings to different groups of individuals, including colleagues, students, the lay public, and the media.

2. Translate the implications of clinical and translational research findings for clinical practice, advocacy, and governmental



groups.

3. Write summaries of scientific information for use in the development of clinical health care policy.

4. Translate clinical and translational research findings into national health strategies or guidelines for use by the general public.

5. Explain the utility and mechanism of commercialization for clinical and translational research findings, the patent process, and technology transfer.

X. CULTURAL DIVERSITY

1. Differentiate between cultural competency and cultural sensitivity principles.

2. Recognize the demographic, geographic, and ethnographic features within communities and populations when designing a clinical study.

3. Describe the relevance of cultural and population diversity in clinical research design.

4. Describe cultural and social variation in standards of research integrity.

5. Critique studies for evidence of health disparities, such as disproportional health effects on select populations (e.g., gender, age, ethnicity, race).

XI. TRANSLATIONAL TEAMWORK

1. Build an interdisciplinary/ intradisciplinary/ multidisciplinary team that matches the objectives of the research problem.

2. Manage an interdisciplinary team of scientists.

3. Advocate for multiple points of view.



4. Clarify language differences across disciplines.

5. Demonstrate group decision-making techniques.

6. Manage conflict.

7. Manage a clinical and/or translational research study.

Pediatric1. Describe special considerations in assembling and managing a multidisciplinary team to conduct longitudinal, lifespan studies (e.g., transitioning of child to adult care).

XII. LEADERSHIP

1. Work as a leader of a multidisciplinary research team.

2. Manage a multidisciplinary team across its fiscal, personnel, regulatory compliance and problem solving requirements.

3. Maintain skills as mentor and mentee.

4. Validate others as a mentor.

5. Foster innovation and creativity.

XIII. CROSS DISCIPLINARY

1. Apply principles of adult learning and competency-based instruction to educational activities.

2. Provide clinical and translational science instruction to beginning scientists.



TRAINING

3. Incorporate adult learning principles and mentoring strategies into interactions with beginning scientists and scholars in order to engage them in clinical and translational research.

4. Develop strategies for overcoming the unique curricular challenges associated with merging scholars from diverse backgrounds.

XIV. COMMUNITY ENGAGEMENT

1. Examine the characteristics that bind people together as a community, including social ties, common perspectives or interests, and geography.

2. Appraise the role of community engagement as a strategy for identifying community health issues, translating health research to communities and reducing health disparities.

3. Summarize the principles and practices of the spectrum of community-engaged research.

4. Analyze the ethical complexities of conducting community-engaged research.

5. Specify how cultural and linguistic competence and health literacy have an impact on the conduct of community engaged research.

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