The following comprise the core, required courses of the Human Investigation Program for the certificate and M.C.R. and are offered as tuition-free.  A University Fee will be applied each term enrolled.  See more about tuition and fees for the HIP program.

HIP 510 Introduction to Clinical Research (1 credit)

Course Director: Cynthia Morris, Ph.D., M.P.H.
Format: Online asynchronous; informational presentations, discussions, online lectures and resources
The specific goal of Introduction to Clinical Research is to provide an early education to students in the essential skills and structure of clinical research and in the basic process of building a patient-oriented research study. Discussions will include the essential elements of a career in clinical research, opportunities for obtaining early career funding, and the importance of mentorship. Although didactic methods will be employed, there will also be an emphasis on introducing available resources to early career investigators. Subsequent courses will build on this foundation in specific areas (biostatistics, clinical research design, translational research, etc.).
Offered: Fall term
 

HIP 511, 512, 513 Clinical Research Design I, II and III (2 credits each)

Course Directors: Team taught - Cynthia Morris, Ph.D., M.P.H., Barbara Brumbach, Ph.D., Ryan Cook, Ph.D., M.S.P.H., Alicia Johnson, M.P.H., and M.E. (Beth) Smith, D.O., M.C.R.
Format: Hybrid; interactive classroom lectures and small group work
This course sequence is the cornerstone of HIP. The goal is to educate students in the basic competencies of clinical and translational research and to propose, design, critique, and analyze a patient-oriented research study. Interactive classroom lectures and discussions are conducted with emphasis on causal inference, measures of association, bias, confounding, and strengths and weaknesses of various study designs. Students learn basic concepts in probability, estimation, and hypothesis testing as well as statistical methods frequently used in clinical research. The objectives of the course are to provide familiarity with basic statistical concepts and issues in clinical research and in-depth study of research design with integration of biostatistical methods. More advanced topics include uses of more complex designs and modeling to control for confounding in experimental and observational studies. Evaluation of diagnostic testing is discussed, focusing on study design and implementation. Students will be asked to read current clinical literature to reflect on these themes.
Offered: sequentially Fall, Winter and Spring terms; full terms
Note: must be enrolled all 3 terms
 

HIP 511A Proposal Development (3 credits)

Format: Online synchronous; small group sessions
Offered in conjunction with HIP 511, 512, 513 (Clinical Research Design I, II and III), this course offers a small group session experience in which students develop a research hypothesis, specific aims, and research methods to answer a clinical question. Intertwined with lectures in HIP 511, 512, and 513, students will meet a total of 6 times in small groups led by experienced clinical research faculty members to discuss research ideas and methods for testing specific hypotheses. At each session, students complete a written assignment that is similar to required sections of any grant. In the end, the assignments come together as a complete grant proposal, with the exception of budget. Students in the small groups are expected to read and contribute to the development of the other proposals in the small group.
Offered: Must be enrolled Fall, Winter and Spring terms; 2 sessions per term
Note: Must be taken in conjunction with HIP 511, 512 and 513, or with permission, the following year. No auditors.

HIP 523 Data Science for Clinical and Translational Research (2 credits)

Course Directors: Mohammad Adibuzzaman, Ph.D.
Format: Hybrid; interactive classroom lectures, data wrangling sessions, and asynchronous content
This course provides an introduction to principles of clinical research informatics, including use of data sources such as clinical information systems, data management, collection and storage of clinical data, database design, and data security.  This includes exercises in working with data to answer clinical questions.  Course objectives include developing skills and comfort to construct and implement a data collection, management, and secure storage plan for clinical data; and developing the facility with clinical data to wrangle data to answer questions and test hypotheses. 
Offered: Fall term; 8 weeks

HIP 516 Protection of Human Subjects (1 credit)

Course Director: Kathryn Schuff, M.D., M.C.R.
Format: Hybrid; large-group lecture, case-based, interactive discussion, attendance at an IRB meeting. 
This course enables clinical researchers to recognize and appropriately address legal, regulatory, and ethical issues in research, with special attention to vulnerable subjects and regulatory issues unique to Oregon. This is accomplished by: 1) teaching basic concepts in law, federal regulation, study design, and ethics related to clinical research; 2) reviewing common problems encountered in human subjects protocols and informed consent documents to demonstrate how to identify and remedy deficiencies; 3) reviewing the roles and responsibilities of institutional review boards, investigators, and sponsors involved in the conduct of human research; and 4) reviewing the obligations of clinical researchers in relation to initial and continuing reviews, reporting of unanticipated problems, reporting changes in approved research, and consenting human subjects and monitoring safety in research as required by federal regulations. The course includes discussion of the historical roots for current regulations, Oregon law, federal regulations, OHSU policies, and practical advice for navigating the compliance milieu related to human subjects research.
Offered: Fall term; 4 weeks

HIP 517 Scientific Writing and Data Presentation (1.5 credits)

Course Director: Rachel Dresbeck, Ph.D.
Format: Online synchronous; seminar series with case-based learning
Success in clinical research rests on the researcher’s ability to communicate the findings of research clearly and effectively. The purpose of this course is to provide insight into the peer-reviewed journal process in clinical medicine and surgery. The student also gains an understanding of the elements of clinical science writing that are expected in peer-reviewed publications. This course covers the following topics: writing for success in academic medicine; elements of the clinical science paper; ethics in writing, defining the peer-review process; selecting best journals for submission; strategies for collaborative writing; crafting data displays; and how to review a paper and how to respond to reviewers’ comments.
Offered: Winter term; 6 weeks

HIP 507A Evidence-based Medicine Seminar (2 credits)

Course Directors:  Moira Ray, M.D., M.P.H.
Format: Hybrid; small group seminar series
Evidence-based medicine relies on three fundamental skills: 1) awareness of the best available evidence, 2) assessment of the applicability or trustworthiness of the evidence, and 3) aligning the balance of harms/benefits/costs with the values and preferences of the patient. This evidence-based medicine seminar expands upon earlier teaching on research design to guide students in the critical assessment of evidence arising from to the broad array of clinical research designs used in published studies. The goal of this seminar is for students to gain familiarity with evaluating the validity of various study designs used in published research and identify the advantages and disadvantages of various methods of presenting the results of a study (e.g., relative risk reduction versus absolute risk reduction). As they learn about clinical research design in other courses or encounter studies in their daily work, the students have the opportunity to immediately apply that knowledge by critically reading recently published studies or hone their skills using supplied articles. This module is conducted through short didactic sessions, guest lecturers, and small group discussion and caps the learning process from the previous 18 months of HIP courses through critically reading and appraising the literature.
Prerequisites: HIP 511, 512 and 513
Offered: Winter and Spring terms; 8 weeks (credits divided between terms)

HIP 526 Capstone – Mentored Experience (6 credits)

The mentored experience is the centerpiece of HIP and is designed to create independent clinical investigators. The mentored experience results in an academic product, either a grant submission or peer-reviewed publication. Developing a research proposal with a mentor allows the student the optimal opportunity to experience all the steps in this process. These include reviewing the background literature, developing a hypothesis and specific aims, designing an appropriate and fundable study to answer the hypothesis, formulating the statistical analysis, and refining the written work to maximize fundability. This exercise replicates the critical experience necessary to creating an independent, funded research program.
Offered:  Credits are divided between variable terms typically after completing the first year.

Certificate students are required to complete at least one elective course of 1.5 credits or more.  MCR students are required to complete at least 22.5 elective credits.

The following elective courses may be subject to tuition as noted.  A University Fee will be applied each term enrolled.  See more about tuition and fees for the HIP program.

HIP 512A Biostatistics with STATA (1 credit)

Course Instructor: Jennifer Lucas, Ph.D., M.P.H
Format: Asynchronous; experiential, independent learning
This module consists of a series of tutorials showing students how to analyze data using the statistical software program STATA. Students can work through individual tutorials on their own and at their own pace. They can attend office hours, held weekly, for help on completing the assignment.
Offered: Any term, after completing HIP 511, 512, and 513 or with permission. Contact the HIP program.
Cost: Tuition-free
Note: This tutorial is required for elective HIP 528 and HIP 529 Applied Biostatistics I and II
 

HIP 520 Medical Informatics (2 credits)

Course Director: William Hersh, M.D.
Format: Online asynchronous; lectures and threaded online discussions
Medical informatics is described as “the rapidly developing scientific field that deals with the storage, retrieval, and optimal use of biomedical information, data, and knowledge for problem solving and decision making.” An understanding of medical informatics is crucial to clinical researchers. The widespread adoption of electronic medical records and the emerging standards on which they are based will influence how researchers acquire and use patient data; the revolution in bioinformatics may fundamentally alter how we view and research disease; and growing concerns over confidentiality of health information, most notable HIPAA regulations, determine how patient information is stored and used. Course topics include fundamentals of medical computing, electronic medical records, data interchange and terminology standards, information retrieval from databases, security and confidentiality, and bioinformatics. The course consists of readings and online lectures with assignments that include hands-one use of electronic medical records, decision support applications, and information retrieval systems.
Offered: Summer term; 7 weeks
Cost: Subject to tuition

HIP 522 Fundamental of RCTs (1.5 credits)

Course Director: Cynthia Morris, Ph.D., M.P.H.
Format: Hybrid; lecture, interactive exercises, and discussion
This course covers the principles of clinical trial design, implementation, and management, including single- and multi-center trials and new trial designs (pragmatic, adaptive). Each student is expected to develop a working protocol for a clinical trial as a result of this class, and to read and critically appraise published trials. Conventional trials of drug treatment will be discussed, with some emphasis on conducting trials of alternative medicines, surgical or device therapy, and nutritional and other interventions requiring counseling. There is an enhanced focus on new methods and current controversies. Each class period includes discussion of a recently published clinical trial that illustrates the lecture topic.
Prerequisites: HIP 511, 512 and 513
Offered: Summer term; 7 weeks
Cost: Tuition-free

HIP 514 Cellular and Molecular Approaches to Disease (1.5 credits)

Course Director: Peter Mayinger, Ph.D.
Format: Online synchronous and asynchronous; lecture and discussion
The power of contemporary methods in molecular and cell biology to reveal complex mechanisms of pathogenesis has increased geometrically over the past 25 years. With completion of the human genome project, and with new technologies for genomic screening and bioinformatics, clinician scientists have unique opportunities to rapidly define pathways of disease pathogenesis. They must be well trained in fundamental concepts of basic research technologies in fields of molecular and cell biology, biochemistry and molecular pharmacology. Similarly, basic researchers require training in clinical research methods and translational study design. The lectures review important molecular, cellular and biological approaches frequently encountered with an emphasis on how these can be applied clinical studies. The objectives are to provide a fully integrated experience for both basic and clinician scientists in fundamentals of translational clinical research with examples from successful research projects. Three conceptually linked strategies are used: 1) lectures cover molecular techniques, 2) in-class participation in topical discussions, and 3) project development in student’s area of interest utilizing the methodologies covered in the course. This course is taught by clinician scientists with expertise in applying molecular biology to translational research, which allows for clinical correlation and application of the subject matter. Specific topics may include genetic and genomic technologies, use of animal models, use of bioregistries, basic and clinical cancer research, approaches to infectious diseases, auditory disorders, sleep physiology, cardiorenal medicine and gene therapy, study design and statistical considerations.
Offered: Every other Spring term (next offered Spring 2024); 6 weeks
Cost: Tuition-free

HIP 527 Systematic Reviews (2 credits)

Course Director: David Buckley, M.D., M.P. H.
Format: Online synchronous; didactic learning, interactive exercises, and discussion
This course will introduce students to the methodology of systematic reviews by working through the steps of a review using examples and discussion to explore various methodological approaches and identifying quality standards. Students will be asked to read and evaluate systematic reviews and primary studies. Various methodological approaches, including the pros and cons and suitable contexts for each, will be investigated. The course includes introduction to meta-analysis and grading the strength of bodies of evidence. At the end of the course, students will feel comfortable reading, evaluating, and applying systematic reviews from the perspective of a user.
Prerequisites: HIP 511, 512 and 513
Offered: Fall term; 8 weeks
Cost: Subject to tuition

HIP 528 Applied Biostatistics I (3 credits)

Course Director: Barbara Brumbach, Ph.D.
Format: Online synchronous; didactic learning paired with experience in use of statistical software
This course explores the application of fundamental biostatistics topics that are widely used in health sciences research, including categorical data methods, linear regression and others. Most topics will be covered on a conceptual and applied level by evaluating literature, exploring datasets and discussing interesting examples provided by instructor and/or guest faculty. Students will also provide examples of articles in their area of interest for discussion.  The objective of this course is to expand upon the biostatistics foundation provided in earlier clinical research training courses (HIP 511, 512, 513) so that students can: (1) learn how to perform basic biostatistics analyses, (2) evaluate which methods or statistical tools may be appropriate for their own research projects, and, (3) communicate effectively with biostatistics collaborators to design, analyze and interpret data. Students will apply the concepts covered in class using real datasets through weekly homework and other applied practice opportunities.  The primary software used in class will be STATA.
Prerequisites: HIP 511, 512, 513 and HIP 512A Biostatistics Tutorial in Stata
Offered: Winter term; full term
Cost: Subject to tuition
Note: Class sessions held for three hours each, one day a week for 11 weeks

HIP 529 Applied Biostatistics II (3 credits)

Course Director: Barbara Brumbach, Ph.D.
Format: Online synchronous; didactic learning paired interactive discussion
This course explores advanced biostatistics topics that are widely used in health sciences research, including logistic regression, time-to-event analyses, longitudinal approaches and others. Most topics will be covered on a conceptual level by evaluating literature, exploring datasets and discussing interesting examples provided by instructor and/or guest faculty. Students will also provide examples of articles in their area of interest for discussion. The objective of this course is to expand upon biostatistics foundation provided in earlier clinical research training courses (HIP 528) so that students can: (1) understand and critically evaluate analytic methods used in the medical literature, (2) decide which methods may be appropriate for their own research projects, and, (3) communicate effectively with biostatistics collaborators to design, analyze and interpret data.  The majority of the biostatistics material covered will be at the conceptual level; however, there may be some limited applied practice. 
Prerequisites: HIP 511, 512, 513 , HIP 512A Biostatistics Tutorial and HIP 528
Offered: Spring term; full term
Cost: Subject to tuition
Note: Class sessions held for three hours each, one day a week for 11 weeks

HIP 530 Leadership Skills in Team Science (2 credits)

Course Director: Niki Steckler, Ph.D.
Format: Online synchronous and asynchronous; short lectures, discussion, self-assessment and group exercises, and experiential learning
Team science requires skillful leadership from multiple members of research teams. Effective academic leaders influence others through self-awareness and relationship. They are clear and open about what they want to accomplish and aware of the impact they have on others. They are skilled at understanding other perspectives, sensing others' emotions, and reading political currents. They manage relationships well, motivate others, resolve disagreements, and move to action in collaboration with others. This course offers practical communication skills for influencing and leading team members in a collaborative team science environment. After completing this course, you will be able to: increase your awareness of the impact you have on others; invite and work with different academic and political perspectives; build strong collaborative relationships; mentor and coach others; and use dialogue and “crucial conversations” to set direction and move your research team to action. Each session of this course combines invigorating, practical skill building with the opportunity for students to contribute personal experiences in leadership and to learn from other students in a structured collective learning process.
Offered: Fall term; 6 weeks
Cost: Subject to tuition

HIP 531 Best Practices in Project Management (2 credits)

Course Director: Kat Phillips, M.S.H.A., P.M.P.
Format: Online synchronous; short lectures, discussion, group exercises, and experiential learning
This course teaches project management from the standpoint of implementing a clinical research project. It emphasizes practical tools and techniques that students can use immediately on real projects. The class walks through the project life cycle in the same sequence that project leaders will use in the workplace, such as defining scope, planning a project, developing a timeline, executing and controlling project work, and closing a project. As part of the class, students will apply some of the project management techniques to real projects.
Offered: Winter term; 6 weeks
Cost: Subject to tuition
Note: This course will meet for six 3-hour sessions on Thursdays in Winter 2024

HIP 532 Organizational Mindsets for Effective Research Careers (2 credits)

Course Director: Niki Steckler, Ph.D.
Format: Online synchronous and asynchronous; short lectures, discussion, group exercises, and experiential learning
Clinical research careers require the ability to make sense of complex organizational challenges through multiple lenses and mindsets. Effective academic leaders bring a strengths-based appreciative approach to managing their own careers and to mentoring others. This course offers practice analyzing how roles, goals and objectives, differences in human skills, motivations and cultures, strategic and operational networks of relationships, and clarity about meaning and purpose each contribute to effective responses to organizational challenges. The course includes practical tools for resiliency, work-life alignment, and managing time, energy and attention in the course of a professional career.
Offered: Spring term; 6 weeks
Cost: Subject to tuition
 

HIP 538 Community-Engaged Research (2 credits)

Course Director: Dora Raymaker, Ph.D.
Format: Online synchronous; didactic learning paired interactive discussion
The goal of Community-Engaged Research is to educate students about: 1) the history and rationale for including marginalized, vulnerable, and difficult-to-reach populations in research; 2) the major frameworks for community-engaged research and how to match them with inquiry; 3) the advantages, disadvantages, and ethical, methodological, and logistical considerations of community-engaged research; 4) how to apply course concepts to their own research. Faculty with experience in clinical, health services, and community-engaged research will discuss theoretical and practical aspects of these topics. The course employs didactic lectures and interactive exercises.
Offered: Summer term; 5 weeks

HIP 509: Systematic Review Practicum (variable credits)

Course Director: Varies
Format: Experiential learning
The goal of this practicum is to give students hands-on experience in the formal systematic review process by working with the Oregon Evidence-based Practice Center (EPC) on one of its USPSTF reviews. Students will work with a faculty mentor and the EPC team on all aspects of the systematic review process including: work plan creation and revision; search strategy planning; article abstraction; evidence synthesis; and drafting of a formal report manuscript. Students will meet periodically with their mentor throughout their practicum as needed to plan and discuss their research. Students will be expected to attend EPC meetings and complete a significant amount of independent work for the review itself. Students will also take part in the final presentation of results at a national meeting, as well as submission of a manuscript for publication. 
Prerequisites: HIP 511, 512, 513 and HIP 527
Offered: Offered each term with instructor approval; 3 months

HIP 536 Biomarkers of Psychological Stress (2 credits)

Course Director: Barry Oken, MD, PhD
Format: Online synchronous; didactic learning paired interactive discussion
This course discusses how to incorporate physiological biomarkers of psychological stress into clinical trials. It will cover an array of biomarkers, including hypothalamic-pituitary-adrenal (HPA) axis (mostly cortisol), autonomic nervous system activity (heart rate, heart rate variability, respiration rate), sleep measures, functional neuro-imaging, EEG, and cytokines. The logistics of implementation will be a focus (spontaneous measures or in response to a stress; state vs trait issues, confounds of the various measures, and quantitative analyses).
Offered: Every other Spring term (next offered Spring 2025); 8 weeks
Cost: Tuition-free

HIP 537 Introduction to Implementation Science (1.5 credits)

Course Director: Deborah Cohen, PhD, and Sue Flocke, PhD
Format: Online synchronous; didactic learning paired interactive discussion
Despite scientific progress, there is a lag between evidence and practice. An emerging science, called implementation science, seeks to reduce this gap and ensure evidence-based interventions (practices, programs, policies) are implemented in ‘real-world’ settings. This interactive course is an introduction to and overview of implementation science in the context of clinical research. Students will receive an overview of the topic and focus on learning several of its essential components including: Purpose of and reason for implementation science; Theories, frameworks, and conceptual models; Mechanisms of change / Implementation strategies; Measures; Research methods and study design.  Students will choose an evidence-based intervention from their field of study at the beginning of the course which they will use throughout to understand the above components. At the end of the course, students will present a research study they designed to implement their evidence-based intervention using the concepts learned throughout the course. Each week, students will be expected to read several articles, apply them to their intervention, and be prepared to share with the class.
Prerequisites: HIP 511, 512, and 513
Offered: Spring term; 6 weeks
Cost: Tuition-free

Students may apply credits from courses taken in other graduate programs at OHSU to the 22.5 elective credits needed for the M.C.R. or certificate with approval from the HIP program.

The following graduate programs offer electives that commonly taken in the M.C.R. though many other graduate level courses may also be appropriate depending on your focus of study. Note any prerequisites or other course limitations.  Tuition and fees will apply when taking courses in other graduate programs.  Students will be graded based upon the requirements of the graduate program offering the specific course of enrollment. Contact the Human Investigations Program about enrollment in these classes.

• Biomedical informatics
• Public health and biostatistics
• Human nutrition
• Other degree programs

Courses of Interest:

BMI 523: Clinical Research Informatics

Course Director: Nicole Weiskopf, Ph.D.
Format: Online synchronous and asynchronous; didactic learning paired interactive discussion
This class will introduce the student to the principles of clinical research informatics. Topics include the design of clinical research, clinical trial administration, good clinical data management, clinical trial registration and publication, subject recruitment, use of administrative databases, registries and electronic health records in research, practice-based research networks, standards in terminology and messaging for clinical research, and research collaboration. Requires virtual real time attendance every Monday, 5:00-6:30pm PST.
Offered: Summer term
Cost: Subject to tuition