Orientation to Research: The Responsible Conduct of Research

OGB-BIO-5000-AA - Credits: 3.0
This course sequence is composed of a number of topics that have been defined by the Office of Research Integrity (ORI) as key elements for the proper conduct of research. Several granting agencies, most notably the NIH and NSF, have mandated training for all faculty and students involved in any aspect of research with a funding link to these agencies. Some of the topics are also integrated into the research methodology courses. Other required topics, contained herein, are organized in three groupings: those involved in ethics and professionalism; the role of mentorship and student interactions, as well as departmental guidelines including data acquisition and proper scientific writing; and the oversight by institutional committees. Thus the course consists of three sections, all of which present information related to the proper conduct of research. Each section addresses specific issues.
  • Section (a) focuses on the courses required by the Office of Research Integrity (ORI) of the federal government. The list of CITI modules and courses that must be completed can be found in the syllabus.
  • Section (b) addresses multiple issues related to graduate student requirements at Salus University and includes a discussion of the vault, the e-labber system, the “Record” book of all graduate activities, any additional laboratory books, student-mentor relationships expectations, a course on Scientific Writing strategies and other student’s responsibilities and obligations. Much of this is presented during orientation; the rest is completed during the Fall Term.
  • Section (c) concerns the regulatory mandates as formulated by the institutional policies, the Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC) and the Safety and Radiation Committees at Salus University. This is presented during orientation with follow up during the research process.

Research Methodology: Introduction to Research Methods

OGB-BIO-5100-AA - Credits: 1.5
This course presents the scientific method and examines the way in which one reviews and uses the literature in developing and formulating a research question. It discusses the hierarchy of the strength of evidence found in different forms of research literature including the results from clinical trials so as to help the student be a critical appraiser of the current information. The course addresses some aspects important to the formulation of a research question.

Course discussion will include identification of cognitive errors and biases as major pitfalls to avoid. Approaches to problem-solving before, during and after a study will also be discussed.

Research Methodology: Measurement and Design

OGB-BIO-5101-AA -  Credits: 2.0
This course focusses on how to design studies to answer clinical research questions. It includes design of cohort, cross-sectional and natural history studies as well as pilot studies and clinical trials. The course will cover the conduct of studies including development of a research question, study monitoring, data assessment and outcome analysis writing. Discussion will include how to critically evaluate research findings on the basis of construct validity, internal validity, statistical significance and conformity to ethical research principles.

Research Methodology: Data Analysis and Biostatistics

OGB-BIO-5102-AA - Credits: 2.0 
This course reviews methods for describing data sets statistically. The student will learn probability distributions and their role in the testing for statistical significance. The most commonly used parametric and non-parametric comparison and correlation tests are taught and applied to biomedical hypotheses within appropriate research study designs.

Research Methodology: Approaches and Concepts in Biomedical Research

OGB-BIO-5103-AA - Credits: 2.0 
The student must choose one of the following two options:
  • Option 1: is directed at those students who will be undertaking clinical research. The students will be registered and participate in the NIH course entitled “Principles and Practice of Clinical Research” which begins each year in mid- October with on-line weekly lectures and ends with an exam at the end of March. Students must pass this examination. They must also fulfill a list of assignments which Salus University mandates in order to receive credit for this course which prepares clinicians for participation in NIH-supported clinical trials and research.
  • Option 2: addresses the application of laboratory techniques to basic science research in biomedicine and is directed at those students that wish to undertake lab-bench research. Candidates will be trained in aspects related to their areas of research. For example, for basic research in biomedicine, the teaching will include but not be limited to protein chemistry, biochemistry, clinical immunology, RNA/DNA analysis, microscopy and tissue culture procedures. In addition, the course will include competencies in the evaluation and interpretation of the results obtained via laboratory techniques.

Research Methodology: Epidemiology

OGB-BIO-7100-AA - Credits: 2.0 
The course discusses the distribution and determinants of human health and disease. It focuses on the quantitative aspects of measuring disease frequency, the use of large public data sources, and how the data are acquired. The student will learn the types of study designs used in biomedical research, the advantages and disadvantages of each, and results of some major epidemiology studies.

Particular attention is given to interpreting and critiquing published biomedical research articles.

Research Methodology: Budget Construction

OGB-BIO-7101-AA - Credits: 1.0 
This course trains the student in budget preparation skills and strategy for an NIH or NSF grant submission, and for grants/contract submissions to industry and military agencies. Fundamental concept and nuances of each funding agency’s budget requirements are reviewed and discussed. Guest lectures from experts  in the field participate in the presentations.

During the course of the term, the student will be asked to prepare a research budget for the project that each is pursuing for his/her Ph.D. degree.

Research Methodology: Special Issues Related to Biomedical Research

OGB-BIO-7102-AA - Credits: 2.0 
This course discusses certain topics which require decision-making expertise in several aspects of research. The course will consist of various scenarios from which discussion will occur. Topics will include issues of data acquisition, data management, academic-industry conflicts, authorship, publication, as well as problems that occur in the course of studies such as relying on graduate students, issues of integrity, and authority/responsibility issues in the laboratory to name a few. While some of the scenarios relate to clinical and clinical trials research problems, many apply to research in general. The format will be for students to receive scenarios and to undertake group discussion as to how to address and resolve the problems ethically and professionally.

Research Seminar: Introduction to Teaching and Learning

OGB-BIO-5300-AA - Credits: 1.0 
This course begins by discussing the fundamentals of presenting a quality seminar or lecture. Specific rules and guidelines are used as a template, and “real world” examples of presentation techniques and strategies will be demonstrated through the use of specific internet sites. Students will be asked to review, critique and comment through lively class discussions, and through their own presentations. The final exam is a seminar that demonstrates all of the skills that the students have learned during the course of the entire term.

Research Seminar: Critical Review of the Literature

OGB-BIO-5301-AA - Credits: 1.0 
During the introductory course of studies, the students will have developed skills in performing a literature search as well as techniques in delivering an effective presentation. This course takes the skills acquired in the previous seminar experience and asks the students to use their established literature base as a seminar resource for the justification of their planned research projects. The student prepares and subsequently presents a seminar on his/her reasons and justification for undertaking the proposed research project. The course instructor, the student’s mentor and a faculty member critique and comment on the

student’s effort in a constructive approach and provide feedback. All students are expected to participate in each other’s presentation by asking one focused question each of the presenter who then formulates an appropriate answer.

Research Seminar: How to Prepare Present and Critique Posters

OGB-BIO-5302-AA - Credits: 1.0 
This seminar begins with lectures on how to construct a poster for presentation at a scientific meeting. Both traditional and e-posters are reviewed. The lectures present the elements of good poster presentations and several pitfalls to avoid.

Students then write up an abstract and draft a poster using their pilot data which they then present to the course director for constructive review. During the term, students review ten (10) posters at a national convention in the company of their mentor or faculty appointee. They will use a form which identifies several features of effective posters as a guide. Upon returning to their institutions, the student then presents the critiques to the course director as part of the course requirements. Armed with this experience and feedback from the course director, the student than modifies and presents his/her poster in seminar fashion to the class. The audience is expected to ask questions and comment on the poster as part of their class participation.

Research Seminar: Epidemiology and Biomedical Research.

OGB-BIO-6300-AA - Credits: 1.0 
Having previously identified their research question and topic, students will prepare and present a review of data sources on the distribution, prevalence and incidence of their topic. Each student will address specific risk and preventive factors, organize their findings by biologic and behavioral variables, and prioritize the at-risk populations.

Research Seminar: The Research Project-1

OGB-BIO-6330-AA - Credits: 1.0
Each student presents a seminar on their individual research project and the data gathered so far. Other attending students must formulate questions and constructively critique their colleagues’ presentation on the overall organization of the material, the clarity of the questions being asked and the method of presentation of the data. Faculty members are also expected to provide written suggestions to the student regarding the presentation. If there are too few students, other invited speakers may be asked to present.

Research Seminar: The Research Project-2

OGB-BIO-7331-AA - Credits: 1.0
This seminar is a continuation of the seminar series in which the student presents his/her data and is critiqued by students and faculty. These seminars are expected to facilitate the process of dissertation defense and oral presentations at meetings.

Research Seminar: The Research Project- 3

OGB-BIO-7332-AA - Credits: 1.0
This seminar is a continuation of the seminar series in which the student presents his/her data and is critiqued by students and faculty. These seminars are expected to facilitate the process of dissertation defense and oral presentations at meetings

Oral Examination: The Qualifying Examination (Viva)

OGB-BIO-5600-AA - Credits: 0.5
This course reviews the purpose and the elements of the qualifying examination, the strategy behind the selection of the examining committee, how to prepare for a viva voce format and the possible outcomes. The student is then guided through the organization of the submitted document, the relevance of each section and what must be included. There is also a discussion of how the student should structure answers to questions and the way one addresses differences. Role playing is used to make certain points with examples of successful and unsuccessful documents and behaviors. If the student is not successful, the alternatives are discussed as are the various appeal procedures so that the student is informed prior to the examination.

The Viva Seminar 1

OGB-BIO-8330-AA - Credits: 0.5
The first seminar in this series is presented at the first viva for the doctoral degree, prior to the defense of the preliminary document. Both the seminar and the following examination are required for transfer of the student to the “candidate” status. The first viva seminar not only builds on the skills learned so far but also serves as a “training rehearsal” for the final defense of the dissertation. This seminar also serves as the final defense seminar for the master’s student.

The Viva Seminar 2

OGB-BIO-8331-AA - Credits: 0.5
The second seminar is the last of the seminars in the doctoral program and is to be presented immediately before the final defense of the dissertation.

Research Rotation 1

OGB-BIO-8730-AA - Credits: 1.0
Students rotate for 10 days through a laboratory site that conducts research using a different approach than that used by the student. For example, if a student is doing wet-lab bench work, he/she may rotate through a clinical trial site or an industrial site. During the rotation the student analyzes the research protocol, attends research meetings, looks at data gathering and housekeeping, and analyzes any publications that have been published by the site. When the student returns to campus, he/she must write a report on his/her experience.

Research Rotation 2

OGB-BIO-8731-AA - Credits: 1.0
The student completes a second rotation (10 days) in a research environment different than his/her own. Other venues include industrial or military research, multicenter clinical trials, and laboratory; i.e., dry vs. wet lab research, or specialized equipment development.

Research Project 1

OGB-BIO-6930-AA/OGB-BIO-8930-AA - Credits*: 3.0/4.0
The student together with the primary mentor is expected to identify a project and meet certain documentation requirements such as, but not limited to a preliminary title, a search strategy for the review of the literature, and a draft Table of Contents for the dissertation. All will be refined and revised as the project develops.

While the role of the primary mentor is limited at this time, this mentor takes on a far more significant role in the following terms. The interaction is used as one during which the mentor and student become acquainted and form the bond of trust that leads to more effective mentorship and training.

The project utilizes a “Record of Research Activity” booklet, in which all activities are documented and signed so as to provide confirmation of the student’s accomplishments and the mentor’s agreement with the outcome. This Record must be presented at the time of the final viva.

Research Project 2

OGB-BIO-6931-AA/OGB-BIO-8931-AA - Credits*: 3.0/6.0
Each student will be expected to complete his/her first draft of the literature review to be presented and discussed at length with the primary mentor. The student will also be expected to develop his/her primary hypothesis and identify the specific aims as guided by the primary mentor. At the end of the term, the student will identify his/her pilot data experiment.

The student is expected to attend a national or international meeting  such as the Association for Research in Vision and Ophthalmology (ARVO). During those meetings he/she is expected to spend one session with his/her primary mentor and review posters in the student’s field of interest. A similar session will be spent in the paper/symposia sections. At least ten posters/papers must be discussed at length with the mentor, critiquing the strengths and weaknesses of the presentations.

Research Project 3

OGB-BIO-6932-AA/OGB-BIO-8932-AA - Credits*: 4.0/7.0
During the term, the student must refine the experimental design to an actionable entity. This is the time when submission of the project to IRB committee is expected. The student must also identify pilot experiments for the submission.

These will be directly related to facilitation of later research work. Record keeping of all experimentation must conform to the directives provided in the “Responsible Conduct of Research” course.

Research Project 4

OGB-BIO-6933-AA/OGB-BIO-8933-AA - Credits*: 4.5/8.0
This course is subdivided into three components. The first includes conducting and organizing pilot data, and its analysis. This is followed by a description of how the experimental design has been altered by the results of pilot experiments. The greater part of the time is devoted to step two, (i.e., the writing of the qualifying report or the thesis for the master’s student). The elements include a substantial review of the literature, the hypothesis, specific aims and the experimental design. At this stage, the doctoral student will present the pilot data, while the master’s student is gathering most of his/her data and developing the discussion part of the thesis. The MSc student then proceeds to write the thesis, while the PhD student schedules the viva examination. Passing this examination allows the doctoral student to enter the “doctoral candidacy” stage. The last component involves writing an abstract for submission to a major meeting such as AOA, ARVO, AAA or the like based on either the literature or the pilot data.

Research Project 5

OGB-BIO-6934-AA/OGB-BIO-8934-AA - Credits*: 4.5/8.0
During this term, the doctoral candidate continues his/her experimentation and data gathering and has regular meetings with the mentors. The student addresses any issues that have surfaced with the pilot projects and adjusts the experimental design or methodology as determined by the outcome of the qualifying examination. At this point, the Ph.D. candidate begins aggressive experimentation.

Since this is the endpoint for the master’s student, he/she must complete gathering and interpreting the data for the master’s thesis and prepares for the thesis viva. The process of the viva is very similar to that for the Ph.D. Please refer to the Student Manual further instruction and the viva master’s form on pages 38-39.

Research Project 6

OGB-BIO-8935-AA - Credits: 7.0
During this phase of the course, the student is expected to acquire a major accumulation of data through single and replicate studies and pursue statistical analysis of the data. Having completed the major review of the literature, the student is expected to write his/her first publication either as a review article or as a presentation of a completed part of the experimentation if such exists at this time. If publication of early experimentation occurs, the student may use the publication as a chapter of his/her dissertation. The student should also begin drafting the overall organization of the data and discussion chapters for his/her dissertation.

Research Project

OGB-BIO-8936-AA - Credits: 10.0
This course continues with further accumulation of data, replicate experiments and data analysis. At this stage, the student should be able to identify what are the embellishments to the design that might increase the significance of the research and provide pilot data for the next grant. The writing of the dissertation continues and the student begins drafting a second abstract from the study. If the work has progressed significantly, a rough outline or draft of a grant proposal may be initiated.

Research Project 8

OGB-BIO-8937-AA - Credits: 10.0
The candidate should be working almost exclusively on completing the experimentation, the data collection and its analysis. Further experimental work can be continued after the term if requested by the mentor or directed by the Viva Committee. The writing of the dissertation continues and the candidate is expected to present a second poster/paper at a major meeting. The candidate is also expected to develop a draft of a grant application.

Research Project 9: Defense of the Dissertation

OGB-BIO-8938-AA - Credits: 0.00
The candidate is expected to complete and submit the dissertation and register for the Defense of the Dissertation through the Office of Graduate Programs in Biomedicine. The completed Record of Research Activity must be submitted before the viva date can be set. If no publications have as yet been submitted or accepted, the candidate must also present drafts of one publication before the viva can be set. The viva will have an examining committee which will consist of a faculty member who did not serve as a mentor to the student and an external examiner and will be conducted in a closed session. The candidate is expected to present his/her last seminar on his/her research on the day of the viva.

The candidate has up to one academic year to schedule the viva which must be held within that academic year, after which the candidature of the student will be closed without award if no document has been submitted and the viva has not been successfully completed. If there are extenuating circumstances, an appeal granting appropriate extension of time may be submitted to the Office of Graduate Programs in Biomedicine at least four months before then end of that year. A response will be given to the candidate within a time frame (three months) which will allow him/her to prepare for the defense should additional time not be granted.


Independent Study-1

OGB-BIO-6530-AA - Credits: 1.0
The topics are to be tailored to the individual student needs.

Independent Study-2

OGB-BIO-6531-AA - Credits: 1.0
The topics are to be tailored to the individual student needs.

Independent Study-3

OGB-BIO-6532-AA - Credits: 1.0
The topics are to be tailored to the individual student needs.

Independent Study-4

OGB-BIO-6533-AA - Credits: 1.0
The topics are to be tailored to the individual student needs.

Special Topics: Genetics, Genomics, and Research

OGB-BIO-7500-AA - Credits: 1.0
The Human Genome Project and other revolutionary advances have increased and broadened the importance of genetics/genomics in all health care fields.

Since virtually all diseases have a genetic component, the clinician and researcher will need to raise genetic hypotheses with every patient and realize when genetic factors play a role in a patient’s condition. This course will provide students with a basic knowledge of genomics and genetics necessary for clinical care and research and will enhance their scientific skills. The course will be individualized to accommodate students with varying interests.

Special Topics: From Bench to Impact

OGB-BIO-7501-AA - Credits: 2.0
This course covers the methods whereby research findings can be translated into specific applications or products and how researchers can protect themselves and their intellectual property in the process. The various ways in which one can move bench findings to clinical, industrial, and military applications are discussed by faculty experienced in this process. Legal advice is also provided to discuss royalties, contractual agreements and institutional/shared ownership. Lastly, financial advice is given in general terms about expectations and self-protection.

Special Topics: Approaches to Education

OGB-BIO-7502-AA - Credits: 2.0
Since research is often based in academic centers and many graduates will be employed by institutions of higher learning, this course is designed to introduce the student to contemporary principles and practices in education, including distance learning approaches. It describes the difference between various modes of student learning and proposes multiple methods of assessment.

Special Topics: Writing Competitive Grant Proposals (Part 1)

OGB-BIO-8530-AA - Credits: 1.0
The candidate is expected to put together a draft grant proposal. This may be for a Post-Doctoral Fellowship, a Young Investigator award, a K08 or K23, an R01 or for an industrial or military contract. The mentors will review and critique the proposal which will be amended and presented in Part 2 by the student.

Special Topics: Academic Life and Stewardship

OGB-BIO-8500-AA - Credits: 1.0
During this course, the post-doctoral fellowship and research associate positions are discussed as options for the new graduate. Establishing oneself in Academia is also discussed with a review of academic life and expectations, promotions and the hierarchy of professorships, tenure and grantsmanship, including the K08 and the K23. The students and faculty discuss establishing one’s professional identity, the role of societies, meetings, and service to the profession.  Special attention is devoted to group research and its advantages.

The last lecture is devoted to what it means to be a “steward of a discipline.”

Special Topics: Writing Competitive Grant Proposals (Part 2)

OGB-BIO-8531-AA - Credits: 1.0
The candidate is expected to construct a substantive grant proposal based on the feedback received in BI 850 (Part 1). This may be for a Post-Doctoral Fellowship, a Young Investigator award, a K08 or K23, an R01 or for an industrial or     military contract. The mentors will review once again and critique the proposal such that the candidate has a proposal in hand, ready to submit as the student moves to graduation and employment. This course is a continuation of BIO  8500.

Special Topics: Writing Competitive Grant Proposals (Part 3)

OGB-BIO-8532-AA - Credits: 1.0
This is a continuation of BIO 8531 that facilitates the completion of the grant proposal.

Research Modeling Using Computing Software and other Tools

OGB-BIO-8501-AA - Credits: 1.0
This course will present different techniques in the modeling of experimental paradigms and population dynamics. New technologies have revolutionized the study of medicine and biological phenomena. Mathematical strategies are being increasingly used to measure and track health and disease. Students will be introduced as to how mathematics, biology and health care converge to disclose new dimensions to understanding biomedical interventions.

* Courses with an asterisk are PhD/MSc courses which have a different credit value depending on the course requirements.