Appendix 2.6.c. Clinical Research MS Program Competency Statement

Ability to conceptualize and design clinical research of high quality and scientific integrity

• PubH 6301: Fundamentals of Clinical Research where research designs for clinical research are presented and resources designed to support clinical research are described.
• PubH 6303: Seminar in Clinical Research requires the students to design and present a clinical research study in their own field.
• PubH 6330: Epidemiology I teaches study design for research on human populations. It includes both observational and intervention studies.
• PubH 6348: Writing Research Grants requires the students to write and defend an NIH research proposal based on their own scientific hypotheses.
• PubH 7420: Clinical Trials requires students to develop an advanced understanding of the design implementation and analysis of clinical trials.
• PubH 8777: Thesis. The thesis is core to a graduate school master’s degree. It must involve a project initiated, implemented and analyzed by the student suitable for publication in the peer-reviewed literature.

• Classroom exams
• Demonstrated knowledge
• Faculty evaluation of written assignments
• Presentation of student projects in the classroom setting

Ability to plan and manage clinical research studies

• PubH 6345: Epidemiology Methods: Data Collection. This course teaches students about collecting high quality data from human populations. It involves questionnaire design, quality control and other elements in the planning and implementation of a research protocol.
• PubH 6780: Management for Clinical Research. This course is designed to aid students in developing management skills to implement clinical research. It involves budgeting, hiring, staff management, study organization and other factors essential to an effective research career.

• Formal exams required for all courses
• Graded exercises include those on planning and management of clinical studies
• MS thesis: student must demonstrate that he/she is able to develop, implement and analyze a clinical study

 them at professional meeting and in the peer-reviewed literature

• PubH 6345: Epidemiology Methods: Data Collection. This course teaches students about collecting high quality data from human populations. It involves questionnaire design, quality control and other elements in the planning and implementation of a research protocol.
• PubH 6780: Management for Clinical Research. This course is designed to aid students in developing management skills to implement clinical research. It involves budgeting, hiring, staff management, study organization and other factors essential to an effective research career.
• PubH 6450 & 6451: Biostatistics 1 & 2. These courses teach analytic techniques using biostatistical methods and interpretation of data that derives from this statistical information.

• Formal exams required for all courses
• Graded exercises include those on planning and management of clinical studies
• MS thesis: student must demonstrate that he/she is able to develop, implement and analyze a clinical study

Thorough understanding of human subjects’ protection and the responsible conduct of research

• PubH 6742: Ethics in Public Health: Research and Policy. This course is designed to convey ethical principles that are core to the study of human beings.
• Responsible Conduct of Research: The students are designed to attend a one-half day course in this area and complete a web-based program.
• PubH 6301: Fundamentals of Clinical Research: Included in this course is a lecture from Dr. Kahn, Director of the Center for Bioethics. He discusses the implications of experimentation on human beings.
• PubH 6348: Writing Research Grants. This course includes lectures by representatives of the Institutional Review Board (IRB) and requires the students to complete an application to the IRB to perform clinical research. This includes writing letters of consent.

• Examinations, which include questions on the ethics associated with research in human beings.
• Students write application to the IRB for a human study, to be graded by faculty.

• PubH 6348: Writing Research Grant requires an NIH application, written by the student as part of the program. It demonstrates their skills to conceptualize a research idea and implement it.
• PubH 6303: Seminar in Clinical Research. At this seminar, students must present a research protocol that they have written as part of a grant application.

• Written applications and public presentations graded; feedback and constructive suggestions for improvement provided to each student

• The clinical research program involves students from different clinical disciplines: medicine, nursing and pharmacy. These are brought together in this class and lectures come from the many disciplines represented by the Academic Health Center.

• Outcome will only be determined when students enter their research positions. (Before that, we have only the ability to answer content questions in this area and get a sense of the students' appreciation of multidisciplinary work.)