Educational Objectives

Students in this course are provided with an overview of the complex environment that supports the academic research enterprise from a historical and evolutionary perspective, including examples of seminal studies and research controversies. Students consider the partnerships between the federal government, industry, and academic and clinical research institutions.  The course explores design and implementation human research studies and explores a variety of topics, including the components, general principles, and issues in academic research. 

Research involves many ethical, legal, and regulatory issues related to the treatment of subjects, personal privacy, and institutional compliance, among others. This course examines ethical codes of conduct, regulatory requirements, and existing laws that govern research, recruitment and protection of human subjects; diversity and vulnerable populations in research; informed consent; privacy and confidentiality; the role of independent review committees; and the importance of reporting serious adverse events.

This course covers all topics related to Grants Management and Awards. Students will learn how to setup grants proposals and awards, bill and perform cost reimbursement, and distribute indirect costs. Students will examine various aspects of maintaining grant and contract awards including increasing or decreasing award funding, adjusting the award budget, updating grant information, updating project status, and closing a grant or contract.

This course introduces the concept of intellectual property in advancing technological innovation and promoting economic development.   Students will learn how to safeguard intellectual property and facilitate technology transfer including the legal, licensing, and disclosure.  The course will also explore the requirements for issue of a patent including preparation of a patent application.  The course explores how research or an invention may be commercialized in the process of technology transfer. Emphasis is placed on the patenting and transfer of technologies pertinent to the biotechnology, pharmaceutical and medical device industries.