Clinical Research Protocol Development and Scientific Writing
(3) REQUIRED
Faculty: TBA
The goal of this course is to further enhance the career development of outstanding clinical researchers by providing didactic training in writing skills and proposal development. Other topics to be covered in this course include: governance structure of funding agencies; identifying appropriate funding opportunities; how funding decisions are made; peer review and secondary review; the NIH application processing; how to read a Request for Application; compliance issues covering fiscal, human subjects, and animal subjects; and awarding procedures. Trainees will be judged on the merits of their mentored research proposals, which they will write as NIH Small Grant applications. Required reading will include relevant literature.
Course Number : Biomed 645
Course Title : Clinical Research Protocol Development and Scientific Writing
Course Credit : 3 credits
Prerequisite : Permission of Instructor
Course Description :
The goal of this course is to further enhance the career development of outstanding clinical researchers by providing didactic training in writing skills and proposal development. Other topics to be covered in this course include: governance structure of funding agencies; identifying appropriate funding opportunities; how funding decisions are made; peer review and secondary review; the NIH application processing; how to read a Request for Application; compliance issues covering fiscal, human subjects, and animal subjects; and awarding procedures. Instruction on the meaning of race, ethnicity, social class, and culture, and how these constructs affect the conduct and interpretation of clinical research as well as the types of questions that can be addressed with large administrative and clinical databases; gaining access to these databases; determining validity of information; risk adjustment; linking datasets; and building registries. Trainees will be judged on the merits of their mentored research proposals, which they will write as NIH Small Grant applications. Required reading will include individualized searches of relevant literature
Course Objectives :
At the conclusion of the course student will be able to:
Describe the governance structures of funding agencies
Identify funding opportunities of their own research program
Read and Interpret an RFA
Participate in a peer and secondary review process
Apply an understanding of the NIH application process
Apply knowledge related to compliance with IRB, HIPPA and DSMB criteria for both animals and humans
Document concepts related to the meaning of race, ethnicity, social class, and culture, and how these constructs affect the conduct and interpretation of clinical research
Identify the types of questions that can be addressed with large administrative and clinical databases; gaining access to these databases; determining validity of information; risk adjustment; linking datasets; and building registries.
Critique research protocols according to defined criteria
Apply an understanding of award criteria
Prepare an article for publication in an referred journal
Topical Outline :
Structure of funding agencies
Structure of RFA's
The Peer Review process
The NIH application
Cultural Sensitivity
Utilization of databases
Participation in the Peer Review process
Scoring criteria
Award criteria
Measurement
Matrix Analysis
Reading and Writing Research
The poster presentation
The podium presentation
Preparing a publishable manuscript
Required Text :
Individualized assignments will be made from the serials literature by the student's mentor
Students will conduct individualized searches of the data based literature related to their area of research interest with faculty assistance
Learning Experiences :
Lecture, discussion, practicum
Evaluation
Examination 30%
Project 70%