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BIOM 667: Clinical Research Protocol Development and Scientific Writing

(3) REQUIRED

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%