STAT 414 Study proposal guidelines (Study/Surveillance Proposal Guidelines) Due Date: 2/28/2014

This will be the first part of two papers in this course. Please note that this paper is going to deviate in instructions from the paper as stated in the syllabus as I will be combining them into one final project. The purpose of this paper will be to address questions regarding the design, planning, and implications of an epidemiologic study. Through your work, you will address issues in the study of a health outcome or disease in a way that is consistent with proposing a study that would be addressed by an IRB or granting agency. The general outline for a proposal is as follows.
Introduction Topic area Study Hypothesis Significance to knowledge (value added by the study) Literature review (Background Information) More detailed description of the disorder or disease including natural history, prevalence, portals of entry/exit, suspected or known causes, transmission dynamics, etc... Previous research Interlocking findings and Unanswered questions Any preliminary work on the topic The remaining questions and inter-locking logic Reprise of your research question(s) in this context Methodology Approach (Study Design, Study Population and methods of Recruitment) Data needs and sample size (variables you should collect, types of data, etc) Methods of data collection Analytic techniques (statistical software and methods you expect to use) Plan for interpreting results Expected results Ethics (Including the protection and reasonable dissemination of data, informed consent from human subjects, and ethical implications of the study to subjects involved) Time Table Budget (Make a guess) Dissemination of Results Conclusion Bibliography (or References)

The general guideline above will give you an idea of how a study proposal may take place (in terms of overall design). Every study is different, and therefore, the distribution and importance of each section may vary by disease, health outcome, etc... What I am looking for is a well formatted, senior level paper that covers each of these areas (save for the budget) in a way that, if I were a member of an IRB and knew nothing about the disease, I would be able to understand the proposal in question and make a judgment as to whether the design is well planned and ethical or whether the study is inappropriate.

Length requirement: Its doubtful that you will be able to complete the requirements of this paper in less than five or six pages. Try to keep in to the point though (i.e. 15 pages would be pushing it as this is the upper limit for many grant applications.) Remember that you havent actually collected the data yet, so Im not looking for results either. This is request for permission to do a study.

I will post the grading rubric as soon as I have finished writing it.

Good luck.