The Research Plan is the JHSPH IRB’s “protocol” document that you will complete and upload into the PHIRST system when you submit a New Research Application. Choose the research plan that is appropriate to your study. The Research Plan for Secondary Data Analysis of Existing Data/Specimens only should be used when the study involves data/specimens that exist and were collected for purposes OTHER THAN FOR THIS STUDY. For example, new studies proposing to use existing medical records, pathology samples, census data, or research data collected under a separate IRB approved study, fall into this category.
Studies involving new data collection, whether or not they also involve existing data/specimens, should use the Research Plan for New Data Collection. This locked version is for fill-in purposes. We understand that research teams may need an unlocked version for circulation amongst the team to use Word tools for editing, comments, and comparisons. Here is an UNLOCKED Research Plan for New Data Collection to use for that purpose. DO NOT DELETE ANY QUESTIONS FROM THIS TEMPLATE. Doing so could delay the review of your application. Use only these templates; all previous research plan templates should be deleted from your computers.
We have prepared an Instructional Research Plan Template for the Research Plan for New Data Collection to help explain what the IRB will look for when reviewing your research plan. Please review before you submit your application as it may save review time.