First, review the following two documents:
Harvard University Human Research Protection Program (HRPP) Plan - This is the "30,000 foot view" document that ties all of the pieces of our program together. It defines roles and mission and includes a complete outline of the regulatory requirements that must be met. Please also see the HRPP Overview page for more information.
Investigator Manual (IM) - This is your comprehensive guide. In addition to topics covered here on our website, the IM covers many more, such as reporting financial interests, consent considerations, conflict of interest, data management/ security, research in schools, secondary data analysis, deception and incomplete disclosure, subject pools, additional requirements for federally funded research, HIPAA privacy rule, Principal Investigator responsibilities and assurance statement, Provostial review, and more
Next, review the following information:
There are 3 Levels of IRB Review and Other IRB Determinations
During review, IRB Administrators will determine which level of review is required.