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research protocol in medicine
1. Guidelines for Writing a Research Protocol
To ensure an effective review by the RSRB, the board must be provided with certain critical elements of
information. The protocol (study design) should address these areas in detail. The RSRB no longer
requires a separate protocol summary in addition to the protocol itself because a section to summarize the
protocol is included within the application for research review.
The format below is suggested when writing a protocol (use the Instructions for Submission as a guide for
submitting a new study to the RSRB).
If you have any questions, contact an RSRB Human Subject Protection Specialist at
(716) 275-2398, Fax: (716) 275-7896.
I. PURPOSE OF THE STUDY AND BACKGROUND
1. Purpose of the study. State the specific scientific objectives (aims) of the research.
2. Background. This paragraph should support the purpose of the study. [Note: References may be
cited in the Background.]
II. CHARACTERISTICS OF THE