Research Subjects
Review Board
"... to protect the rights and welfare of human research subjects at the
University of Rochester. To accomplish this, we review, approve the initiation of,
and conduct periodic review of research involving human subjects."
Research Education
and Training
GCP Training - offered on-line through CITI...
ROSS Training ....
RSRB ROSS training 3rd Monday of every month from 2pm to 3pm. Please Click HERE to sign up.
Quality Improvement
"To assess and assist the Investigator (PI) in assuring the rights and wellbeing of human subjects are protected and that the study is being conducted in accordance with IRB requirements, the approved protocol, applicable Federal regulations, U of R policies and best practice (GCP) standards."Change of Principal Investigator
The amendment process for a change in study responsibility from one investigator to another usually requires the following information to be submitted to WIRB®.
- A letter stating that there will be a change in study responsibility. The new principal investigator should be named.
- A letter or fax from the sponsor indicating acknowledgment and approval of this change in responsibility.
- A completed WIRB&ref; Research Review Submission Form
- A letter accepting responsibility for the study
- A revised FDA Form 1572 [Statement of Investigator] (if applicable)
- A copy of the new investigator's Curriculum Vitae
- A copy of the new investigator's current medical license
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Policies/Guidance
Document Templates
Applying to WIRB
- WIRB or RSRB Review
- WIRB Submission Process
- Change in Study Responsibility
- WIRB.com
- WIRB Fee Schedule
