Guidelines for IRB Assistance

Contact: Office of Nursing Research
Phone:   215.898.3151
Email:    research@nursing.upenn.edu

The mission of the IRB is to promote the rights and welfare of human research participants; to facilitate
excellence in human research by providing timely and high quality review of human research, and to provide professional guidance and support to the research community.

Staff at the Office of Nursing Research (ONR) is available to assist researchers with the IRB application process, including but not limited to:  

• Assistance with a preliminary review of the research proposal with the researcher present. The purpose of the preliminary review is to help identify aspects of the study that need work before the final proposal is sent to the IRB. For instance, ONR can assist in identifying the elements of information that are necessary to include in a consent document or a protocol summary. This may involve a discussion with the researcher about the research plan or the process of informed consent. ONR cannot write proposals and informed consents for researchers, but can assist with revisions.
   
• Assist researchers to determine if their study meets the criteria for exempt, expedited or a full board review. Researchers should be aware that the IRB office makes the final determination upon review of the proposal.    
   
• Assist researchers with electronic online application process and identification of correct forms that need to be filled out with their IRB submission, provide guidance and answer questions about how to complete the application.
   
• Assist in preparing the IRB application for Continuing Review or for filing for an Amendment to a proposal.
   
• Assist the researcher with answering IRB stipulation letters and the process of revisions.
  
  ONR advises all researchers to save electronic copies of their applications in a distinctive folder on their shared drive on the network. ONR will keep a hard copy of your proposal, human subject certification, IRB letters and grant-related information in a file should you require copies of this information in the future.