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Instructions


Instructions for submitting a protocol for review to the IRB


PROTOCOLS SUBMITTED WITHOUT ALL THE REQUIRED DOCUMENTATION
WILL NOT BE REVIEWED

All investigators must obtain IRB approval for research protocols involving human subjects prior to initiating the study. Please submit the following documents:
 
  • A cover letter from the Principal Investigator (PI) stating the title of the protocol and all items attached (make a bullet list of all items submitted). Indicate whether the protocol is being submitted for: 
     
    • Full Review
    • Expedite Review
    • Exempt Certification
    • Emergency Waiver- (Emergency use of a test article in a life threatening situation. A test article is an investigational drug, biological product, or medical device)

      The pages titled REVIEW CRITERIA will help the PI make a decision on how the protocol is to be reviewed.
       
  • IRB form 1 (page 1 and 2), and form 2 must be submitted for Full, Expedite and Exempt Review. These forms must be completed electronically and signed. All IRB forms must be submitted in English. An Emergency Waiver has its own procedure which is outlined on page 4 of the Review Criteria.
     
  • Research protocol (research proposal/ concept paper)
     
  • IRB form 3 (expedite), form 4 (exempt) and form 7 (emergency) are only to be completed for protocols that are being submitted for expedite, exempt, or emergency.
     
  • Consent form, assent form (if applicable), and all supplemental material (flyers, posters, questionnaires, interviews, advertisements) must be submitted both in English and in Spanish. These forms must be written in simple language at an 8th grade reading level.
    All protocols involving tissue and DNA sample collection must have HIPAA language included in the consent form.
     
  • Certificates of Human Subjects training (http://phrp.nihtraining.com), and Research Aspects of HIPAA Tutorial (http://irb.ucsd.edu/hipaatutorial/login.html), for all investigators and key personnel. Training certificates are valid for three years.
     
  • Authorization Letter from study site.
     
  • Biohazards approval letter (if applicable)
     
  • All submissions must be done electronically to: irbpsmhs@psm.edu
     

Please note the difference between anonymity and confidentiality. An anonymous study does not collect any information that may identify the human subject. If personal information is to be collected, then appropriate measures to protect the privacy and assume confidentiality of the data must be explained.