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
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:
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.
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/
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
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
Authorization Letter from study site.
Biohazards approval letter (if applicable)
All submissions must
be done electronically to:
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.