Human Research Protocol Template
IRB Template Version Date 11/19/2010
If you believe your activity may not meet the definition of “Human Research”
subject to IRB oversight, contact the IRB Office prior to developing your
Prepare a document with all of the sections listed below, using the
“INSTRUCTIONS: How to Write a Human Research Protocol” document as
guidance. If a section does not pertain, indicate with “N/A.”
Note that, depending on the nature of your research, certain sections below may
not be applicable. Indicate this as appropriate.
For any items described in the sponsor’s protocol or other documents submitted
with the application, you may reference the page numbers of these documents. If
you reference page numbers, attach those pages to the Investigator Protocol.
Limit attached pages to those referenced in the Investigator Protocol.
When you write a protocol, keep an electronic copy. You will need to modify this
copy when making changes to the protocol.
1) Protocol Title
5) Setting of the Human Research
6) Resources available to conduct the Human Research
7) Study Design
a) Recruitment Methods [Please include the expected number of participants
needed to complete the Human Research.]
b) Inclusion and Exclusion Criteria
c) Study Endpoints
d) Procedures involved in the Human Research.
e) Data management
f) Provisions to monitor the data for the safety of participants (Required
when Human Research involves more than minimal risk to participants.)
g) Withdrawal of participants
8) Risks to participants
9) Potential benefits to participants
10) Provisions to protect the privacy interests of participants
11) Provisions to maintain the confidentiality of data
12) Medical care and compensation for injury
13) Cost to participants
14) Consent process
15) Process to document consent in writing
16) Vulnerable populations (Pregnant Women, Minors, Prisoners, Decisionally
compromised adults, others)
17) Drugs or Devices
18) Multi-site Human Research
19) Sharing of results with participants