OPTIONAL CHECKLIST FOR SUBMITTING HUMAN SUBJECTS PROTOCOLS This checklist is for your own use in preparing your protocol submission materials.
A.
COMPLETED PROTOCOL APPLICATION – Must be submitted on current version of the application posted on the website; typed, 12 point font.
B.
CITI EDUCATION REQUIREMENT – all research personnel (including faculty advisors) must complete the CITI education requirement and provide the dates of completion on the protocol application (Effective February 15, 2007).
ADDITIONAL APPLICATION ATTACHMENTS – Some studies require additional information for review. Attachments are available at http://humansubjects.uoregon.edu/application.htm. See PART TWO of this application
E.
CONSENT FORM(S) – one for each group of subjects (samples available here) in language appropriate to the subjects.Studies with vulnerable populations and/or those involving more than minimal risk require additional information in the informed consent form. Consult the Investigator's Manualfor more information.
1. Cover Letter or Text Statement – for studies not involving signed written consent
2. Advertisement(s), recruitment letter, introductory letter or verbal statement used prior to consent form, if applicable.
F.
INSTRUMENTS – questionnaires, interview protocols, etc.
G.
AUTHORIZATION FORM – for projects collecting Private Health Information on subjects (HIPAA guidelines)
H.
APPROVAL FROM PARTICIPATING INSTITUTIONS – if applicable
I.
SPECIAL TRAINING CERTIFICATES – (e.g. fMRI, ACLS, etc.), if applicable
J.
FOR RESEARCH IN FOREIGN COUNTRIES – consent form(s) in native language and English translation, permission documents and/or research visa.
K.
FUNDING PROPOSALS TO FEDERAL AGENCIES – submit one copy of the Research Plan/Project Description, if applicable.
L.
GRADUATE STUDENTS FILING FOR THEIR DEGREE THROUGH THE GRADUATE SCHOOL MUST SUBMIT one copy of the approved thesis/project or dissertation proposal and the Required Clearance For Master's Thesis/Project or Doctoral Dissertation (form available from the Graduate School - http://gradschool.uoregon.edu/pdf/researchClearanceGS910.pdf). NOTE: If the thesis or dissertation proposal has not been approved, the protocol may need to be revised to reflect the approved proposal.
M.
SUBMIT 2 TYPED COPIES – original plus one readable copy of all documents.