Drexel Non-Medical/Medical IRB Submission Flowchart
http://www.research.drexel.edu/compliance/IRB/non_medical_irb.aspx
WHAT IS MY LEVEL OF SUBMISSION?
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Release Letter
No interaction with human subjects or
privately held material
Examples: Policy brief, literature review, US
census data
WHAT FORMS DO I NEED?
Exempt Category 1 (link to form) - Research on regular
and special education instructional strategies, comparison of
instructional techniques, curricula, classroom management
methods
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Exempt Review
Less than “minimal risk”* to human subjects
Example:
Anonymous response survey, focus group or
questionnaire
Working with a completely deidentified
(anonymous) secondary data set
Expedited Review
“Minimal risk”* to human subjects
Minimal risk studies involving Vulnerable
Populations** that may benefit the subject
Examples: Prospective or retrospective chart
review, surveys/questionnaires collecting
limited personal identifiers or health
information, any intervention or interaction
with the subject
Full Review
More than “minimal risk”* to participants
Any research project involving human
subjects not covered under other review
categories
Contact with vulnerable populations with no
potential for direct benefit
Working with data that can be traced or
linked to individual participants
Interventions involving physical or emotional
discomfort
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Letter of Determination
1-2 page study description
written by student
Exempt Category 2 (link to form) - Research on
educational tests, survey/interview procedures, subjects must
be deidentified, no vulnerable populations, must be “benign
research” (no risk of liability or damage due to release of data)
Exempt Category 3 (link to form) - Participants are
appointed public officials or candidates for public office
Exempt Category 4 (link to form) - Collection or study of
existing publicly available deidentified data or specimens
Exempt Category 6 (link to form) - Taste and food quality
evaluation and consumer acceptance studies
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Submit to Jack Medendorp for review ASAP
Office of Regulatory Research Compliance (ORRC)
informs student re: approval status
If approved, ORRC sends student Release Letter
All Submissions:
• Proposal Submission Checklist [ MS Word ]
• Project Submission Transmittal Form [ PDF ] – only required if there is external funding
• Co-Investigator Form (if more than 2 co-investigators) [ MS Word ]
• Research Proposal (sections addressing data collection/analysis, participant enrollment
only)
• Data Collection Instruments (surveys, questionnaires, advertisements etc.)
Additional Forms for Exempt Review (submit original and two copies of all forms)
• Conflict of Interest Form [ MS Word ]
Additional forms for Expedited Review (submit original and three copies of all forms)
• Expedited Review Application for Research involving Pathological Samples with
Identifiers (if applicable)
• Expedited Review for Charts (if applicable) [ MS Word ]
• Expedited Certification Form [ MS Word ]
Additional forms for Expedited and Full Review
(Submit original and six copies of all forms for Full review)
• Full Review/Expedited Review Combined Form [ MS Word ]
• Conflict of Interest Form (Use this form if there is more than 1 collaborator who has a
conflict of interest) [ MS Word ]
• Informed Consent Non-medical Without HIPAA Authorization [ MS Word ]
• Assent Form Template (for participation of children and minors) [ MS Word ]
• Request for Consent Waiver (to waive or alter informed consent) [ MS Word ]
• Internal Indemnification Form (for studies with no external sponsor, not applicable for
chart reviews) [ MS Word ]
• HIPPA Waiver of Authorization (access protected health information without participant
consent) [ PDF ]
• Investigators brochure or pertinent information documents (Patient Information
Supplement) if research involves the use of a drug/device/interventional procedure
*”Minimal risk” means that the risks of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily
encountered in daily life or during the performance of routine physical and physiological examinations or tests (noninvasive examples, physical, blood pressure, EKG).
Note that all proposals must include a risk/benefit assessment to identify whether the research will pose more than a "minimal risk" to the subject.
**"Vulnerable Populations” include those whose interests require special protection, e.g., Pregnant women/fetus, prisoners, minors, subjects with psychiatric/mental
disorders, etc.
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IMPORTANT
Example submissions available from Director of Community
Projects (DCP)
Copies of all approval paperwork go to DCP
Review all paperwork carefully before submitting paperwork
to IRB