IRB Forms, Submission Requirements, Review Categories

Refer to the categories below to determine if the research meets the requirements for an Exempt or Expedited approval. If the research does not meet those requirements it should be submitted for Full Board approval.

ATTENTION! Download your comprehensive, "how-to" handbook for investigators! Simply click on the link below. Handbook for Investigators: A Guide to the IRB and Human Research Protection Program

See the revision date of each form below, those in red font have recently been changed. If you have any questions while completing the IRB forms please contact the IRB Administration Office at (313) 577-1628.

Save a copy of these forms on your computer's hard drive before filling them in.

Right-click links and select "Save Link As..." or "Save Target As..." to save a copy of the form on your hard drive, then double-click the saved file to launch MS Word and fill in the form.

MS Word macros must be enabled in order to use the automation features of these documents.

INITIAL PROTOCOL SUBMISSIONS:

Electronic Submissions to Select Institutional Review Boards
M1 (Medical IRB)	B3 (Behavioral IRB)	PH1 (Phase I IRB)

Complete one of the following forms depending on the type of review you are requesting: Exempt, Expedited or Full Board.

Medical Exemption Protocol Summary Form (9/2010) REQUIRED for Exempt Medical Research

Medical/Behavioral Protocol Summary Form (7/2011b) REQUIRED for all Behavioral Research and Expedited or Full Board Medical Research See Protocol Summary Form for which Appendix is required; it may be more than one.

NEW FORM: Medical/Behavioral Protocol Summary Form (02/2012) - Available for use now, MANDATORY 03/12/2012. Question #6 was added.

APPENDICES:

Appendix A - International Research (9/2010)
Appendix B - Internet Use in Research (8/2010)
Appendix C - Children as Research Participants (7/2011)
Appendix D - Cognitively Impaired or Mentally Disabled Research Participants (12/2006)
Appendix E - Prisoners as Research Participants (7/2011)
Appendix F - Use of Drugs, Biologic Agents, or Devices (8/2008)
Appendix G - Imaging/Diagnostic Radiation (7/2011) Radiation Exposure Calculation Link: http://www.safety.duke.edu/radsafety/consents/default.asp
Appendix H - The Use of Biological Specimens (3/2008)
Appendix I - Research Funded by a Component of the Department of Defense (DoD) (6/14/2010)
Appendix J - Studies Conducted at or by the VA (8/2011)
Appendix K - Pregnancy, Fetuses, Neonates (7/2011)

HELPFUL HINT: Refer to the following page to review the IRB Reviewer Form for committee expectations during the review process http://irb.wayne.edu/irb-members.php.

TEMPLATES, HIPAA, AND ADDITIONAL FORMS FOR INITIAL SUBMISSIONS:

Complete a Consent Form or Permission Template, if required.