Research Project Checklist

Review and Approval of Research Involving Human Subjects

Ö or N/A* / Activity / Reference
Determine if the research qualifies as human subject research; or
if the research qualifies for IRB waiver / http://www.niaid.nih.gov/ncn/clinical/decisiontrees/humansub.htm
http://www.niaid.nih.gov/ncn/clinical/decisiontrees/irbwaiver.htm
Complete Human Subject Protection Program (HSPP) (research involving more than minimal risk) / http://www.rochester.edu/ohsp/certification/hspp.html
Complete Ethical Principles in Research Program (EPRP) (research involving minimal risk) / http://www.rochester.edu/ohsp/certification/eprp.html
Complete RSRB Review Application (for federal, foundation, departmental sponsored studies, investigator initiated) / http://rsrb01.urmc.rochester.edu/rsrb
http://www.rochester.edu/rsrb/documents/pdf/irbReview.pdf
Complete WIRB Initial Review Submission Form (for industry - sponsored studies) / http://rsrb01.urmc.rochester.edu/rsrb
http://www.rochester.edu/rsrb/documents/pdf/irbReview.pdf
Complete U of R Application for Industry-Sponsored Research review (for industry - sponsored studies) / http://rsrb01.urmc.rochester.edu/rsrb
Prepare subject recruitment materials / http://www.rochester.edu/rsrb/documents/pdf/invguidance.pdf#pagemode=bookmarks&page=67

* All questions may not be applicable for sponsored studies

Industry sponsored research must be submitted to WIRB via the Office for Human Subject Protect, Box 628.

Federal, foundation, departmental sponsored, investigator-initiated, and gene transfer studies can be submitted to the RSRB, Box 315.

Research Project Checklist

Additional Review Approvals**

Ö or N/A / Activity / Reference
Research involves the use of recombinant DNA, vaccines or biohazards / Institutional Biosafety Committee http://www.safety.rochester.edu/ibc

Research involves pregnant woman or woman trying to become pregnant; newborns/infants

/ Contact Perinatal Research Committee Chair at 275-7480
Research involves the use of the General Clinical Research Center (GCRC) / Contact Director of CRC at 275-5295
Research involves subjects from the cancer center / Contact the Clinical Trials Office in the Cancer Center at 275-5345 for information on how to obtain approval
Research involves subjects from the Emergency Department / Contact the Emergency Department at 463-2926 for instructions for obtaining Emergency Medicine Research Committee Approval
Research involves materials or isotopes / Contact Radiation Safety Officer at 275-1473

** These are additional approvals that maybe required depending on the nature of the research project and/or the facilities utilized.