The Principal Investigator must provide materials in sufficient detail in order for the Institutional Review Board (IRB) to make a determination on whether the research meets the requirements to approve the project. As part of the Human Investigation Committee (HIC) process improvement it was determined that the current Medical/Behavioral Protocol Summary Form (PSF) should be expanded to allow investigators the ability to provide more concise information to the HIC concerning their research protocol submissions. This additional information will, in turn, significantly aid the review processes of the HIC and the four IRBs thereof.

The general outline of the new PSF remains the same. The new PSF has been expanded to include eight appendices for protocol specific information when the research project may involve the participation of specified vulnerable groups, or research that may require special consideration such as international research, use of the internet, use of drugs/devices, use of radiation and use of biological specimens. The new PSF will also include some additional questions that are posited to garner information meant to facilitate the review process. One new requirement is that all principal investigators, faculty advisors or sponsors, department chairs, co-investigators and key personnel are required to disclose any potential for financial conflict of interest (See article on HIC Financial Conflict of Interest Policy).

Please check the HIC website January 3, 2006 to begin using the new PSF. Once posted, the new PSF should be used for all new submissions. Further, because the new PSF may require minor alterations from time-to-time, please access the HIC website to ensure use of the most current version of the PSF for each new submission.

If you have further questions you can contact the HIC Education Coordinator, Patti Webber, RN at (313) 577-9534 or email her at pwebber@wayne.edu.