If you haven’t been to the Human Investigation Committee’s (HIC) website (www.hic.wayne.edu ) in a while, there are many updates and changes. All of the HIC submission forms have been updated to reflect the current information needed when the HIC/Institutional Review Board (IRB) reviews a protocol submission. Most of the changes were minor and provide better guidance on the information that should be provided when submitting to the HIC. Old versions of forms will not be accepted after March 31, 2007.

The informed consent templates have been changed to simplify questions and provide more guidance to help write an appropriate consent form. The big change is that the HIPAA Authorization form now follows the Informed Consent document. Combining these documents make consenting for research simplified. The HIPAA Summary still must be completed and remains unchanged from 3/16/06 form. Consent forms and HIPAA Authorizations submitted prior to this change will be grandfathered and able to use the older formats of two separate forms. If you wish to combine the two forms into one, please submit an expedited amendment to change the format.

Check out our new section “Policy/Procedures” which combines polices and standard operating procedures into one section. Many of the policy/procedures have been updated or created to reflect the current research culture. You might be surprised to see what is out there.

The Office of the Vice President for Research of application to the Association for the Accreditation of Human Research Protection Programs (AAHRPP), a nonprofit organization dedicated to the protection of the rights and welfare of research participants and the promotion of scientifically meritorious and ethically sound research, is in its final stages. The site visit is scheduled for April 25-27 2007.

As reminder, AAHRPP accreditation is the “gold standard” for human subject research requiring that its member institutions reach performance standards that surpass the threshold of state and federal requirements and adhere to the highest ethical practices in the protection of research participants.

AAHRPP standards approach the human research protection program from a broad organizational perspective. The evaluation process is divided into five Domains: Organization, Institutional Review Board, Sponsored Research and Public Outreach. All types of human participant research are covered, from biomedical and pharmaceutical research to social and behavioral research, ensuring, in each case, that regulatory and ethical standards are applied appropriately.

Very shortly your department will be contacted for an educational program regarding the accreditation process. All divisions involved in human subject research, clinical or behavioral, will be asked to become involved in the final self-assessment and site visit. AAHRPP site visitors will interview University Administration, Deans and Department Chairs, as well as those who conduct human subject research, in order to determine if Wayne State University policies and procedures comply with federal, state and local guidelines on human participant research, and are integrated into the fabric of research practices. Your participation in this process is very important and much appreciated. For questions about AAHRPP, please call Mary Duncan Ph.D. Associate Director for Research Compliance in the Office of the Vice President for Research @ 313-577-3977.

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

–Patti Webber