FRIDAY, MARCH 8, 2002

Members:  Katarina Borer, Kitty Bridges, David Brophy, Bruno Giordani (chair), Scott Stoltenberg, J. Hunter Waite, Peter Ward, Mark Wenzel, David Wu, John G. Younger

OVPR:  Judy Nowack, Marvin Parnes, Rob Todd, Judy Crecelius (staff),

Guest:   James Hilton, Associate Provost for Academic, Information and

                 Instructional Technology Affairs

The minutes from February 8, 2002 were approved.

Bruno Giordani asked for the committee's comments on how the budget changes are affecting their departments (1996 Report on VCM and Research Excellence, attached).

Audit update:  Judy Nowack announced that the U-M just received a "full continuing accreditation" for the 2nd full year in a row from Association for Assessment and Accreditation of laboratory Animal Care's (AAALAC) recent audit of U-M's animal care units.  AAALAC, in their exit interview, was very complimentary of every facet of the animal care program.

Presently U-M is considering several accreditation programs--  The Association for the Accreditation of Human Research Protection Programs (AAHRPP) and the National Committee for Quality Assurance (NCQA).

The  AAHRPP standards allocate the criteria for accreditation of Human Research Protection Programs into five domains, with the heaviest emphasis on the first three--

(1) Organization  (2) Research Review Unit  (3) Investigator   (4) Sponsor  (5) Participant  (AAHRPP program is attached)

Plans for human subjects audit programs will also have five domains.  The proposed changes will not rely completely on the IRB, but fall more upon the institution.

               (1) lowest level-  IRB’s, investment in staffing, database, business processing.   A team from Arthur Anderson is assisting us in analyzing how to make these processes work better and assist with the overlaps.

               (2)  The Center for Clinical Investigation and Therapeutics (CCIT).  It will later convert to the Center for the Advancement of Clinical Research (CACR).  It will provide facilitating services for faculty members.

               (3)  PEERRS- Program for the Education and Evaluation of Responsible Research and Scholarship (presented at February's meeting).  PEERRS is the educational component of the MPRIME project.

               (4) Audit program- discussed below.  

               (5) MPRIME-- business re-engineering in general.  The Michigan Program for Research Information Management and Education is being developed to improve the administration and approval process of projects and protocols involving human subjects.

THE AUDIT PROGRAM:  The IRB has been authorized to go into the basic data in research projects, but typically the IRB does not have the expertise to do this.  The proposed new audit program will have a better systematic review to see if the system is on tract.

There will be a satellite office on the Medical Campus that will report to OVPR.  The IRB-Med has seen 160 high-risk projects (out of 25,000).  We plan to randomly choose 10 of them for review by outside audit people.  In the future we will gain the expertise to do this ourselves.

It was suggested that it would be helpful to have one place/one face where investigators can go for answers to questions --a drop-off place for the project, where it will be sent to the proper place and/or committee.  Ultimately MPRIME's vision is to design a system that will help investigators to "get through the maize."  A team at Arthur Anderson is designing such a system.

We need closer coordination on grand proposals, so the same proposal is actually what NIH or NSF sees.  NIH is looking at  “just in time” applications. 

The "treaty" is on web.  The structure will talk about the “default”.  The default will recognize various criteria that determines which IRB should review which proposal; i.e. where the PI's primary appointment is; does the PI use health system data and facilities, etc.  The IRB sets the minimal standards.  For example, cancer center may have higher standards than other departments.  If the PI wants to use certain facilities they have to be approved by that committee.

ACTION:  Judy Nowack will provide copies of the "treaty".

Intellectual Property Policy:  James Hilton

Background:  A committee was charged by the President to study the U-M's current intellectual property policy as it applies to copyrighted works.  To help U-M faculty and staff understand their rights and responsibilities, a special committee has drafted a “Copyright Policy on Works Created at or in Affiliation with the University of Michigan.”

Hilton says the new policy is needed to preserve and promote the open exchange and access to ideas.  The policy recommends that the University should own copyrightable works that are specifically commissioned, created in administrative roles, the product of sponsored research, or involved the unusual investment of resources.   It recommends that faculty should own copyrightable works that are created at their own initiative with no unusual University resources.   It also has language prohibiting faculty from using copyrightable works, including those that are faculty-owned, to compete against the University while they still are employed by U-M.  Even in instances where the faculty owns the copyright, we would like the faculty to think about UM, and reserve the right of UM to use the faculty's intellectual property.

Copies of the "Copyright Policy" and "Sec.3.10. Ownership of Patents, Copyrights, Computer Software, Property rights, and Other" are attached.  The draft copyright policy can also be viewed at http://www.copyright.umich.edu./

Next meeting - Friday, April 12, 2002