Friday, May 7, 2004
4006 Fleming Building
9:00 a.m. - 11:00 a.m.
 

MEMBERS PRESENT: Lajos Balogh, Fred Bookstein, Katarina Borer (chair), Mary Haan, Rex Holland, Pinaki Mazumder, Jane Ritter (staff), J. Hunter Waite, Roscoe Warner, Jens Zorn

MEMBERS ABSENT: Steve Ceccio, Chris Jensen, Jillian Yant, John Younger,

GUESTS:  John Mather, Director, Office of Research Compliance Review
                Judy Nowack, Associate Vice President for Research

AGENDA 

• Approve revised March 12, 2004 minutes
• Review and approve April 9, 2004 minutes
• Accreditation– John Mather, Director, Office of Research Compliance Review
• Comments from VP Ulaby – Jane Ritter
• Final meeting of 2003/2004 academic year
   

ACTIONS

1.          Approval of the minutes.

Revised March 12, 2004 RPC meeting minutes were distributed for review. Information about the second STPP task force needs to be added and will be sought from Lee Katterman. This information will be inserted in ACTIONS section under point 3, at the end of the text marked by third bullet. The minutes as amended were approved.

Minutes of the April 9 RPC meeting were distributed for review. The following changes were entered: In ACTIONS 2, the whole first sentence in point (1) was underscored; in ACTIONS 3, the sentence on 1968 UM policy was changed to include nonacceptance of unreasonable restrictions on publication; a sentence on end-use criterion was deleted; a sentence was modified to read "UM by policy may accept some classified research"; and a sentence was qualified with "At the time the Regental research policy was approved". The minutes as amended were approved.

2.          Presentation of Human Research Protection (HRP) by John Mather and RPC discussion

Dr. Mather gave a PowerPoint presentation on the University of Michigan commitment to institutional accreditation by Association for the Accreditation of Human Research Protection Program (AAHRPP) and the steps taken toward that goal so far. The main points presented were that:

• UM has established and Office of HRP (OHRP) under the directorship of Dr. Mather. Its goal is to prevent failures in human subject protection that have caused costly shutdowns of research at several institutions (University of Pennsylvania, Duke, Johns Hopkins University and a few others).
• The accreditation entails institutional commitment to improving subject protection to which end UM has launched PEERRS educational program, M-PRIME (Program for Research Information Management and Education) gateway for integrated IRB approvals, established OHRP, and is working toward institutional accreditation by AAHRPP.
• Accreditation program is voluntary, and so far 9 institutions have applied. Five received full, and 4 received conditional accreditation. This program is confidential. UM is aiming for January 2005 application and is anticipating March 2005 site visit prior to approval.
• Benefits of accreditation include prevention of research shutdown, improves human research protection program, heightens ethical standards and increases research integrity, and instills public and sponsor confidence and trust
• Accreditation standards require not only adherence to existing SHHS and USDA guidelines but best research practices beyond the minimum
• UM is currently self evaluating existing policies, IRB operating procedures. After standardizing and correcting any deficiencies, UM will apply for accreditation. If the text meets AAHRPP expectations, a site visit will be arranged. A report will then be sent to Accreditation Council for approval. A report will be sent to UM within 30 days of site visit, and UM will have an equivalent amount of time to respond to the report

RPC discussion of Dr. Mather's report focused on the following:

(1) Standardization of IRB applications through a single M-PRIME portal may produce greater efficiencies in the application process, where currently minor protocol revisions sometimes delay approvals for weeks or months. M-PRIME will integrate applications to all 5 IRBs and also to GCRC, Cancer Center, use of isotopes and the like. Vice President Nowak explained that an IRB Council is currently examining some of these issues. The Council is seeking additional faculty members.

(2) Cost to benefit and risk to benefit ratios of the accreditation process and in IRB decisions were questioned. The admission was that this is a complicated and perhaps inadequately developed area.

(3) RPC members (Haan, Borer) expressed hope that some procedures will accept feedback from researchers especially as they mandate actions that do not necessarily increase subject safety, but greatly increase investigator paperwork. Issues in question are requirements for data safety monitoring in observational studies, requirements to file adverse events in such studies in the event of coincidental death, requirements for presence of an MD in submaximal treadmill tests of healthy older subjects etc. Rather than encouraging fear in investigators who do whatever requirement is mandated by IRB, procedures could be made less cumbersome by accepting some feedback from the investigators.

(4) UM research community exists in a distributed environment. IRB sometimes err on the side of extra safety and are risk averse. UM is obligated by law to follow federal regulations, such as the FDA requirement for filing of adverse events reports. Some regulations are 20 or more years old and may not reflect current research needs.

(5) Responsibility for safe conduct of research rests on the individual. While accreditation may reduce the risk of legal liability, it will not prevent. UM backs the investigators with legal assistance and indemnity.

3. Comments from VP Ulaby – Jane Ritter

In the absence of Vice President Ulaby, who was at Rutgers University in connection with assumption of his new Vice Presidential appointment there, Ms. Ritter expressed thanks to the RPC members and Katarina Borer who has chaired RPC during the past two years, for a good year of significant accomplishments. VP Ulaby expressed his appreciation for RPC assistance with several policies, particularly the passage of Research Professor title change, as well as with COI/COC, data ownership, intellectual properties, STPP, and for the review of PEERRS.  Ms. Ritter presented RPC members with a cake, which was enjoyed by all present.