Friday, April 15, 2005
4006 Fleming Building
10:00 a.m. – 12:00 p.m.
 

MEMBERS:  Mary Haan (chair), Toni Antonucci, David Blair, Michael Combi (SACUA rep), Rex Holland, Josephine Kasa-Vubu, Jane Ritter (staff), Susan Shore, J. Hunter Waite, and Elizabeth Young

ABSENT: Anika Ball-Anthony, Wendy Bank, Jack Li, Pinaki Mazumder, Carol Persad, and Roscoe Warner

GUESTS: Al Franzblau, Judy Birk, John O'Shea, and Ray Ruddon

OVPR:  Judy Nowack
 

1.         Approve minutes from March 18, 2005 meeting                      Committee
                    Approved by mail vote.

2.               Interdisciplinary Research - Case Studies from School of Medicine
            Presentation by Raymond Ruddon
            Professor, Department of Pharmacology
            Senior Associate Dean of Research and Graduate Studies, Medical School

Dr. Ruddon was invited to give the committee an overview of interdisciplinary research examples between the School of Medicine (SOM) and various other biomedically-related units. Dr. Ruddon presented a slide show entitled, "Research Initiatives in the SOM Collaborating Units" that addressed different centers in the SOM and specific groups devoted to interdisciplinary research. The Task Force on Research Enterprise (TFORE) is part of the Office of Research and Graduate Studies within the SOM. The membership of TFORE can be found at http://www.med.umich.edu/medschool/orgs/researchcommittees/tfore.html and consists of faculty from the SOM. A list of the members is included with these minutes. One of SOM T-FORE's subcommittees is looking at the core facilities across campus and has so far identified 65 with interdisciplinary focus.  There are 4 other subcommittees with different topics.  Dr. Ruddon has created an Industry Advisory Board – bridges to industry.  There are 4 funded Research Interest Groups so far, one example is Gary Freed's (Pediatrics) group focusing on health services research which includes faculty in Law and Business.  SOM-ORGS also has RFAs for planning grants and will fund 3-4 this year.  One SOM T-FORE subcommittee is looking at the impediments at the levels of the different schools/units and at the University level.  They are looking at what the barriers are and think a culture change within SOM is required.  Impediments include the differences in time devoted to research v. teaching and tenure issues such as credit for promotions.  We need to make sure people get credit and get motivated.  M. Haan sent out the URL for the NAS report on Interdisciplinary Research.  We need to incorporate training on interdisciplinary research for undergraduates and graduates.  There are some training grants that do this already.  Dr Antonucci pointed out that excellent, longstanding, examples of interdisciplinary research and curriculum already exist in the social sciences and particularly in the Institute for Social Research. Dr. Haan also pointed out the existence of several large-scale IDR collaborations in Public Health. The specific barriers that exist to encouraging IDR may vary by discipline. The U of M should take care to include a broad perspective on this issue rather than confining it to a narrower group of disciplines.

Dr. Ruddon thought that UM would need to have fairly major effort to identify areas of research and group them. Easier access to faculty research topics and funding would be helpful in this. At present, the PRISM database affords this capacity to a degree. 

Dr. Haan:  What would you recommend RPC look at in terms of research policies and how they affect the IDR goals?

Dr. Ruddon:  Barriers need to be addressed; cultural differences between colleges; reward system needs to recognize the importance of IDR; need someone at national level working with other universities; we need to figure out how to locally fund at least seed grants and translational seed grant is small step.  E.g.:  nanotechnology being facilitated by OVPR with internal funding.  We need to think about other, additional ways to fund these things.  From industry experience, they do better at team building research.  We need to do a better job.  BREM Ctr. example.   We need to find ways to make this easier, internal funding. 

AGENDA:  Interdisciplinary Research will be on the May RPC agenda.

ACTION:  The RP Committee's goal is to draft a report on IDR recommendations in the fall.  Additional input from successful IDR groups, such as in public health or social sciences, is needed to broaden our perspective on this issue. There will be future opportunities to comment on this issue.  J. Nowack mentioned a faculty task force led by John Godfrey and their report.  She will try to get a copy of this report for the Fall meetings.

3.     IRB BehavSci - Discussion                                                     Judy Birk
                                                                                                 Al Franzblau
                                                                                                 John O'Shea

The following questions were posed to the guests from IRB Behav/Sci and Health:

a.     Should IRB Health and BehavSci resources be increased to support an investigator education program similar to IRB MED?

4/15:  Could be area of conflict w/o education of faculty.  What should support look like? 

J. O'Shea:  would certainly help with eResearch and classroom research.  All involved in research need a level of training and competence to deal with Human Subjects Research.  Many issues have to do with student research.  In last 4 yrs, UM has changed systems three times.  The new system will be easier for people to use and coupled with PEERRS training and additional outreach, should help. 
A. Franzblau:  IRB Health/Behav Sci made some changes in student internship and Dr. Franzblau met with many faculty to communicate new policy.  Med School has different methods to communicate: there are FTE in SOM devoted to faculty education.  There is a need for IRB Health/Behav Sci to educate users and provide in-person continuing education for members of the IRB as well. 
E. Young:  is it possible for IRB Med and Health/Behav-Sci to share the SOM faculty education staff? 
J. O'Shea/A. Franzblau:  This would not work: the Med School person because the areas are too different.  But person in IRB Health and BehavSci would be able to share within the non-SOM groups. 
M. Haan:  additional education would benefit everyone – in Med School.  How do you think we could do this?  PEERRS is great but can’t do everything. 
A. Franzblau:  Med school has CE type activities, they send out broadcast type announcements, have an hour or so, talk about pertinent issues – mostly traditional face-to-face didactic activity.  This is the kind of thing that IRB Health/Behav Sci needs. 
J. Birk:  UM has a regulatory obligation to provide education to IRB board members on changing regulations, etc.  Only mechanism currently is to carve out 10-15 minutes in board meetings but can’t always do that.  It would be preferable to have formalized process to develop content to be given multiple times.  OVPR could do a joint program with Med School to develop generalized content and then to each IRB to develop topical. 
J. Nowack:  Chuck Kowalski has been tasked with this topic – what types of outreach on this side of campus and discussions with IRB MED on what happens.  He is to come back with germ of framework.  RPC would like to hear about that.

b.     Should there be increase in faculty compensation or release time for work on IRBs?

A. Franzblau:  Med School is independent and can dictate their own budgets.  For IRB Health/Behav Scii there are too many departments on campus with different burdens – cannot have one policy that fits all.  For Dr Franzblau personally, OVPR has never communicated with his chair on release time, or compensation.  It is challenging to find people who will be willing to fill these roles.  John finishes at end of August and Al next year – has concerns about who will fill their roles because the burdens of the position are so great that many faculty will decline.
J. O'Shea:  there is financial incentive and personal commitment to Human Subject research protections.  Next chair is funded on 'soft money' and chose effort given to IRB.  There is not enough time for IRB Chairs to attend the necessary policy level meetings.
A. Franzblau:  There are 4 co-chairs in IRB Health/Behav Sci. Dr Kowalski has assumed leadership role on policy issues – he has the interest and the time and the dental school allows him to spend the time.
M. Haan:  This is an ad hoc fix that happens to work well (Chuck to work on policy) but there is no consistent recognition of the effort level and the need for release time or compensation. 

c.      What are examples of ways in which study review processes, sources and burdens have changed recently? Does this imply a change in organization or resource allocation for IRB Health and BehavSci?

A. Franzblau:  eResearch is coming along; data shown last meeting is accurate reflection of what has been going on the last few years.  It is hard to predict what the workload will be once it gets going – eResearch applications are coming on in mid-June – if there were an opportunity to come back with newer data, that would be helpful.
J. Birk:  We will standardize submission across campus, for IRBs and investigators.  Currently, to renew IRB app, you can also modify it at the same time.  In eResearch, this will require two separate activities.  This will be a large volume increase in the IRB Health/Behav Sci office and will have a huge impact on the office.  For example, adverse event reporting will change across the University; things currently bundled will be unbundled.  For IRBs, enormous change in workload and volume. 
M. Haan:  any plans for increase in funding? 
J. Birk:  not known at this time. 
J. O'Shea:  hopeful side is that if you have more accurate apps to begin with, they will move faster through the system.  There may be more items and activity but time required to cycle back will decrease. 
J. Kasa-Vubu:  There is a big advantage for an investigator since they will know where they are in the process and not waiting for campus mail. 
J. Birk:  eResearch will be more transparent than current system or Med School system.
M. Haan:  Do we wait for more information before we prepare the RPC report?
J. Birk:  what we present today will be "legacy" system and eResearch will be the new system.
E. Young:  think this will be a steep learning curve for investigators.
A. Franzblau:  Why are people willing to serve and what is appropriate way to compensate people who serve as chairs or co-chairs?  Not a simple answer.  There needs to be some consideration and openness with OVPR – if IRB Health/Behav Sci stays in OVPR.  OVPR needs to become more actively involved in discussions with chairs and deans regarding compensation and release time. 
J. O'Shea:  There would be a positive benefit to have a wide range of disciplines involved in IRBs.  Such a strategy almost serves as educational tool.  There is a need to come up with way to guarantee wide range of disciplines/departments/units to serve on the IRBS in order to allow adequate understanding of the science.
M. Haan:  OVPR should make this a priority in communicating with deans, etc.  Not just like other service committees – requires a lot of time and education.
A. Franzblau:  For regular members, the service load is not that bad.
J. O'Shea:  The burden is greatest for chairs and expediting chairs.

                     d.     Should a routine survey of faculty experience with IRB be instituted as part of the application process and during annual renewal    cycle for all investigators with new or existing protocols?

J. O'Shea:  IRB could have conflict if we knew who was filling out the survey but the information would be useful.  When we have better tracking with eResearch, we will have 2 sets of data, one the e tracking and the other the responses.  It would be better to do it at one time and send to everyone who’s submitted in the last 2 years, for e.g.. There may be outliers.
Dr. Haan:  Outliers are the grumpy faculty phenomenon – if we make it voluntary we may only hear from ones with bad experiences.
J. O'Shea:  It should not be tied to applications.
E. Young:  People who are unhappy are the ones who will respond.
M. Haan:  Happy people won't respond.
J. Birk:  OVPR is talking with people who do this type of research and know how to work with this.
A. Franzblau:  IRB MED just did this.  The survey was too long.
J. O'Shea:  Responders could be rewarded with guaranteed expedited review next time.
M. Haan:  A routine survey sounds good but idea that people with bad experiences will respond (computer-weak).

4.               Comments on the Conflict of Interest documents.                   Committee

Request from SACUA for comments.  RPC looked at this issue last year.  Policy looked at comments from Woolliscroft Committee (who spoke to RPC last year.)

J. Nowack:  "Meat" of package is that it will be the unit's responsibility to implement the policy as they know best what activities are important and what would be out of line. 
E. Young:  9-month and 12-month appointments are different.
J. Nowack:  There is some slight room for vetting/movement but these documents have been looked at a lot.  They must be issued by President and Regents to make official SPG.  Then they will be sent to the schools and colleges to implement.  Implementation will be lots of work for schools and colleges and for OVPR to assist. 
M. Combi:  The policies are perceived at SACUA as lots of lists of what you shouldn't do but not as much guidance as to what you should do.  There are lots of provisos that direct how you can do your work. 
J. Nowack:  is hopeful that units will provide guidance because it will dovetail with COI and Sponsored Projects Policy.  More faculty will have to know how their projects work within established policies.  OVPR is thinking about interest groups, websites, resource materials, what other institutions do. 
M. Haan:  what are implementation plans that OVPR has?  Vis-à-vis units/schools. This seems like an unfunded mandate for units.
J. Nowack:  OVPR's responsibility now is for OVPR's units.  The mandate is coming out of President and Provost's office.  There is some uncertainty about how units will be helped by whom, what kind of resources, what help is available.  It will apply to everyone in the CFO's office.  OVPR has both research and service units.  She cannot answer how unfunded mandate will be implemented.
E. Young:  e-mail brought up issue of review above unit/dept?
M. Combi:  perhaps a SACUA committee to provide oversight.
M. Haan:  do we want to make that recommendation?
E. Young:  There should be appeals process.

SUMMARY:  This committee accepted this document last year.  Would we like to add that we recommend that there be an appeals process supra the unit, instituted as part of this policy for individual faculty, at the Provost level?

T. Antonucci:  perhaps way to skip college level if you know there is a conflict?
M. Haan:  what is above school/college level?
J. Nowack:  all schools and colleges report to the Provost.  OVPR is appeals location for COI and sponsored projects.  For COI/COC, all rolls up to Provost.

The committee passed the following recommendation to SACUA:
"the RPC recommends that an appeals process be instituted whereby individual faculty can appeal unit decisions regarding COI/COC to the Provost level".

5.         General Discussion                                                                                    Committee

The May agenda will include discussion on Interdisciplinary research, led by H. Waite, in M. Haan's absence.  J. Nowack reminded RPC that she will present the Annual Experience with Regental Research at the May meeting.  There will be no meetings in June, July or August.

One goal for the fall is for RPC to write a draft set of recommendations on the impact of changes in Human Subject Research on faculty researchers.

6.         Next meeting:          May 20, 2005
                                              10:00 a.m. – 12:00 p.m.
                                              4006 Fleming Building       

7. AGENDA FOR NEXT MEETING

• Continuation of IDR discussion

• Regents report on research   (Nowack)

• Data ownership (?)                 (Parnes)