The notes were approved with minor corrections.

Fawwaz Ulaby said he would like to look into the question of how well does University of Michigan compare with its peers with regard to participation in national policy-setting groups. He said he is interested in how we can be influential in policy setting – this is another level of service, beyond membership in professional societies. The group reviewed a list of rankings of seats, by university, on national advisory boards. UM is fifth on the list. The first four on the list are Harvard, MIT, Stanford, and UC-Berkeley, in that order. Committee members said that they were impressed with this ranking, though the question was raised of how we can intervene and influence the process so that more UM faculty do get to serve on these boards. Fawwaz Ulaby said we need to affirm within the University that this is something we value. He said the deans are going to begin recognizing it more. In addition, the Washington office can play a role by watching for when openings on committees arise.

Marvin Parnes said the discrepancy between the numbers and our perception that there are fewer representatives from UM may be attributed to how we utilize (within the University) the individuals who are advisory board members. He also noted the Medical School’s recent reception for Institute of Medicine inductees as an example of what could be done to celebrate such appointments. Lloyd Johnston said there appear to be two issues: first, how do we influence the process, and second, how do we recognize our awardees.

Richard Ford pointed out that all faculty on campus will have received a memo from either Fawwaz Ulaby and Gil Omenn jointly (for the Medical School) or from Fawwaz Ulaby alone (the rest of the campus), regarding the importance of protecting human subjects and obtaining the proper approvals for research involving them. Judy Nowack has been the point-person on human subjects issues. Fawwaz Ulaby briefly summarized recent national issues with regard to gene therapy research, and efforts to keep investigators here apprised of these important issues. Judy Nowack described the evolution of the UM human subjects review system. In the context of a burgeoning research volume, in 1995 the system was reconfigured down to three IRBs (from twelve). She said she believes there is a growing recognition that this is a vital endeavor. Nowack said an educational program on human subjects research is being designed. She said the standards for this program have been set by OPRR and include that it be ongoing, mandatory, reach all investigators, and have a certain minimum content. Part of the educational program will provide information to instructors on what, in coursework, is research and what is not. There was discussion of the differing views across disciplines of what constitutes research. Nowack said this is a system that will need to grow by modules, and it will be brought to RPC for comment.

There was discussion of how non-compliance problems have affected institutions such as University of Minnesota. Such outcomes can also affect other institutions through changes in regulations. Marvin Parnes said these instances point out that science is a human endeavor, subject to human judgements and thus there is always some measure of risk. He said the public needs a better understanding of research beyond just what is portrayed in the media.

Robert Todd said plans for the Life Sciences Corridor are proceeding. UM and its partners from around the state will be submitting a large infrastructure proposal. He said the President, Lee Bollinger, is working on identifying a candidate for the directorship.

To introduce the topic, Judy Nowack gave some of the history behind the current Regental Research Policy, and the long involvement of the Research Policies Committee with these issues. She recounted back to October 1967 when 300 protesters occupied the Fleming Building asking for an end to classified research. Classified research is defined as research where at least one individual on the project needs to have a federal personnel security clearance. In 1968, the Research Policies Committee recommended four criteria against which classified research should be judged. These criteria were approved by the Regents. In 1971 a separation was made between classified and proprietary research. A committee was formed to rule on proposals for classified research; if no agreement was reached, the proposals would go to RPC for a decision. In 1984 the debate was reopened on whether to accept any classified research and there was a blue ribbon commission on the matter. The outcome was the policy we have today which calls for balancing decisions in cases where, due to a proposed restriction, the principles of open scholarly exchange and academic freedom are in conflict. Judy Nowack said that people at other institutions are often impressed that our policy provides the ability to weigh situations in which principles conflict.

Marvin Parnes introduced Elaine Brock. He said most people don’t realize how many proposals DRDA actually negotiates with industry. Parnes noted that Brock has been involved in these negotiations for 15 years, has served on national committees, and has helped to set the norms in this area. Judy Nowack said the numbers in the FY99 report now before RPC represent only the non-standard clauses that DRDA has not been able to negotiate out, and it is a tribute to Brock and her staff that there is so much success in negotiating out non-standard clauses. The items in Table 7 of the FY99 report represent a balancing decision that it is in the interest of the institution to go forward with the research.

Elaine Brock said that almost all contracts proposed by industry come in with publication restrictions, and DRDA is very successful at negotiating them out. She said now there is a surprising trend for publication restrictions to come from places other than industry, such as the National Academy of Sciences. This particular restriction is unusual because it's not that they don’t want publication of the results, instead they want a statement added to the publication saying they either disagree or agree with the findings.

Brock said that likely due to concerns about economic security, more activity is now being seen with regard to export controls and restrictions on foreign nationals. Marvin Parnes cited the recent Los Alamos scandal as a contributing factor to the requests for this type of restriction.

In discussing other recent developments related to the policy Brock said that an accommodation has been added for multi-center trials that would allow for multi-center trial data to be published before that for individual sites.

Tim Killeen asked whether an increase has been noticed in direct gifts to faculty as a way to circumvent contract negotiations. Elaine Brock said the fact that companies want patents often prevents this. Marvin Parnes said DRDA has worked with staff in Development and with unit administrators to educate them about this possibility and what to do when it happens.

The group discussed the data in Tables 4 and 7 of the report. It was noted that almost half of the restrictions had to do with foreign nationals. Marvin Parnes and Elaine Brock noted that it is possible that our policy is keeping us from accepting contracts where the restriction is simply requiring compliance with the law. Richard Ford said he would like to have the committee discuss the export control issue at a future meeting.

Richard Ford said that at the next meeting RPC will have James Hilton as a guest to discuss the issue of media rights. He asked that committee members read the Media Rights Task Force Report (enclosed with this agenda) prior to the next meeting. Ford said he views media rights issues as translating into intellectual property issues, including the question of what in the current environment constitutes copyright. Ford said he also sees this as relating to the issues of note-takers in classes, classes on the internet, and articles being published on the internet.