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DOCUMENTS OF THE GENERAL FACULTY
ANNUAL REPORT OF THE RESEARCH POLICY COMMITTEE OF THE GENERAL FACULTY FOR 2007-2008
The annual report of the Research Policy Committee of the General Faculty for 2007-08 is reproduced below.
Sue Alexander Greninger, Secretary
The Faculty Council
C-11 Research Policy Committee
During the 2007-08 academic year, the Faculty Council’s Research Policy Committee (membership listed at the end of this report) elected to investigate questions surrounding the institutional review board (IRB). Several committee members had heard frequent complaints from both faculty and students that certain aspects of the IRB review process limited the research mission at The University of Texas. We undertook an assessment of the validity of these complaints and compiled a series of recommendations that aim to improve the process.
Several people generously accepted an invitation to meet with us as we gathered information, and our investigations into the workings of the IRB process were greatly assisted and informed by these discussions. Guests (with their affiliations) are listed below in the order of their attendance at the committee meetings:
The major issues that we identified along with our recommendations are given below.
- Jean Germain (Human Research Participants Program Coordinator, Office of Research Support)
- Patricia Levin (IBC Program Coordinator, Office of Research Support)
- Justin McNulty (IACUC Program Coordinator, Office of Research Support)
- Lisa Leiden (former Director, Office of Research Support and Compliance; now Associate Vice Chancellor for Research and Sponsored Programs, Office of Research & Technology Transfer, UT System)
- Judith H. Langlois (Associate Vice Provost, and Charles and Sarah Seay Regents' Professor of Developmental Psychology)
- Mark D. Hayward (Chair, Director, Population Research Center, and Centennial Commission Professor of Sociology)
- Jody L. Jensen (Chair, Institutional Review Board, and Professor, Department of Kinesiology and Health Education)
- Brian E. Roberts (VP for Information Technology)
- Susan W. Sedwick (Director, Office of Sponsored Projects, and Interim Director, Office of Research Support)
Proposal Review Workload for the IRB Board
Many complaints focused on the perception that the review process is slow and cumbersome. It is clearly the case that the number of proposals submitted for review is higher now than it was a few years ago, and the workload only continues to increase. This increase is becoming especially acute since more and more students are being encouraged to conduct research, and their proposals differ fundamentally from faculty proposals because the time for submission, review, implementation, and completion is so much shorter (e.g., an academic year for some of the honors thesis work as compared to several years for a faculty project). An undergraduate proposal that is stalled in the review process is certain to become a project that stands no chance of completion. In addition, the number of proposals on biomedical topics is also growing and will likely continue to increase,
especially as discussions for a medical school advance. Given the high workload for such a small committee, it seems that the burden placed on Board members is becoming onerous and unreasonable.
Exempt, Expedited, and Full Board review
- It is recommended that the IRB review committee membership be expanded to include more members so that the increased workload can be better managed in a more timely fashion. A larger committee can also delegate specific topics to specialized subcommittees.
- It is recommended that a separate IRB review committee be established for student proposals.
- It is recommended that a separate IRB review committee be established for biomedical proposals.
Approval for exempt projects appears to be unnecessarily slow. Part of the delay is perhaps due to new applicants not knowing exactly what sort of research is included under the “exempt” classification, but it seems to us that ORS could streamline the process for exempt projects so that the turnaround is much faster than the current two-four weeks. The distinction between expedited and full board reviews could also be better explained and also perhaps streamlined.
- It is recommended that ORS investigate ways to fast track exempt projects. Some suggestions include assigning a staff member and/or a subcommittee of the full board to review these applications.
- It is recommended that ORS investigate ways to fast track expedited proposals so that these proposals receive a quicker turn around than the full board proposals.
The committee heard many complaints about the current state of the ORS website, ranging from basic questions about its organization, to the inability to readily find needed information. We understand from ORS staff that the website is undergoing a much needed revision. Given the importance of using the web to disseminate information, we feel that bringing the website up to date should be ranked as a very high priority for ORS. Users should be able to readily navigate the website, use the “search” function to easily find answers to the most frequently asked questions, and see examples of successful applications. The website should have its FAQ updated and expanded by tracking which items or topics receive a large number of search hits.
On line Submission and Tracking System
- It is recommended that ORS undertake a full review and revision of its website.
The staff and former director of the Office of Research Support spoke very highly of a new software program, eProtocol, which they are testing for the online submission and tracking of proposals. Unfortunately, ORS did not thoroughly test the program before purchasing it, and this was a glaring mistake especially in light of the sensitive sorts of data involved in IRB research. VP Roberts reported that this particular program is a security sieve, and the vendor has proven to be less than responsive to requests for programming fixes.
ORS “Mission Creep”
- It is recommended that ORS work closely with ITS on this and all future software purchases so that they take full advantage of in-house software testing before the purchase order is signed. If the eProtocol software vendor is unable or unwilling to fix the outstanding issues, UT should seek legal recourse to attempt a refund of the funds that were spent on this software program.
Perhaps the most troubling complaint that we encountered can best be described as “mission creep.” We received many complaints that ORS staff went beyond their duties when they told PIs what they thought was or was not appropriate about their proposed research design or sometimes even the research topic itself. This sort of micromanaging of the proposal process appears to step far beyond ORS duties and is viewed by some faculty to represent a gross over interpretation of the guidelines. Certainly, all PIs must adhere to the federal regulations, but there must be an understanding that the duty of the ORS is to facilitate the research mission of the faculty and students. A successful dialogue between ORS and the faculty and students is a critical foundation for conducting research at UT Austin, and it seems to us that the culture of the office should be examined so that its mission is clearly articulated.
- It is recommended that ORS organize a meeting that will review how to best address the issue of “mission creep.” The itinerary for the meeting should be planned in consultation with members of the IRB Advisory Board and Institutional Review Board. A cross-section of faculty and students should be invited to the meeting, and the meeting should include staff from ORS and members of the IRB Advisory Board and the Institutional Review Board.
Faculty Council’s Research Policy Committee 2007-2008
Crismon, Miles L. 2006-2008 interim dean and professor, pharmacy
Franklin, Cynthia G. S. 2006-2008 professor, social work
Kappelman, John W. 2006-2008 professor, anthropology, chair
Keckler, Stephen W. 2007-2009 associate professor, computer science
Lewis, Marc S. 2006-2008 associate professor, psychology
Poindexter, Paula M. 2007-2009 associate professor, journalism
Riley, Peter J. 2007-2009 professor and associate dean for research, physics
Stein, David S. 2006-2008 associate professor, biological sciences
Straubhaar, Joseph 2006-2008 professor, radio-television-film
Faculty Council Appointees:
Bettinger, Tawny L. 2007-2008 assistant professor, pharmacy
Cary, Lisa J. 2007-2008 assistant professor, curriculum and instruction
Two Research Staff:
Loucks, Robert G. 2007-2009 senior research scientist, economic geology
Wenz, Robert P. 2006-2008 research associate, molecular genetics
One College or School Administrator:
Charbeneau, Randall J. 2007-2008 associate dean, engineering
Acee, Taylor W. 2007-2008 Graduate Student Assembly representative
London, Mara R. 2007-2008 Graduate Student Assembly representative
Sudderth, Meggie 2007-2008 Senate of College Councils representative
Rodriguez, Victoria ex officio vice provost and dean of graduate studies
Sanchez, Juan M. ex officio vice president for research
John Kappelman Chair
Professor, Department of Anthropology
The University of Texas at Austin