TO: DATE: Bill Haltom, Chair Faculty Senate Ray Preiss, Chair Institutional Review Board April 17, 2000 RE: End-of-year Report FROM: The Institutional Review Board (IRB) entered the 1999-2000 academic year charged with implementing the Puget Sound guidelines for protecting human subjects. These guidelines were developed in 19921993 and became the primary function of the IRB in the 1994-1995 academic year. I am pleased to report that the review process continues to function smoothly, as this report documents. Response to the Faculty Senate Inquiry In September of 1999, the Faculty Senate inquired as to the role of the Institutional Review Board in monitoring research involving animals. After due investigation, The IRB concludes that the University of Puget Sound should develop and implement an Animal Care Board. This deliberative body is mandated by Federal statute and has as its primary mission the humane treatment of animals used as research subjects. Until this body is created, the IRB concludes that it has investigative and deliberative authority over the use of animals in research at Puget Sound. This conclusion is rooted in the Guidelines document developed in 1992 and approved by a vote of the faculty in 1993. That document specifies that the IRB is charged with protecting human and animal research subjects. Formal guidelines were posted on the Web Page in 1998. Pursuant to the inquiry regarding animal research, members of the IRB toured facilities in Thompson Hall. Following our visits, we were informed that funds were made available to remodel several rooms and update facilities. We also notified Wayne Rickoll of our concerns regarding security of the rooms housing reptiles. Because these modifications are underway, we will again tour Thompson Hall in September of 2000. At that time we will issue a report on animal care at Puget Sound. On-going Charges to the IRB Considering our activities this year, we have diligently pursued three charges from the Faculty Senate: (a) The routine activities of monitoring protocols; (b) Maintaining our presence on the World Wide Web; (c) Clarifying a policy for the ethical treatment of animals used in research. Routine activities: As a Standing Committee, the IRB is tasked with monitoring protocols, maintaining a system for managing records, and deliberating on policy questions. During the 1999-2000 academic year, most of our time was devoted to evaluating protocols. We formally approved 14 research projects and authorized two modifications of existing protocols. All deliberations are posted in IRB Committee Minutes. Because the Chair is often contacted with questions related to these deliberations, the Chair’s Notebook tracks all protocols. The Associate Deans Office is the repository of records, protocols, and final reports. Presence on the World Wide Web: The IRB established a presence on the World Wide Web in the Summer of 1998 (www.ups.edu/dean/irb/). Documents posted on the IRB Web Page include the revised IRB Guidelines document and various forms for protocol preparation. These forms can be downloaded. In addition, the Web Page includes the IRB policy on the Ethical Care and Use of Animals that was adopted in the Spring of 1998. We continue to add documents and links to resources that may assist student and faculty researchers. The IRB first established a presence on the World Wide Web in the Summer of 1998. Currently we post links to the National Institutes of Health Office of Extra-mural Research, as well as an array of on-line resources useful to active researchers and students enrolled in research methods courses or engaged in independent research projects. In addition, the page now includes a description of the activities of the IRB, a roster of IRB members and department IRB designates, scheduled IRB meetings, and a list of frequently asked questions. Informal feedback regarding the Web Page continues to be favorable. The Web Page is consulted regularly for forms and procedures, to resolve questions related to individual research projects, and as a guide for protocol preparation. We will continue to refine the Web Page as the needs of our students and faculty evolve. We are pleased to report that the Web Page has increased the visibility of the IRB and provides a useful resource. The Ethical Treatment of Animals used in Research. The policy regarding the Ethical Care and Use of Animals (adopted in 1998) is currently posted on the IRB Web Page. The IRB is not aware of any instances in which student or faculty researchers are engaged in animal research during this academic year. We do believe, however, that the university needs to be engaged in an on-going discussion of standards for animal care. This discussion will be initiated by the IRB (if so tasked by the Faculty Senate) in the Fall of 2000. Upcoming Agenda Items Based upon the progress made in addressing the charges given by the Faculty Senate this year, the IRB has identified the following goals for the next academic year: 1. Continue to monitor protocols and maintain and manage records for research involving human subjects. 2. Upgrade and refine the IRB Web Page with information appropriate for student and faculty researchers. 3. In concert with IRB department designates, develop a system of outreach and education that promotes IRB review as an integral part of the research planning process. 4. Report on changes to Thompson Hall related to animal care. I owe special thanks to IRB members for hard work at inconvenient hours: Roger Allen (Secretary), John Finney, Suzanne Holland, Mary Rose Lamb, Jane Moore (Community Representative), Katherine Wadsworth, Melissa Weinman, and Tom Wells.