1. Announcements/Minutes: The minutes of December s board meeting were approved as written,

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1 Institutional Review Board Minutes of Regular Meeting January 20, 2004 Members present: Brad Chase (School of Business), Jane Georges (School of Nursing), Bernadette Maldonado (Staff Rep), Daniel Martinez (Undergraduate Student Rep.), Donald J. McGraw (Administration), Ron Pachence, (College of Arts & Sciences Rep), Jacqueline Rychnovsky (Graduate Student Rep), Mary Scherr (School of Education), Allen Snyder (School of Law), Annette Taylor (Chair, Arts & Sciences, Psychology Department). Members Absent: Sandra Bibb (Community Member) Guest: Carole Huston (College of Arts & Sciences, Comm. Studies) 1. Announcements/Minutes: The minutes of December s board meeting were approved as written, Summary Reports, Continuation Reports, Modifications Pending and Approved, Full-Reviews, and Other Business: A Summary Reports: B. Continuation Approvals: Dr. Kenneth Serbin Fac A&S Alex: A Student Against Dictatorship. Approved: 12/29/03 C. Modifications Pending and Approved: D. Expedited Review Actions: Victor Sanders UG Biol. Dr. Curt Spanis Fac Biol. "Physical Fitness of USD Crew Subjects..." Approved: 12/10/ Drs. Reyes Quezada and Reyes Romo Fac Educ "Multiculturalism, Peace Education and Social Justice in Teacher Education." Approved: 12/10/03 (inadvertantly not seen when submitted in Sept.) Min S. Chung-Park Doc Nurs Dr. Jane Georges Fac Nurs "Pregnancy Prevention Intervention and Female Navy Recruits." Approved: 12/30/03 Page 1 of 5

2 Ms. Lori Waite Doc Educ Dr. Sue Zgliczynski Fac Educ "Implementing Student Learning Outcomes: The Link to Accreditation in California Community Colleges." E. Exempt Reviews: Nancy Carol Carter Fac Legal Research Center "LibQUAL+ Survey." Approved: 12/5/03 F. SDSU/USD Joint Doctoral Program Reviews: G. Full Reviews: H. Other Business: Dr. Taylor led a discussion regarding the Summer University Senate actions and implications for USD IRB relationship with OHRP and how we do our routine business. She informed the Board that although the Fall 03 Senate approved the motion resulting in an amendment (attached) to IRB policy changes, the Summer Senate developed, drafted, and brought this motion to the F03 Senate. Calling the Board s attention to Part II of the amendment, she stated that this section addressed the Scope of the IRB and only those studies fitting Part II, criteria I.A. through I.F. (pgs. 2-3) need to come before the Board for oversight. Dr. Georges asked Dr. Taylor to read this section for the minutes of record, Dr. Taylor agreed and read the appropriate section beginning with Part Two. Projects Requiring IRB Review. and ending with Part II, criterion I.F (pgs. 2-3). Before opening the floor up for discussion, Dr. Taylor asked that the minutes indicate that she found the language of the Senate s rationale to be quite demeaning to the work of this Board. In support of this, Dr. Georges quoted the following from the text of pg. 3 of the Senate rationale: The scope of the previous PHS policy, and of the CPHS s jurisdiction over projects involving human subjects, was persistently problematic. Dr. Georges stated that this was one illustration of many egregiously ambivalent statements contained within the document directed toward the Board and its work. Dr. Taylor, while drawing attention to each of the checkboxes on the FWA form (p.5), referred to a section of the Senate minutes from 9/11/03 where Dr. Lazarus was on record stating the following: Lazarus said the expanded scope of IRB oversight at universities is the result of research that was shut down at some universities when they weren t in compliance with federal regulations. Page 2 of 5

3 He noted his support for reducing the scope of the document, but cautioned that USD s IRB could become a test case. This scope is correct within the rules of the Belmont Report; however, it is not considered best practice by many research universities. Dr. Taylor opened the floor for discussion and asked the Board to focus its discussion around the scope of the approved Senate amendment. Dr. Huston took issue with Section 5 of the amendment s rationale, Additional Federal Requirements: Statement of Ethical Principles (p.6), and quoted the following: If passed, the proposed amendment probably would not require a change in the University s statement in this section of DHHS Assurance form. That is so because the amendment would explicitly refer to The Belmont Report as its primary source of ethical principles guiding its human-subjects research. She objected to the use of the Belmont Report as the sole reference for determining the University s ethical responsibilities to human-subjects. Dr. Georges, in support of Dr. Huston s objection, stated that the Belmont Report was a document with a specific philosophical goal whose principles were fashioned around that goal. She stated that there could be serious implications should the University use the Belmont Report as its exclusive guiding ethical text in matters involving human subjects. Dr. Taylor distributed her notes to the Board from a telephone conversation she had that same morning with OHRP Compliance Oversight Coordinator, Dr. Patrick McNeilly (attached). In summary, Dr. Taylor reported that, as a result of her conversation with Dr. McNeilly, the Board must draw the conclusion that non-federally-funded research projects do not need IRB review unless they fall under Part II, criteria I.A. through I.F. (pgs. 2-3), since the Senate amendment called for a change to the University s FWA from one standard of review to two, that of federally-funded research projects. Moreover, according to Dr. McNeilly, the decision on which box to check on the FWA is an institutional, and not an IRB decision (Taylor s notes, attached). In addition, Dr. Taylor stated that this section had serious consequences for the Psychology Department because Part II, criterion I.C. did not include behavioral tests or procedures as research in need of IRB review; in fact, this criterion required IRB review only for projects that involved the use of medical or biomedical tests or procedures or other invasions of the human body (p. 3, emphasis added). In addition, Dr. Taylor read a pertinent section from 4.F. of the amendment s rationale (p.5) to stress the omission of the behavioral sciences from research governed by the IRB: Although academics and professionals in some disciplines (for example, biology or medicine) may consider these definitions to have a fairly clear and in any event limited denotation, academics and professionals in other disciplines (for example, law, business, and social services) may properly consider these definitions to be exceedingly broad and potentially to cover most human interactions from which generalizations about human behavior, knowledge, or understanding might be made. Page 3 of 5

4 Dr. Taylor asked the minutes to reflect that she has brought this to the attention of her Department Chair, Dr. Ken Keith, and that Dr. Keith would put this issue on the next Department meeting agenda. Additionally, the minutes should include Dr. Taylor s interpreted commentary regarding Dr. Keith s input on this matter, which was that the omission of the behavioral sciences from the IRB policy impacted the entire Psychology Department and would be detrimental to department faculty and student research endeavors. In order to guide the discussion, Dr. Taylor made the motion, with Dr. McGraw seconding, that: a) the Board should emphasis the main flaws of the Senate amendment to the IRB policy; b) that she would then coalesce these points into a letter addressed to Dr. Lyons/Dr. Lazarus illustrating the implications for the University as interpreted by the Board; c) and that she would distribute the draft of the letter to the Board, waiting only 24 hours for feedback. The motion carried, As a result of the above motion, the Board s discussion focused upon the subsequent concerns: o Many Board members expressed confusion regarding criterion I.E in Part II of the amendment (p. 3) due to the ambiguity of the phrase responsible University unit. In addition, the Board expressed this criterion vaguely applied the term University unit, and the example was made using Graduate Studies as a unit versus each individual Graduate Program as its own University unit. This example illustrates a weakness in Part II, criterion I.E. because neither the criterion itself nor the remaining language of the amendment indicates which unit is the final responsible University unit that specifies the types of research projects requiring IRB oversight. Similarly, University units with different expectations and mandates regarding research requiring necessary IRB oversight would create inequity among colleagues throughout the various schools and college. o The Board expressed a lack of understanding pertaining to the order of criteria I.A. through I.F found in Part II of the amendment; in other words, whether or not the Board must implement a strict sequential order/list of the amendment s IRB oversight parameters or if one criterion can trump another in the sequence. If one criterion can trump another in the sequence, then many Board members believed that criterion I.C should be applied first to all research proposals whether or not the proposals fit the other amendment criteria for research projects requiring IRB oversight. o Whether or not the Senate is the governing body of the Board or if it serves the Board in an advisory capacity. o That the Senate motion to the IRB policy was flawed in its application/when implemented into practice. o That the Senate amendment contained inherent structural problems because the language restricted itself to full review projects but did not address projects under the categories of exempt or expedited reviews. Page 4 of 5

5 o The overt omission of the behavioral sciences from research governed by the IRB (see IRB minutes p.3), as behavioral research should be included in Part II, I.C. of the amendment or else the amendment would invalidate the work and progress by OHRP. o The ambiguity of the terms medical or biomedical tests and procedures in Part II, I.C. of the amendment (p.3), noting the lack of a substantial distinction between the terms medical and biomedical as well as the lack of clarity defining what types of procedures constitute a medical/biomedical test or a medical/biomedical procedure. o The University, by virtue of this amendment, changed its IRB policy but did not instruct the IRB to change its Federal-wide Assurance (FWA); thus, if research were conducted under the provisions of the new IRB policy, which Board members believed to be the case due to the low number of research submissions for the current academic year, it would be in violation of the University s current FWA on file. In addition, the Board thought that the following would be noteworthy for inclusion in Dr. Taylor s letter to Dr. Lyons/Lazarus: o In light of the fact that the Senate amendment restricts full review for only federally-funded research projects, research that does not occur with great frequency at the University, and specifies full review only for certain categories (Part II, I.A.-I.F., attached) the Board would: 1. Lose the ability to provide the University with thoughtful and expert insight involving the institution s ongoing research endeavors by members who compose an educational body of volunteers with diverse backgrounds, interest, and levels of expertise; 2. Lose frequent opportunities for provocative, stimulating, research-driven debates, an expectation consistent with the University s mission. Concluding this discussion, Dr. Huston offered to give Dr. Taylor case studies highlighting the problems addressed by the Board for inclusion in the letter to Dr. Lyons/Lazarus. Dr. Scherr asked whether or not the Senate amendment was effective immediately. Following a brief discussion resulting from her question, Dr. Georges made the motion, with Dr. Scherr seconding, that the Board continue to operate under the premise of the current FWA until it receives further instruction from the President. The motion carried, I. Adjournment: The meeting was adjourned at 1:47 pm. Respectfully submitted, Bernadette Maldonado IRB Staff Representative/IRB Administrative Support Page 5 of 5