ࡱ> EGD bjbj:: 0.PP{{{{{  OQQQQQQ"^Q{Qw{{fwww{{OwOww{{w`+=kU"wO|0wwwww{3 A:   E-mail sent Thursday May 8, 2014 Dear Mr. Beeson, I am sending you this e-mail in your capacity as Chair of the Board of Regents of the University of Minnesota and am copying executive director Brian Steeves with the request that his office distribute this e-mail to the other members of the Board. As you know, the University of Minnesota has been confronted with serious criticism from within and outside the University about how it has dealt with the death of a research subject (Dan Markingson) in a clinical trial in one of its university hospitals, and how it has handled concerns raised about research practices, and repeated request for a further investigation. With Raymond Devries, Alice Dreger, Jerome Kassirer, Susan Reverby and Lois Shepherd, I have written in October of 2013 to the University of Minnesota Senate, requesting that the University set up an independent and publicly accountable inquiry into the Markingson case, into issues raised by this and possibly related cases, and into how the University has dealt with the issues.This letter was co-signed by more than 170 US and international scholars of research ethics, medicine, health law, and other relevant disciplines (see attachments). In part in response to our letter, the University of Minnesota Senate overwhelmingly supported a motion to set up an independent inquiry. In the text submitted to the Senate, and in the public discussions, explicit references were made to the Markingson case. The case and the ongoing controversies surrounding it were put forward as the rationale for setting up an inquiry. Yet, the text of the motion was vague, and referred to the need to review current policies and practices. In the end, the University decided to post a Request for Proposals on its contracting website, asking for proposals to evaluate only current practices and procedures. We have recently written a letter (attached letter April 23) to the Chair of the University of Minnesota Senate (President Kaler) and to the Senators, indicating that we disapprove of the very narrow scope of a 'Request for Proposals' . We have no confidence in this narrow inquiry, also because of how the reporting and selection of the committees members is organized. We received a letter in response to this April 23, 2014 letterby the Vice-President Research and the Chair of the Faculty and Senate Consultative Committees of the University(attached letter April 29). The response fails to even acknowledge our question about the exclusion of a review of the Markingson case, rejects our and other colleagues' criticism of the procedure that is being used and of the narrow scope of the review that is being set up, and simply invokes accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) to support the claim that the University research practices are beyond reproach. Yet, this organization only looks at standards and procedures, and has explicitly stated in response to an e-mail I sent to the president and CEO of AAHRPP that the organization does not conduct any investigation. In other words, this accreditation process sticks to a narrow review of standards and procedures, not at what is actually happening in the context of research. The inquiry the administration is now setting up would thus be a mere duplication of what is already being done. With this e-mail, I would like to inform you, on behalf of my colleagues, of our disapproval of how the university administration is now proceeding and urge you to explicitly ask for the establishment of a more independent inquiry with a wider mandate. We can only improve research standards and procedures if we are willing to learn from what may have gone wrong. If there is no reason to be concerned about current and past research practices, there is no reason to refuse a thorough and fully independent inquiry of what may have gone wrong in the Markingson case. Yours sincerely, Trudo Lemmens (LicJur, LLM bioethics, DCL) Associate Professor Scholl Chair in Health Law and Policy Faculty of Law, University of Toronto 39 Queen's Park Toronto Ontario M5S 2C3 Canada tel. 416 978 4201 e-mail: trudo.lemmens@utoronto.ca faculty webpage: http://www.law.utoronto.ca/faculty/lemmens SSRN publications: http://ssrn.com/author=99811 !"24- / PQRSw=?wx̽̽̽̽̽̽̽̽wdQMhr]%h&thr]B*CJOJQJaJph%h&thr]B*CJ OJQJaJ phh&thr]B*OJQJph%h&thr]B*CJOJQJaJph%h&thr]B*CJOJQJaJph!h&thr]B*CJOJQJphh&thr]B*OJQJph%h&thr]B*CJOJQJaJphhr]B*CJOJQJaJphh&tB*CJOJQJaJph!"34. / QS>?xgdr]@&gdr].:pr]/ =!"#$% 666666666vvvvvvvvv666666>6666666666666666666666666666666666666666666666666hH6666666666666666666666666666666666666666666666666666666666666666666666666662 0@P`p2( 0@P`p 0@P`p 0@P`p 0@P`p 0@P`p 0@P`p8XV~ OJPJQJ_HmH nH sH tH @`@ wLNormalCJ_HaJmH sH tH DA D Default Paragraph FontRiR Table Normal4 l4a (k ( No List 88 &tapple-style-spanP^P &t0 Normal (Web) XDYDCJOJQJ^JaJ<Y< '50 Document MapOJQJB/!B '50Document Map CharOJQJPK![Content_Types].xmlj0 u$Nwc$ans@8JbVKS(.Y$8MVgLYS]"(U֎_o[gv; f>KH|;\XV!]օ Oȥsh]Hg3߶PK!֧6 _rels/.relsj0 }Q%v/C/}(h"O = C?hv=Ʌ%[xp{۵_Pѣ<1H0ORBdJE4b$q_6LR7`0̞O,En7Lib/SeеPK!kytheme/theme/themeManager.xml M @}w7c(EbˮCAǠҟ7՛K Y, e.|,H,lxɴIsQ}#Ր ֵ+!,^$j=GW)E+& 8PK!\theme/theme/theme1.xmlYOoE#F{o'NDuر i-q;N3' G$$DAč*iEP~wq4;{o?g^;N:$BR64Mvsi-@R4Œ mUb V*XX! cyg$w.Q "@oWL8*Bycjđ0蠦r,[LC9VbX*x_yuoBL͐u_. 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