ÐÏࡱá>þÿ 35þÿÿÿ2ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿì¥ÁÀ ð¿¼bjbjüÊüÊ 8!ž ž ¼ÿÿÿÿÿÿ·ªªÿÿÿÿ,,ýªXXXXX333|~~~~~~$§²YÈ¢ 33  ¢XXÛ·ÀÀÀ  XX|À |ÀÀ<Xÿÿÿÿ ›*ДîÓÿÿÿÿ²,hÍ0ý4! Æ! <! <,3L6Àµ,á)333¢¢Æú333ý    ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿ! 333333333ª Ê: Checklist for Institutional Risk Assessment for Externally-Sponsored Investigator-Initiated Clinical Trials Date Submitted to ORPA___________ Principal Investigator:____________________________________ Dept. __________________________________________________ Phone:____________ Email:______________________________ External Sponsor________________________________________ (If UR is a sub-site, provide name of prime sponsor as well) To be provided by department: ___ Copy of RSRB application – if available ___ Copy of most recent version of protocol ___ Copy of RSRB model consent form ___ Copy of the Faculty Questionnaire (attached) To be provided by ORPA: ___ Copy of latest draft/final contract (supplied by ORPA) Indicate level of Indemnification offered by sponsor: ___ Product Liability ___ Use of results ___ None ___ Other:_____________________________________ Additional Comments: ________________________________________________________________________________________________ ORPA Research Administrator: ___________________________________ Date Scheduled for Committee: _____________ Date Submitted to Dean: _________________ H:/dept/forms/Risk Assessment Checklist 5/18 ÌÇÐÄ´«Ã½ Risk Assessment – Faculty Comments Please answer the following questions to bring forth or clarify issues that might be helpful during the University’s risk assessment review process. What are the unique risks inherent in the study protocol, if any? What is your assessment of these risks in comparison to the benefits gained from the study? What do you believe is the “worst” case scenario with respect to potential risk and/or subject injury? Why should the University bear the risks that the sponsor is unwilling to assume? Is the immediate health of the subjects/patients at risk if this trial does not go forward? Explain how future outcomes of this trial might directly benefit you or the University, e.g., future grant applications, publications, discoveries/patents, career path? Are there any other special circumstances with respect to this trial that the University should consider in its risk assessment? H:/dept/forms/risk assessment PI comments 1-07 mn��‘y ¶ · Õ Ö Û ß ó   ( 8 < E J ^ i ‹ Œ � “ › £ ¥ ¦ â ã í  € — ù  9 : @ X y } ~ ‘ óèäÞÓȽȽ´È©È©È©È©È©È©È©È©ž½“½´Š©´©ÈÓÈèä†ä´Š´}Š´hSs 5�OJQJh¥åh¥å5�OJQJh¥å5�6�OJQJhð}5�CJOJQJh¥å5�CJOJQJh^T—5�OJQJh^T—5�6�OJQJh^T—5�CJOJQJh^T—5�CJOJQJ h^T—CJh^T—h^T—5�CJ OJQJh^T—5�>*CJOJQJ01mn�‘Í @ y ¶ · Õ Ö   2 3 X Y ‹ Œ � ¥ ¦ úúúøïééééàÚÚÚÚÚÚØØØØØØéé ÆÐ$ ÆÐa$ Æh$ Æha$$a$¦ â ã  0 D N  € ø ù : ; g ‘ ’ ¿ Ø û ü ’ “ ” 3úøòøøøøøøøðøøøîîððøøøøâ & F ÆÐgdð} Æhgd¥å‘ • ž ¾ À û ¯±Œ»¼úõðõìäÚäÚÌäìõh^T—B* CJOJQJph€h^T—CJOJQJh^T—OJQJh^T— hSs 5� h^T—5� hð}5� 34567žŸ ¡¢ôõö÷øÈÈÈȼÈÈÈȼ����: & F„h>ÆT€Tfÿ^„hgdð} & F ÆÐgdð}6 & F>ÆT€Tfÿgdð}øUVWXY‡ˆ‰Š󸸸¸ó¸�¸¸óy„h^„h6 & F>ÆT€Tfÿgdð}: & F„h>ÆT€Tfÿ^„hgdð} & F ÆÐgdð}Š‹Œ�¼ýýýý6ÒÔÿhxÿhxÿhxÿhxÿhxÿhxÿhxÿhxÿhx?ðo?ð?ðo?ð?ðo?ðP8Ò$ÿÿÿÿÿÿÿÿÿ:pð}°Ð/ °à=!°"°#�„$�8%°°Ð°Ð �ÐDp^ 2ÀÐàð 0@P`p€�ÀÐàð2(Øè 0@P`p€�ÀÐàð 0@P`p€�ÀÐàð 0@P`p€�ÀÐàð 0@P`p€�ÀÐàð 0@P`p€�ÀÐàð 0@P`p€�8XøV~_HmH nH sH tH L`ñÿL Normal5$7$8$9DH$CJ_HmH sH tH @@@  Heading 1$@& 5�OJQJX@X  Heading 2$$„„Ð@&^„`„Ða$5�6�OJQJD@D  Heading 3$@&5�CJOJQJDA òÿ¡D Default Paragraph FontVióÿ³V  Table Normal :V ö4Ö4Ö laö (k ôÿÁ(No List @™@ò@ Balloon Text CJOJQJPK!éÞ¿ÿ[Content_Types].xml¬‘ËNÃ0E÷Hüƒå-Jœ²@%é‚ÇŽÇ¢|ÀÈ™$ÉØ²§Uû÷LÒTB¨ l,Ù3÷ž;ãr½µÃ˜œ§J¯òB+$ëG]¥ß7OÙ­V‰�$ùãûÿ©«×îÇ !)OÚ^ýrÍC$ñy@“°íÝö/­yH*œ˜ñ„´½)‘Þµ�÷ß»Š×UDb‚`}"×qÛ‹”J×—–¤ÃX^æ)I`nÌEŒ¼Šp)øèÆli¹V[]Š1M<”àÈÞ�©OÐP“ô6râ=¯‰’zÀgb Ig…Áu��SÙebÖö€OÀ�†ä¾òÃRÁDÛ«™Ÿ·´qu ¯g‹˜Z°¶´®o~ÙºlAp°lxŠpT0­÷­+[}`j×ëõº½zAϰV–2ÍF­ÞÉi–@öqžv·Ö¬5\|‰þʜ̭N§Óle²X¢dsøµÚjcsÙÁ�Å7çð�Îf·»êà ÈâWçðý+­Õ†‹7 ˆÑä`­ÚïgÔ È˜³íJøÀ×j|†‚h(¢K³óD-еß㢠dXÑ©iJÆØ‡(îâx$(Ö ð:Á¥;ä˹!Í I_ÐTµ½S 1£÷êù÷¯ž?EÇž?øéøáÃã?ZBΪmœ„åU/¿ýìÏÇ£?ž~óòÑÕxYÆÿúÃ'¿üüy5Òg&΋/ŸüöìÉ‹¯>ýý»GðM�Geø�ÆD¢›äíó3Vq%'#q¾ÃÓòŠÍ$”8ÁšKýžŠôÍ)f™w9:ĵàå£ x}rÏx‰‰¢œw¢ØîrÎ:\TZaGó*™y8IÂjæbRÆíc|XÅ»‹Ç¿½I u3KGñnD1÷NIBÒsü€� íîRêØu—ú‚K>Vè.EL+M2¤#'šf‹¶i ~™Vé þvl³{u8«Òz‹ºHÈ Ì*„æ˜ñ:ž(W‘☕ ~«¨JÈÁTøe\O*ðtHG½€HYµæ–}KNßÁP±*ݾ˦±‹ŠTѼ�9/#·øA7ÂqZ…Ð$*c?�¢íqUßån†èwðNºû%Ž»O¯·ièˆ4 =3¾¼N¸¿ƒ)cbJ u§VÇ4ù»ÂÍ(TnËáâ 7”Ê_?®�ûm-Ù›°{UåÌö‰B½w²ÒzÏû¨nœ”ÇÊœ"Z úàxŠÕJÜZšìp;‹“Êì ØåÞ{/å<óP;™Ž,)''KÐQÛk5—›òqÚöÆpN†Ç8¯KÝGbÂe“¯„ ûS“ÙdùÌ›­\17 êpõaí>§°SR!Õ–‘ 3•…K4'+ÿrÌzQ TT£³I±²Áð¯Ivt]KÆc⫲³K#Úvö5+¥|¢ˆDÁ±‰ØÇà~ª O@%\w˜Š _ànN[ÛL¹Å9Kºò�˜ÁÙqÌÒgåV§hžÉn R!ƒy+‰ºUÊn”;¿*&å/H•rÿÏTÑû Ü>¬Ú>\ Œt¦´=.TÄ¡ ¥õûS; Zà~¦!¨à‚ÚüäPÿ·9gi˜´†C¤Ú§!ö# Bö ,™è;…X=Û»,I–2UW¦Vì9$l¨kàªÞÛ=A¨›j’•ƒ;î{–A£P79å|s*Y±÷Úø§;›Ì ”[‡MC“Û¿±hf»ª]o–ç{oY=1k³yV³ÒVÐÊÒþ5E8çVk+ÖœÆËÍ\8ðâ¼Æ0X4D)Ü!!ýö?*|f¿vè uÈ÷¡¶"øx¡‰AØ@T_²�ÒÒŽ q²ƒ6˜4)kÚ¬uÒVË7ë ît ¾'Œ­%;‹¿Ïiì¢9sÙ9¹x‘ÆÎ,ìØÚŽ-45xödŠÂÐ8?ÈǘÏdå/Y|t½ß &LILð�J`è¡& ù-G³tã/ÿÿPK! Ñ�Ÿ¶'theme/theme/_rels/themeManager.xml.rels„�M Â0„÷‚wooÓº‘&݈ЭÔ„ä5 6?$Qìí ®,.‡a¾™i»—�Éc2Þ1hª:é•qšÁm¸ìŽ@RN‰Ù;d°`‚Žo7íg‘K(M&$R(.1˜r'J“œÐŠTù€®8£�Vä"£¦AÈ»ÐH÷u} ñ›|Å$½b{Õ–Pšÿ³ý8‰g/]þQAsÙ…(¢ÆÌà#›ªLÊ[ººÄßÿÿPK-!éÞ¿ÿ[Content_Types].xmlPK-!¥Ö§çÀ6 0_rels/.relsPK-!ky–ƒŠtheme/theme/themeManager.xmlPK-!0ÝC)¨¤Ötheme/theme/theme1.xmlPK-! Ñ�Ÿ¶'² theme/theme/_rels/themeManager.xml.relsPK]­ ¼ ÿÿÿÿ‘ ¼ ¦ 3øŠ¼ ð8ð@ñÿÿÿ€€€÷ð’ðð0ð( ð ððB ðS ð¿Ëÿ ?ðÿÿ3N3N3N3N3N}}ÀÀξÊ××¾9*€urn:schemas-microsoft-com:office:smarttags€place€8*€urn:schemas-microsoft-com:office:smarttags€City€=*€urn:schemas-microsoft-com:office:smarttags €PlaceType€=*€urn:schemas-microsoft-com:office:smarttags €PlaceName€ Ⱦ§©  Øß 5<[b¨¯%28FMPX“•¿ÀŽ�¾3333333333333Ûßó  (8<EJ^iŠ�“›¤¥¦âãí9::@Xy~�•º¾»¾Ûßó  (8<EJ^iŠŒ��“›¤¥¦âãí9::@Xy~�º¾¾Ìrnx:Cæaÿÿÿÿÿÿÿÿÿ@xh„Є˜þ^„Ð`„˜þCJ)ÌrnxÿÿÿÿÿÿÿÿåSs ð}^T—„˜¥å¼¾ÿ@€¿¿¿¿¼˜@ÿÿUnknownÿÿÿÿÿÿÿÿÿÿÿÿG�ÿ*àAxÀ ÿTimes New Roman5�€Symbol3.� ÿ*àCxÀ ÿArial?=� ÿ*àCxÀ ÿCourier New;�€Wingdings5.� ÿ.á[`À)ÿTahomaA�ÿàÿ$BŸCambria Math"ÁˆðÐh©‘e§©‘e§Ò:¸FMoƒMo!ð„¥Àxx€24¸¸3ƒQð„ÿßÿýHP ðÿ?äÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿð}2!xx  Üÿÿ+Checklist for Institutional Risk AssessmentHP Authorized CustomerDonna L. Beyea þÿà…ŸòùOh«‘+'³Ù0€€ˆ¼Üì  0 < H T`hpxä,Checklist for Institutional Risk AssessmentHP Authorized CustomerNormalDonna L. Beyea2Microsoft Office Word@FÃ#@„ú#ÙÇ@†¶”îÓ@†¶”îÓMoþÿÕÍÕœ.“—+,ù®0( hp�˜ ¨ °¸ÀÈ Ð äÌÇÐÄ´«Ã½¸ ,Checklist for Institutional Risk Assessment Title þÿÿÿ !þÿÿÿ#$%&'()þÿÿÿ+,-./01þÿÿÿýÿÿÿ4þÿÿÿþÿÿÿþÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿRoot Entryÿÿÿÿÿÿÿÿ ÀFÀ‹DДîÓ6€1Tableÿÿÿÿÿÿÿÿ1 WordDocumentÿÿÿÿÿÿÿÿ8!SummaryInformation(ÿÿÿÿ"DocumentSummaryInformation8ÿÿÿÿÿÿÿÿÿÿÿÿ*CompObjÿÿÿÿÿÿÿÿÿÿÿÿrÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿþÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿþÿ ÿÿÿÿ ÀF Microsoft Word 97-2003 Document MSWordDocWord.Document.8ô9²q