ࡱ>  4bjbj}} yC,:F.%.%~%~%~%$%%%P%&%Y' )"***k+,-HpXrXrXrXrXrXrX$Z]xX~%/I+"k+//X.%.%**EX 666/.%8*~%*pX6/pX66Lf%O*3 aZn.0hN,\XX<YNL^0^XO^~%O|-h3.J6}.<.---XX3---Y////^--------- #: *IRB #:________  SAINT LOUIS UNIVERSITY Institutional Review Board (IRB) 3556 Caroline St., Room 110 Phone: (314) 977-7744 HUMANITARIAN USE DEVICE New Submission Form The definition of a HUD is a device that is intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect or are manifested in fewer than 4,000 individuals in the United States per year. A Humanitarian Device Exemption (HDE) is an application that is similar to a pre-market approval (PMA) application. An approved HDE authorizes marketing of a Humanitarian Use Device (HUD). This is not used for systematic investigations (research), only for clinical use of a non-FDA approved device. Because the Saint ˻ֱ University IRB must conduct an initial review and continuing reviews of humanitarian use device submissions, SLU clinicians will need to complete and submit this form. For additional guidance on HUDs, please visit the HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/guidelines_hud.doc"HUD guidelines. Clinician/Physician: Administrative Contact: Department: Test article used: E-Mail: Phone: HDE number:  HDE/Project Title:  SPONSOR INFORMATION: Please provide information so the IRB can call the sponsor to discuss the device. Sponsor Name: Address: Sponsor Contact: E-Mail: Phone:  Are you using this HDE as part of a research study?  FORMCHECKBOX Yes, we are using the HDE as part of a research study to systematically evaluate its use, safety, and/or effectiveness. STOP! Do not proceed any further. Rather than completing and submitting this form you must instead submit a full IRB application in eIRB:  HYPERLINK "https://eirb.slu.edu/" https://eirb.slu.edu/.  FORMCHECKBOX NO, we are only using the HDE for clinical care (this is not a systematic investigation). Please continue with this form and submit to the IRB.  Describe the device and how you intend to use it:   State the age range of intended patients: Clinical Team and Training 4a. Describe what kind of training is required to use the device:  4b. Will the clinician(s) receive a certificate for training?  FORMCHECKBOX  Yes before the device is ever used. You must submit a copy of the certificate for all clinicians who will use the device before the use of the HDE can be approved.  FORMCHECKBOX  Yes after_____ proctored/monitored cases. You must submit the certificates as soon as they are available.  FORMCHECKBOX  No In the table below, list names of all members of the clinical team, their degrees, academic rank or title, department or outside organization (if not affiliated with SLU), experience and assigned duties. In the third column, provide sufficient detail regarding a clinicians experience to reflect his/her ability to capably perform the duties listed in the fourth column. The clinical team includes all individuals (faculty, staff, or students) who have contact or interactions with patients or with patients private identifiable information or individuals who are specifically designated to perform an integral component of treatment. By submitting the protocol, the treating physician affirms that each individual named has reviewed the protocol and has consented to his or her inclusion. The treating physician and clinical team must have completed human subjects education and HIPAA training (an online course is available on the SLU IRB website). Name(s), DegreeAcademic Rank and Department or describe non-SLU Affiliation Experience (Specify experience which reflects the ability to capably perform study related duties such as certification (if applicable), other trials conducted, related courses completed, etc.)Describe responsibilities administering treatment using HUD1.  2. 3. 4. You may add members to the table above by expanding as needed (place cursor in the last box of the table, right side, and hit the tab key). SITE(S) 5a. Indicate where the treatment will be administered:  FORMCHECKBOX  Saint ˻ֱ University, Medical Center Campus  FORMCHECKBOX  SSM Health St. Marys  FORMCHECKBOX  Saint ˻ֱ University, Frost Campus  FORMCHECKBOX  SSM Health Cardinal Glennon  FORMCHECKBOX  SLUCare Locations  FORMCHECKBOX  SSM Health Saint ˻ֱ University Hospital 5b. Will there be any in-patient SSM Health (SLUH or other) Hospital procedures?  FORMCHECKBOX  No  FORMCHECKBOX  Yes. Please submit a copy of this form to the appropriate hospital review committee. PATIENT CONSENT It is SLU policy to obtain patient consent to treat with a HUD when practicable. Please prepare and submit a consent document using the HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/hud_consent_form.doc"SLU HUD Consent Form Template and provide details of the consent process below. If consent cannot practicably be obtained, provide justification for a  HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/consent_waiver.doc" waiver, below. Note: in emergent cases, consent can be waived prior to treatment, but should be obtained at the earliest opportunity thereafter.  CONFLICT OF INTEREST Indicate whether you, your spouse or dependent children have, or anticipate having, any income from or financial interest in a sponsor or device manufacturer of this HUD. Please remember that you are responding for you and any other clinician participating in treatment. Financial Interest includes but is not limited to: consulting; speaking or other fees; honoraria; gifts; licensing revenues; equity interests (including stock, stock options, warrants, partnership and other equitable ownership interests). Check one of the following. Please remember you are answering for yourself, your spouse, dependent children and any investigator on the study, his/her spouse and dependent children. 1.)  FORMCHECKBOX  No Equity Interest and/or Financial Interest less than or equal to $5K2.)  FORMCHECKBOX  Any Equity Interest and/or Financial Interest exceeding $5K but not exceeding $25K in the past year or expected in the current year3. )  FORMCHECKBOX  Financial Interest exceeding $25K in the past year or expected in the current year(Check all those that apply):  FORMCHECKBOX  Consulting  FORMCHECKBOX  Speaking Fees or Honoraria  FORMCHECKBOX  Gifts  FORMCHECKBOX  Licensing agreement or royalty income  FORMCHECKBOX  Equity interests, including stock, stock options, warrants, partnership or equitable ownership interests), or serving on a scientific advisory board or board of directors  FORMCHECKBOX  Other fees/compensation(Check all that apply):  FORMCHECKBOX  Consulting  FORMCHECKBOX  Speaking Fees or Honoraria  FORMCHECKBOX  Gifts  FORMCHECKBOX  Licensing agreement or royalty income  FORMCHECKBOX  Equity interests, including stock, stock options, warrants, partnership or equitable ownership interests), or serving on a scientific advisory board or board of directors  FORMCHECKBOX  Other fees/compensation If you have marked box #2 or #3, please contact  HYPERLINK "mailto:coi@slu.edu" coi@slu.edu to initiate review of this study and provide the following information: A Conflict of Interest Management Plan has been approved for this study  FORMCHECKBOX ; is pending  FORMCHECKBOX ; has not been initiated  FORMCHECKBOX  Describe who has, and briefly explain, the conflict of interest and indicate specific amounts for each subcategory checked: __________________________________________________________________________________________________________________________________________________________________________________________________ Note to Provider(s) Reporting a Potential Conflict of Interest Investigator(s) must have: Current, up-to-date Conflict of Interest Disclosure Form on file with the SLU Conflict of Interest in ˻ֱ Committee (COIRC) that describes any financial relationship indicated above. This information must be disclosed on the SLU confidential Conflict of Interest Disclosure Form and reviewed by the COIRC before accruing research subjects in this study. If your current Disclosure Form does not contain this information, you are required to submit an updated Disclosure Form to the COIRC. You may not begin your study until your Disclosure Form has been reviewed and any required management plan has been approved by the COIRC for this study. To initiate COIRC review of your study, please contact  HYPERLINK "mailto:coi@slu.edu" coi@slu.edu. In signing this form, the PI certifies that he/she has read the Universitys Conflict of Interest ˻ֱ Policy and has checked the appropriate boxes above. In addition, the PI certifies that, to the best of his/her knowledge, no person working on this project at SLU has a conflict of interest or if a conflict of interest does exist, that an appropriate management plan is in place. By his/her signature, the CHAIR certifies that, to their knowledge, no conflict of interest exists or a conflict does exist for which a management plan has been approved or is under review.  HDE Enclosures: check all that apply.  FORMCHECKBOX  FDA HDE approval letter (REQUIRED)  FORMCHECKBOX  All information from the sponsor concerning the device [protocol, model consent, etc.] (REQUIRED)  FORMCHECKBOX  HUD Consent Form and any other information given to patient (REQUIRED)  FORMCHECKBOX  Training Certificates for all treating physician(s) (REQUIRED if certification is performed)  FORMCHECKBOX  Other Information:note: You are required under 21 CFR part 803 medical device reporting to submit a report to THE fda whenever a device with an approved hUMANITARIAN dEVICE eXEMPTION may have caused or contributed to a death or serious injury, or has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. ASSURANCES: The signature of the Treating Physician and the Department Chairperson or advisor indicates that the Treating Physician has the requisite funding, credentials, training and any necessary hospital privileges, if needed, to carry out all procedures and treatments involved in the protocol. The signatures also affirm that the activities involving patients will not begin without prior review and approval by the Institutional Review Board, and that all activities will be performed in accordance with state and federal regulations and Saint ˻ֱ Universitys Assurance with the Department of Health and Human Services. The undersigned assures that if members of the SLU clinical team access protected health information from a SLU covered entity in order to seek consent / authorization for treatment, such access is necessary for the treatment, is solely for that purpose, and the information will not be removed from the covered entity without IRB authorization or approved waiver. TREATING PHYSICIANDEPARTMENT CHAIRPERSON SignatureDateSignatureDateTyped NameTyped Name     IRB Version: 7/2016 PAGE  PAGE 4 *An IRB number will be assigned to your protocol by the IRB office. )FIJKhijV ôxndnYH hF zhcCJOJQJ^JaJhF zhcCJ aJ hF zhI&5aJhF zhc5aJhF zhc5CJ aJ hF zhchF zh5 h+5hF zh_U5hF zhc5hB CJOJQJ^JhF zhcCJOJQJ^JhF zhg5CJ,jhF zhgOJQJU^JmHnHuhF zhg5\"hF zhg5CJOJQJ\^J*Ki\ ] t $Ifgdcgdcgd_U$a$gdcgdc$a$gd_Udxgdg$ !5$7$8$9DH$^`a$gd?wV ] d I J K Y Z [ \ ޸o\G2)hF zhcB* CJOJQJ^JaJph)hF zh]u]B* CJOJQJ^JaJph$hF zhc0JCJOJQJ^JaJ8jhF zh~:>B* CJOJQJU^JaJph#h~:>B* CJOJQJ^JaJph2jhF zh]u]B* CJOJQJU^JaJph)hF zhcB* CJOJQJ^JaJph hF zhcCJOJQJ^JaJ hF zhawCJOJQJ^JaJ hF zh{CJOJQJ^JaJ \ ] p t ɵɡɡɡɡɡɒn[E[*hF zht5@CJOJQJ\^JaJ$hF zht@CJOJQJ^JaJ#hF zh15CJOJQJ^JaJ#hF zht5CJOJQJ^JaJhF zhcB* CJaJph'hF zhc5@CJOJQJ^JaJ'hF zhD5@CJOJQJ^JaJ$hF zhc@CJOJQJ^JaJ'hF zhh5@CJOJQJ^JaJhF zhcB* CJaJph qd[ $Ifgdc $Ifgdckd$$Ifs 0_(_i ``0(4 sasp naPG $Ifgdc =$If^=gdc $Ifgdckdd$$Ifs4 0_(_i ``0(4 sasf4p PKK6- $IfgdD5 @$If^`gdD5gdckdG$$Ifs4 F/ _(/ 0 i ```0(    4 sasf4p  @=$If^=`gdD5 $IfgdD5 gdckdx$$Ifs43ֈf|8(mj u+ 0(4 salf4p<ytD5  D a b q | } νxxxj\RA4hF zh} OJQJ^J!jhF zh} OJQJU^JhB OJQJ^JhF zhW5OJQJ^JhF zhI5OJQJ^JhF zhP,85CJOJQJaJhF zhP,85@OJQJ^J'hF zhP,85@CJOJQJ^JaJ hF zh"kCCJOJQJ^JaJ hF zhcCJOJQJ^JaJ#hF zhc5CJOJQJ^JaJhF zh1B* CJaJph hF zhtCJOJQJ^JaJ b q | } gZD !$5$7$8$9DH$Ifgdm$ $Ifgdm$kd$$Ifs4 0(0(4 sasp $Ifgdm$ $Ifgdm$gdc }p_V $Ifgdm$ =$If^=gdm$ $Ifgdm$kdH$$Ifs4 0( 0(4 sasf4p ./0eXH???? $IfgdW & F5$7$8$9DH$gdI 5$7$8$9DH$gdIkd$$Ifs4 FC (C  0(    4 sasf4p di*+-.01?@AӾӺӲӗڃoӐaShF zh} 5OJQJ^JhF zhW5OJQJ^J'j hF zh} OJQJU^JhF zh} OJQJ^J hF zhI hF zhWhB hB 0JjLhB UjhB UhB hF zh{hF zh} 5>*B*ph hF zh} !jhF zh} OJQJU^J'jhF zh} OJQJU^J0xh_ $Ifgdc & F5$7$8$9DH$gdIh5$7$8$9DH$^hgdWlkdi $$Ifl&' t0'644 laytI $IfgdW   78STXEPžХЬЌХ{nZ{nRЌhF zhv5'j} hF zhvOJQJU^JhF zhvOJQJ^J!jhF zhvOJQJU^J hF zhh hF zhwhI hF zhg hF zh} hEhF zhv5OJQJ^J hF zhEhE5OJQJ^J hF zhvh3_hT^hT^< hF zhc hbGMhchF zhc5OJQJ^J    {{$&#$/Ifgd3_gdT^lkd $$Ifl&' t0'644 layt3_   78S}upug^^^ $Ifgdg`gdvgdE & FgdIgdg|kdj $$IflM t 60644 lap yt3_ ' $Ifgdggdghkd $$Ifl&' t0644 laytD5P!"#$&()>KN^g0ۿۤۿo`QhF zhq]CJOJQJ^JhF zhpCJOJQJ^JhF zhg>*CJOJQJ^JhF zhgCJOJQJ^JhF zh{CJOJQJ^J hF zh} 'je hF zhvOJQJU^J hF zh{hF zhv5'j hF zhvOJQJU^JhF zhvOJQJ^J!jhF zhvOJQJU^J hF zhv'()GH9DlcWW $$Ifa$gd $Ifgd !5$7$8$9DH$gdg !*$5$7$8$9DH$gdggdghkd $$Ifl&' t0644 laytD5 0<!*+L{DGHL^cpD⠎rerer^NhF zhg5CJOJQJ^J hF zhghF zhhOJQJ^JhF zhgOJQJ^JhF zhgOJQJ^JaJ"hF zhh5CJOJQJ\^J"hF zhg5CJOJQJ\^J"hF zhg6CJOJQJ]^JhF zh?wCJOJQJ^JhF zhpCJOJQJ^JhF zhgCJOJQJ^JhF zhhCJOJQJ^JD89:LMTU\ ˻tdUC1#hF zhFuE5CJOJQJ^JaJ#hF zhv5CJOJQJ^JaJhD5CJOJQJ^JaJhF zhg5CJOJQJ^JhF zhgOJQJ^J hF zhgCJOJQJ^JaJ hF zhCJOJQJ^JaJ hF zhgCJOJQJ^JaJ hF zhghF zhg5CJOJQJ^JhF zhP5CJOJQJ^J#hF zhv5CJOJQJ^JaJ#hF zhg5CJOJQJ^JaJD9:+kdN $$Ifs\u)/ ````(0)4 sap( $$Ifa$gd:>?@ABCDHIJWkdV$$Ifs\u)/ 0)4 sa  !$Ifgd JKLPQRSWkd$$Ifs\u)/ 0)4 sa  !$IfgdSTXYZ[eWWWW  !$Ifgdkd$$Ifs\u)/ 0)4 sa[\+e]TLG; hdh^hgdvgdg & FgdIh^hgdg$a$gdP,8kdW$$Ifs\u)/ 0)4 sa )*+,:;<U\ckrs̽ocM+jhF zhFuECJOJQJU^JhOwHCJOJQJ^J+jzhF zhFuECJOJQJU^JhF zhsWCJOJQJ^J+jhF zhFuECJOJQJU^J%jhF zhFuECJOJQJU^JhF zhFuECJOJQJ^J#hF zhFuE5CJOJQJ^JaJ#hF zhOwH5CJOJQJ^JaJhOwH5CJOJQJ^JaJ+qr@AQR012345$IfgdEo5>*CJUh~:>5>*CJjhD5>*CJUh2z5>*CJhD5>*CJhE5>*CJ hF zhE hE>*hF zhE>* hD>* hF zhg#hF zhgCJOJQJ]^JaJ#hF zhawCJOJQJ]^JaJ&hF zh{6CJOJQJ]^JaJ /03457KLM^ϼ۰|ul]Mh3_hFuE5CJOJQJ^JhF zhFuECJOJQJ^JhF zhFuECJ hF zhFuEhF zhFuE>*hE hNKhECJOJQJ^JaJ hOwHhE hwhEhD5>*CJhhshD0J5CJ%j[hhshhs5>*CJUhhshhs5>*CJjhhshhs5>*CJUhhshD5>*CJhE5>*CJ567LMKL _ tggZQ $IfgdgR ^`gdNK ^`gdFuE  !dxgdFuE $ & Fa$gdIgd3_nkd$$Ifl&' t0644 lap yt]\JL      c d r s t 媘rZrrBr/jhqhNKCJOJQJU^JaJ/jrhqhNKCJOJQJU^JaJ)jhqhNKCJOJQJU^JaJ hqhNKCJOJQJ^JaJ"hqhNK5CJOJQJ\^J"hF zhFuE5CJOJQJ\^JhOwH5CJOJQJ^JhDCJOJQJ^Jh3_hOwH5CJOJQJ^JhF zhFuECJOJQJ^JhOwHCJOJQJ^J !!!!!&!/!f!g!h!!!!!!!!!!!!!!!!!ܯܢ܎v^F/jhqhNKCJOJQJU^JaJ/j<hqhNKCJOJQJU^JaJ/jhqhNKCJOJQJU^JaJ&hqhNK5CJOJQJ\^JaJhqhNKOJQJ^J/jbhqhNKCJOJQJU^JaJ)jhqhNKCJOJQJU^JaJ hqhNKCJOJQJ^JaJ#hqhNK>*CJOJQJ^JaJ_ f!g!h!!!F=== $IfgdgRkd$$IfsF Iu) ,, ```0    4 sapytgRd$If^d`gdgR!!!""" ###@#m###z$$$skdd $$IfsF Iu) ,,0    4 saytgR $IfgdgR !!!!!""#"1"2"3"""""" ###$#2#3#4#@#A#O#P#Q#m#n#|#٩ّ}eM/j hqhNKCJOJQJU^JaJ/jhqhNKCJOJQJU^JaJ&hqhNK5CJOJQJ\^JaJ/jhqhNKCJOJQJU^JaJ/jhqhNKCJOJQJU^JaJ/j,hqhNKCJOJQJU^JaJ hqhNKCJOJQJ^JaJ)jhqhNKCJOJQJU^JaJ|#}#~###########z${$$$$$$$$yl]MhqhNK>*CJOJQJ^JhqhNKCJOJQJ^JhqhNKOJQJ^J/jhqhNKCJOJQJU^JaJ/jthqhNKCJOJQJU^JaJ/jhqhNKCJOJQJU^JaJ hqhNKCJOJQJ^JaJ)jhqhNKCJOJQJU^JaJ/jhqhNKCJOJQJU^JaJ$$M%%k&.'/'0'o''x)y)zupc & F$Ifgd3_gdNKgdNKakdk"$$Ifs4u))04 saf4ytgR $If^gdgR & F$IfgdNK $IfgdgR $$$$%%%%%%%%%%%%%%%%%%%%%%.'ۻۻ}eM/j!hqhNKCJOJQJU^JaJ/j{!hqhNKCJOJQJU^JaJ/j!hqhNKCJOJQJU^JaJ hqhNKCJOJQJ^JaJ)jhqhNKCJOJQJU^JaJhqhNKCJOJQJ^J hqhNK0JCJOJQJ^JhqhNK>*CJOJQJ^J(jhqhNK>*CJOJQJU^J.'/'0'8'@'o''''E(F(4)w)x)**J*K*k*l*ԸsbN99)jhqhNKCJOJQJU^JaJ&hqhNK5>*CJOJQJ^JaJ h3_hNKCJOJQJ^JaJ&h3_hNK5>*CJOJQJ^JaJhNKCJOJQJ^JaJ#h3_hNK5CJOJQJ^JaJ h3_hNKCJOJQJ^JaJ hqhNKCJOJQJ^JaJhNK>*OJQJ^JhqhNK>*OJQJ^J hqhNKCJOJQJ^JaJhqhNKOJQJ^Jl*w*x*,,,,,,,,,,,- -!-/-0-ǶobUDb0'j#hF zhUw OJQJU^J!jhF zhUw OJQJU^JhF zhIOJQJ^JhF zhUw OJQJ^J'j#hF zhawOJQJU^J!jhF zhawOJQJU^JhF zhawOJQJ^JhF zhaw5OJQJ^J hqhNK hqhNKCJOJQJ^JaJ hqhNKCJOJQJ^JaJ)jhqhNKCJOJQJU^JaJ$hqhNK0JCJOJQJ^JaJy){*|*,,,,- -----sjjjjjj $IfgdD5 & F5$7$8$9DH$gdIgdNK\kd#$$Ifs9))0)4 saytgR $If^gdgR & F$IfgdgR 0-1-h--------------------...4.5.].^._.ǺǕNj~Ǻj]LǺ hF zhhCJOJQJ^JaJhF zhhOJQJ^J'j$hF zhawOJQJU^JhF zhDOJQJ^JhDOJQJ^J'jq$hF zhawOJQJU^J!jhF zhawOJQJU^JhF zhIOJQJ^JhF zhawOJQJ^JhF zh{OJQJ^JhF zhUw OJQJ^J!jhF zhUw OJQJU^J-^._...///333xssb $If^ `gdpgdIPgdIgdawPgd{jkd%$$Ifl&' t0644 layt{ $IfgdD5 _.`.n.o.p.v.../////3333p_Q@1hF zhICJOJQJ^J hF zh%CJOJQJ^JaJhICJOJQJ^JaJ hF zhICJOJQJ^JaJ hF zhICJOJQJ^JaJ"hF zhI5CJOJQJ\^J%hF zhI5;CJOJQJ\^J%hF zh{5;CJOJQJ\^J hF zhawhF zhUw OJQJ^J'jY%hF zhawOJQJU^JhF zhawOJQJ^J!jhF zhawOJQJU^J333334444eTTT $If^ `gdpkdG&$$IfsF]4*hh0*    4 saytp $Ifgd% $Ifgdp33344$4%4(4)454?4@4A4B4C4D4F4G4I4J4L4M4O4\4]4b4c4d4e4Ǹ友wog\XNjhp\0JUhp\hhp\CJaJhwCJaJhNKCJaJhp\CJaJhjhUhI9j,+hIh56<B*OJQJU\]^JphhIOJQJ^JaJhF zhIOJQJ^JaJhF zhICJOJQJ^JhF zh CJOJQJ^JhICJOJQJ^JhF zhICJOJQJ^J44444B11 $If^ `gdpkd&$$Ifsr\ ](#4* h 0*4 saytp $If]gdp444$4%4&4'4H7 $If^ `gdpkd($$Ifsr\ ](#4* h 0*4 saytp $Ifgdp'4(4)44454@4iXB !$5$7$8$9DH$Ifgdp $If^ `gdpkd$)$$Ifs4F]4*hh0*    4 saf4ytp $Ifgdp@4A4C4E4F4H4I4K4L4N4O4c4d4rmkkkkkkkkikgd~:>kd/*$$Ifs4pF]4*hh0*    4 saf4ytp e4k4l4m4o4p4v4w4x4y4z4{4|4}44444¶²hIh[+hp\5CJaJh hp\H*h2z0JCJmHnHuhp\0JCJjhp\0JCJUhp\jhp\0JU hp\0Jd4m4n4o4z4{4|4}44444gd~:>gdgh]hgd*&#$h]h&`#$ C-p/R 6:pNK/ =!"8#$% 21h:p"kC/ =!"#$% DyK yK $https://www.slu.edu/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/guidelines_hud.docyX;H,]ą'c$$Ifs!vh#v_#vi:V s  ``0(,5_5i44 sasp$$Ifs!vh#v_#vi:V s4  ``0(,5_5i/ 44 sasf4p/$$Ifs!vh#v/ #v0 #vi:V s4  ```0(,5/ 50 5i/ /  / / 44 sasf4p$$Ifl!vh#vm#vj#v#v #vu#v+ :V s430(5m5j55 5u5+ 44 salf4p<ytD5$$Ifs!vh#v#v:V s4 0(+,5544 sasp$$Ifs!vh#v#v:V s4 0(+,5544 sasf4p$$Ifs!vh#vC #v #v:V s4 0(+,5C 5 544 sasf4ptDeCheck1DyK yK Dhttps://eirb.slu.edu/yX;H,]ą'chDe$$If!vh#v':V l t0'65'aytI|$$If!vh#v':V l t0'65'yt3_$$If!vh#v:V lM t 6065p yt3_s$$If!vh#v':V l t065'ytD5tDeCheck8tDeCheck8tDeCheck8s$$If!vh#v':V l t065'ytD5$$If!vh#v/#v#v#v :V s ````(0)5/555 44 sp($$If!vh#v/#v#v#v :V s0)5/555 44 s$$If!vh#v/#v#v#v :V s0)5/555 44 s$$If!vh#v/#v#v#v :V s0)5/555 44 s$$If!vh#v/#v#v#v :V s0)5/555 44 sxDeCheck137xDeCheck144xDeCheck138xDeCheck142xDeCheck139xDeCheck140xDeCheck145xDeCheck146DyK yK (https://www.slu.edu/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/hud_consent_form.docyX;H,]ą'cDyK yK $https://www.slu.edu/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/consent_waiver.docyX;H,]ą'c$$If!vh#v':V l t065'p yt]xDeCheck114xDeCheck115xDeCheck116$$If!vh#v #v,:V s ```05 5,/ 44 spytgRxDeCheck117xDeCheck118xDeCheck119xDeCheck120xDeCheck121xDeCheck122xDeCheck123xDeCheck124xDeCheck125xDeCheck126xDeCheck127xDeCheck128$$If!vh#v #v,:V s05 5,/ 44 sytgRxDeCheck121xDeCheck121xDeCheck121$$If!vh#v):V s405)/ 44 sf4ytgR$$If!vh#v):V s0)5)44 sytgRtDeCheck1tDeCheck1tDeCheck2tDeCheck7tDeCheck8x$$If!vh#v':V l t065'yt{$$If!vh#vh#vh#v:V s0*5h5h5/ 44 sytp$$If!vh#v #v#vh#v#v :V s0*5 55h55 / / / / / /  / 44 sytp $$If!vh#v #v#vh#v#v :V s0*5 55h55 / / / / / / 44 sytp $$If!vh#vh#vh#v:V s40*5h5h5/ / / / / /  / 44 sf4ytp$$If!vh#vh#vh#v:V s4p0*5h5h5/ / / / / / 44 sf4ytpDd\  C *ABD14568_"@@bf7d|vy9[p+Bnf7d|vy9[PNG  IHDR [APLTEff33fff*-tRNS@* cmPPJCmp0712Om/IDATc0ccC%e 0bf0V@P%P P`S|GIENDB`^E 2 0@P`p2( 0@P`p 0@P`p 0@P`p 0@P`p 0@P`p 0@P`p8XV~_HmH nH sH tH @`@ gNormalCJ_HaJmH sH tH R@R g Heading 1$$5$7$8$9D@&H$a$>*aJN@N g Heading 2$$@&a$5CJOJQJ^JR@R g Heading 3$ d@&5CJOJQJ\^JP@P g Heading 4$$@&a$5>*CJOJQJ^JR@R g Heading 5$ P@&5>*CJOJQJ^JD@D g Heading 6$$@&a$ 5>*\R@R g Heading 7$h@&^h5CJOJQJ\^Jn@n g Heading 8+$$h&`#$/@&^ha$b$5CJOJQJ\^JP @P g Heading 9 $$@&a$5>*CJOJQJ^JDA`D Default Paragraph FontRi@R  Table Normal4 l4a (k (No List H>@H gTitle$5$7$8$9DH$a$ 5CJaJ6U`6 g Hyperlink >*B*phL @L gFooter !5$7$8$9DH$CJaJ4@"4 gHeader  !dQ@2d g Body Text 3 L,dL*$1$7$8$CJOJQJ^JaJLP@BL g Body Text 2$a$CJOJQJ\^JHB@RH g Body Text5$7$8$9DH$ 5\aJhC@bh gBody Text Indent* |5$7$8$9DH$^`|aJvT@rv g Block TextD )  d]^CJ6)`6 g Page Number5CJFV`F gFollowedHyperlink >*B* phbR@b gBody Text Indent 2 *$^6CJOJQJ]^JnM@Qn gBody Text First Indentx5$7$8$9DH$` 5\aJ|N@a| gBody Text First Indent 2- hx5$7$8$9DH$^h`aJTS@T gBody Text Indent 3hx^hCJaJ2?2 gClosing ^$L$ gDate<[< gE-mail Signature h$@h gEnvelope Address!!@ &+D/^@ OJQJ^JN%@"N gEnvelope Return"CJOJQJ^JaJ:`@2: g HTML Address#6]Re@BR gHTML Preformatted$CJOJQJ^JaJ4/R4 gList%h^h`82b8 gList 2&^`83r8 gList 3'8^8`848 gList 4(^`858 gList 5)^`:0: g List Bullet * & F>6> g List Bullet 2 + & F>7> g List Bullet 3 , & F>8> g List Bullet 4 - & F>9> g List Bullet 5 . & FBDB g List Continue/hx^hFEF gList Continue 20x^FFF gList Continue 318x^8FG"F gList Continue 42x^FH2F gList Continue 53x^:1B: g List Number 4 & F >:R> g List Number 2 5 & F >;b> g List Number 3 6 & F ><r> g List Number 4 7 & F >=> g List Number 5 8 & F I@ gMessage Headerg98$d%d&d'd-DM NOPQ^8` OJQJ^J4^4 g Normal (Web):>> g Normal Indent ;^4O4 g Note Heading<DZ@D g Plain Text=CJOJQJ^JaJ0K0 g Salutation>6@6 g Signature ?^FJ@F gSubtitle@$<@&a$ OJQJ^J.X`. gEmphasis6]j#j g Table Grid7:V_0BH@2H Dw Balloon TextCCJOJQJ^JaJNoAN CwBalloon Text CharCJOJQJ^JaJPK![Content_Types].xmlN0EH-J@%ǎǢ|ș$زULTB l,3;rØJB+$G]7O٭V$ !)O^rC$y@/yH*񄴽)޵߻UDb`}"qۋJחX^)I`nEp)liV[]1M<OP6r=zgbIguSebORD۫qu gZo~ٺlAplxpT0+[}`jzAV2Fi@qv֬5\|ʜ̭NleXdsjcs7f W+Ն7`g ȘJj|h(KD- dXiJ؇(x$( :;˹! I_TS 1?E??ZBΪmU/?~xY'y5g&΋/ɋ>GMGeD3Vq%'#q$8K)fw9:ĵ x}rxwr:\TZaG*y8IjbRc|XŻǿI u3KGnD1NIBs RuK>V.EL+M2#'fi ~V vl{u8zH *:(W☕ ~JTe\O*tHGHY}KNP*ݾ˦TѼ9/#A7qZ$*c?qUnwN%Oi4 =3N)cbJ uV4(Tn 7_?m-ٛ{UBwznʜ"Z xJZp; {/<P;,)''KQk5qpN8KGbe Sd̛\17 pa>SR! 3K4'+rzQ TTIIvt]Kc⫲K#v5+|D~O@%\w_nN[L9KqgVhn R!y+Un;*&/HrT >>\ t=.Tġ S; Z~!P9giCڧ!# B,;X=ۻ,I2UWV9$lk=Aj;{AP79|s*Y;̠[MCۿhf]o{oY=1kyVV5E8Vk+֜\80X4D)!!?*|fv u"xA@T_q64)kڬuV7 t '%;i9s9x,ڎ-45xd8?ǘd/Y|t &LILJ`& -Gt/PK! ѐ'theme/theme/_rels/themeManager.xml.relsM 0wooӺ&݈Э5 6?$Q ,.aic21h:qm@RN;d`o7gK(M&$R(.1r'JЊT8V"AȻHu}|$b{P8g/]QAsم(#L[PK-![Content_Types].xmlPK-!֧6 0_rels/.relsPK-!kytheme/theme/themeManager.xmlPK-!0C)theme/theme/theme1.xmlPK-! ѐ' theme/theme/_rels/themeManager.xml.relsPK] E,EH0,**E !,999<V \ P0D s !|#$.'l*0-_.3e44$(*.0179:;<>?BCEFGIKMR 0 'D:JS[+5_ !$y)-344'4@4d44 !"#%&')+,-/234568=@ADHJLNOPQSJY*0@  " +;r4Docs"2#3@Pm}zJ"k"w"$$ %0%%%%%_&o&,XG$XG$G$G$G$G,G,G,G,G,G,G,G,XXG,G,G,G,G,G,G,G,G,G,G,G,G,G,G,XG,G,G,XG$G$G$G$G$!(,35<! !8@(  b  3 #" `? B S  ?,<((t OLE_LINK1 OLE_LINK3 _Hlt439230019 _Hlt439230020Check1ExternalIRBtraining_Name(s),_Degree ExternalSiteCheck137Check144Check138Check142Check139Check140 OLE_LINK6 OLE_LINK7_PictureBulletsPPF ,s5AAA,,@@ QQF <E$$&&B,,]u ^u _u `u au bu cu KK&&+'k'}',\\&&.'n'',:*urn:schemas-microsoft-com:office:smarttagsStreet8*urn:schemas-microsoft-com:office:smarttagsdate;*urn:schemas-microsoft-com:office:smarttagsaddress 5A,B,C,E,F,H,I,K,L,N,O,|,},,,U`vzA,B,C,E,F,H,I,K,L,N,O,|,},,,333ij66J+  77SSTT ) *-FQppqs..77\JJL$%%%%&&''++A,B,C,C,E,F,F,H,I,K,L,N,O,d,|,},,,ij66J+  77SSTT ) *-FQppqs..77\JJL$%%%%&&''++A,B,C,C,E,F,F,H,I,K,L,N,O,\,b,|,},,,|$8}Rj7~M6q 5M.E.-&E,ON$+x4A*2"iz u(;l(&WqhD#ULK!,i 8;]1 ";"^"a"G#v~#+$I$R}$%%F)%E%"&$&9%&I&L&_(S7(:(<( )&)d)p>*4|-k00"1%2|-2"3g3t3ax34ne4J)5D5J5x5_69,6(7>37?7P,838m9p:Qu:v:($=t=>~:> ;>S>T>X>)]>1?I?a?Xz?~?@"ArC:C7BC"kCDbD EFuEFG>GZG6bG*uHOwH6I8`IkI1JFJMJ}KNK4QKL?L-{L#MEMbGMKM N$N~NUOhOP9Qk RxoRIzR:}RST5TVUVUsWfX,YD;YBxYU!Z=A[]S[\X\q\p]c;]N]]u]^ ^c^3_h`aKa b<bRbSbxb^c@dU/e"me8f;fkgh,i8i?Ti!j(j]j*l2lflHmrnzzno+oE2oU2ono: pk4p>Fp&#rgrguBvj%vD\vww^wawYx~y'yF zz=5{ |#V|4}nQ~$}cb:XKtkgpNt&MmPsh o4GkBVy}Oe ' F*dL>U3T-Tp}Qg[q]MH7_i|3 t)C%<M4An7!# t{ !5LlIQ8Ag"e._*\R't'!R$TcD Mu#g(%`lzUz}\p/Z-CcYv| S}]+c{t A$Iid>!'T ^HgRSJ!3IZwdhsN8m$(> AIXPF b .#t01<P{}\(Lt5Tlv91Yn^qUXpE<L_vo_|&#$M?w12-x@HVZ[S^TPKX@finkvp~SEay[5$R>e5415a /DT^ rw*/ O A=g"$166c),AkJ/wqyj A v C{*3LUVD4 'v,=KTi/~Jw f<)KIuhqy>YC,E,@,P@UnknownFinkG*Ax Times New Roman5Symbol3. *Cx Arial71 Courier?= *Cx Courier New5. .[`)Tahoma;WingdingsA$BCambria Math"1hygygQ?@ABCDEFGHIJKLMNOPQRSTVWXYZ[\]^_`abcdefghijkmnopqrstuvwxyz{|}~Root Entry FЁ aZn@Data U,1Tablelk^WordDocument ySummaryInformation(DocumentSummaryInformation8MsoDataStorepaZn3 aZnD0UPYUWUE==2paZn3 aZnItem  PropertiesUCompObj r   F Microsoft Word 97-2003 Document MSWordDocWord.Document.89q