ࡱ> [ J>bjbj  ?@pa!\pa!\v* * 8dR<$FL $ٜ`]@ob$pBCFKR Vؙ0vppT* > h:  Informed Consent Appendix: Total Waiver or Alteration PROTOCOL TITLE:  FORMTEXT   IRB REFERENCE #/ACCT #:  FORMTEXT       Principal Investigator:  FORMTEXT   Instructions: Complete this form if you want to waive or alter the informed consent requirement for the entire study.  Please contact the HRPP Office (860-972-2893 or  HYPERLINK "mailto:irb@hhchealth.org" irb@hhchealth.org ) if you have questions about this form. Total Waiver or Alteration Do you want to request to totally waive OR alter the informed consent requirement for the Entire Study?  FORMCHECKBOX Yes - Request to totally waive the informed consent requirement  FORMCHECKBOX Yes - Request to alter the informed consent process  FORMCHECKBOX No - I will be obtaining written informed consent OR requesting other types of consent and/or waivers Note: The most common type of study that the IRB would allow a complete waiver of informed consent would be a Retrospective Chart Review Totally waiving or altering the consent form is NOT applicable for FDA-regulated research except for planned emergency research or research involving human specimens that are not individually identifiable for FDA-regulated in vitro diagnostic device investigations as per FDA guidance (OMB Control No. 0910-0582). Answer the following questions related to waiving/altering informed consent The research involves no more than minimal risk to the participants because:  FORMTEXT       The waiver or alteration will not adversely affect the rights and welfare of participants because:  FORMTEXT       The research could not practicably be carried out without the waiver or alteration because: (Indicate why it is not feasible to get consent and wh&:<>rtvҽ~m[M:,h=hK/0>*OJQJ^J$jh=hK/0>*OJQJU^JhK/0CJOJQJ^JaJ#h-hK/05CJOJQJ^JaJ hHh CJOJQJ^JaJhZhYOJQJ^JhlB5OJQJ\^J hZ5CJOJQJ\^JaJ&hZhZ5CJOJQJ\^JaJ)hZhZ5;CJOJQJ\^JaJ#hlB5;CJOJQJ\^JaJhH5CJOJQJ^JaJhH]hH]OJQJ^J >tv. 0 C $1$IfgdlB1$gdS71$gd  $h1$^ha$gdb\ $ H1$a$gdK/0      , . ײr\D6hK/0CJOJQJ^JaJ/jh=h >*OJQJU^JmHnHu*jjh=h >*OJQJU^Jh=h >*OJQJ^J$jh=h >*OJQJU^J hHh CJOJQJ^JaJh CJOJQJ^JaJ hHhK/0CJOJQJ^JaJ&h=h_S>*OJQJ^JmHnHu$jh=hK/0>*OJQJU^J*jh&fhQ>*OJQJU^J. 0 \ ^ b d x z | ~ ʼq`Q@,&hZh0^5CJOJQJ\^JaJ hS75;CJOJQJ^JaJhS7;CJOJQJ^JaJ hHhS7CJOJQJ^JaJ&h=hS7>*OJQJ^JmHnHu*jh&fhS7>*OJQJU^Jh=hS7>*OJQJ^J$jh=hS7>*OJQJU^JhS7CJOJQJ^JaJ#h-hS75CJOJQJ^JaJ&hS7hS75;CJOJQJ^JaJh ;CJOJQJ^JaJ @ B C D E i l u v п~l^M^M^l:l^$hah0JCJOJQJ^JaJ hZhCJOJQJ^JaJhCJOJQJ^JaJ#jhCJOJQJU^JaJh7CJOJQJ^JaJ hZhCCJOJQJ^JaJ hZh`BCJOJQJ^JaJ hHhYCJOJQJ^JaJ hZhYCJOJQJ^JaJ hZh0^CJOJQJ^JaJhlBCJOJQJ^JaJ hZhZCJOJQJ^JaJC D E {m & F$1$Ifgd7 $1$Ifgd,BykdH$$Ifl''  f064 l` alp fyt  _ ` a ͼjYH6$#hRh75CJOJQJ^JaJ#h7h95CJOJQJ^JaJ hlBhlBCJOJQJ^JaJ hp5>*CJOJQJ^JaJ,hrYh+5B*CJOJQJ^JaJph)hlB5>*B*CJOJQJ^JaJph&hchrY5>*CJOJQJ^JaJ#hHhQ[>*CJOJQJ^JaJ hHhYCJOJQJ^JaJ hZhYCJOJQJ^JaJ hZh,BCJOJQJ^JaJ hZh[CJOJQJ^JaJ ` a {pdTT$ h1$`hgdlB $h1$^hgd7 $ & F%1$gdlB1$gd  1$gd7 $1$a$gd,B $1$^gd  ckd$$Ifl''064 lalyt a b p q r u w     ] ^ _ ` ٳٳ|d|LHhlB/j`hHh7CJOJQJU^JaJ/jhHhlBCJOJQJU^JaJ hHhlBCJOJQJ^JaJ)jhHhlBCJOJQJU^JaJ hlBhlBCJOJQJ^JaJhlBCJOJQJ^JaJ/jxhHh7CJOJQJU^JaJ hHh7CJOJQJ^JaJ)jhHh7CJOJQJU^JaJ ^ y z   $1$gd9 $ & F%1$gdI$1$gdI $d1$^dgdlB$ & F'<<a$gdlB $h1$`hgdlB$ Fh1$`hgdI$ h1$`hgdlB ` b x y z  ῱ᣕ{dRA/#hRh95CJOJQJ^JaJ hIhICJOJQJ^JaJ#h'hI5CJOJQJ^JaJ,h75>*B*CJOJQJ\^JaJph2hIhI5>*B*CJOJQJ\^JaJphhlBCJOJQJ^JaJh7CJOJQJ^JaJhlBCJOJQJ^JaJ&hZhlB5>*CJOJQJ^JaJh9CJOJQJ^JaJ hlBhlBCJOJQJ^JaJhICJOJQJ^JaJŪ؍|jYG8hI5CJOJQJ^JaJ#hRhI5CJOJQJ^JaJ hIhICJOJQJ^JaJ#h jh95CJOJQJ^JaJ h)h9CJOJQJ^JaJ9jh=h956>*CJOJQJU^JmHnHu4jh=h956>*CJOJQJU^J%h=h956>*CJOJQJ^J.jh=h956>*CJOJQJU^Jh95CJOJQJ^JaJ x0z0000xlx $h1$^hgdI6$h$d%d&d'd-D1$M NOPQ^hgdI$1$gdI $ & F%1$gdI$1$gd96$h$d%d&d'd-D1$M NOPQ^hgd9 0v0x0z0|000պzigiUF+4jh=hI56>*CJOJQJU^JhI5CJOJQJ^JaJ#hRhI5CJOJQJ^JaJU hIhICJOJQJ^JaJ#hIhI5CJOJQJ^JaJ h)hICJOJQJ^JaJ9jh=hI56>*CJOJQJU^JmHnHu4jHh=hI56>*CJOJQJU^J%h=hI56>*CJOJQJ^J.jh=hI56>*CJOJQJU^Jy the research could not be done if consent were required.)  FORMTEXT       Informed Consent Alteration - Special If you want to alter some or all of the elements of informed consent or use a consent procedure that varies significantly from the usual consent process, explain which elements will be altered and why.  FORMTEXT       If necessary, load the alternate consent form or tools at the end of the form.     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