ࡱ> [ bjbj~~ 8bb+K """8Z6D"B[zc)!%"YYYYYYY$]`rZ"cc""ZZ9)9)9)"FY9)"Y9)9)TDcX;NH"fV&Y[0B[EVaQ$taLcXqXaXD""9)"""""ZZ&t"""B[""""a""""""""" B : IRB Form F SWAGƵIRB Application for Waiver or Alteration of Informed Consent Procedures Informed consent of the subject is one of the fundamental principles of ethical research for human subjects. Informed consent also is mandated by Federal regulations  HYPERLINK "http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm" \l "46.116" (OHRP 45 CFR 46 and FDA 21 CFR), as well as SWAGƵpolicy for research with human subjects. An investigator should seek a waiver of written or verbal informed consent, or required elements thereof, only under compelling circumstances. Date:  FORMTEXT       Principal Investigator:  FORMTEXT       School/Unit VCOM:  FORMCHECKBOX  Faculty  FORMCHECKBOX  Staff  FORMCHECKBOX  Student  FORMCHECKBOX  Administration  FORMCHECKBOX  Other  FORMTEXT       Other Unit:  FORMCHECKBOX  Faculty  FORMCHECKBOX  Staff  FORMCHECKBOX  Student  FORMCHECKBOX  Administration  FORMCHECKBOX  Other  FORMTEXT       Street Address:  FORMTEXT       City:  FORMTEXT       State:  FORMTEXT       Zip Code:  FORMTEXT       Telephone (work): ( FORMTEXT    )  FORMTEXT    - FORMTEXT      Telephone (home): ( FORMTEXT    )  FORMTEXT    - FORMTEXT      Email Address:  FORMTEXT      @ FORMTEXT      . FORMTEXT     Faculty Supervisor:  FORMTEXT       (if applicable) School/Unit VCOM:  FORMCHECKBOX  Biomedical  FORMCHECKBOX  Clinical  FORMCHECKBOX  Administration Other:  FORMCHECKBOX  (please specify):  FORMTEXT       Telephone (work): ( FORMTEXT    )  FORMTEXT    - FORMTEXT      Email Address:  FORMTEXT      @ FORMTEXT      . FORMTEXT     Is the Faculty Supervisor Review Form Attached?  FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  N/A Project Title:  FORMTEXT       Type of Project (Check all that apply):  FORMCHECKBOX  Dissertation/Thesis  FORMCHECKBOX  VCOM 4th year Research Project  FORMCHECKBOX  Undergraduate Research  FORMCHECKBOX  Independent Study  FORMCHECKBOX  Classroom Project  FORMCHECKBOX  Faculty Research  FORMCHECKBOX  International Project  FORMCHECKBOX  Other Has the investigator completed education on research with human subjects?  FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  N/A (explain)  FORMTEXT       If applicable, attach certification forms to this application. SECTION A Check the appropriate boxes regarding your application for waiver or alteration of informed consent procedures:  FORMCHECKBOX  FORMCHECKBOX  Requesting Waiver or Alteration of the Informed Consent Process (Complete Section B)  FORMCHECKBOX  FORMCHECKBOX  Requesting Waiver of Documentation of Informed Consent (Complete Section C) SECTION B Request for Waiver or Alteration of the Informed Consent Process - 45 CFR 46.116(c) & 45 CFR 46.111(d) Under certain circumstances, the IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent (see last page of this application), or the IRB may waive the requirements to obtain informed consent. The following questions are designed to guide the decision making of the investigator and the IRB. Check your answer to each question:  FORMCHECKBOX  YES  FORMCHECKBOX  NO B.1. Will the proposed research or demonstration project be conducted by or subject to the approval of state or local government officials. {45 CFR 46.116(c)(1)} Comments:  FORMTEXT       If you answered no to question B.1, skip to question B.3.  FORMCHECKBOX  YES  FORMCHECKBOX  NO B.2. Is the proposed project designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs {45 CFR 46.116(c)(1)} Comments:  FORMTEXT       If you answered yes to questions B.1 and B.2, skip to question B.6.  FORMCHECKBOX  YES  FORMCHECKBOX  NO B.3. Will the proposed research involve greater than minimal risk? (Minimal risk is defined as the probability and magnitude of harm or discomfort anticipated in the research which are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.) {45 CFR 46.116(d)(1)} Comments:  FORMTEXT        FORMCHECKBOX  YES  FORMCHECKBOX  NO B.4. Will waiving or altering the informed consent process adversely affect the rights and welfare of the subjects?{45 CFR 46.116(d)(2)} Comments:  FORMTEXT        FORMCHECKBOX  YES  FORMCHECKBOX  NO B.5. Will pertinent information regarding the research be provided to the subjects later, if appropriate?{45 CFR 46.116(d)(4)} Comments:  FORMTEXT        FORMCHECKBOX  YES  FORMCHECKBOX  NO B.6. Is it practicable to conduct the research without the waiver or alteration? (Practicable is not an inconvenience or increase in time or expense to the investigator or investigation, rather it is for instances in which the additional cost would make the research prohibitively expensive or where the identification and contact of thousands of potential subjects, while not impossible, may not be feasible for the anticipated results of the study.) {45 CFR 46.116(d)(3)} Comments:  FORMTEXT       Waiver or alteration of the informed consent process is only allowable if: The answer to questions B.1 and B.2 are yes and the answer to question B.6 is no, OR The answers to question B.1 is no, B.3 is no, B.4 is no, B.5 is yes, and B.6 is no. If your application meets the conditions for waiver or alteration of the informed consent process, provide the following information for IRB review. A brief explanation of your experimental protocol in support of your answers to questions B.1 - B.6. Identify which elements of consent will be altered or omitted, and provide justification for the alteration. The risks involved in the proposed research and why the research presents no more than minimal risk to the subject. Describe how the waiver or alteration of consent will not adversely affect the rights, including the privacy rights, and the welfare of the individual. Define the plan, where appropriate, to provide individuals with additional pertinent information after participation. Explain why the research could not practicably be conducted without the waiver or alteration. Other information, as required, in support of your answers to questions B.1 - B.6. SECTION C Request for Waiver of Documentation of Informed Consent - 45 CFR 46.117(c) An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all of the subjects. The following questions are designed to guide the decision making of the investigator and the IRB regarding this topic. Check the appropriate box for your answer to each question.  FORMCHECKBOX  YES  FORMCHECKBOX  NO C.1. Was informed consent waived in Section B of this application? If yes, skip Section C, documentation of informed consent if not applicable.  FORMCHECKBOX  YES  FO!ef  f g h i n w x   ̍̉sa]UJhY h%hhL5hY h%h5hzp#jh4bh%h>*UmHnHujhO$h%hUjh%hUh%hhh0J>*B*phhh_(0J>*B*phjhh_(U hh_(jhh_(Uh_(hErhh-|a5\ h-|a5\ h/Y5\&h#7h/Y56B*CJ\aJph!ef > @ X 4gd%h $gd%h ! | $@@gd%h ! | @@@gd%h |$@gdzp]gd_( $gdEr$a$gd-|agd/Y  , . 0 : < > @ V X b d f    > @ \ 񺶮vh`jh#jUjYhLh%hUjhLh%hUjqh4bUjh4bUjh%hUh%hh#jhzp>*h#jh#j>*h#jhY h%h5&jh4bh%h5>*UmHnHu!juh4bh%h5>*Uh4bh%h5>*jh4bh%h5>*U#\ ^ ` n p       0 2 4 8 D F H d f h j خت媣媛媛w媛ijh_nh%hUjh_nh%hUj+h4bUjh4bUjh%hU hh%hh%h#jh4bh#j>*UmHnHujAh4bh#j>*Uh4bh#j>*jh4bh#j>*Uh#jjh#jUjhLh#jU) "$&02@BVXZdf|~ͽիm]mjh4bh%h>*U#jh4bh%h>*UmHnHujwh4bh%h>*Uh4bh%h>*jh4bh%h>*U hh%h#jh4bh#j>*UmHnHujh4bh#j>*Uh4bh#j>*jh4bh#j>*Uh#jjh_nh%hUjh%hUh%h    "$*,02FHJPRTVjlnvxŵťŕŅuj h4bh%h>*UjE h4bh%h>*Uj h4bh%h>*UjM h4bh%h>*Ujh4bh%h>*Uh4bh%h>*h%h#jh4bh%h>*UmHnHujh4bh%h>*Ujah4bh%h>*U*24HJLVXZ\prt~ŵťŌ|lg h%h5j h4bh%h>*Uj% h4bh%h>*Uj h4bh%h>*UhY h%hCJj9 h4bh%h>*Uj h4bh%h>*Uh4bh%h>*h%h#jh4bh%h>*UmHnHujh4bh%h>*Uj? h4bh%h>*(02<>@\^`bz| "$HJ^`bӲӤӖ׉qjh4bh%h>*Uh4bh%h>*jh4bh%h>*Ujhdh%hUj h_nh%hUjh_nh%hUj!h4bUjh%hUh%hh_(h#jh_(>*h#jh%h>* h4b>* hh%hhY h%h6%2rt*9gdb ] $gd%h  $@! ^! gd%h ]$@gd%hgd%h ! | $@@gd%hblnprt.0DFHRTVXlnpz|~ɹɩəɉpjYh4bh%h>*UhY h%hCJjh4bh%h>*Ujeh4bh%h>*Ujh4bh%h>*Ujmh4bh%h>*Uh4bh%h>*h_(h%h hh%hjh4bh%h>*U#jh4bh%h>*UmHnHu+ &(*68:<XZ\dfhͻƭƻƟͻƑ͉{q`{!jh4bh%h5>*Uh4bh%h5>*jh4bh%h5>*UhY h%h5jChY h%hUjhY h%hUjWhY h%hUjhY h%hU hY h%hh%h#jh4bh%h>*UmHnHujh4bh%h>*Ujh4bh%h>*U*,HJLftvx$%&9:HIJ]^l|njhO$h%hUjhO$h%hUjhO$h%hUh#jh#jH*jhO$h%hUh#jj-hO$h%hU hO$h%hjhO$h%hUh%hhY h%h5jh4bh%h5>*U&jh4bh%h5>*UmHnHu%lmn   !'()*89:>?@NͿͻzlzz^zzjIhY h%hUjhY h%hUjhY h%hU hY h%hh%h hh%hj]hO$hmGU hO$hmGjhO$hmGUhmGh#jjhO$h#jU hO$h#jjhO$h#jU hO$h%hjhO$h%hUjqhO$h%hU#NOPTV]_`jk  ƾƜƘێvlve^TMBjhb hb U hb hb hh*h!h#jh%h56h%h#jh4bh#j>*UmHnHuj5h4bh#j>*Uh4bh#j>*jh4bh#j>*Uh#jh#j6h#j hY h%hjhY h%hUjhY h%hU?#$: $ ^$ `gd?@NOQ`an "ι~rf~fhhh5CJ\hh5CJ\hhRxT5CJ\hh-|a5CJ\hh;GF5CJ\h;GFh;GF5>*\hRxT5>*\h} hb 56j!hb h4bUh*h?h-|a5\'~   9 : ǽǘǐ|q||f|b^W^W^WSh*U\mHnHu!jh4bh>*U\h4bh>*\jh4bh>*U\ h\hh6\h56\hh56\hFhh56\ : ? 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" "T"""""""ƾrjbZjVNjhUhhhP56\h< 56\hRxT56\&jh4bh>*U\mHnHu!jh4bh>*U\h4bh>*\jh4bh>*U\ h\hh6\h56\ hhhhFhh56\hh56\hFhh56h h-|ahhh*U\mHnHu!jQh4bh>*U\h4bh>*\jh4bh>*U\ h\hh6\hFh56\h56\hFh56 h6CJhhRxT6CJ h-|ahoho hhhRxThRxTjhUhjhUjahU &&&&&0&2&4&D&F&b&d&f&p&t&v&X'Z't'v'x'~'''''''''''ŷ뤬뜒udP&jh4bh>*U\mHnHu!j h4bh>*U\h4bh>*\jh4bh>*U\ h\hh6\h56\h< 56\hFhRxT56\hFhRxT56h< hRxTj= hUjhUhjhUhRxT56\ hRxT56 h6''''''''''((("((()))) )")$)6)8):)N)P)R)\)^)`)b)d))ؾ䏊o[&jh4bh>*U\mHnHu!j"h4bh>*U\h4bh>*\ h\hh6\hO56\hFh< 56\h< 56\hFh< 56h< j!hUj)!hUhjhUh56\ hRxT\jh4bh>*U\")))))))))))**1*3*+++++++++++++, , ,¸}sb}N}&jh4bh>*U\mHnHu!j}#h4bh>*U\h4bh>*\jh4bh>*U\ h\hh6\hhRxT56\hFh56\h56\hFh56hRxThRxT6 hhhRxThPhRxTh< j#hUhjhUj"hU ,,,,@,,,, -P-R-----c.o.. //./g/// 010P0r0t00001F1111111i223 3!3"3#313о~jhU hPh7hh2Kh7h h-|ahhhhCJOJQJ^J hh\hb hh>*\ hh>*\ h%h5\ h]jh]jhOh]jhPh6l56\hO56\hP56\h56\hRxTh/..h//t00H11111111!3"333,kjknkLmmmq $ ^$ `gdgdhgd7h$a$gdhgdh & Fgd]j132333;3<3J3K3L3Q333333334jjjj.j*k,k.k@kBkDkXkZk\kfkhkjkٹٵ|kW&jh4bh>*U\mHnHu!j%h4bh>*U\h4bh>*\jh4bh>*U\ h\hh6\h56\hFhD56hDjY%hTUUj$hTUjhTUhTji$hUhjhUj#hU!RMCHECKBOX  NO C.2. Does the proposed research project qualify for alteration of the informed consent process under Section B of this application? Comments:  FORMTEXT        FORMCHECKBOX  YES  FORMCHECKBOX  NO C.3. The consent document is the only record linking the subject and the research, and the principal risk is potential harm resulting from a breach of confidentiality. {45 CFR 46.117(c)(1)} Comments:  FORMTEXT        FORMCHECKBOX  YES  FORMCHECKBOX  NO C.4. The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context. {45 CFR 46.117(c)(2)} (Minimal risk is defined as the probability and magnitude of harm or discomfort anticipated in the research which are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.) Comments:  FORMTEXT       Waiver of documentation of the informed consent is only allowable if: The answer to question C.1 is yes, OR The answer to questions C.1 is no and the answer to either question C.3 or C.4 is yes. If your application meets the conditions for waiver of documentation of informed consent, provide the following additional information, supplementing the material provided in Part C of this application, for IRB review. How the consent document is the only record linking the subject to the research. How the principal risk to the subject is the potential harm from a breach of confidentiality. Why, if performed outside the research context, written consent is not normally required for the proposed experimental procedures. If the IRB approves a Waiver of Documentation of Informed Consent, the investigator must: Ask each participant if he or she wants documentation linking the participant with the research (i.e., wishes to complete an informed consent form). The participant s wishes will govern whether informed consent is documented. {45 CFR 46.117(c)(1)} AND At the direction of the IRB, provide participants with a written statement regarding the research. {45 CFR 46.117(c)} Required elements for an Informed Consent A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental . A description of any reasonably foreseeable risks or discomforts to the subject. A description of any benefits to the subject or to others which may reasonably be expected from the research. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.     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