ࡱ> rtq5 8bjbjl2l2 4lXhXh 0 8|PT="z=|=|=|=|=|=|=$?B=7!7!7!==###7!Fz=#7!z=##8; <rW}!*;f==0=<KC"KC0 < <"KCB<$b# %==;#=7!7!7!7!KC X N: 91Ϣ of Health Sciences Whittier, CA 90604 Consent to act as a Research Participant Title of study (must match the research protocol submitted to IRB) Participants Name: _______________________________________________________________ We invite you to take part in this research study which seeks to (briefly state purpose of study). You must be willing to provide a written informed consent prior to participation. Participation in this research study is completely voluntary. Please read this information below and ask questions about anything that you do not understand before deciding if you want to participate. A researcher listed below will be available to answer your questions. Investigators and Sponsor Principal Investigator(s): State the Principal Investigators name and department here. (If applicable, the students name if the research is being performed by a student under the direction of the Principal Investigator). Study Sponsor(s): (list sponsor(s) if available/applicable) Purpose of Study The purpose of this research study is (explain purpose (i.e., thesis, research) in one or two paragraphs in easily understood language). End this paragraph with, To participate in this study you must sign this consent form. (consider adding) The following definitions may help you to understand this study: (add definitions as necessary) Inclusion Requirements You are being asked to participate because (state criteria for patient selection). Number of Participants: The investigator plans to enroll (state number of people) participants at this site. (Clarify if enrollment will occur within the Whittier area, throughout the United States or internationally) Procedures In creating the sections on Procedures, Benefits, and Risks, information a reasonable person would want to have to make an informed choice about participation MUST be included. This information must be provided in sufficient detail and organized and presented in a way that facilitates an understanding of why one might, or might not, want to participate. Outline the procedures of the study and explain exactly what will happen to the participant during the study. Clearly identify what parts of the procedure, if any, are experimental. Describe clearly how often and how much time will be expected at each interaction for the protocol. Total Time Involved: If you agree to take part in this study, your involvement will include: (provide details for the expected frequency and duration for time of participation: x days, weeks, months, etc. i.e., this is a 6 months study with 4 weeks of active participation by each participant and 4 months collection of medical information for each participant. If there is a washout or a follow-up period, state so in easily understood language). Potential Benefits (Describe any benefits to the participant and to others that may reasonably be expected from the research). OR If none, state - There are no known benefits to you that would result from your participation in this research. OR if appropriate, add: This research may help us to understand (limit to a brief statement). Do NOT include payments or other types of direct compensation here. Likelihood of benefits: (brief explanation of severity and likelihood of benefits) Potential Risks If none, state There are no anticipated risks associated with your participation in this study. OR There are certain risks or discomforts associated with this research. They include (describe any reasonably foreseeable risks or discomforts to the participant. Provide additional information as it relates to instances of risks, stress or known discomforts (physical, psychological, social or legal) as a result of a participants involvement in your study (i.e., you do not have to answer any questions that make you uncomfortable.. You may also describe the measures you will take to minimize these risks and discomforts. Include a brief description of any benefit and/or justification to be derived from the work.) Likelihood of risks: (brief explanation of severity and likelihood of risks) If you feel discomfort at any time, notify the Principal Investigator immediately and you can discontinue the treatment at any time. Alternatives to Participation: (state alternatives to participation, for e.g. you can continue medical care with your current physician or seek care alternatively from licensed health care providers elsewhere) OR There is currently no alternative treatment. Statement of Responsibility for Research-Related Risks Every effort to prevent injury as a result of your participation will be taken. It is possible, however, that you could develop complications or injuries as a result of participating in this research study. If you suffer an injury directly related to your participation in this project, SCU will help you obtain medical treatment for the specific injury and provide referrals to other health care facilities, as appropriate. SCU will not provide you with financial compensation or reimbursement for the cost of care provided to treat a research-related injury or for other expenses arising from a research related injury. The institution or group providing medical treatment will charge your insurance carrier, you or any other party responsible for your treatment costs Alternatives to Participation: (state alternatives to participation, for e.g. you can continue medical care with your current physician or seek care alternatively from licensed health care providers elsewhere) OR There is currently no alternative treatment. Compensation/Cost/Reimbursement: (list compensation or cost to participants. Include statement of insurance billing if any costs will be billed to the subjects insurance. If treatments are free of charge, consider stating: You will not be required to pay for research related procedures/treatments.) Confidentiality: (Explain how and where study results will be kept (i.e., results of this study may be published but no names or identifying information will be included for publication; results will be reported in group format, etc.) Research records will be kept confidential to the extent allowed by law. You should also state where data will be stored and when destroyed (i.e., data will be kept for three years in a locked filing cabinet with only the researcher having access to collected data.) Data Storage (how will data be stored? Mention clearly about encryption of data and password protection of electronic data, if applicable) Data Access (who will have permission to access data and how?) Level of Privacy (what is the level of privacy?) Use of Personal Health Identifiers (State whether participants' information or biospecimens collected as part of the proposed research might be stripped of identifiers and used for other research in the future or it will not be stripped and potentially used for other future research. Note that this is only about future research use of information and biospecimens that will be stripped of identifiers. Consent for the future use of identifiable private information and identifiable biospecimens for future unspecified research is covered under the section for "broad consent," or could also occur under conditions where an IRB determines that a waiver of informed consent is appropriate.) Whole Genome Sequencing: (notice to participant if whole genome sequencing will be completed, remove if not applicable) New Findings: If during the course of this study, significant new information becomes available that may relate to your willingness to continue to participate, this information will be provided to you by the investigator. Clinically Relevant Findings: (notice about whether clinically relevant research results will be returned to the subjects) Conflict of Interest Investigators must satisfy campus requirements for identifying and managing potential conflicts of interest before a research study can be approved. The purpose of these requirements is to ensure that the design, conduct and reporting of the research will not be affected by any conflicting interests. If at any time you have specific questions about the financial arrangements or other potential conflicts for this study, please feel free to contact any of the individuals listed above. (consider adding The person inviting you to participate in this research may also be your treating doctor. In such cases, the doctor has an interest in both your care and promoting the successful conduct of this research. Sometimes these two interests may cause conflict. You can choose not to participate in the research and still receive treatment from your doctor. If you wish, you may also request to speak to another doctor who is not a member of the research team about your options.) (Statement about potential Commercial Profit secondary to research, if applicable) University Statement: The 91Ϣ of Health Sciences at Whittier, CA, is committed to the safety of subjects participating in research. For further questions or concerns about this project, please contact (principle investigator, degrees obtained), Principal Investigator of this project at (562) ____________ Extn _______. Any other questions with regards to patients' rights can be directed to Dr. Christine Lemke, DC, Chair of the SCU-IRB at  HYPERLINK "mailto:christinelemke@scuhs.edu" christinelemke@scuhs.edu. We will give you a copy of this form to keep for your records. Withdrawal or Termination from Study: You are free to withdraw from the study at any time. If you decide to withdraw from the study, you should inform the researchers immediately. You may also be removed from the study without your consent because of the following: (consider listing: A) based on the researcher's judgment to improve your health and welfare, B) because you have not followed the study procedures, or C) because the study sponsor decides to stop the study.) If you withdraw or are terminated from the study, you may be asked to (e.g., return all unused medications, return to the clinic for a final evaluation). Final procedures are necessary to make sure there have been no changes in your health. Statement of Consent: I (print your name), __________________________________, have read the attached "Experimental Subject's Bill of Rights" and have been given a copy of it and this consent form to keep. I understand that participation in this study is voluntary. I may refuse to answer any question or discontinue my involvement at any time without penalty or loss of benefits to which I might otherwise be entitled. My decision will not affect my future relationship with or the quality of care I receive at SCU. My signature below indicates that I have read the information in this consent form and have had a chance to ask any questions I have about the study. I consent to participate. _________________________________________________________PRINTED NAME of ParticipantDate __________________________________________ _______________Signature of ParticipantDate _________________________________________________________Signature of WitnessDate _________________________________________________________Signature of Investigator Date Assent form Addition for all participants under the age of 18. The study has been explained to me and I understand what is going to happen. I had a chance to ask questions and know that I can ask the doctor if I have any others. I agree to participate. ___ The subject is capable of reading and understanding the document and has signed the consent/assent form to take place in the study. ___ The subject is not capable of reading, but the document was read and explained to them. The subject has signed the assent form to take place in the study. Parent or guardians printed name: __________________________________________ Parent or guardians signature: __________________________________________ Date:______________ Investigator conducting assent protocols printed name: ___________________________________________ Investigator conducting assent protocols signature: ___________________________________________ Date:___________     PAGE  PAGE 4 91Ϣ of Health Sciences Consent to act as a Research Participant 23FGopqz  & * : I J L M i j k  ǹxqihHh9r>* h 1:>*hHh{f:>*hHh{f5:>* hHh$ hHh9rh 1h 1B*ph hfh 1h 1hHh 15h 1h 15:B*ph h 15: h9r5:hHh5:hHh{f5hHh]M<5 h]M<5:hHh{f5:)3FGpq k    o p gd{fgdcVgd[ f$a$gd 1 dd[$\$gd9r)$$d%d&d'dNOPQa$gd{f$a$gd]M<    A S       ? @ ϼϧϠϧǁ偠}}}}vo hHh{f hHh[ fh3%eh3hHh 1:h{f5:>*hHh{f5:>* hHh9rhHh[ fB*phhHh{f5:hHh9rB*phh3B*phhHhB*phhHhHB*phh3h3B*ph hHhHhHh{f:'  M P Q m n o p $./0<=Kоtit^^tthHh9rB*phhHh]M<B*phhHhHB*phhHh{f5 hHhz0h3hz0B*phh3hHB*ph hHhh 15:>*hHh{f5:>* hHh9rhHh[ fB*phhHhB*phhHh{f:hHh{f5: hHh{fhHh{fB*ph$ *+FG h&'p]pgd*I Rgdz0gdz0gdtgdj_gd3$a$gd3%egd{fgdcVdeuvw|()*+2Ztҹng_TT__h3%eh3%eB*phh3%eB*ph hHh 11hf\h{f6B*CJaJfHphq 1hhf\6B*CJaJfHphq 1hf\hf\6B*CJaJfHphq 0hf\B*CJOJQJaJfHphq 6hf\hf\B*CJOJQJaJfHphq hHh{f5:>* hHh9r ;@DEFG[^   츸츸츸츱h*IB*phh{hhj_B*phhHh 15:>*hthj_5:>*h*I5:>* hHh3%ehHh3%eB*ph hfh3%ehHh3%e:hHh3%e5:h3%eh3h3B*phh3%eB*phh3%eh3%eB*ph/=Z[𸰣{phpaaVKKhthj_5:>*hthyE5:>* hHhthtB*phh{hhtB*phhHht: ht5:hHht5:hj_hOH7hOH7B*phhOH7hOH76B*phh*IB*phh{hhj_B*phhOH7hj_B*phh*Ih*IB*phh3h3B*phh3h3B*ph hHhj_h{hhj_>*]fhj]]y%&']պ°wme^Sh{hhB*ph hHhhHh:hHh5:hHh5:>* hH:h*IhH: hHhH hHhj_h{hhj_B*phhHhj_:hHhj_5:hz0B*phh{hhz0B*phh*IB*phh{hhB*phh{hh>* hHh hOH76hHh 15:>*  (5ù|u hHh<hHhj_5:hHh:hHh5:hHh5:>*hHhj_: hHhcV hfhf\hHh 15>*hj_5:>*hHhj_5:>*hHh5 hHh hlhh{hhB*phhB*ph.!!!!"$G%H%'&(&&&&***E-G-"/gd7^gdz0gdcVgdj_gd%7CDEMh$%&'(89:;KK ! !!!-!.!G!鸭颗~wmf h{h5:hHh5: hHh< hHhhHh5:>* hHh9rh{hh7^B*phh{hh9rB*phh{hh<B*phh{hB*phhf\B*phh{hhTBB*phh{hh{hB*phh{hh$B*phh{hhz0B*phh{hhB*ph(G!K!!!!!!!!!!!!!""#">"?"E"S"""""##8#V#\#####$$$$$$$$$$$"%F%G%ǽ{{{{hMw#hMw#B*phhMw#hMw#5:hh5B*phhh6B*phhhB*phhB*phhh5:hB*phh#pB*ph h{h5:hHh5: hHhh{hB*phhlB*ph/G%H%U%W%v%%%&&&'&(&<&F&&&&&&&&&&''((((())**************觧wwhMw#hB*phhh#phcVB*phh#phz0B*phh#phB*ph hHhcV hHhhMw#hMw#B*phhMw#hMw#5:>*hMw#hcVhf\ hHh9rhHh5:hHh5:>*hHh56\]+**F+++++++*,-,.,1,9,;,F,,,,,,,,,--E-F-G-l-n--F.R.S.e.. /!/"/#/F/h/i/j///ĩ~~剉w~~ hHh<h#phcVB*phh#ph<B*phhHh5:hHh5:>*hHh7^0JB*phjhHh7^UjhHh7^UhB? hHhcVh#ph7^B*phh#phB*ph hHh7^hHhcV5."/#/022222 3 3(3-3Lkd$$If0uD%634ayt dd$If[$\$gd gdcV ////0*0+0-0.0/000?0@0F0N0[0_0b0e00F1122F2222222 3 333'3(3,3-3.3/303[3\3l3m33333Ľׯׯרר׶׶}}}hHh:hHhr!p:hr!phr!p:CJaJ hHhr!phr!phcV hHh hHh hHh9r hHh:hHhTB5hHh5:>* hHhcVh#phcVB*phh#phB*phh#ph<B*ph1-3.3/303[3\3l3m333VIkd$$If0uD%634a dd$If[$\$gdcVLkd>$$If0uD%634ayt  3333333333333334"4#4=4>4B4C4D4E44445D5E5q555555566o6p6666666666666666(7)7*737b7c7777778 8 8 8 8 88888888h_sjh_sU hHhyEh'hr!pCJaJhr!pCJaJh9rhHh: hHh9rN33333333TIkd7$$If0uD%634a dd$If[$\$ d[$gd9rIkd$$If0uD%634a3334"4#4>4C4TIkd$$If0uD%634a dd$If[$\$ d[$gd9rIkd$$If0uD%634aC4D4E444D5E555o6p6666666(7)7*7gdr!pgd9rIkd*$$If0uD%634a*7b7c777778 8 8 8 88888888 8!8,8^88 $h]ha$gd) $h]ha$gd)h]hgd9r &`#$gdMgd9rgdr!p8888888 8!8"8(8)8*8+8,8^8_8o888888׻ʯ hHhyEhR=h\CJaJhR=h\:CJaJh\:CJaJhR=h\:CJaJhyE0JCJaJmHnHuh:h\0JCJaJ!jh:h\0JCJUaJh\ h\0Jjh\0JUh_s8888gd9r21h:pmc/ =!"#h$h% DyK christinelemke@scuhs.eduyK @mailto:christinelemke@scuhs.eduU$$If!vh#vu#v :V 6,534 yt U$$If!vh#vu#v :V 6,534 yt O$$If!vh#vu#v :V 6,534 O$$If!vh#vu#v :V 6,534 O$$If!vh#vu#v :V 6,534 O$$If!vh#vu#v :V 6,534 O$$If!vh#vu#v :V 6,534 O$$If!vh#vu#v :V 6,534 x2&6FVfv2(&6FVfv&6FVfv&6FVfv&6FVfv&6FVfv&6FVfv8XV~ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@66666_HmH nH sH tH @`@ NormalCJ_HaJmH sH tH DA`D Default Paragraph FontRi@R  Table Normal4 l4a (k (No List 4 @4 9rFooter  !.)@. 9r Page Number6U`6 7^ Hyperlink >*B*ph4"4 :Header  !L2L {fNormal + small caps$a$5d/Ad {fNormal + small caps Char5CJ_HaJmH sH tH B' QB yEComment ReferenceCJaJ<b< yE Comment TextCJaJ:q: yEComment Text Char@jab@ yEComment Subject5\F/F yEComment Subject Char5\HH yE Balloon TextCJOJQJ^JaJN/N yEBalloon Text CharCJOJQJ^JaJZoZ 1 SL-Fl Lft Sgl$da$CJ_HmH sH tH PK![Content_Types].xmlN0EH-J@%ǎǢ|ș$زULTB l,3;rØJB+$G]7O٭Vj\{cp/IDg6wZ0s=Dĵw %;r,qlEآyDQ"Q,=c8B,!gxMD&铁M./SAe^QשF½|SˌDإbj|E7C<bʼNpr8fnߧFrI.{1fVԅ$21(t}kJV1/ ÚQL×07#]fVIhcMZ6/Hߏ bW`Gv Ts'BCt!LQ#JxݴyJ] C:= ċ(tRQ;^e1/-/A_Y)^6(p[_&N}njzb\->;nVb*.7p]M|MMM# ud9c47=iV7̪~㦓ødfÕ 5j z'^9J{rJЃ3Ax| FU9…i3Q/B)LʾRPx)04N O'> agYeHj*kblC=hPW!alfpX OAXl:XVZbr Zy4Sw3?WӊhPxzSq]y 0l  G!G%*/388 "#$%&()*+-/4 "/-333C4*788!',.01235$$%0X  !!8@0(  B S  ?#´FôFĴFŴF ƴFǴFȴFɴFʴF˴F̴F ʹFδFϴFдFѴFҴFӴFԴF մF ִF״FشF ٴF ڴF۴F ܴFݴF޴FߴFFFFFF"?P(PK= ly:!H # $R&i'/(@0@0N00      !"((hh +n/Y %| %K"#%$g&'@(J0T0T00  !"? *urn:schemas-microsoft-com:office:smarttags stockticker*isiresearchsoft-com/cwywcitation=#*urn:schemas-microsoft-com:office:smarttags PlaceType=!*urn:schemas-microsoft-com:office:smarttags PlaceName9" *urn:schemas-microsoft-com:office:smarttagsplace #"!     #"! 0 0 000000000MQ( .  7;"'Zn ##//// 0 0 000000000333333333333333333333.....)/ 0 0 0 0 0 0000000_000033.....)/ 0 0 0 0 0 000000000 wNIOiЉДE!ΙuL5Jj8n2>K ,V `QdPZ] ln0^`CJOJQJo(^`CJOJQJo(pp^p`CJOJQJo(@ @ ^@ `CJOJQJo(^`CJOJQJo(^`CJOJQJo(^`CJOJQJo(^`CJOJQJo(PP^P`CJOJQJo(^`CJOJQJo(^`CJOJQJo(pp^p`CJOJQJo(@ @ ^@ `CJOJQJo(^`CJOJQJo(^`CJOJQJo(^`CJOJQJo(^`CJOJQJo(PP^P`CJOJQJo(^`CJOJQJo(^`CJOJQJo(pp^p`CJOJQJo(@ @ ^@ `CJOJQJo(^`CJOJQJo(^`CJOJQJo(^`CJOJQJo(^`CJOJQJo(PP^P`CJOJQJo(^`CJOJQJo(^`CJOJQJo(pp^p`CJOJQJo(@ @ ^@ `CJOJQJo(^`CJOJQJo(^`CJOJQJo(^`CJOJQJo(^`CJOJQJo(PP^P`CJOJQJo(^`CJOJQJo(^`CJOJQJo(pp^p`CJOJQJo(@ @ ^@ `CJOJQJo(^`CJOJQJo(^`CJOJQJo(^`CJOJQJo(^`CJOJQJo(PP^P`CJOJQJo(^`CJOJQJo(^`CJOJQJo(pp^p`CJOJQJo(@ @ ^@ `CJOJQJo(^`CJOJQJo(^`CJOJQJo(^`CJOJQJo(^`CJOJQJo(PP^P`CJOJQJo(^`CJOJQJo(^`CJOJQJo(pp^p`CJOJQJo(@ @ ^@ `CJOJQJo(^`CJOJQJo(^`CJOJQJo(^`CJOJQJo(^`CJOJQJo(PP^P`CJOJQJo(^`CJOJQJo(^`CJOJQJo(pp^p`CJOJQJo(@ @ ^@ `CJOJQJo(^`CJOJQJo(^`CJOJQJo(^`CJOJQJo(^`CJOJQJo(PP^P`CJOJQJo(^`CJOJQJo(^`CJOJQJo(pp^p`CJOJQJo(@ @ ^@ `CJOJQJo(^`CJOJQJo(^`CJOJQJo(^`CJOJQJo(^`CJOJQJo(PP^P`CJOJQJo( Oij8E!uL5w2> lPZV `Q DE22CB:<}= z0*dtg"9r) Mw#J- 0 1OH7*89]M<B?TBL/CyE)BH*I?VKMcVf\7^3%e[ f{f(}hlr!p_smc$6HMP-P{h&#p`EG}fl3j_YDR=_/@734\ 0 0@0 @UnknownG.[x Times New Roman5Symbol3. .[x Arial;. .[x Helvetica9. . Segoe UIC.,.{$ Calibri Light7..{$ CalibriA$BCambria Math"h<&$gT+(W+(W!h20//3q@P ?9r2!xx^p -California State University, Fullerton (CSUF)Nina LaChristine Lemke0         Oh+'0 ,8 X d p|0California State University, Fullerton (CSUF)Nina LaNormalChristine Lemke8Microsoft Office Word@ @'z~@nW+( ՜.+,D՜.+,X hp|  W/ .California State University, Fullerton (CSUF) Title 8@ _PID_HLINKSAx% mailto:christinelemke@scuhs.edu  !"#$%&'()*+,-./012345689:;<=>@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`bcdefghjklmnopsRoot Entry FuWuData 71Table?{CWordDocument4lSummaryInformation(aDocumentSummaryInformation8iCompObjr  F Microsoft Word 97-2003 Document MSWordDocWord.Document.89q