ࡱ> fjex '0bjbjR(R( 4l0B~_0B~_'v 8k\%($$$$$$$$'o*\$$$j$$:",.#v/v^v" n$$0%#.**.#*.#@$$%* Y Q: Instructions for Preparer: Provide the information requested in bolded italics, and then delete the instructions. Include a version date in the footer. If your study has more than one consent form, clearly identify the individual forms in the footer. IRB Protocol Title:IRB Protocol #:Principal Investigator: Phone Number:Sponsor/Supporter:[insert names of funding agencies; if not funded, delete]Participation Duration:Anticipated number of research participants: Introduction__________________________________________________________________ We are asking you to take part in a research study. This form provides you with information about the study. The principal investigator (the lead researcher for this project) [INSERT OTHER APPROPRIATE TITLE IF THE PI WILL NOT CONDUCT THE DISCUSSION] will provide you with a copy of this form to keep for your reference and will also describe this study to you and answer all of your questions. If at any time you have questions about the study, please ask a member of the study team. Take all the time you need to decide whether you want to take part in this research study. [Describe the purposes of the research, include a description of the procedures to be followed, the amount of time required for participation, what information will be collected, if educational records will be requested, and how the study data will be collected] Risks_______________________________________________________________________ [Describe the risks (physical, social, financial, psychological, privacy, or other) and possible discomforts related to the study. Depending on the study, there can be risks related to confidentiality of information, risks from procedures, risks from incidental findings, and discomforts from the procedures.] This [treatment, procedure, intervention, or describe other] may involve risks that are currently unforeseeable. A risk of taking part in this study is the possibility of a loss of confidentiality or privacy. Loss of privacy means having your personal information shared with someone who is not on the study team and was not supposed to see or know about your information. The study team plans to protect your privacy. Their plans for keeping your information private are described in the Confidentiality section below. Benefits_______________________________________________________________________ You will not benefit from taking part in this study, but your participation may help people who have [insert condition] in the future. [OR] You may or may not receive personal (direct) benefit from taking part in this study. The possible benefits of taking part in this study include: [insert specifics]. Confidentiality________________________________________________________ ___ Any information collected during this study that can identify you by name will be kept confidential. We will do everything we can to keep your data secure, however, complete confidentiality cannot be promised. Despite all efforts, unanticipated problems, such as a stolen computer may occur, although it is highly unlikely. The data resulting from your participation may be made available to other researchers in the future for research purposes not detailed within this consent form. In these cases, the data will contain no identifying information that could associate you with it, or with your participation in any study. If you choose to take part in this study, you are giving us the authorization (i.e. your permission) to use the protected health information or personally identifiable information collected during the research. The information that we may collect and use for this research may include medical information that may be considered sensitive. [Add a description of the information/PHI/PII that will be disclosed in a specific and meaningful way.] [Add a statement of why the requested use or disclosure is made.] [If you are collecting HIV test results, history of drug or alcohol abuse, or mental health information it must be stated.] [If you are NOT collecting HIV test results, history of drug or alcohol abuse, or mental health information include a statement that the project does not involve collecting health information that may be considered sensitive.] [If you are requesting academic records (grades) from the registrars office: include a statement which clarifies which specific records or information are being requested for release, the purpose, and recipients of educational records i.e., GPA, psychology 301 class grade, etc]. [Revise as necessary if identifiers will be shared outside of UMassD] The research information that is shared with people outside of University of Massachusetts Dartmouth will not include your name, address, telephone number or any other direct identifiers unless disclosure of the information is required by law, or you have authorized the disclosure. [Identify the persons or class of persons authorized to make the disclosure.] [Identify the persons or class of persons to whom the covered entity may make the requested disclosure] [Describe procedures for maintaining confidentiality, such as the following statements] Your questionnaire responses will be assigned a code number, and separated from your name or any other information that could identify you. [OR] The research file that links your name to the code number will be kept in a locked file cabinet or an encrypted data file and only the investigator and authorized study staff will have access to the file. The following individuals and/or agencies will be able to look at, copy, use, and share your research information: - The investigator, University of Massachusetts Dartmouth study staff, and other professionals who may be evaluating the study. [List other entities that may receive and process PHI/PII, i.e. Data Coordinating Center, Data Safety and Monitoring Board/Committee ...] - Authorities from University of Massachusetts Dartmouth, including the Institutional Review Board ('IRB'). - The Federal Office of Human Research Protections ('OHRP') [add FDA if applicable] and the United States Food and Drug Administration ('FDA'). [If this study is sponsored (money or supplies are being provided)] - The sponsor of this study, [NAME SPONSOR], including persons or organizations working with or owned by the sponsor. - Other government regulatory agencies (including agencies in other countries) if the sponsor is seeking marketing approval for new products resulting from this research. [if applicable] [Choose one of the following statements:] Your authorization to use and share the information collected for this research purpose does not have an expiration (ending) date. [OR] Your authorization to use and share the information collected for this research purpose will expire when the research is completed. Participants do not have to sign the authorization, but if they do not, they may not participate in the research. Participants may revoke the authorization in writing, (include instructions on how to exercise such right and who the individual needs to write, name and address). If you revoke your consent and authorization, you will not be allowed to continue taking part in the Research. Even if you revoke (take back) this consent and authorization, the researchers, and the sponsor (if applicable) may continue to use and disclose the information they have already collected. Once your research information has been disclosed to a third party (for example, a pharmaceutical company participating in a study), federal privacy laws may no longer protect it from further disclosure. Whom do I call if I have questions or problems? If you have any questions or concerns about this study, no longer want to participate in this research, you may contact [insert name of Principal Investigator or study contact] at telephone # [insert phone number]. Your participation is entirely voluntary. You can refuse to participate without penalty or loss of benefits to which you are otherwise entitled. You can stop your participation at any time and your refusal will not impact current or future relationships with UMassD or participating sites. If you have questions about your rights as a research participant, complaints, concerns, or questions about the research please contact The 91ɫƬ Office of Institutional Compliance at HYPERLINK "mailto:IRB.research@umassd.edu"IRB.research@umassd.edu. [If this study is registered with clinicaltrials.gov add Clinical Trial Language for Consent]: A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time. Statement of Consent and Authorization: I have read the consent and authorization form and talked about this research study, including the purpose, procedures, risks, benefits and alternatives with the researcher. Any questions I had were answered to my satisfaction. I am aware that by signing below, I am agreeing to take part in this research study and that I can stop being in the study at any time. I am not waiving (giving up) any of my legal rights by signing this consent form. I will be given a copy of this consent and authorization form to keep for my records. Signatures: [Ensure signature lines are not separated from the statement of consent] Participant Name: _____________________________________________________________ Participant Signature: ______________________________ Date: _________________ Investigator Signature: _____________________________ Date: _________________ [If you are requesting academic records (grades) from the registrars office: I consent to the release of my educational records and grade(s): specify what being requested for release) from the registrars office for [clarify the purpose] to Investigator: [Identify the Investigator by name]. Participant Signature: ______________________________ Date: _________________     University of Massachusetts Dartmouth Consent & Authorization Page  PAGE 3 of  NUMPAGES 3 "@GJNPTp    ｫ}m]M>>h h#qCJOJQJaJh h#q5CJOJQJaJh h85CJOJQJaJh h7 >*CJOJQJaJh h#q6CJOJQJaJh h,CJOJQJaJh hV1CJOJQJaJ"h hx;56CJOJQJaJ"h h:S56CJOJQJaJh hV16CJOJQJaJh h:S6CJOJQJaJh hx;6CJOJQJaJ   " # oakd$$Ifll0p$ t644 lapytNd$If^gdNd$IfgdN d^gdx; ! " # $ ; < = > ? M N O b c d e f mWA-&h h*H56CJOJPJQJaJ*h h*H56@CJOJPJQJaJ*h h*H56@CJOJPJQJaJ#h h*H6CJOJPJQJaJh h*H5CJOJQJaJh h8CJOJQJaJ#h h86CJOJPJQJaJh h7 5CJOJQJaJh h85CJOJQJaJh h#qCJOJQJaJh h#q5CJOJQJaJh h 5CJOJQJaJ# $ = > }d$If^gdNd$IfgdNakd$$Ifll0p$ t644 lapytN> ? M N }d$If^gdNd$IfgdNakd$$Ifl-0p$ t644 lapytNN O b }d$If^gdNd$IfgdNakd}$$Iflp0p$ t644 lapytNf g h i j k l m n p q r s t u w x y z { } ~  yyg"h h85>*CJOJQJaJh h*H5CJOJQJaJh h*HCJOJQJaJ#h h*H6CJOJPJQJaJ*h h*H56@CJOJPJQJaJ&h h*H56CJOJPJQJaJ*h h*H56@CJOJPJQJaJ*h h*H56@CJOJPJQJaJ# }d$If^gdNd$IfgdNakd$$Iflp0p$ t644 lapytN }d$If^gdNd$IfgdNakd{$$Ifl20d$ t644 lapytN 6 v w ~    ]{ dd`dgdx; dgd7 dgdx;akd$$Ifll0d$ t644 lapytN 5 6 j . 0 t u v w x paO=O"h h856CJOJQJaJ"h h|E56CJOJQJaJh h*HCJOJQJaJh hx;CJOJQJaJ%h hn56CJOJQJ]aJh hn5CJOJQJaJh hnCJOJQJaJh h7 CJOJQJaJh h8CJOJQJaJh h|ECJOJQJaJh h|E>*CJOJQJaJ"h h|E5>*CJOJQJaJ   ( R S T X ` j | } ~  ܸʦܔܔ܅vgUEh h|E>*CJOJQJaJ"h h|E5>*CJOJQJaJh hnCJOJQJaJh h,hCJOJQJaJh h*HCJOJQJaJ"h h.N56CJOJQJaJ"h h8`56CJOJQJaJ"h h7 56CJOJQJaJ"h h856CJOJQJaJ"h h|E56CJOJQJaJ"h hx;56CJOJQJaJ 9Mu   ]ͽxfVGh h:SCJOJQJaJh hx;>*CJOJQJaJ"h hx;5>*CJOJQJaJ/h h85>*CJOJPJQJ\aJwhh hdCJOJQJaJh hnCJOJQJaJh h7 CJOJQJaJh hx;6CJOJQJaJ"h hx;56CJOJQJaJ"h hd56CJOJQJaJh hx;CJOJQJaJ{KLMNоЬ{l{{]lK{{"h h55CJOJQJ\aJh hnCJOJQJaJh hczsCJOJQJaJh h5CJOJQJaJ"h h 5>*CJOJQJaJh hx;5CJOJQJaJ"h hx;5>*CJOJQJaJ"h hx;56CJOJQJaJh hx;CJOJQJaJh h:SCJOJQJaJ"h h:S56CJOJQJaJMN !!!<"A""" dgd5 dgdx; dgd:Ss~KL%.⾩◅vvaLa(h h.N56CJOJQJ\]aJ(h h=56CJOJQJ\]aJh h=CJOJQJaJ"h h7 56CJOJQJaJ"h h556CJOJQJaJ(h ho56CJOJQJ\]aJ(h hczs56CJOJQJ\]aJh hGCJOJQJaJh h5CJOJQJaJh h7 CJOJQJaJ.59EIfj Nv+ѼѼѼѼzk\Mh hnCJOJQJaJh hGCJOJQJaJh h*CJOJQJaJ"h h8`5>*CJOJQJaJ"h hG5>*CJOJQJaJ"h h!5>*CJOJQJaJh hGCJOJQJaJh h5CJOJQJaJh htCJOJQJaJ(h ht56CJOJQJ\]aJ(h hczs56CJOJQJ\]aJh hczsCJOJQJaJ"%%&&& ( (*)+)****,,,E-F----- dgdU dgdczs dgd.N dgdt dgdx; dgd5&8&F&w&&&&&&&&&&( ( ( ((())&)')))*)ñteReRARe h hi0JCJOJQJaJ%jh hiCJOJQJUaJh hiCJOJQJaJh h,CJOJQJaJh hx;CJOJQJaJh h:S5CJOJQJaJh h:SCJOJQJaJ"h h:S56CJOJQJaJh hK6CJOJQJaJh hnCJOJQJaJh hKCJOJQJaJh h!CJOJQJaJ*)+))********)+,,,,,)-D-E-F-ɶuuffQQ*CJOJQJ\aJ%h hU5>*CJOJQJ\aJ%h hn5>*CJOJQJ\aJ%h h.N5>*CJOJQJ\aJ(h ht56CJOJQJ\]aJh htCJOJQJaJF----------...8.9....//&/'/)/9/\/^/_/////////////////įĠĠĠĠĠĘ"h h7 5>*CJOJQJaJh/+jh/+Uh h^CJOJQJaJ(h h.N56CJOJQJ\]aJh h.NCJOJQJaJh hczsCJOJQJaJh htCJOJQJaJh hUCJOJQJaJ*---8.9.^/_///////////////"0#0gd*@CJOJPJQJ\aJwh3h h7 5>*@CJOJPJQJ\aJwh3h h7 5>*@CJOJPJQJ\aJwh3h h7 5>*@CJOJPJQJ\aJwh/h h7 5>*CJOJPJQJ\aJwh0000 0!0"0#0$0%0&0'0³h h.NCJOJQJaJh/+h hBehBehBe6PJ hBePJ\hq+\mHnHujhBehBeU\hBehBe\ #0$0%0&0'0 dgdczs21h:p/+/ =!"#$% }$$If!vh#v#v:V ll t6,55/ pytN}$$If!vh#v#v:V ll t6,55/ pytN}$$If!vh#v#v:V l- t6,55/ pytN}$$If!vh#v#v:V lp t6,55/ pytN}$$If!vh#v#v:V lp t6,55/ pytN}$$If!vh#v#v:V l2 t6,55/ pytN}$$If!vh#v#v:V ll t6,55/ pytNx666666666vvvvvvvvv666666>6666666666666666666666666666666666666666666666666hH6666666666666666666666666666666666666666666666666666666666666666662 0@P`p2( 0@P`p 0@P`p 0@P`p 0@P`p 0@P`p 0@P`p8XV~8XV~ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@OJQJ_HmH nH sH tH J`J Normal dCJ_HaJmH sH tH DA D Default Paragraph FontRi@R 0 Table Normal4 l4a (k ( 0No List TT ! Colorful List - Accent 1 ^m$6U`6 ,h0 Hyperlink >*B*phtt #q Table Grid7:V0 d< !< _V0 Medium Grid 1 B*phR2R _V0 Balloon Text dCJOJQJ^JaJN/AN _V0Balloon Text CharCJOJQJ^JaJ>@R> Be0HeaderdH$.a. Be0 Header Char> @r> Be0FooterdH$.. Be0 Footer CharRR czs No Spacing dCJOJPJQJ^JaJFV F i0FollowedHyperlink >*B*phOrRv!R iUnresolved MentionB*ph`^\q PK![Content_Types].xmlN0EH-J@%ǎǢ|ș$زULTB l,3;rØJB+$G]7O٭V (BO)MBT.$@0H!A>풠Uc-zD[&!rX=}zC0` ި%.]Ssd--7 +fOZեrŵVœ\lji2ZGwm-3˵j7\ Uk5FҨ-:xRkcr3Ϣ+9kji9OP Et-j|#p;E=Ɖ5Z2sgF=8 K}*7c<`*HJTcB<{Jc]\ Ҡk=ti"MGfIw&9ql> $>HmPd{(6%z:"'/f7w0qBcF6f Iöi1(\}B5ҹ~Bcr6I;}mY/lIz1!) ac 1fm ƪN^I77yrJ'd$s<{uC>== Ƌ(uX=WA NC2>GK<(C,ݖm: &-8j^N܀ݑ$4:/x vTu>*ٞn{M.Ǿ0v4<1>&ⶏVn.B>1CḑOk!#;Ҍ}$pQ˙y')fY?u \$/1d8*ZI$G#d\,{uk<$:lWV j^ZơSc*+ESa1똀 k3Ģxzjv3,jZU3@jWu;z \v5i?{8&==ϘNX1?  O4׹ӧCvHa01 %xz24ĥ=m X\(7Xjg !Ӆqd? cG7.`~w*?, 2 nN*"Fz_&n &\ F:l[+%f '(Ul NNuuux f .+!E#&*)F-/0'0#$%&()*+,-/0134# > N "-#0'0 !"'.25 !&!'(XSZ\amox!L# @0(  B S  ? '''''''''%(((Ol *!X#`#'''''''''%(((333 $EIfj '!)!)!""%%%%&&&&&&&&''&'''9'\']''''''( (( (!(!((( $EIfj '!)!)!""%%%%&&&&&&&&''&'''9'\']''''''( (( (!(!(((QadLRH ^`OJQJo( 8^8`OJQJo(^`OJQJ^Jo(o  p^ `OJ QJ o(  @ ^ `OJ QJ o( x^x`OJQJo(H^H`OJQJ^Jo(o ^`OJ QJ o( ^`OJ QJ o( ^`OJQJo(^`OJQJ^Jo(o p^p`OJ QJ o( @ ^@ `OJQJo(^`OJQJ^Jo(o ^`OJ QJ o( ^`OJQJo(^`OJQJ^Jo(o P^P`OJ QJ o(QadL         J/+Tq7 T~UQwxCSf j#y+$f:'V1;^K r*H>W{ Tx;#qni,h Y,F:S=85d6+[\>Eoq+q0 JG''@)!)!)!)!'(P@Unknown S.[x Times New RomanTimes5^Symbol?. .[x ArialArial7..{$ Calibri5. .[`)TahomaC.,.{$ Calibri LightC.  Aptos Display3.  Aptos?= .Cx Courier New;^MWingdingsA$BCambria Math"Ahb'0sÇsÇ !H!H20'' OQ@P $P|E2! xxb_N  Susie KimStephanie A Pena  Oh+'0|   , 8 D P\dlt' Susie Kim Normal.dotmStephanie A Pena9Microsoft Office Word@߽@S,v@]@ _/v!՜.+,D՜.+,L hp  '$Columbia University Medical CenterH'  Title 8@ _PID_HLINKS'Ax!@mailto:IRB.research@umassd.edu  !"#$%&'()*+,-./012345689:;<=>@ABCDEFGHIJKLMNOPQRSTVWXYZ[\^_`abcdghilnopqrstuvwyz{|}~Root Entry Fv/vk Data 71Table?*WordDocument4lSummaryInformation(UDocumentSummaryInformation8]MsoDataStore v/vv/vOBIXGU42JQ==2v/vv/vItem  PropertiesO3UDUGODVCX==2 v/vv/vItem  m4Properties }TIFRIRQ1==2v/vv/vItem Properties U !"#$%'DocumentLibraryFormDocumentLibraryFormDocumentLibraryForm This value indicates the number of saves or revisions. The application is responsible for updating this value after each revision. metaAttributes"/>   F Microsoft Word 97-2003 Document MSWordDocWord.Document.89qCompObj&r