ࡱ> CcBY bjbj 70ҜiҜit t 8RnL,$ ZLsX0,   ", t X : GUIDANCE: Study Team Roles and BSPH IRB Requirements The organizational structure of every study involves personnel whose involvement with the human subjects and/or their data varies, depending upon their functional roles. The BSPH IRB wants to make sure that all personnel who come into contact with human subjects and/or their identifiable data* are qualified and have completed appropriate human subjects research ethics training. Here are our definitions, training requirements, and process for changing personnel. Study Team RoleDescription and QualificationsTrainingTo Add/Change PersonnelBSPH Principal Investigator (PI)Faculty responsible for overseeing the responsibilities described in the roles section of the research plan.CITI Human Subjects Research Training; GCP (Good Clinical Practice) training if conducting clinical trial; HIPAA training if accessing/using Protected Health InformationSubmit an Amendment ApplicationBSPH Co-Investigator, Faculty, student (in the role as hired staff), staff involved in the project, and responsible for aspects of study operationsCITI Human Subjects Research Training; GCP training if conducting clinical trial; HIPAA training if accessing/using Protected Health InformationSubmit an Administrative Amendment for Change in Study PersonnelNon-BSPH Co-InvestigatorMust have qualifications to perform delegated role and be responsible for aspects of study operationsCITI Human Subjects Research Training; Family Health International (FHI) Training; NIH training; or training from their home institution.Submit an Administrative Amendment for Change in Study PersonnelStudent InvestigatorJHSPH student; the project must be associated with the students academic objectiveCITI Human Subjects Research Training; GCP training if conducting clinical trial; HIPAA training if accessing/using Protected Health InformationSubmit an Administrative Amendment for Change in Study PersonnelBSPH study team memberMust have qualifications to perform delegated role. This category could include research coordinators, data coordinators, lab personnel who will see identifiers, interviewers, etc.CITI Human Subjects Research Training; GCP training if conducting clinical trial; HIPAA training if accessing/using Protected Health InformationSubmit an Administrative Amendment for Change in Study PersonnelNon-BSPH study team memberMust have qualifications to perform delegated role. This category could include research coordinators, data coordinators, lab personnel who will see identifiers, interviewers, etc.Any of the computer-based modules mentioned above, or an in-person research ethics training conducted by a qualified person and approved by the IRB. Curriculum must be IRB approved, like the Field Training Guide found here: HYPERLINK "/offices-and-services/institutional-review-board-irb/training/human-subjects-research-ethics-field-training-guide"Human Subjects Research Ethics Field Training Guide | Johns Hopkins | Bloomberg School of Public Health (jhu.edu)No need to name these personnel unless responsible for execution of study operation. Submit an Administrative Amendment for Change in Study Personnel.Study ContactAdministrative role only receives copies of IRB communications to PINo training required. Should have no contact with study participants or data (unless listed in one of the above roles).Send an email to BSPH.irboffice@jhu.edu*Study team members whose only activities are limited only to use of deidentified data are not considered engaged and do not need to be added to the PHIRST application; this includes research assistants, data analysts, and the Johns Hopkins Biostatics Center (JHBC).     02/05/2024   !56  / \ ] ^ ~  * 9 B Y Z [ ` |  - ] H I     % 4 5 ] g  %efg|]a h&hAh&hA5 hA5h;hA5hAX6  9 B Z [ Ekd$$Ifl\<>+N9Bf t09644 laytfM$d$Ifa$gdfMgdA[ | I Mkd$$Ifl\<>+N9Bf t09644 laytfMd$IfgdfM   5 %fMkdH$$Ifl\<>+N9Bf t09644 laytfMd$IfgdfMfg|a[MMMMd$IfgdfMkd$$Ifl\<>+N9Bf t09644 laytfMpB[MMMMd$IfgdfMkd$$Ifl\<>+N9Bf t09644 laytfM pABCDG]^ '(LMWg EEk|}1hAB*eh@fHphq r@7hA5B*\eh@fHphq r@ hA0JjhAUjhAU h&hAhA@BC^[MMMMd$IfgdfMkd4$$Ifl\<>+N9Bf t09644 laytfMk}[MMMMMd$IfgdfMkd$$Ifl\<>+N9Bf t09644 laytfM[VLJLJLJ dgd]:gdAkd$$Ifl\<>+N9Bf t09644 laytfMh@(h]:h@(6CJaJhA6CJaJh}jh}U hAh@(gdA dgd]:51h0:p}= /!"#$% $$If!vh#vB#vf#v#v:V l t0965B5f55ytfM$$If!vh#vB#vf#v#v:V l t0965B5f55ytfM$$If!vh#vB#vf#v#v:V l t0965B5f55ytfM$$If!vh#vB#vf#v#v:V l t0965B5f55ytfM$$If!vh#vB#vf#v#v:V l t0965B5f55ytfM$$If!vh#vB#vf#v#v:V l t0965B5f55ytfMDD$$If!vh#vB#vf#v#v:V l t0965B5f55ytfM$$If!vh#vB#vf#v#v:V l t0965B5f55ytfMx666666666vvvvvvvvv666666>6666666666666666666666666666666666666666666666666hH6666666666666666666666666666666666666666666666666666666666666666662 0@P`p2( 0@P`p 0@P`p 0@P`p 0@P`p 0@P`p 0@P`p8XV~ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@66666 OJPJQJ_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 - Table Grid7:V0 d44 ]:0Header  H$6/6 ]:0 Header CharCJaJ4 @"4 ]:0Footer  H$6/16 ]:0 Footer CharCJaJ6U`A6 A0 Hyperlink >*B*phRRR ;0 Balloon Text dCJOJQJ^JaJN/aN ;0Balloon Text CharCJOJQJ^JaJPK![Content_Types].xmlN0EH-J@%ǎǢ|ș$زULTB l,3;rØJB+$G]7O٭Vj\{cp/IDg6wZ0s=Dĵw %;r,qlEآyDQ"Q,=c8B,!gxMD&铁M./SAe^QשF½|SˌDإbj|E7C<bʼNpr8fnߧFrI.{1fVԅ$21(t}kJV1/ ÚQL×07#]fVIhcMZ6/Hߏ bW`Gv Ts'BCt!LQ#JxݴyJ] C:= ċ(tRQ;^e1/-/A_Y)^6(p[_&N}njzb\->;nVb*.7p]M|MMM# ud9c47=iV7̪~㦓ødfÕ 5j z'^9J{rJЃ3Ax| FU9…i3Q/B)LʾRPx)04N O'> agYeHj*kblC=hPW!alfpX OAXl:XVZbr Zy4Sw3?WӊhPxzSq]y /0  [ fB   X8@0(  B S  ? |5g|Z s4aqPx{~!q I L A &Nv_@(vzwv #$#Lt#V#$LO&>, 0/13C5e*7;<;/ >A)B'DAD=F eKkJLLdLfM8MVXXRXZ]}\_L`caRc'Xgh|hHi\8kn*uRurOxwx}9M&4Zfa1&3Iq7ZeU-6P3ZU 4AK Kq,=F2[uO|o'5[o{8:t{17Tw2|]:d6;,9&E9t<418_@@UnknownG.[x Times New Roman5Symbol3. .[x Arial7..{$ Calibri5. .[`)TahomaC.,.{$ Calibri LightA$BCambria Math"h+'+'.r .r !n20 2Q@P $P'D2!xxja D  IRB OfficeOwens, Shannon Oh+'0t  0 < HT\dl IRB OfficeNormalOwens, Shannon2Microsoft Office Word@F#@|sX@|sX.r  ՜.+,D՜.+,t0 px   0Johns ѻý Document  Title0px _PID_HLINKSContentTypeId _activityAThttps://publichealth.jhu.edu/offices-and-services/institutional-review-board-irb/training/human-subjects-research-ethics-field-training-guide,0x010100AB1D5B90334B484BB1A6E6D18BC0AEB6  "#$%&'()*+,-./013456789;<=>?@ADEFHIJKLMNOPQRSTUVWXYZ[\]^_`abefgRoot Entry F0usXdData 1Table! 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