Reviewer Infrmatin Sheet fr Cmmittee Members OSIRIS is a web-based applicatin that was created t imprve human subject prtectins and t enable the IRB t better serve the research cmmunity. The applicatin is based n the use f a questin and answer frmat using smart frms. Based n respnses t specific smart frm questins the system may branch t additinal questins. OSIRIS presents the investigatr the unique pprtunity t submit ne applicatin fr the entire review prcess. In additin, it prvides all cmmittee members access t all the dcuments submitted fr review. This infrmatin sheet is designed t prvide yu with the basic tls t initiate yur review f an OSIRIS applicatin. Infrmatin sheets will be peridically updated as enhancements t the system are cmpleted. Yu are strngly encuraged t review the instructins n-line s yu will have access t the mst current versin. Please cntact Patty Orndff (rndffpa@upmc.edu) r Melissa Mikls (miklsm@upmc.edu) with any questins, cncerns r t schedule training. All questins regarding a specific research applicatin shuld be directed t the listed IRB Crdinatr. If yu experience technical prblems please email us at irb@pitt.edu. Since this system is a web-based applicatin we are able t prvide yu with n-line assistance. Feel free t cntact the IRB Office (412-383-1480) at any time fr assistance. Table f Cntents Page 2..Lgin Page 2..Cnfirm/Decline meeting attendance Page 2..Initiate yur review Page 3..Add reviewer ntes Page 3-4..Cmplete summary review (primary, secndary, r nn-scientific review) Page 5..Review a recnsideratin 1
Lgin G t https://www.siris.pitt.edu Click n Lgin (tp right-hand crner f page) Enter Username (email address) and Passwrd as registered with HSCnnect If yu have Frgtten yur passwrd Click n link available frm the lgin page and HSCnnect will email yur username and passwrd t yu G t https://www.siris.pitt.edu and Lgin again T end yur sessin, click the Lgff buttn (tp right-hand crner f page) Cnfirm/Decline Meeting Attendance Under My Rles Click n Cmmittee Member (pens view f all member activities) Click n My Meetings tab Select the cmmittee meeting which requires yu t Cnfirm r Decline Under My Activities Click n the Cnfirm r Decline buttn A new web brwser windw will appear, click n the OK buttn available at the bttmright crner f the windw Yu may need t scrll dwn t see the buttn Initiate yur review Under My Rles (lcated n the left-hand side f the page) Select Cmmittee Member Click n My Meetings tab Select the cmmittee meeting fr which yu wish t initiate a review The Meeting Agenda is available n the upper left-hand side f the page Click n the Meeting Agenda buttn n the upper left-hand side which permits access t all the items n the agenda Click n the hyperlinked title f agenda item yu wish t review When yu have finished reviewing that item, clse the brwser windw and yu will be returned t the meeting agenda Paper submissins will be upladed t the agenda fr review 2
Add Reviewer Ntes Tw methds are available t add reviewer ntes: View Study r Reviewer Versin Click n View Study buttn Page by page review f the agenda item Click n Add buttn, write yur reviewer nte, and click the OK buttn befre clsing the windw Click n Reviewer Versin buttn (preferred methd) Prvides a view f the entire IRB prtcl n ne page Click n the [reviewer ntes] link which will autmatically take yu t the specific page where yu can Add yur reviewer nte Remember t click n the [reviewer ntes] link fund at the tp f each questin r set f questins When yu have cmpleted yur cmment(s), click n the RED buttn lcated in tp right-hand crner f the page which will clse the brwser (mst brwsers) and yu will be returned t the meeting agenda If mre than ne questin exists n the page, please remember t identify the questin fr which yu are cmmenting Fr example, 4.1 Will ptential research subjects be identified thrugh the use f advertisements? Sample reviewer cmment: 4.1 - Yu failed t include the advertisements fr review and apprval Edit yur reviewer ntes Click n View Study buttn g t the reviewer nte yu wish t edit (Add, Delete, Next r Previus buttns available) Click n the reviewer nte (e.g., Cmmittee Cmment (Private)) Windw pps up and yu can edit yur cmments Ability t edit cmments befre r during the cnvened meeting Yu can cut and paste yur cmments frm a Wrd dcument Yu can cut and paste sectins frm the applicatin and add t yur reviewer cmments Assigned as Primary, Secndary, r Nn-Scientific Reviewer The My Tasks tab Lists all agenda items which yu are assigned Preferred methd fr review is using the Meeting Agenda as utlined previusly Under My Activities sectin f a study s wrkspace Click n Cmplete Review which is based n yur reviewer rle (primary, secndary, nn-scientific) Windw pens which cntains 3 sectins My Reviewer Ntes publishes all yur reviewer ntes Viewable nly t yu and the IRB staff Brief Summary synpsis f study t be presented at cnvened meeting Viewable by all cmmittee members and IRB staff Add attachments- click n add and brwser pens Uplad the checklist - Designated reviewers assigned t NEW STUDIES are required t cmplete the checklist 3
Uplad the cnsent dcument(s) if track changes utilized fr review Uplad any ther supprting dcuments Instructins fr uplading a dcument (e.g., checklist, cnsent) Click n the Add buttn Brwser windw will pen Title: add the title f the dcument File: click n Brwse and uplad the dcument (e.g., desktp, disk) Click OK t publish the dcument int OSIRIS Remember t click OK t save yur wrk befre clsing the windw Yu have nw reviewed the study, added reviewer ntes as needed, and cmpleted yur rle as an assigned reviewer. 4
Hw t review a study that was recnsidered Frm the Recnsidered study wrkspace Review all f the previus meeting cmments by pening the Letter t PI Click n [View] in the summary sectin lcated t the right f the Letter t PI Displays all the cmmittee cmments fr recnsidering the study Click n the first cmment in the letter yu wish t review Example: 1. 2.6 - Experimental Interventins Please prvide detailed infrmatin n each research prcedure t be cnducted. Be sure t click n the hyperlink (2.6 - Experimental Interventins) which will pen anther page directly in the OSIRIS applicatin Click n the Cmmittee Change Request t view the cmmittee and PI cmments Cmmittee Change Request This Opens a textbx displaying bth the cmment frm the cmmittee and the PI s respnse Clse the windw r click n Cancel when yur review f this cmment is cmpleted Add an additinal cmment regarding the PI s respnse Click n the Add buttn in the Reviewer ntes sectin as yu nrmally d t add ther cmments T g back t the letter t view the cmmittee cmments fr recnsideratin Click n the <<Back buttn lcated directly abut the Reviewer Nte sectin Yu are nw back t the Letter t PI where yu can click n the next cmment and cntinue yur review Other Review Optins Using View Study G t the study wrkspace and click n View Study Click n the Next buttn in the Reviewer Nte sectin t review all the Cmmittee Change Request cmments Again use the Add buttn in the Reviewer Ntes sectin t add yur cmment Using the Change Lg G t the study wrkspace and click n Change Lg Click n the hyperlink Change Lg: Page 5.12 t display the highlighted changes within the OSIRIS applicatin 5