ࡱ> {}z ]bjbj cvf f Dml0N]`(X`MMMMMMMPvSM9444MM^"^"^"4xM^"4M^"^"G0OJ|8T3H$MN00NWH:T H:THOJ:TOJL44^"44444MM!|4440N4444:T444444444f o:  CLINICAL QUALITY IMPROVEMENT/MEASUREMENT CHECKLIST The checklist below can be utilized to help determine whether your proposed activity is Clinical Quality Improvement/Measurement that does not need IRB review, or Quality Improvement Research which does require IRB review. Consider consulting the IRB on challenging projects, for example those involving international sites, vulnerable populations, sensitive content, medical errors, or monetary incentives that are not hospital-wide. If necessary, review this checklist with the appropriate Department Chairperson or Administrative Supervisor where your project will be conducted. Examples of QI Projects not requiring IRB review: Evaluation of characteristics of patients with catheter-associated UTIs on a particular service to minimize this problem. Implementation of a daily checklist to routinely assess extubation readiness in an ICU. Examination of no-shows at a clinic in order to insure linkage to care and cost-effective utilization of staff time. This could include calling patients to ascertain why they did not make a scheduled visit. Tracking Door-to-Procedure or Door-to-Drug turnaround times to develop ways to better meet accepted standards or goals. Monitoring radiation dosimetry in order to minimize radiation exposure in young patients likely to undergo multiple scans for care. Implementing a safety assessment in a clinic seeing geriatric patients, in order to recommend/initiate appropriate referrals and services designed to keep older people safely in their homes. Reviewing pharmacy records to determine whether certain medications can be switched from IV to oral formulations in order to minimize risks and reduce costs. Publication of Results: The intent to publish the results of a project does not determine whether or not it needs IRB review. Publication of a quality improvement project does not necessarily mean it fits the definition of research. You may wish to publish something if you believe others would be interested in learning about your activities without it being research. The publication should not refer to the activity as research and should make it clear that the publication is the result of a quality improvement activity. In addition, some QI projects are in fact better classified as research even when there is no intention of disseminating or publishing the findings. External Funding: If your project is funded by an external research grant you should submit it for IRB review, as it is likely the funding agency is considering your project, or a part of it, research. If your project is funded by some other external entity, but not as a RESEARCH grant (e.g., foundation or individual philanthropy), send the grant title, funder, PI and a one paragraph summary of your project to Melissa Abraham PhD, IRB Chair. She can assist you in determining whether the project should be formally reviewed by the IRB. Additional References: PHRC Guidance: Review of Quality Measurement Initiatives: HYPERLINK "http://healthcare.partners.org/phsirb/qmeasure.htm"http://healthcare.partners.org/phsirb/qmeasure.htm OHRP Quality Improvement Activities FAQs: HYPERLINK "http://answers.hhs.gov/ohrp/categories/1569"http://answers.hhs.gov/ohrp/categories/1569 CLINICAL QUALITY IMPROVEMENT CHECKLISTDate:  FORMTEXT      Division:  FORMTEXT      Project Leader: FORMTEXT      Instructions: Answer YES or NO to each of the following statements about QI projects.YESNOThe aim(s) of the project is to improve the process or delivery of care with established /accepted quality standards, or to implement change according to mandates of the hospitals Clinical Quality Improvement programs. There is no intention of using the data for research purposes. FORMCHECKBOX  FORMCHECKBOX The specific aim is to improve performance on a specific service or program in the hospital and is part of usual care. All participants will receive standard of care. FORMCHECKBOX  FORMCHECKBOX The project is not designed to answer a research question or test a hypothesis and is not intended to develop or contribute to generalizable knowledge. FORMCHECKBOX  FORMCHECKBOX The project does not follow a research design (e.g., hypothesis testing or group comparison (randomization, control groups, prospective comparison groups, cross-sectional, case-control)). The project does not follow a protocol that over-rides clinical decision-making. FORMCHECKBOX  FORMCHECKBOX The project involves implementation of established and tested quality standards and/or systematic monitoring, assessment or evaluation of the organization to ensure that existing quality standards are being met. The project does not develop paradigms or untested methods or new untested standards. FORMCHECKBOX  FORMCHECKBOX The project involves implementation of care practices and interventions that are consensus-based or evidence-based. The project does not seek to test an intervention that is beyond current science and experience.  FORMCHECKBOX  FORMCHECKBOX The project is conducted by staff where the project will take place, and involves staff who are working at, or patients who are seen at the Partners institution. FORMCHECKBOX  FORMCHECKBOX The project has no funding from federal agencies or research-focused organizations, and is not receiving funding for implementation research (see External Funding on pg 1). FORMCHECKBOX  FORMCHECKBOX The clinical practice unit (hospital, clinic, division, or care group) agrees that this is a QI project that will be implemented to improve the process or delivery of care (i.e., not a personal research project that is dependent upon the voluntary participation of your colleagues, students and/or patients). FORMCHECKBOX  FORMCHECKBOX If there is an intent to, or possibility of publishing your work, you and your Department/QI Oversight group are comfortable with the following statement in your methods section: This project was undertaken as a Quality Improvement Initiative at X hospital or clinic, and as such was not formally supervised by the Institutional Review Board per their policies. ** FORMCHECKBOX  FORMCHECKBOX ANSWER KEY: If the answer to ALL of these questions is YES, the activity can be considered a Clinical Quality Improvement/Measurement activity that does not meet the definition of research. IRB review is not required. Keep a dated copy of this checklist in your files. If the answer to ANY of these questions is NO, the project must be submitted to the IRB for review.**If projects *+56  g |  _ } ~  +,mt]^_o.2_|}ǺǺDzDzǓDzDžDzDzDzDžxDzDzDzDzh~ h{q>*B*phh~ h{q5>*B*ph&h~ h{q5:>*B*OJQJphhih{qB*phh{qB*phh~ h{q5B*phh~ h{qB*phhh{qB*CJaJph hh{q5B*CJaJphh{q5B*CJaJph,56~  , W W ^_}~E^gd[pgd?gd)W & Fgdcgdcgdigd2m[$a$gd^}~CDqr  ع쭡vlW(jhtB*CJOJQJUaJphhh{qhU/hh{qB*ph hh{q5B*CJaJphhh{qB*CJaJphh{qB*CJaJphhtB*CJaJphjhtUh~ h{q0JjhtUh{qjh{qUh{qB*phh~ h{qB*phhtB*phL]@kd$$Iflur&''644 layt" <<$IfgdhY9@kd$$Iflur&''644 layt"$xx$Ifa$gdw4gd)W   "$&:<>HJLN^`lnԿznSzGzh{qB*CJaJph4jhthtB*CJOJQJUaJphhtB*CJaJphhh{qB*CJaJphhh{qhU/#hth{qhU/B*OJQJph3jhtB*CJOJQJUaJmHnHphu(jhtB*CJOJQJUaJph4j9hthtB*CJOJQJUaJphhtB*CJOJQJaJphLNBJPr^MMxx$If^gdw4dxx$If^gd@kdg$$Iflur&''644 layt" <<$IfgdhY9@kd$$Iflur&''644 layt">BPR%/жЧ}q`q`q}Y}q}q}H<htB*OJQJph jhtB*OJQJUph hh{q h+O)h{q5B*OJQJphh{qB*OJQJphhh{qB*OJQJph hh{q5B*OJQJphhh{qhU/hth{qB*OJQJph3jhtB*CJOJQJUaJmHnHphu(jhtB*CJOJQJUaJph4jhthtB*CJOJQJUaJphPRtt$$If^a$gdtd<<$If^gdgkd$$IflFI T#r&!  t'6    44 layt"J_bؽɟɓɓɂtcؽLؽ,jChthtB*OJQJUph hIAh{q>*B*OJQJphh{q5B*OJQJph hh{q5B*OJQJphh{qB*OJQJph hh{q,jhthtB*OJQJUphhtB*OJQJphhh{qB*OJQJph jhtB*OJQJUph,jhthtB*OJQJUphq]MM$$If^a$gdtd<<$If^gdkdk$$IflFI T#r&!  t0'6    44 layt" OP^_`abpqrstɮɑɑ؅n؅W,ji hthtB*OJQJUph,jhthtB*OJQJUphhtB*OJQJphh{qB*OJQJph h{q5:>*B*OJQJph&h 1@h{q5:>*B*OJQJph hh{qhh{qB*OJQJph jhtB*OJQJUph,jhthtB*OJQJUphOasq]MM$$If^a$gdtd<<$If^gdkd+$$IflFI T#r&!  t0'6    44 layt"stq]MM$$If^a$gdtd<<$If^gdkd $$IflFI T#r&!  t0'6    44 layt"-1=BELM *BQby hh{q,j hthtB*OJQJUph,j hthtB*OJQJUphhtB*OJQJph jhtB*OJQJUphh{qB*OJQJphhh{qB*OJQJph&h^h{q5:>*B*OJQJph-q]MM$$If^a$gdtd<<$If^gdkd $$IflFI T#r&!  t0'6    44 layt" }݋kT,j hthtB*OJQJUph&h^h{q5:>*B*OJQJphh{qB*OJQJph hh{q,j hthtB*OJQJUph,jY hthtB*OJQJUphhtB*OJQJph jhtB*OJQJUphhh{qB*OJQJph&h 1@h{q5:>*B*OJQJphq]MM$$If^a$gdtd<<$If^gdkdC $$IflFI T#r&!  t0'6    44 layt"Gghiwxyz{ضضthضQض,jyhthtB*OJQJUphh{qB*OJQJph&hSh{q5:>*B*OJQJph,j9hthtB*OJQJUph,jhthtB*OJQJUphhtB*OJQJph hh{qhh{qB*OJQJph jhtB*OJQJUph,jhthtB*OJQJUphq]MM$$If^a$gdtd<<$If^gdkd$$IflFI T#r&!  t0'6    44 layt"hzq]MM$$If^a$gdtd<<$If^gdkd$$IflFI T#r&!  t0'6    44 layt"  > ? @ C !W"X"Y"g"ɶɶɶɥɶؙؙkZؙ hh{q6B*OJQJph,jhthtB*OJQJUph,j/hthtB*OJQJUphhtB*OJQJph hh{q>*B*OJQJphh{qB*OJQJph hh{qhh{qB*OJQJph jhtB*OJQJUph,jhthtB*OJQJUph q]MM$$If^a$gdtd<<$If^gdkde$$IflFI T#r&!  t0'6    44 layt" X"j"|"q]MM$$If^a$gdtd<<$If^gdkd$$IflFI T#r&!  t0'6    44 layt"g"h"i"j"k"y"z"{"|"}"""""""""# ###1#<#?#@#X#Y####ؽɟtteɅɅɅɑTtt h|lh{q5B*OJQJphh "h{qB*OJQJph hh{q5B*OJQJphh{qB*OJQJphh{q5B*OJQJph hh{q,j[hthtB*OJQJUphhtB*OJQJphhh{qB*OJQJph jhtB*OJQJUph,jhthtB*OJQJUph|"}"#q`<<$If^gd"kd$$IflFI T#r&!  t0'6    44 layt"#########$\\\ \\\\\ ] ] ]|p_S<_,jJh0h 5B*OJQJUphh0B*OJQJph jhtB*OJQJUphhwB*OJQJphh{qB*OJQJph#hh{q5:B*OJQJphU hh{qh|lh{qB*OJQJphh{q5B*OJQJphh;Ch{qB*OJQJph hh{q5B*OJQJphhh{qB*OJQJph h;Ch{q5B*OJQJph##\^]`]a]c]d]f]g]i]j]k]ssqqqqqqqqodxx]^gd"wkd$$Iflr&'  t 0'644 lap yt" meet all of the criteria on this list and an editor or publication has concerns about, or disagrees with this statement, the IRB is willing to write in support of your submission, clarifying the IRB policy/approach (contact HYPERLINK "mailto:ehohmann@partners.org"Elizabeth L. Hohmann MD, Director and Chair, Partners Human Research Committee).     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[ @Verdana7@Cambria7.@ Calibri5. .[`)Tahoma?= *Cx Courier New;WingdingsA$BCambria Math"hk'Gk'G]1]1!`4dhh3HX ?VTt*! xxQI RESEARCH CHECKLISTPartners Information SystemsPartners Information SystemsH          Oh+'0  8 D P \hpxQI RESEARCH CHECKLIST Partners Information Systems Normal.dotm Partners Information Systems2Microsoft Office Word@F#@X4@* T@* T]՜.+,D՜.+,\ hp   Partners HealthCare System, Inc1h QI RESEARCH CHECKLIST Title X4<<\  _PID_HLINKS_AdHocReviewCycleID_NewReviewCycle_EmailSubject _AuthorEmail_AuthorEmailDisplayName_PreviousAdHocReviewCycleID _ReviewingToolsShownOnceA 7mailto:ehohmann@partners.org+/a,http://answers.hhs.gov/ohrp/categories/1569+-%3http://healthcare.partners.org/phsirb/qmeasure.htm+@new documents for the Nursing Research Day Web info and thanks!SLOOBY@mgh.harvard.eduLooby, Sara E. 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