ethics. above all. ONTARIO CANCER RESEARCH ETHICS BOARD ANNUAL REPORT

Transcription

1 Otario Cacer Research Ethics Board ethics. above all. ONTARIO CANCER RESEARCH ETHICS BOARD ANNUAL REPORT

2 ABOUT RESEARCH ETHICS BOARDS Research Ethics Boards (REBs) are idepedet, multi - discipliary committees that review the ethical acceptability of research ivolvig humas to determie whether the research should be permitted to start or to cotiue. REBs that review biomedical research geerally iclude doctors, other healthcare professioals ad members of the scietific commuity, as well as o - scietific members with specific expertise, icludig ethicists, lawyers, privacy experts ad commuity members. Workig withi a defied regulatory ad ethical framework, the REB s role is to safeguard the rights ad welfare of the idividuals who voluteer to participate i research. This is carried out by esurig that the study sposor ad the researchers have adequately cosidered ad applied the required ethical priciples for the coduct of research to the desig ad implemetatio of the research, icludig the coset form. The REB also serves as a cosultative body to the research commuity ad thus cotributes to the creatio ad preservatio of a culture of research ethics.

3 reviewig. ad cotributig. INNOvATIvE. COLLABORATIvE. PROgRESSIvE. Sice Jauary 2004, the Otario Cacer Research Ethics Board (OCREB), a cetral, expert ocology REB, has bee workig with researchers, istitutios ad sposors to safeguard the rights ad welfare of research participats i Otario while advacig ethically soud cacer research. OCREB: Applies extesive ocology expertise to its review of the research; Reduces duplicatio ad cost by elimiatig the eed to gai local REB approval of the research at each participatig cetre; Facilitates the start-up of the research at multiple cetres across Otario oce the provicial submissio is approved, participatig cetres usually receive approval to coduct the research withi days of submittig to OCREB; Serves all but two of the cacer cetres i Otario that coduct cliical trials, icludig pediatrics; Is a respected leader i cacer research ethics; Was the first REB qualified uder the Cliical Trials Otario REB Qualificatio Program. OCREB is accoutable to the Otario Istitute for Cacer Research (OICR) s Board of Directors through the OCREB Goverace Committee. To lear more about the OCREB Goverace Committee Membership, please visit OCREB ANNUAL REPORT

4 workig. with you. MESSAgE FROM THE CHAIRS AND EXECUTIvE DIRECTOR For more tha 12 years, the Otario Cacer Research Ethics Board (OCREB) has bee workig with our colleagues i the research commuity to safeguard the rights ad welfare of research participats, while advacig ethically soud cacer research. This report illustrates how we remai steadfast i those efforts. Followig years of meetigs ad preparatio, OCREB broadeed its madate to iclude pediatric research ad sice May 2015, has reviewed eight Childre s Ocology Group trials. It has bee a excitig challege to expad ito this importat area of research. We are pleased with the recet ews that the Board of Trustees of the Childre s Hospital of Easter Otario has authorized the use of OCREB. Havig OCREB serve as the REB of record for all five pediatric cetres i Otario udoubtedly will improve access to multi-cetre cliical trials for childre with cacer. While OCREB s priority is the protectio of those idividuals who voluteer to participate i research, we are well aware that to most of our research parters, icludig patiets, time is also of the essece. Timeliess is oe of the key beefits to OCREB s cetralized model; oce a study is approved, participatig cetres usually obtai OCREB approval to coduct the study withi days. However, we all are frustrated that it cotiues to take a average of about three moths to get a study approved. For this reaso, last year we put sigificat effort ito aalyzig timelies i hopes of idetifyig ways to reduce delays while maitaiig high quality i the review of icreasigly complex research. Not surprisigly, there was o obvious sigle cause of the delays. However, we ucovered importat iformatio that is relevat to all parties. 2 OCREB ANNUAL REPORT

5 Dr. ray Sagiur Chair of the OCREB goverace Committee mr. richard Sugarma Chair of OCREB ms. JaET mazo Executive Director of OCREB The feedback from this year s aual researcher survey was strogly positive, with the highest ratigs to date i almost all areas. Despite the low respose rate, we believe the overall message is steady as she goes. Next year promises to be aother excitig oe. I additio to cotiuig quality improvemet efforts, we will assess the feasibility of expadig OCREB s madate to iclude all pediatric cliical trials. Additioally, ow that Cliical Trials Otario (CTO) has bee successfully operatig a olie ethics system for over a year, providig Otario with the ifrastructure to support a sigle ethics review for multi-cetre o-cacer research, we pla to evaluate the practicality of trasferrig to CTO s electroic system. Doig so will reduce the umber of differet REB systems that researchers i Otario will have to avigate ad with which istitutios must relate. The feedback from this year s aual researcher survey was strogly positive, with the highest ratigs to date i almost all areas. Fially, orgaizatios such as the Network of Networks (N2), the Caadia Cacer Cliical Trials Network (3CTN), ad the BC Cliical Research Ifrastructure Network (BCCRIN) are leadig efforts to raise awareess ad to better egage patiets ad the public i cliical research. Three recetly implemeted iitiatives iclude a atioal cliical trials participatio survey (BCCRIN), a atioal Ask Me Campaig to raise awareess of cacer cliical trials (3CTN) ad a N2 suite of resources ad strategies icludig the cliical trial video It Starts With Me ; Ça Commece Avec Moi, developed with patiet ad caregiver iput. OCREB will parter with these orgaizatios ad will egage with other iitiatives to lear more about the research participat perspective, the most importat voice i the etire research eterprise. As always, we are grateful to the may idividuals whose dedicatio ad commitmet are critical to OCREB s success. We look forward to cotiued support ad ogoig collaboratios with all of our parters i the research commuity, thaks to whom OCREB remais strog ad steady. OCREB ANNUAL REPORT

6 protec tig. participats. 4 OCREB ANNUAL REPORT

7 REPORT ON OBjECTIvES The metrics data relate to the 2015 caledar year; all other data reflect the fiscal year April 1, 2015 March 31, Because the average is strogly iflueced by a small umber of outlyig values, uless otherwise idicated, the media is used whe presetig the metrics data to provide a more typical picture. OCREB establishes its aual goals based o iteral (OCREB members ad office persoel) ad exteral iput (researchers, study staff, sposors), as well as chagig regulatios ad guidelies ad emergig ethical issues. The goals are preseted below. Although the goals predomiatly have a operatioal focus, OCREB s priority remais to safeguard the rights ad welfare of research participats. 01 g oa l Researchers ad sposors have expressed the desire to get studies up ad ruig faster. Sice OCREB s first year of operatio, the time it takes to get ew studies approved has bee betwee 56 ad 66 busiess days (a average of about three moths). With the implemetatio of a olie system i 2011 ad despite icreasig volume OCREB was able to reduce the timelies uder its cotrol. However, the time it takes for the lead or Provicial Applicat (PA) to submit the fial respose to a OCREB review letter has barely budged. Sice this cotiues to be the area of biggest delay (seve weeks or loger), last year we edeavoured to idetify actioable causes of the delays. We examied 35 of the 59 ew studies submitted i 2014 for which it took more tha six weeks from the time that OCREB issued its review letter to the time that OCREB received the fial respose from the PA. For 17 of those studies (almost 50 per cet), it took more tha six weeks to receive the first PA respose. For 30 studies, the applicatio was set back to the PA more tha oce for correctios or clarificatios, usually due to issues with the coset form or other deficiecies i the submissio. The umber of times that a applicatio is set back icreases the potetial for delay, due to the requiremet for iput or review each time by all parties (the PA, the sposor or Cotract Research Orgaizatio (CRO) ad the REB). TIME FROM SUBMISSION TO APPROvAL FOR NEw STUDIES SUBMIT TED IN 2014 AND IN BUSINESS DAyS ( mea, (media, rage)) (6, 2-19) (35, 2-232) (2, 0-14) (6, 0-15) (44, 2-163) (2, 0-12) Submissio to Meetig Meetig to Review Letter Review Letter to Fial PI Respose PI Respose to Approval The ethics review process is measured i four stages: 1) The time from the deadlie for receipt of submissios to the OCREB meetig. 2) The time it takes OCREB to issue a review letter after the OCREB meetig. 3) The time it takes to receive the fial PA respose to the review letter. 4) The time it takes for OCREB to issue its approval/fial decisio after receipt of the fial PA respose. OCREB ANNUAL REPORT

8 Sice the PA respose period icludes the back-ad-forth betwee OCREB ad the PA, we also looked at potetial delays at OCREB. For six of the studies, it took more tha three weeks for OCREB to review the PA respose. This appears to be due to factors such as staffig chages or abseces, competig workload resposibilities, receipt of the PA respose just before a holiday break or waitig o multiple REB members to review the PA respose. Whe the PA respose requires review by more tha oe OCREB member, delays ca be expected i the OCREB review time. However, the overall legth of time that the applicatio was with the PA durig that period was four times greater tha the time it was uder OCREB cotrol. I lookig at other potetial factors (e.g., study sposor, ivolvemet of a CRO, submittig cetre, PA, study staff, umber of coset forms), there was o obvious sigle factor causig the delays i the PA respose times. Cotributig factors appear to be: the level of research team experiece with ad kowledge of OCREB processes ad expectatios, icludig familiarity with OCREB s olie system; the degree of compliace with OCREB s coset form template; ad, istitutioal issues such as staff turover ad lack of relevat experiece ad traiig of the persoel resposible for REB submissios. OCREB will cotiue to ivestigate activities OCREB will cotiue to ivestigate activities uder its cotrol i order to idetify gaps ad areas for improvemet. uder its cotrol i order to idetify gaps ad areas for improvemet. We will also work with the PA to ivestigate delays as they happe ad to idetify strategies to reduce delays. I additio, OCREB will build o previous efforts to work with sposors ad CROs o ways they ca facilitate the review process. 02 g oa l Oe of the beefits of OCREB s streamlied model is that oce a study is approved, participatig cetres are able to obtai OCREB approval withi days. However, other coditios also must be met before a cetre is authorized to start or activate a study. I order to determie if ivestig further efforts ito reducig the OCREB approval time of ew studies was likely to have a meaigful impact o study start-up times at the cetres, we eeded to uderstad how log it took participatig cetres to submit their cetre-specific applicatios to OCREB, as well as how log it took them to activate the study. Two reports were created to collect this data o the 650 cetre applicatios submitted betwee 2012 ad 2014, iclusive. The average time for participatig cetres to activate studies followig study approval was ie weeks. This icluded three weeks to submit their iitial applicatio followig study approval ad aother six weeks to activate the study. This suggests that there are o-ocreb depedet factors resposible for most of the delays i study start-up. Although ivestig more time i reducig the delays to iitial study approval might ot have a sigificat impact o study start-up, OCREB will cotiue to work with the cetres to try to better uderstad the causes of study activatio delays ad where possible, to idetify strategies to reduce delays. 6 OCREB ANNUAL REPORT

9 03 g oa l As oted earlier, the more times that a submissio goes back ad forth betwee the applicat ad the REB, the greater the likelihood of delays. I a majority of cases, OCREB seds the submissio back due to issues with the coset form. Other reasos are icomplete applicatios or other deficiecies with the overall submissio. I a effort to reduce the back-ad-forth, we cosidered establishig a formal cosultative service to ehace the research team s uderstadig of research ethics ad thus improve the quality of the submissios. Such a service would require the provisio of relevat iformatio, icludig: the ethical priciples that gover research; the purpose, the roles ad resposibilities ad the expectatios of the REB; the regulatory ad guidace criteria that must be applied to the review ad implemetatio of research; ad pragmatic aspects of the REB submissio processes. To ivestigate the feasibility of establishig a formal cosultative service, a review was coducted of existig iitiatives such as the mothly telecofereces, expaded olie system traiig, o-site educatio sessios for study staff, ad hoc cosultatio requests by sposors, researchers ad research staff, as well as a review of a past outreach project. The aalysis revealed that each iitiative had bee created to fulfill a specific purpose ad there are may factors that would make it difficult to tailor ay ew iitiatives appropriately. For example, although the geeral target populatios are kow, the specifics of the populatios (e.g., roles We will cotiue to promote participatio i our curret iitiatives ad provide cosultatio services o a ad hoc basis. ad resposibilities of persoel at each cetre) vary widely. I additio, the targeted populatios ca be trasiet ad support for traiig ad educatio is icosistet across istitutios. Iterestigly, most attempts to acquire directioal feedback o the various iitiatives have to date yielded limited ad o-geeralizable iformatio. Those cosultative programs that seem to fuctio best are those that egage the study persoel at a grassroots level. Fially, most studies submitted to OCREB are well-developed multi-cetre protocols that require limited cosultatio. I coclusio, a ew cosultative service does ot appear to be a pressig eed. We will cotiue to promote participatio i our curret iitiatives ad provide cosultatio services o a ad hoc basis. I additio, we periodically will revisit the effectiveess of the programs ad make chages or establish ew iitiatives as eeded. OCREB ANNUAL REPORT

10 04 g oa l Pre-screeig coset forms are sometimes used to evaluate a sigle eligibility criterio as a prelimiary meas of determiig whether a patiet might be eligible for a study. After seeig a icrease i the use of pre-screeig coset forms, OCREB cosidered developig a pre-screeig coset form template. However, because of variatios observed i their use, OCREB sought first to assess the validity, value ad purpose of obtaiig pre-screeig coset, begiig with a review of existig literature. A review is uderway of all of the eligibility criteria (i.e., iclusio ad exclusio criteria) observed i studies submitted to OCREB i 2013, 2014 ad 2015, highlightig those studies desigated specifically as requirig pre-screeig criteria. Collectio ad collatio of this data is ogoig. Oce the data has bee evaluated, the fidigs will be preseted to the Board for a determiatio regardig the acceptability ad recommeded use of pre-screeig coset forms. 8 OCREB ANNUAL REPORT

11 05 g oa l OCREB s focus always has bee o improvig the quality ad efficiecy of research ethics review for multi-cetre cliical trials. For the purposes of its madate, multi-cetre is defied as more tha oe participatig Otario cetre ad cliical trial is defied as ay research that prospectively assigs huma participats to oe or more health-related itervetios to evaluate the effects o health outcomes. Itervetios are restricted to drugs ad other biological products, surgical procedures, radiological procedures, diagostics ad devices. Sice OCREB occasioally receives requests to accept multi-cetre cacer research that falls outside of its curret madate, such as research ivolvig database likages ad chart abstractio, we attempted to idetify the types ad volume of o-cliical trial research, as a basis for assessig the feasibility of broadeig OCREB s madate. After examiig the out-of-scope requests ad i discussios with researchers makig those requests, we cofirmed that obtaiig sufficiet quatitative iformatio o the type ad volume of o-cliical trial cacer research is difficult. Without that iformatio, it is problematic to develop a busiess case for a madate expasio. Establishig the appropriate ifrastructure (e.g., processes ad procedures, workload, forms) to accommodate a expaded madate would require additioal resources such as REB Chair ad member time, REB member expertise, staff traiig ad educatio ad associated costs. I additio, havig a cetral OCREB review would ot address existig istitutioal review ad policy requiremets such as privacy traiig, health records access, data trasfer agreemets ad local PI ivolvemet. Moreover, with the establishmet of CTO i 2012, a OCREB madate expasio may be uecessary. Uder the CTO process, existig istitutioal REBs serve as the REB of record for all participatig Otario cetres. Give that those REBs oversee much broader types of research tha OCREB ad that may of the ethical issues i the review of o-cliical trial research are related to methodology or to privacy, a CTO Qualified REB might be better equipped to review o-cliical trial cacer research tha OCREB. However, this also would ot elimiate the eed for researchers to comply with other istitutioal review ad policy requiremets. I the meatime, OCREB will cotiue to iterpret its madate liberally, with a focus o multi-cetre trials that support the strategic iitiatives of OICR. OCREB will cotiue to iterpret its madate liberally, with a focus o multi-cetre trials that support the strategic iitiatives of OICR. OCREB ANNUAL REPORT

12 evaluatig. ad measurig. 10 OCREB ANNUAL REPORT

13 REPORT ON INSTITUTIONAL MEMBERSHIP AND OTHER PERFORMANCE ME ASURES Istitutioal Membership Oe ew istitutio, Markham Stouffville Hospital, established a affiliatio with OCREB i 2015, brigig the umber of Otario istitutios that are authorized to use OCREB to 28 (of 30). The Childre s Hospital of Easter Otario has istitutioal approval to use OCREB ad is curretly workig through the affiliatio steps. For a list of all istitutios authorized to use OCREB, please visit Timelie Metrics: New Studies OCREB received 92 ew studies i 2015, which is a icrease of 56 per cet over 2014 ad 26 per cet over the average of 73 ew studies sice Of the 92 ew studies, 85 were reviewed by the full Board ad seve met the criteria for expedited/delegated review. Three were deferred to a secod review by the full Board. Five studies subsequetly were withdraw, oe has completed ad closed ad three are awaitig the PA respose. For the approved studies, the media time from submissio to approval was 12 weeks. The delay i time to overall approval cotiues to be the time to receive the fial PA respose to the OCREB review letter. Timelie Metrics: New Cetre Applicatios OCREB received 306 cetre iitial applicatios i 2015 compared to 183 i 2014, a icrease of 67 per cet. This icluded cetres joiig studies that were origially approved betwee 2010 ad The media time from submissio to approval was three busiess days. Volume: New Studies, Active Studies ad Active Cetres 2011 to 2015 Of the 741 studies submitted to OCREB sice Jauary 2004, at the ed of 2015, there were 338 active studies ivolvig 1,001 active participatig cetres. This compares to 327 studies ivolvig 915 active cetres at the ed of Below is a chart showig the umber of ew studies submitted each year sice 2011, as well as the umber of active studies ad the umber of active participatig cetres o those studies at the ed of each year. The lauch of a olie system i 2011 allowed for more comprehesive data collectio. NEw STUDIES, ACTIvE STUDIES AND ACTIvE CENTRES , New Studies Active Studies Active Cetres OCREB ANNUAL REPORT

14 Volume: Post-Approval Submissios 2012 to 2015 Oce a study is up ad ruig, it is usually associated with multiple post-approval submissios. These submissios ca be applicatios from cetres for approval to joi the study, chages related to ew iformatio gleaed durig the coduct of the study, reports of evets that occurred durig the study, aual reports of the study progress, or study closure forms. Below is a table illustratig the umber of post-approval submissios each year. SUBMISSION T ype Cetre Iitial Applicatios Provicial Amedmets Cetre Amedmets Provicial Cotiuig Review Applicatios Cetre Cotiuig Review Applicatios Provicial Reportable Evets Cetre Reportable Evets Provicial Study Closures Cetre Closures Total Post-Approval Submissios 2,593 3,109 2,878 2,775 Quality Improvemet Iitiatives As part of its ogoig commitmet to quality improvemet (QI), OCREB employs a variety of methods for commuicatio ad dissemiatio of iformatio, as well as multiple approaches to process improvemet. A few of the QI activities are described below: Policy ad Procedures Committee: established i 2006, this Committee serves as a advisory group to OCREB, with a madate to ivestigate emergig issues ad to develop relevat policies ad procedures. Activities iclude cosultatios with the Pael o Research Ethics, with Health Caada, with the Office for Huma Research Protectio i the U.S. or with the Office of the Iformatio ad Privacy Commissioer of Otario, whe warrated. Natioal Coset Form Template Developmet Team: a joit effort (sice 2010) betwee the Caadia Cacer Trials Group, the BC Cacer Agecy REB ad OCREB, ad more recetly CTO ad represetatives from Alberta ad Saskatchewa. The purpose is to provide a iclusive, systematic approach to improvig the coset form template ad to promote cosistecy i the geeral iformatio provided to research participats. A updated coset form template was issued last year ad a completely revamped optioal coset form template will be issued i April Cotiuig Educatio: OCREB members ad office persoel are provided the opportuity to atted the aual atioal coferece hosted by the Caadia Associatio of Research Ethics Boards (CAREB), as well as other webiars ad cofereces throughout the year. The secod aual Educatio Retreat was held the eveig of December 10, A follow-o sessio was held at the December 11, 2015 OCREB meetig. The topics covered at the two sessios were: 1. Cacer Care Otario draft cliical trial drug reimbursemet policy. 2. Questios ad cosideratios for ethics committees evaluatig pediatric drug trials. 3. Scietific elemets ad ethical cosideratios i the REB review of ovel cliical trial desigs. 4. Precisio medicie trials. 12 OCREB ANNUAL REPORT

15 Mothly webiars/ Telecofereces: sice 2006, OCREB has bee hostig mothly sessios for study staff across Otario to promote educatio ad commuicatio relevat to research participat protectio. The sessios iclude updates o the regulatios, presetatios o curret ad emergig issues as well as relevat oteworthy items. The sessios also provide a forum for commuicatig updates to OCREB s policies or procedures, as well as for obtaiig iput from study staff. The eight sessios held i were atteded by a average of 12 cetres (rage ie to 16). Regular Team Meetigs: the OCREB office holds regular team meetigs to foster cosistecy i the applicatio of procedures ad policies. Meetigs also take place o a ad hoc basis as procedural or policy issues arise. Stakeholder Feedback: i additio to exit iterviews with outgoig OCREB members, OCREB formally seeks iput from researchers ad sposors. The respose rate to this year s survey from the researcher group was 12 per cet (dow from 16 per cet last year), evely split betwee ivestigators, study coordiators ad other members of the research team. Oly 23 resposes were received from sposors ad CROs. Give the low respose rates, the results are difficult to iterpret. However, the overall feedback was positive ad the costructive suggestios for improvemet will assist i directig improvemet efforts. PERCENT OF SURvEy RESPONDENTS THAT RATED THE CATEgORy AS good OR EXCELLENT Overall Ethics Review Ser vices Quality of Work Timeliess of Resposes Cosistecy of Resposes Ability to Commuicate Clearly ad Effectively Cost Recovery O April 1, 2013, OCREB bega chargig for the review of all ew idustry-sposored studies. OCREB had ot charged for its services prior to that time because of the OICR ifrastructure fudig arragemet with the Otario cetres. The fees were derived from a assessmet of the amouts charged by REBs i Caada ad the U.S., as well as a aalysis of the review activities required by OCREB over the life cycle of a trial. The fial fee structure also took ito cosideratio a pragmatic approach to maagig the overall process. The total amout recovered each year represets approximately 25 per cet of the overall aual operatig costs. OCREB COST RECOvERy $165,000 $249,000 $252, O CRE B A N N U A L RE P O R T

16 participatig. throughout otario. ad beyod.

17 OBjECTIvES FOR OCREB cotiues to actively participate i a variety of ethics-related iitiatives i Otario ad Caada such as CTO, the Network of Networks (N2), CAREB, the Otario Health Study, the Pael o Resposible Coduct of Research, a atioal REB Accreditatio Workig Group, the Caadia Cacer Cliical Trials Network (3CTN) ad various harmoizatio efforts. I additio to those ogoig efforts, specific objectives for ext year iclude: Develop specific objectives ad procedures to obtai iput from idividuals who have participated 1. i cliical trials, i order to assess ad improve OCREB s ability to meet its primary madate of the protectio of research participats. Assess the operatioal requiremets ad develop a tactical pla for expadig the OCREB madate 2.to all pediatric multi-cetre cacer trials. Evaluate the feasibility of movig to the CTO electroic REB review system, ad if appropriate, 3.develop a systematic pla for the move. Collaborate with 3CTN o their pilot permissio to cotact/record review iitiative to facilitate 4.the developmet of a streamlied health record screeig process to determie study eligibility. Collaborate with N2 o the developmet of asset policies, procedures ad templates to facilitate 5.the review of pediatric trials. Survey the evolutio of the coset form documets over the past 10 years to provide a baselie 6.for future ivestigatios ito improvig the coset process. To lear more about OCREB, please visit ad OCREB ANNUAL REPORT

18 professioals. that care. OCREB MEMBERSHIP chair richard Sugarma Chair, OCREB, Otario Istitute for Cacer Research, VicE-chairS yoo-joug (yooj) Ko Vice -Chair, OCREB Medical Ocologist, Suybrook Health Scieces Cetre, mark Whissell Vice -Chair, OCREB Cliical Research Maager, Health Scieces North/Horizo Saté -Nord, Sudbury members James aderso (alterate) Appoited August 2015 Cliical ad Research Ethicist, Hollad Bloorview Kids Rehabilitatio Hospital, Laura bailey Appoited Jauary 2016 Cliical Research Coordiator/ Recruitmet Specialist, Lodo Health Scieces Cetre, Lodo Patti bambury (alterate) Appoited July 2015 Co-Coordiator, Resource Nurse, Childre s Out-patiet Cliic, Grad River Hospital, Kitcheer Sally bea Reappoited August 2015 Seior Ethicist ad Policy Advisor, Suybrook Health Scieces Cetre, Savtaj brar (alterate) Appoited February 2016 Surgical Ocologist, Mout Siai Hospital, Scott bratma Radiatio Ocologist, Pricess Margaret Cacer Cetre, Uiversity Health Network, Lidsay carlsso (alterate) Appoited December 2015 Advaced Practice Ocology Nurse/Cliical Research Coordiator, Pricess Margaret Cacer Cetre, Uiversity Health Network, Elvia chow (alterate) Appoited July 2015 Associate, Baker & McKezie LLP, catrioa buick Reappoited Jue 2015 Advaced Practice Ocology Nurse, Pricess Margaret Cacer Cetre, Uiversity Health Network, Stephaie chadwick Stepped dow October 2015 Cliical Nurse Specialist, Pricess Margaret Cacer Cetre, Uiversity Health Network, Flay charboeau (alterate) Term eded November 2015 Maager, Pharmacy (Ocology), Suybrook Health Scieces Cetre, carol cheug Reappoited August 2015 Pathologist, Pricess Margaret Cacer Cetre, Uiversity Health Network, carlo De agelis Term eded November 2015 Ocology Pharmacy Cliicia Scietist, Suybrook Health Scieces Cetre, christie Elser (alterate) Appoited Jue 2015 Medical Ocologist, Pricess Margaret Cacer Cetre, Uiversity Health Network, Mout Siai Hospital, Joseph Ferebok Appoited Jue 2015 Director Traslatioal Research Program, Uiversity of, roald Feld (alterate) Term eded Jue 2015 Medical Ocologist, Pricess Margaret Cacer Cetre, Uiversity Health Network, catherie Forti Cliical Program Maager, Otario Regioal Biotherapeutics Program, Ottawa Hospital Research Istitute, Ottawa graeme Fraser Hematologist, Juraviski Cacer Cetre, Hamilto Lee a gallat Pediatricia, Gallat Medical Cliic, Jaet gammo Cliical Program Coordiator/ Cotact Nurse, Neuro-Ocology, The Hospital for Sick Childre, roald grat (alterate) Appoited August 2015 Pediatric Medical Ocologist, The Hospital for Sick Childre, rebecca greeberg Bioethicist, The Hospital for Sick Childre, Kare haas Appoited October 2015 Commuity Represetative, Brampto aie huag (alterate) Pediatric Medical Ocologist, The Hospital for Sick Childre, Jaice hodgso Commuity Represetative, Newmarket michael huyh Lawyer, Paul Karaicolas (alterate) Stepped dow November 2015 Surgical Ocologist, Suybrook Health Scieces Cetre, DESIGN: StokEly DESIGN ASSocIAtES INc. StokElyDESIGN.com 16 OCREB ANNUAL REPORT

19 Swati Kulkari (alterate) Medical Ocologist, Widsor Regioal Hospital Cacer Program, Widsor Sara Kuruvilla (alterate) Stepped dow October 2015 Medical Ocologist, Lodo Health Scieces Cetre, Lodo Eric Leug (alterate) Radiatio Ocologist, Suybrook Health Scieces Cetre, alexader Louie (alterate) Appoited February 2016 Radiatio Ocologist, Lodo Health Scieces Cetre, Lodo arif maji (alterate) Appoited August 2015 Pediatric Medical Ocologist, Stroach Regioal Cacer Cetre, Southlake Regioal Health Cetre, Newmarket ad The Hospital for Sick Childre, adrea mattiussi (alterate) Appoited February 2016 Cliical Pharmacist, The Hospital for Sick Childre, michelle mulle (alterate) Appoited February 2016 Bioethicist, Childre s Hospital of Easter Otario, Ottawa caroly essim (alterate) Surgical Ocologist, The Ottawa Hospital, Ottawa atoia Palmer Commuity Represetative, Mississauga Toy Pazarella (alterate) Term eded December 2015 Maager, Biostatistics, Pricess Margaret Cacer Cetre, Uiversity Health Network, icole Park (alterate) Stepped dow December 2015 Associate, Faske Martieau DuMouli LLP, Sameer Parpia (alterate) Appoited Jauary 2016 Biostatisticia, McMaster Uiversity, Otario Cliical Ocology Group, Hamilto Sara rask (alterate) Medical Ocologist, Simcoe Muskoka Regioal Cacer Cetre, Royal Victoria Regioal Health Cetre, Barrie Suzae richter Medical Ocologist, Lodo Health Scieces Cetre, Lodo Kathlee romao Stepped dow Jue 2015 Maager Cliical Trials, Thuder Bay Regioal Research Istitute, Thuder Bay Elizabeth Scheid Research Associate, Immue Therapy Program, Pricess Margaret Cacer Cetre, Uiversity Health Network, ae Smith Medical Ocologist/Hematologist, Cacer Cetre of Southeaster Otario, Kigsto rauka Sriivasa (alterate) Cliical Research Maager, Divisio of Medical Ocology ad Hematology, Pricess Margaret Cacer Cetre, Uiversity Health Network, Liz Strevel (alterate) Medical Ocologist, Trillium Health Parters, Credit Valley Site, george Tomliso Appoited Jauary 2016 Biostatisticia, Uiversity Health Network ad Mout Siai Hospital, Lisa Wag (alterate) Appoited Jauary 2016 Biostatisticia, Pricess Margaret Cacer Cetre, Uiversity Health Network, Sheila Weitzma Pediatric Medical Ocologist, The Hospital for Sick Childre, Joh Wierikowski Cliical Pharmacist, Pediatrics, McMaster Childre s Hospital, Hamilto Joh Wuderlich Term eded May 2015 Privacy ad Security Cosultat, Wei Xu Term eded December 2015 Pricipal Biostatisticia, Pricess Margaret Cacer Cetre, Uiversity Health Network, OcrEb OFFicE STaFF left to right cidy Sadel Research Ethics Coordiator aurora de borja Research Ethics Coordiator aliso va ie Research Ethics Officer Victoria Shelep Research Ethics Coordiator Jaet mazo Executive Director Katherie Zema Research Ethics Coordiator O CRE B A N N UA L RE P O R T

20 FOR MORE INFORMATION Otario Cacer Research Ethics Board c/o Otario Istitute for Cacer Research MaRS Cetre 661 Uiversity Aveue, Suite 510, Otario M5G 0A