<p> Ontario Cancer Research Ethics Board MaRS Centre, South Tower, Suite 800 101 College Street | Toronto, Ontario, Canada M5G 0A3 416-673-6649 | www.ocreb.ca</p><p>Monthly BOR Centre Teleconference Summary Friday October 7, 2011 – 09:00a.m. to 10:00a.m.</p><p>Cambridge, Credit Valley, Hamilton, Kingston, London-RCP, Ottawa-CC, PMH-CTSU, PMH-DDP, Teleconference: PMH-DRO, , Royal Victoria (Barrie), Niagara Health, Sunnybrook-OCC, Toronto East General, Trillium, Ottawa-Other (URO, HEM, OHRI) OCREB office: Aurora de Borja, Andrea Afinec, Safia Moosvi, Simon Wong, Jack Holland, Alison van Nie Grand River, Lakeridge (Oshawa), London-Other (DSO, URO, HEM), North York, , PMH-DSO, PMH- Medical Imaging, St. Michael’s Hospital, Southlake, Southlake-URO, Sudbury, Sunnybrook-CRRU, Regrets: Sunnybrook-DMO, St. Joseph’s (Hamilton), Women’s College, William Osler, Windsor, PMH-DMO, Thunder Bay, Mount Sinai, Janet Manzo, Victoria Shelep, Arshia Ali</p><p>Please dial in from one speaker phone with others at your centre if possible. There are limited numbers of teleconference lines. </p><p>Education On September 7, 2011, the Office for Human Research Protections (OHRP) and the Food and Drug Administration announced in the Federal Register the availability of a joint draft guidance document entitled, “Guidance on Exculpatory Language in Informed Consent,” and are inviting public comments on that document. The joint draft document, among other things, does the following: </p><p>1. Provides guidance on the regulatory prohibition on the inclusion of exculpatory language in informed consent. 2. Includes examples of language that OHRP and FDA consider acceptable as well as examples of language that the agencies would consider exculpatory. 3. Clarifies that OHRP and FDA have concluded that language in informed consent is not exculpatory if it informs subjects that, by agreeing to allow the use of their biospecimens for research purposes, they are giving up any legal right to be compensated for the use of the biospecimens. This represents a change from OHRP’s November 15, 1996 guidance on point, “‘Exculpatory Language’ in Informed Consent,” which identified as “exculpatory” certain informed consent statements in which subjects gave up any rights they might have in their biospecimens.</p><p>OHRP and FDA now consider these statements to be acceptable for inclusion in informed consent, and they are restated as examples of acceptable language in the draft guidance. Thus, for example, it would now be acceptable to include language in a consent form such as ‘I give up any property rights I may have’ in biospecimens, or ‘I voluntarily and freely donate’ the biospecimens to a particular institution. </p><p>Please see examples of language (permitted and not permitted) in the document: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraft Guidances/default.htm</p><p>Policy Clarifications and Updates</p><p>Reimbursement – MEMO This pre-approved ICF change allows each centre to include/exclude the statement regarding reimbursement for participant expenses, found in the “What are the Costs” section of the ICF.</p><p>Please note that in the centre initial application, (4.1) information regarding reimbursement costs for participants is required and will be used to verify the inclusion/exclusion of this statement in the ICF.</p><p>BOR Teleconference 2011-Oct-07 Page 1 of 8 This pre-approved ‘all centre’ ICF change allows each participating centre to modify the reimbursement statement without further review by the board.</p><p>Note to All Centres regarding the implementation of the Reimbursement statement in the ICF: Realizing that each participating centre negotiates a distinct contract with the sponsor, which may/may not include support for reimbursement costs for participants, the Board has approved the following optional language as a pre-approved ICF change that is applicable to all centres:</p><p>Reimbursement Language ( What Are The Costs ?)</p><p>The statement (with minor modifications re specific content): You will be reimbursed for study-related expenses such as [specify, e.g., parking, etc] may be removed, or added to the cost section of the ICF as applicable (in accordance with local policy and/or study contract terms). NOTE: if you have any questions re this pre-approved reimbursement language, or would like the centre-specific language reviewed prior to implementing please contact Alison van Nie</p><p>No other language may be used unless the language has been pre-approved by the Board.</p><p>Please see the accompanying memo and note that this memo is posted under the centre profiles of all OCREB affiliated centres.</p><p>Health Canada REB Attestation (REBA) – MEMO As per Health Canada’s directive, the attestation may be completed either via the use of the REBA form or as part of other documentation. Per OCREB’s practices, the attestation is included in the approval letter which is consistent with Health Canada’s requirements. REF: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/clini/cta_frequent_multiple- eng.php#RESEARCH</p><p>REMINDER: Simultaneous Approvals for Amendments At the time of provincial approval of an amendment, all participating centres are approved simultaneously, and each PI receives an individual approval letter. Centres do not have to submit anything because all participating centres are approved to use the approved provincial documents, including the approved provincial consent form. Centres are expected to download a copy of the new provincially approved consent, and add letterhead and local contact information and make the pre-approved changes only. NOTE: the provincial applicant must not include any centre-specific OCREB approved consent changes in the provincial consent form.</p><p>REMINDER: Requirement for PI signatures The PI can sign off on all submissions to OCREB; however, he/she may wish to delegate this task to another individual for some submission types. The PI’s signature is required in the following instances:</p><p>1. initial submissions (provincial and centre): The PI must log in to O2 to submit initial centre and provincial applications electronically. This also applies when there is a change in PI or provincial applicant. The incoming PI must accept the role and submit the amendment to “sign off” (i.e., record his/her electronic signature) as the incoming PI; 2. PI response letter to OCREB: a scanned signed PI response letter must be attached when resubmitting the revised application/PI response to OCREB; 3. local SAEs: upload a copy of the sponsor’s SAE form, signed by the PI, to the OCREB application. If the sponsor has an electronic SAE reporting system, the SAE can be printed, signed by the PI and uploaded as a *.pdf attachment to the OCREB SAE application. Alternatively, the PI can log into O2 and submit the local SAE application to OCREB online. His/her signature will be recorded in the history log (electronic signature). {Note: The Chair has indicated that the signature of the co-investigator/sub-investigator per the sponsor’s SAE form is permissible.}</p><p>BOR Teleconference 2011-Oct-07 Page 2 of 8 REMINDER: Protocol Deviation Reporting The Protocol Deviation Guidance document is posted on the O2 website (https://ocrebonline.ca) and the OCREB website (www.ocreb.ca). REB Membership Changes – as of Sep 1 Susan Dent and Stephen Welch transferred to alternate members. Anne Smith transferred to a regular member. The membership roster was updated with the changes and posted on www.ocreb.ca Project Submission Summary List The project submission summary spreadsheet is available on the O2 Home page https://ocrebonline.ca. This spreadsheet can be sorted by any column. Currently, the OCREB number and sponsor name only appear in the row of the provincial application, so it is best to sort by sponsor protocol number to find a study and all of the associated centres. An updated spreadsheet was posted on September 30, 2011. Department Approvers and Conflicts of Interest It would be a conflict of interest for a PI or sub-investigator/co-investigator to sign off as the Department Approver on his/her own study. A [Department] Approver not involved in the study must be selected. Listing sub-investigators/co-investigators in centre applications Currently it is not mandatory (although it is preferable) to keep OCREB apprised of changes in sub- investigators/co-investigators, as long as a study personnel log is maintained onsite. However, a new activity is available that will allow you to easily make changes in study staff (i.e., coordinators and sub- investigators) without submitting an amendment. Updating Local SAE Reports When additional information becomes available for a local SAE that has previously been acknowledged, locate the original SAE to update it (see User Guide on O2 Home). Do not submit the follow-up report as a new reportable event. Updating the original SAE report ensures that the information available to the REB is current and the event is accurately reported as it evolves over time in a single report. If the initial SAE has already been submitted but has not yet been acknowledged, contact the REB Coordinator to have it sent back to you to update and resubmit. NOTE: Be sure to include the initial and any available follow-up sponsor SAE reports together in the same reportable event/local SAE application to OCREB. Multiple sponsor SAE reports related to the same SAE can be uploaded within the same application to OCREB. O2 Training The next full day hands-on session is scheduled for October 27 (9am to 2:30pm) in Toronto. Please contact Janet Manzo if you would like to attend. Introductory (2-hour) webcasts also can be arranged for new O2 users.</p><p>OCREB Online Updates See also the “What’s New” section of O2 Home - https://ocrebonline.ca</p><p>Recent Enhancements (Oct 3): Below are issues that have been fixed or enhancements that were made to improve usability. If these are not working as they should, please report it (and any other issues you experience) to O2 Support. 1. The institutional (“Centre Representative) role was created and available in the last enhancement. Individuals in this role have “view only” access to all studies at their institution. In a future enhancement, they will receive notifications when the initial centre approval is issued and when approval of the annual renewal is issued; 2. When a PI is listed on the provincial application as potentially participating, the study staff attached to his/her Researcher’s Profile will receive notices when the initial provincial application is submitted and when it is approved; 3. Study staff listed on the initial application (provincial or centre) will be notified when the application is submitted and when it is approved;</p><p>BOR Teleconference 2011-Oct-07 Page 3 of 8 4. The main study contact/all study staff listed in the application will receive email notifications whenever a study is routed back to the PI. Notifications to other study staff listed in the application will be added in a future enhancement. 5. The number of notifications to PIs and sub-investigators/co-investigators has been reduced to approvals and suspension of approval; 6. The pre-approved consent form changes are now included in the amendment approval letters; 7. When an approval letter is reissued for an amendment, the participating centres were not receiving a reissued letter. This has been resolved. Participating centres should now receive re-issued approval letters simultaneously with the reissued provincial approval letter; 8. Users were seeing studies in which they were not directly involved, listed in their “My Studies” tab. This should be resolved.</p><p>Update on outstanding issues (not yet resolved): 1. We continue to experience issues with date recognition and some studies have been expiring inappropriately even after the renewals are approved. The new expiry date is not being recognized. This is a high priority item; however, there has been no resolution yet. O2 Support will manually update the expiry dates until this is fixed. Due to the issue with expiry dates, the courtesy renewal notices have been temporarily turned off. The monthly teleconference always includes a list of renewal applications due for the next meeting. We have also been sending reminders manually. 2. Coming soon: study staff at participating centres will receive notifications when provincial amendments and reportable events are submitted; 3. We are aware that the system is slow, particularly in the afternoon. This will supposedly improve with the next software version upgrade (in October – exact date to be confirmed); 4. The provincial documents on some studies are inaccessible: this will be fixed in the next software version upgrade (October). In the interim, please notify O2 Support if you cannot access a document. A fix will be applied to your study as soon as possible.</p><p>Reminders:  Email from O2. Please do not reply to emails that you receive from OCREB Online. They do not go to the sender. You must send an email outside O2 to the sender, or log into O2 and send an email from the same study workspace as the email was sent from. You should only send an email from O2 if it is important to record the communication in the history log.</p><p>For technical questions (how to use O2), contact O2 Support Please contact O2 Help (email or call, not both) for any system related issues or questions. During business hours contact Safia Moosvi, Client Coordinator Tel: 416-673-6649 or toll-free at 1-866-678-6427 Ext 6649 Email: [email protected] After business hours, send an email to: [email protected]</p><p>Study-related questions should always be directed to the responsible REB Coordinator.</p><p>OCREB Online Q&A Q: Why am I not getting notices when an application is routed back to my PI? A: We discovered that the notification feature was not set for every type of activity when the application was routed back to the PI. With the last enhancement (“patch”), the main study contact only should receive notices whenever the study is routed back. However, other study staff will not receive notices until a subsequent enhancement. This means that the person who submitted an application will not be notified if it is sent back. Only the main study contact/coordinator will be notified. </p><p>Q: Will the date format be changed to DDMMMYYY or YYYYMMMDD? The way the date is now it is very easy to misinterpret (e.g., 09-03-2011: is that September 3 or 9 March? A: Within project listings, the date format is set to mm/dd/yyyy. In all other parts of the site however, the date format is dependent on the format setting that exists in your computer and browser.</p><p>Q: Under "My Studies" why do I see other centres’ studies listed? A: This should now be fixed. You should now only see studies with your name in the application.</p><p>BOR Teleconference 2011-Oct-07 Page 4 of 8 Q: I would like to be able to search for a study using the OCREB #. The system number (e.g., PRO) is different for every submission type. A: You can search by OCREB #, but unfortunately not in the list in the My Action Item - yet. You can search by “Name”, which should be the sponsor protocol number. Use % before and after a portion of the sponsor protocol number to Filter By “Name”. To search by OCREB #, click on “Studies” on the top blue navigation bar. A list of Provincial – All Studies will be displayed at the top of the page and Centre – All Studies will be displayed in the middle. You can also click on any sub types (amendments, renewals, reportable events) under “Other Submission Types” on the left menu to see a list of those submission types separated by provincial and centre. These views provide more columns you can sort on or search on (Filter By). To find a study by OCREB #, in “Filter By”, select OCREB # from the drop down list and type in the OCREB number in the adjacent field.</p><p>Q: It would be nice to have every document that has been approved or acknowledged for the provincial applicant listed on the centre approval letter at least for the initial approval letter. A: All provincial documents should be listed in the centre approval letters (initial and amendments). However, because of a system glitch, when a provincial approval letter is reissued, the centres were not getting their simultaneous re-approval letters with these updates. This is fixed in the Oct 3 enhancement and now the centers will also receive reissued approval letters.</p><p>Q. Why am I not receiving any renewal deadline reminders from the system? A. Due to a glitch, the system is sending out wrong expiry notifications. We have turned off the expiry notifications going to the sites. Sites will not receive any renewal deadline reminders till the issue is fixed. Please use the project summary sheet on O2 home for expiry dates. STUDY SUBMISSION STATUS For a full list of studies with OCREB, see the Project Submission spreadsheet at https://ocrebonline.ca </p><p>New studies submitted for the October 14 meeting:</p><p>11-043 NEC.2 TOH 11-044 JX594-HEP018 TOH 11-045 CA209012 TOH 11-046 AV-951-09-901 UHN 11-047 l1Q-MC-JDDG UHN 11-048 PHL084/NCI 8912 UHN 11-049 RTOG 0924 Chung SHSC 11-050 CINC424A2401 Hamm WRH</p><p>Studies in Pre Submission: Nov CP1005B016 SHSC</p><p>RENEWALS DUE FOR NOVEMBER MEETING – see next page Renewal Applications due by October 27 deadline for the November 11 OCREB Meeting: (i.e., expiring November 11 to December 8, inclusive).</p><p>Next OCREB teleconference: Friday November 4, 2011 @ 9am</p><p>BOR Teleconference 2011-Oct-07 Page 5 of 8 RENEWALS DUE FOR NOVEMBER MEETING Renewal Applications due by October 79 deadline for the November 11 OCREB Meeting: (i.e., expiring November 11 to December 8, inclusive).</p><p>OCREB Application Expiry # REBC Sponsor Protocol # PI Centre Centre Contact Type Date University Health 05-019 Arshia PMHC PHL-039 Malcolm Moore Network Robert Halford Provincial 12/08/2011 05-019 Arshia PMHC PHL-039 Malcolm Moore University Health Network Elena Hall Centre 12/08/2011 05-019 Arshia PMHC PHL-039 Sébastien Hotte Hamilton Health Sciences Yvonne Kinrade Centre 12/08/2011 EMR 63325-001 Thunder Bay Regional 06-050 Victoria Merck (START) Dimitrios Vergidis Health Sciences Centre Carol Pelletier Provincial 12/08/2011 EMR 63325-001 06-050 Victoria Merck (START) Brian Findlay Niagara Health System Linda Illes Centre 12/08/2011 EMR 63325-001 06-050 Victoria Merck (START) Frances Shepherd University Health Network Nazanin Nouriany Centre 12/08/2011 EMR 63325-001 06-050 Victoria Merck (START) Ronald Burkes Mount Sinai Hospital Janet Smith Centre 12/08/2011 EMR 63325-001 Thunder Bay Regional 06-050 Victoria Merck (START) Dimitrios Vergidis Health Sciences Centre Carol Pelletier Centre 12/08/2011 Toronto East General 06-055 Arshia Novartis CFEM345D2411 James Bin Hospital Andrea Davis Provincial 12/08/2011 Toronto East General 06-055 Arshia Novartis CFEM345D2411 James Bin Hospital Andrea Davis Centre 12/08/2011 Southlake Regional Health 06-055 Arshia Novartis CFEM345D2411 Yasmin Rahim Centre Erin Ross Centre 12/08/2011 Janet 08-047 Andrea GSK OMB110913 MacEachern Grand River Hospital Carol Ballantyne Provincial 11/14/2011 08-047 Andrea GSK OMB110913 Janet MacEachern Grand River Hospital Carol Ballantyne Centre 11/14/2011 EMD121974- Windsor Regional 08-048 Victoria Merck 011 CENTRIC Zeenat Alam Hospital Krista Naccarato Provincial 11/14/2011 EMD121974- Lawson Health Research 08-048 Victoria Merck 011 CENTRIC David MacDonald Institute(London) Mary Beth Husson Centre 11/14/2011 EMD121974- 08-048 Victoria Merck 011 CENTRIC Zeenat Alam Windsor Regional Hospital Krista Naccarato Centre 11/14/2011 EMD121974- 08-048 Victoria Merck 011 CENTRIC Holger (Hal) Hirte Hamilton Health Sciences Yvonne Kinrade Centre 11/14/2011 EMD121974- Sunnybrook Health 08-048 Victoria Merck 011 CENTRIC James Perry Sciences Centre Julie Gundry Centre 11/14/2011 08-050 Andrea NCIC BR.29 Scott Laurie The Ottawa Hospital Yuhui Xu Provincial 11/14/2011 08-050 Andrea NCIC BR.29 Zeenat Alam Windsor Regional Hospital Patricia Dupuis Centre 11/14/2011</p><p>BOR Teleconference 2011-Oct-07 Page 6 of 8 OCREB Application Expiry # REBC Sponsor Protocol # PI Centre Centre Contact Type Date 08-050 Andrea NCIC BR.29 Scott Laurie The Ottawa Hospital Yuhui Xu Centre 11/14/2011 08-050 Andrea NCIC BR.29 Richard Gregg Kingston General Hospital Carrie Lindsay Centre 11/14/2011 Lawson Health Research 08-050 Andrea NCIC BR.29 Mark Vincent Institute(London) Mary Beth Husson Centre 11/14/2011 08-050 Andrea NCIC BR.29 Brian Findlay Niagara Health System Linda Illes Centre 11/14/2011 08-050 Andrea NCIC BR.29 Frances Shepherd University Health Network Nazanin Nouriany Centre 11/14/2011 08-050 Andrea NCIC BR.29 Andrew Arnold Hamilton Health Sciences Yvonne Kinrade Centre 11/14/2011 08-050 Andrea NCIC BR.29 Ronald Burkes Mount Sinai Hospital Janet Smith Centre 11/14/2011 University Health 08-052 Victoria NCIC HN.6 Lillian Siu Network Nishita Parekh Provincial 11/14/2011 08-052 Victoria NCIC HN.6 Lillian Siu University Health Network Nishita Parekh Centre 11/14/2011 08-052 Victoria NCIC HN.6 Libni Eapen The Ottawa Hospital Yuhui Xu Centre 11/14/2011 08-052 Victoria NCIC HN.6 James Wright Hamilton Health Sciences Yvonne Kinrade Centre 11/14/2011 Lawson Health Research 08-052 Victoria NCIC HN.6 Alex Hammond Institute(London) Mary Beth Husson Centre 11/14/2011 Thunder Bay Regional 08-052 Victoria NCIC HN.6 Kevin Ramchandar Health Sciences Centre Carol Pelletier Centre 11/14/2011 08-052 Victoria NCIC HN.6 Timothy Owen Kingston General Hospital Carrie Lindsay Centre 11/14/2011 EN.7 (PORTEC- University Health Linda 08-055 Arshia NCIC 3) Anthony Fyles Network Purushuttam Provincial 11/14/2011 EN.7 (PORTEC- 08-055 Arshia NCIC 3) Anthony Fyles University Health Network Linda Purushuttam Centre 11/14/2011 EN.7 (PORTEC- Lawson Health Research 08-055 Arshia NCIC 3) Alex Hammond Institute(London) Mary Beth Husson Centre 11/14/2011 University Health 08-056 Victoria Novartis CPKC412D2201 Jeffrey Lipton Network Sima Bogomilsky Provincial 11/14/2011 08-056 Victoria Novartis CPKC412D2201 Jeffrey Lipton University Health Network Sima Bogomilsky Centre 11/14/2011 University Health 09-051 Aurora NCIC OV.21 Amit Oza Network Liselle Chieverton Provincial 11/13/2011 09-051 Aurora NCIC OV.21 Julie-Ann Francis Kingston General Hospital Carrie Lindsay Centre 11/13/2011 09-051 Aurora NCIC OV.21 Amit Oza University Health Network Liselle Chieverton Centre 11/13/2011 Johanne 09-051 Aurora NCIC OV.21 Weberpals The Ottawa Hospital Femina Kanji Centre 11/13/2011 University Health 09-054 Victoria Eli Lilly H8K-MC-JZAO Anthony Joshua Network Navdeep Walia Provincial 11/13/2011 09-054 Victoria Eli Lilly H8K-MC-JZAO Anthony Joshua University Health Network Navdeep Walia Centre 11/13/2011</p><p>BOR Teleconference 2011-Oct-07 Page 7 of 8 OCREB Application Expiry # REBC Sponsor Protocol # PI Centre Centre Contact Type Date 09-055 Arshia BMS CA194005 Glenwood Goss The Ottawa Hospital Yuhui Xu Provincial 11/13/2011 09-055 Arshia BMS CA194005 Glenwood Goss The Ottawa Hospital Yuhui Xu Centre 11/13/2011 09-056 Victoria RTOG RTOG 0813 Jason Pantarotto The Ottawa Hospital Yuhui Xu Provincial 11/13/2011 09-056 Victoria RTOG RTOG 0813 Jason Pantarotto The Ottawa Hospital Yuhui Xu Centre 11/13/2011 OCOG-2010- 10-089 Arshia OCOG IMPACT Som Mukherjee Hamilton Health Sciences Yvonne Kinrade Provincial 11/12/2011 OCOG-2010- 10-089 Arshia OCOG IMPACT Som Mukherjee Hamilton Health Sciences Yvonne Kinrade Centre 11/12/2011 NCIC 10-090 Andrea CTG IND.206 Holger (Hal) Hirte Hamilton Health Sciences Yvonne Kinrade Provincial 11/12/2011 NCIC Monika 10-090 Andrea CTG IND.206 Krzyzanowska University Health Network Tara Johnson Centre 11/12/2011 NCIC 10-090 Andrea CTG IND.206 Holger (Hal) Hirte Hamilton Health Sciences Yvonne Kinrade Centre 11/12/2011 University Health 10-091 Aurora Roche MO22923 Amit Oza Network Melanie Powis Provincial 11/12/2011 10-091 Aurora Roche MO22923 Michael Fung The Ottawa Hospital Femina Kanji Centre 11/12/2011 10-091 Aurora Roche MO22923 Amit Oza University Health Network Melanie Powis Centre 11/12/2011 10-092 Victoria CIHR PERIOP-01 Marc Carrier The Ottawa Hospital Catherine Hilliker Provincial 11/12/2011 10-092 Victoria CIHR PERIOP-01 Marc Carrier The Ottawa Hospital Catherine Hilliker Centre 11/12/2011</p><p>BOR Teleconference 2011-Oct-07 Page 8 of 8</p>