Ontario Cancer Research Ethics Board

MaRS Centre, South Tower, Suite 800

101 College Street | Toronto, Ontario, CanadaM5G 0A3

416-673-6649 | www.ocreb.ca

Monthly Teleconference Summary

Friday November 1, 2013 – 9:00a.m. to 10:00a.m.

ATTENDEES

Sites / 1.  Cambridge
2.  Lakeridge (Oshawa)
3.  Niagara Health
4.  North York General
5.  Ottawa Hospital
·  Cancer Centre
·  Biologics
6.  Sudbury
7.  Sunnybrook
·  Clinical Studies Resource Centre
·  Odette Cancer Centre / 8.  Toronto East General
9.  Trillium Health Partners - Credit Valley Hospital
10.  UHN-PMH Cancer Centre
·  Clinical Trial Support Unit
·  Drug Development Program
·  Medical Oncology & hematology
·  Radiation oncology
·  Surgical oncology
OCREB: / Aurora de Borja, Janet Manzo, Safia Moosvi, Victoria Shelep, Richard Sugarman (Chair), Alison van Nie, Mark Whissell (VC)
Regrets: / OCREB: Arshia Ali, Yooj Ko (VC)
Sites:
1.  Grand River
2.  Juravinski Cancer Centre (Hamilton)
3.  Kingston
4.  Lawson (London)
·  LRCP
·  Other (DSO, URO, HEM),
5.  Mount Sinai
6.  Royal Victoria (Barrie)
7.  St. Joseph’s (Toronto)
8.  St. Joseph’s (Hamilton) / 9.  St. Michael’s Hospital
10.  Southlake
11.  Thunder Bay
12.  Trillium Health Partners - Mississauga Hospital
13.  William Osler
14.  Windsor
15.  Women’s College
Departments:
·  UHN-PMH Medical Imaging
·  Ottawa - Other (URO, HEM, OHRI)
·  Sunnybrook - Department of medical oncology

If you temporarily have to leave the teleconference, please hang up and dial in again when you are able to re-join. Putting your phone on hold causes interference with all of the other lines – i.e., intermittent beeping sounds or background music.

EDUCATION

http://jama.jamanetwork.com/article.aspx?articleid=1760318

Fifty years and 7 revisions later, the 2013 version of the Declaration of Helsinki includes several important changes. By changing the format and including several subsections, the revised declaration enhances and improves clarity regarding specific issues. By having specific issues covered under these subsections, the declaration is now “bolder” in the way it addresses specific issues.

Although commentators have provided opinions on the validity and importance of the revisions and have pointed out some of the negative aspects of the document the Declaration of Helsinki has been updated with notable changes intended to address a variety of issues including the following items:

·  access to clinical trials for underrepresented groups needs be increased so these groups also can benefit from research; trial participants need to be treated and compensated for trial-related injuries;

·  researchers must have plans for ensuring access to an intervention if it is proven to be effective;

·  permits the use of unproven interventions in cases for which proven interventions do not exist, after the physician has sought expert advice as well as the patient’s informed consent;

·  requires registration of trials in publicly accessible databases and publication of negative, inconclusive, and positive results;

·  in some cases, such as in close-knit societies, informed consent needs to involve others such as community leaders and significant others;

·  encourages researchers to explain their studies using innovative ways, such as video and vignettes and to assess understanding of the research interventions and purpose by potential research participants before engaging those individuals in their studies;

·  encourages researchers to plan for provision of feedback to participants and their communities;

·  requires all research protocols to be reviewed by a well-constituted and competent committee before studies begin and emphasizes that ethics committees should be transparent and should follow standards, policies, and national laws in performing their functions and should monitor ongoing research;

For research ethics committees, funders, and participants in research, this version of the Declaration of Helsinki should be empowering given its emphasis on issues of justice.

NOTICES

OCREB Staff Changes

Terry Liu started with OCREB on October 28 as the Senior Business Systems Analyst replacing Simon Wong. Safia Moosvi returned from maternity leave on October 21, 2013.

December Deadline for January Meeting

Due to the holidays, the deadline for the January 10 meeting is one week earlier. Please ensure you’re your submissions due for review at the January meeting are received by end of day Wednesday, December 18, 2013.

OCREB Qualification Process

In response to the expressed requirement of institutions to have a mechanism for assessing the quality of REBs outside of their own institution, Clinical Trials Ontario (CTO) is developing an REB qualification process based on the one developed by the Toronto Area Health Sciences Network (TAHSN). The review criteria for REBs will be based on the applicable guidelines and regulations for REBs and clinical trials conducted in Canada, including the recently issued Canadian General Standards Board (CGSB) Standard. OCREB has agreed to be the first REB to go through the pilot CTO Qualification process. This should occur in late November/early December.

OCREB Teleconferences

It’s time to review the timing, format and content of the OCREB monthly teleconferences – further information to follow re a process for review.

O2 Training

Hands-on new user, refresher training and advanced training sessions can be made available via webcast for provincial or centre applications. On-site training (i.e., at the centre) can be arranged if there are enough attendees. For those in the GTA, training at the OCREB office also can be arranged.

Please contact Victoria Shelep or Aurora de Borja to arrange O2 training.

OCREB Outreach

OCREB Outreach is an onsite meeting with one of the OCREB Research Ethics Coordinators (RECs) and your study team. The outreach program aims to promote a partnership between the RECs and the study staff at the OCREB affiliated centres in order to obtain feedback and to provide guidance on the application processes; to improve the quality of submissions; and to improve the review and approval processes and timelines. The assigned OCREB REC will work with you to customize the agenda for your session.

Please contact Arshia Ali for more information.

REMINDERS

ICF Reminders

·  each participating centre may include specific amounts for reimbursement of costs in their centre consent as a pre-approved change.

·  all instructional text in the ICF should be deleted prior to the submission.

·  all tracked changes should be retained in the tracked change version of the ICF document for reference purposes.

Sponsor Access to O2

Please remember that sponsor representatives can be provided with an O2 account and granted access to their studies by the Provincial Applicant. In addition, if the sponsor (or CRO) representative agrees, any provincial application (initial, PI response, amendment, etc.) can be routed to the sponsor or CRO by the Provincial Applicant so that the sponsor/CRO can assist in completing the application. The individual must have an O2 account and be selected in Section 1.5 of the provincial application.

OCREB Membership Changes

The OCREB membership roster was last updated on October 1, 2013. The current and archived membership lists can be accessed from www.ocreb.ca under “Membership”.

Project Submission Summary List

The list of studies with OCREB (project submission summary spreadsheet) is available on the O2 Home page https://ocrebonline.ca. The current version posted is from October 28, 2013

OCREB ONLINE (O2)

Key Recent Enhancements

See also the “What’s New” section of O2 Home - https://ocrebonline.ca

Below are issues that have been fixed or enhancements that were made to improve usability in the last system patches. If these items are not working as they should, please report them (and any other issues you experience) to O2 Support. Patches (enhancements and fixes) are applied approximately every two months.

Patch (tentatively scheduled for November 12):

·  Question 7, section 6.1: Privacy & Confidentiality will be removed from the provincial initial application

·  Study staff will no longer be able to submit a study closure without completing study closure form

·  Ensure that study staff are able to access all documents in the provincial application

Outstanding issues (logged but not yet resolved):

·  Routing of application sub types (and the related notices) to the submitter;

·  Guidance text feature for application forms and workspaces;

·  Archiving for 25 years so system can be used as ethics study files.

There was discussion around using O2 to archive the ethics files. Attendees noted that sponsors will often ask for printed copies of the ethics files even if they have access to O2. If all of the other study files are paper, to have a full set of study files, it is understandable that paper copies of the ethics files would be desirable.

One attendee asked if it were possible for the O2 forms to be extracted as .pdf files. Currently, study staff are printing the forms and then scanning them to .pdf. Janet indicated that it should be possible to save or print the files as .pdfs. This will be investigated and the findings will be discussed at a future teleconference.

STUDY SUBMISSION STATUS

For a list of all studies with OCREB, see the Project Submission spreadsheet at https://ocrebonline.ca

New studies submitted for the November 8 meeting:

13-060 / Aurora / PMHC / PJC-015 / NCI 9591 / Siu, Lillian / UHN / Bonnie Kwan
13-061 / Arshia / Agensys / AGS15E-13-1 / Cheng, Susanna / SHSC / Jessica Yim
13-062 / Victoria / Novartis / CLEE011A2301 / Wheatley-Price, Paul / TOH / Koralee Bergout
13-063 / Victoria / BI / 1200.48 / Burkes, Ronald / MSH / Janet Smith
13-064 / Aurora / Clovis / CO-338-014 / Oza, Amit / UHN / Bonnie Kwan
13-065 / Arshia / NCIC / LYC.1 / Crump, Michael / UHN / Nanthini Tharahan

Studies in Pre Submission:

Weill Cornell / Cabazitaxel - 1208012946 / Ko, Yooj / SHSC / Adam Lam
UofT Theta / RnaDx / Krahn, Murray / U of T / Josephine Wong
Pfizer / B2151007 / Chen, Eric / UHN / Bonnie Kwan
NCIC / PR.15 / Loblaw, Andrew / SHSC / Arlynne Marquez
ROCHE / BO28407 / Hamm, Carolyn / Windsor / Jane Coulter

Other Potential Studies:

·  RTOG 1201: A Phase II Randomized Trial of High Versus Standard Intensity Local or Systemic Therapy for Unresectable Pancreatic Cancer. RTOG email July 25.

·  RTOG 1016 “Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer,” Amendment 4, has been approved by Health Canada. Email Aug 26

·  RTOG 1221 “Randomized Phase II Trial of Transoral Endoscopic Head And Neck Surgery followed by Risk-Based IMRT and Weekly Cisplatin versus IMRT and Weekly Cisplatin for HPV Negative Oropharynx Cancer” has been approved by Health Canada. Email October 31.

·  NCIC CTG ALC.3 (SWOG S1203) study, A Randomized Phase III Study Of Standard Cytarabine Plus Daunorubicin (7+3) Therapy Or Idarubicin With High Dose Cytarabine (IA) Versus IA With Vorinostat (NSC-701852) (IA+ V) In Younger Patients With Previously Untreated Acute Myeloid Leukemia (AML) centrally activated, September 10, 2013

CONTINUING REVIEW APPLICATIONS DUE FOR THE DECEMBER MEETING – see next section

Be sure to keep track of the expiry dates of your studies. The system sends courtesy reminders 49 days, 15 days and 1 day prior to the expiry date.

There are approximately 11 studies involving 28 centre applications (approximately 39 continuing review applications) due by the November 28 deadline for the December 13, 2013 OCREB Meeting: (i.e., expiring December 13th to January 9th, 2014 inclusive) unless a study closure has been or will be submitted.

Next OCREB teleconference: Friday December 6, 2013 @ 9am

Teleconference 2013-Nov-01 Page 1 of 6

CONTINUING REVIEW APPLICATIONS DUE FOR THE DECEMBER MEETING

OCREB # / REC / Sponsor / Protocol # / PI / Centre / Centre Contact / Application Type / Expiry Date /
05-028 / Victoria / PMHC / PHL-037 / Hirte, Holger (Hal) / Hamilton Health Sciences / Yvonne Kinrade / Provincial / 13-Dec-13
05-028 / Victoria / PMHC / PHL-037 / Fung Kee Fung, Michael / The Ottawa Hospital / Femina Kanji / Centre / 13-Dec-13
05-028 / Victoria / PMHC / PHL-037 / Hirte, Holger (Hal) W. / Hamilton Health Sciences / Yvonne Kinrade / Centre / 13-Dec-13
05-028 / Victoria / PMHC / PHL-037 / Oza, Amit M. / University Health Network / Nishita Parekh / Centre / 13-Dec-13
10-002 / Aurora / Roche / NO25026-ROW / Petrella, Teresa / University Health Network / Carolyn Lim / Provincial / 17-Dec-13
10-002 / Aurora / Roche / NO25026-ROW / Hogg, David / University Health Network / Melanie Berger / Centre / 17-Dec-13
10-002 / Aurora / Roche / NO25026-ROW / Petrella, Teresa Marie / Sunnybrook Health Sciences Centre / Carolyn Lim / Centre / 17-Dec-13
11-004 / Victoria / Novartis / CBKM120C2201 / Oza, Amit M. / University Health Network / Neghath Chaudary / Provincial / 17-Dec-13
11-004 / Victoria / Novartis / CBKM120C2201 / Hirte, Holger (Hal) W. / Hamilton Health Sciences / Yvonne Kinrade / Centre / 17-Dec-13
11-004 / Victoria / Novartis / CBKM120C2201 / Oza, Amit M. / University Health Network / Neghath Chaudary / Centre / 17-Dec-13
11-008 / Aurora / Daiichi / ARQ197-A-U302 / Shepherd, Frances / University Health Network / Shweta Patel / Provincial / 07-Jan-14
11-008 / Aurora / Daiichi / ARQ197-A-U302 / Shepherd, Frances A. / University Health Network / Shweta Patel / Centre / 07-Jan-14
12-054 / Victoria / Roche / Q-CROC-01 / Ko, Yoo-Joung / Sunnybrook Health Sciences Centre / Brittany Buck / Provincial / 14-Dec-13
12-054 / Victoria / Roche / Q-CROC-01 / Ko, Yoo-Joung (Yooj) / Sunnybrook Health Sciences Centre / Brittany Buck / Centre / 14-Dec-13
12-054 / Victoria / Roche / Q-CROC-01 / Burkes, Ronald / Mount Sinai Hospital / Janet Smith / Centre / 14-Dec-13
12-055 / Victoria / Roche / MO28231 / Rahim, Yasmin H. / Southlake Regional Health Centre / Sobia Hameed / Provincial / 14-Dec-13
12-055 / Victoria / Roche / MO28231 / Rask , Sara / Royal Victoria Hospital / Christine Di Marco / Centre / 14-Dec-13
12-055 / Victoria / Roche / MO28231 / Brezden-Masley, Christine / St. Michael's Hospital / Daisy Dastur / Centre / 14-Dec-13
12-055 / Victoria / Roche / MO28231 / Younus, Jawaid / Lawson Health Research Institute(London) / Mary Beth Husson / Centre / 14-Dec-13
12-055 / Victoria / Roche / MO28231 / Rahim, Yasmin H. / Southlake Regional Health Centre / Sobia Hameed / Centre / 14-Dec-13
12-056 / Aurora / GSK / BRF115532 / Hogg, David / University Health Network / Alice Black / Provincial / 14-Dec-13
12-056 / Aurora / GSK / BRF115532 / Song, Xinni / The Ottawa Hospital / Lisa Turriff / Centre / 14-Dec-13
12-056 / Aurora / GSK / BRF115532 / Hogg, David / University Health Network / Andreea Sederias / Centre / 14-Dec-13
12-056 / Aurora / GSK / BRF115532 / Chang, Jose / Lakeridge Health / Edeliza Mendoza / Centre / 14-Dec-13
12-056 / Aurora / GSK / BRF115532 / McWhirter, Elaine / Hamilton Health Sciences / Yvonne Kinrade / Centre / 14-Dec-13
12-057 / Arshia / NCIC CTG / MDC.1 / Buckstein, Rena J. / Sunnybrook Health Sciences Centre / Arlene Mete / Provincial / 14-Dec-13
12-057 / Arshia / NCIC CTG / MDC.1 / Yee, Karen W.L. / University Health Network / Nimisha Dave / Centre / 14-Dec-13
12-057 / Arshia / NCIC CTG / MDC.1 / Leber, Brian F. / Hamilton Health Sciences / Yvonne Kinrade / Centre / 14-Dec-13
12-057 / Arshia / NCIC CTG / MDC.1 / Buckstein, Rena J. / Sunnybrook Health Sciences Centre / Arlene Mete / Centre / 14-Dec-13
12-058 / Arshia / NCIC CTG / MEC.3 / Petrella, Teresa / Sunnybrook Health Sciences Centre / Carolyn Lim / Provincial / 14-Dec-13
12-058 / Arshia / NCIC CTG / MEC.3 / Butler, Marcus O / University Health Network / Cody Connolly / Centre / 14-Dec-13
12-058 / Arshia / NCIC CTG / MEC.3 / Knight, Gregory J. / Grand River Hospital / Carol Ballantyne / Centre / 14-Dec-13
12-058 / Arshia / NCIC CTG / MEC.3 / Young, Vincent P.J. / The Ottawa Hospital / Lisa Turriff / Centre / 14-Dec-13
12-058 / Arshia / NCIC CTG / MEC.3 / Petrella, Teresa / Sunnybrook Health Sciences Centre / Carolyn Lim / Centre / 14-Dec-13
12-059 / Aurora / OCOG / OCOG-2011-PETRA / Levine, Mark / Ontario Clinical Oncology Group (OCOG) / Beverly Pond / Provincial / 14-Dec-13
12-059 / Aurora / OCOG / OCOG-2011-PETRA / Mukherjee, Som / Hamilton Health Sciences / Yvonne Kinrade / Centre / 14-Dec-13
12-060 / Victoria / Lilly / IMCL CP02-0861 (I4E-MC-JXBA) / Chen, Eric (Xueyu) / University Health Network / Prachi Mohite / Provincial / 14-Dec-13
12-060 / Victoria / Lilly / IMCL CP02-0861 (I4E-MC-JXBA) / Chen, Eric (Xueyu) / University Health Network / Prachi Mohite / Centre / 14-Dec-13
12-060 / Victoria / Lilly / IMCL CP02-0861 (I4E-MC-JXBA) / Ernst, Scott / Lawson Health Research Institute(London) / Mary Beth Husson / Centre / 14-Dec-13

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