­­­­ Ontario Cancer Research Ethics Board




Yüklə 128.71 Kb.
tarix29.04.2016
ölçüsü128.71 Kb.
­­­­

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






Monthly Teleconference Summary

Friday May 3, 2013 – 09:00a.m. to 10:00a.m.



Teleconference:

Credit Valley, Hamilton (JCC), Lakeridge (Oshawa), London-RCP, Niagara Health, Ottawa-CC, Ottawa-Biologics, PMH-CTSU, Cambridge, Kingston, Ottawa-Other (URO, HEM, OHRI), PMH-DRO, Sudbury, Sunnybrook-CRRU, Sunnybrook-DMO, Thunder Bay, Trillium, Windsor

OCREB office:

Alison van Nie, Arshia Ali, Aurora de Borja, Victoria Shelep, Keitha McMurray (Vice-Chair)

Regrets:

Grand River, London-Other (DSO, URO, HEM), Mount Sinai, North York, , PMH-DSO, PMH-DDP, PMH-DMO, PMH-Medical Imaging, Royal Victoria (Barrie), St. Joseph’s (Toronto), St. Michael’s Hospital, St. Joseph’s (Hamilton), Sunnybrook-OCC, Toronto East General, William Osler, Women’s College, Southlake, Sajna Baboo, Jack Holland (Chair), Janet Manzo, Andrea Afinec


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

The education portion of the teleconference consisted of a discussion based on the review, by Khaled El Emam et al., (circulated by Khaled El Emam), of an article by Rothstein and Shoben, Does Consent Bias Research?, The American Journal of Biioethics, 13 (4):27-37, 2013. In the original article the authors make the argument that consent does not introduce meaningful bias for research results and that the effects of consent bias have been overestimated in the literature. They also contend that consent bias often may be mitigated by statistical intervention and that the residual effects of the bias are not significant. The authors conclude that eliminating the requirement for consent, to address this issue would not be in keeping with the ethical principles which govern research with human being.


In the commentary, by Khaled et al., the authors disagree with the authors of the primary article and argue that the overwhelming evidence does not support the authors’ contentions. Khaled et al. claim that consent does have an impact on the characteristics of the individuals who are included in clinical research studies and that consent bias is a significant concern. Khaled et al. propose two possible solutions to this element of consent bias by the following: de-identifying data to protect privacy and confidentiality, and employing basic strategies to maximize participation rates without compromising ethical standards.
Based on the materials discussed, issues for consideration include: ensuring appropriate recruitment strategies and inclusion/exclusion criteria; predicting the availability of a robust participant population and a willingness to participate that is equally applied to the population under study (to benefit from the outcome); promoting distributive justice and other ethical elements of research practices that are relevant to the process of enrolment.

NOTICES
OCREB Charges for Industry Sponsored Studies – beginning April 2013

As of April 1, OCREB began charging fees for the review of Industry sponsored studies as a partial cost-recovery measure. These fees will be charged for the Provincial study only. Please be sure to include the billing information in all future Provincial initial applications for Industry sponsored studies.


Single Approval Letter for Provincial Amendments

To simplify the Provincial amendment process, as of the April O2 system enhancement (patch), amendment workspaces at the centre level are no longer created for Provincial amendments. Simultaneous approval notices will continue to be issued at the time that the Provincial amendment is approved. However, all information pertaining to a Provincial amendment (including the approval letter) is now accessed at the Provincial study level (i.e., from the Provincial study workspace). A single Amendment approval letter listing all participating PIs is issued to all participating centres that are approved to conduct the study. Individual amendment workspaces at the centre level are no longer created for Provincial amendments. The link in the notice will take the user to the Provincial amendment workspace. If the amendment or a portion of the amendment will not be implemented at your centre, please prepare a memo or Note-to-File explaining the opt-out details.


This new amendment approval process will be incorporated into a new Provincial amendment O2 User Guide and posted to O2 Home.
O2 training

The expectation is that new study staff members will be trained prior to using O2. On-site training also can be provided (at the centre) if there are enough attendees. The next training sessions are:



  • Provincial type applications:

  • Centre type applications:


Please contact Victoria Shelep or Aurora de Borja if you would like O2 training or a refresher.
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 OCREB RECs and the study staff at the OCREB affiliated centres to:



  • obtain feedback and to provide guidance on the application processes;

  • improve the quality of submissions; and

  • improve the review and approval processes and timelines.

The assigned OCREB REC will work with you to customize the agenda for your session


If you would like to participate in an outreach session, please contact Arshia Ali.

POLICY CLARIFICATIONS AND UPDATES
Study Status Change

Please note that any suspension or termination of the research by the sponsor/or the institution, must be reported immediately to OCREB, along with the reasons for the action. This should be submitted as a Provincial reportable event.


Main ICF template – New Version Posted (2013-Mar-22)

Please note that the instructional text (yellow) in the template has been removed and/or modified to reflect the provincial model and a new consent form template (v2013-Mar-22) has been posted to both the OCREB main and O2 websites.



REMINDERS
CR submissions - ICF

When the Centre ICF is submitted for Continuing Review, please provide a copy of the actual document being provided to participants – i.e., printed on institutional letterhead and including any pre-approved, centre-specific changes.


Inconsistencies in processes

Please contact Alison van Nie or Janet Manzo if there are concerns regarding inconsistencies in our processes. (e.g., application of policies, responses to inquiries re processes, review determination, etc.)


Provincial ICF – Centre version

Please remember to remove any instructional text from the provincial ICF prior to submission and final approval.


Glitch with Automatic OCREB Numbering

When the automatic numbering was applied to O2 in March, a glitch was discovered. It has been fixed; however, there might be a few submission sub-types that were created before the issue was fixed that might not have an OCREB number. The OCREB number is assigned when continuing past first page of the smartform (application) for Amendments, Renewals, and Reportable Events. For technical reasons, the OCREB number is not assigned to initial centre applications until the PI submits and the application is routed to the Department Reviewer (i.e., in the “Centre Department Review” state). It you do not see an OCREB number assigned to your submission in the appropriate “state”, please contact O2 Support.


Consent tracked changes

Please note that all of the tracked changes to the consent document (during the review process) should be retained as part of the audit trail for reviewing the revisions to the document. (e.g., amendments to the ICF) Although the review process may be detailed and may include multiple tracked changes, ensuring that the tracked changes are retained is required for review purposes, and as a means of informing participating centres of the revisions that have been incorporated in the new version of the document.

This also applies to other documents (e.g., participant materials) that are undergoing revisions.




When in doubt, or when you are submitting an item that needs an urgent response, please call the responsible Research Ethics Coordinator (REC).



OCREB Membership Changes

The OCREB membership roster was last updated on February 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 April 29, 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 monthly.


April 15 Patch:

  • As of March, the system automatically assigns the OCREB number after the new Provincial application is submitted AND after it is assigned to an OCREB Ethics Coordinator (i.e., in the “REB Staff Review” state). A backend issue with this automation of the OCREB number assignment function had to be fixed;

  • The OCREB number is now assigned when continuing past first page of the smartform for Amendments, Renewals, and Reportable Events. For technical reasons, the OCREB number is not assigned to initial centre applications until the PI submits and the application is routed to the Department Reviewer (i.e., in the “Centre Department Review” state). This issue has been logged and is scheduled to be fixed in a future patch;

  • Simplifying the Provincial Amendment Process: All information pertaining to a Provincial amendment (including the approval letter is now accessed at the Provincial study level (i.e., from the Provincial study workspace). A single Amendment approval letter listing all participating PIs is now issued to all participating centres that are approved to conduct the study. Individual amendment workspaces at the centre level are no longer created for Provincial amendments;

  • Fixed issue where the ‘Submit Changes’ activity in Provincial reportable events was executable by study staff at other centres;

  • Provincial Reportable Events can now be forwarded to participating sponsors for review and completion;

  • Updates to the Provincial Amendment cover form were made. The Word version of the Provincial Amendment Cover Form will be updated and posted to O2 Home (under Application Form Templates). A summary of the revisions will be included;

  • Participating sponsors can now add other sponsor staff with edit rights in the Provincial application;

  • Fixed a bug where a participating sponsor submitting as the Provincial Applicant could not move past the first page of amendment smartform;

  • Minor typographical corrections to the Amendment acknowledgement letter.


Outstanding issues (logged but not yet resolved):

  • Improvements in navigation/user interface;

  • Guidance text feature for application forms and workspaces;

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



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 May 10 meeting:

13-026

Andrea

Merck

EMR200592-001

McWhirter, Elaine

HHS

Yvonne Kinrade

13-027

Victoria

BMS

CA209067

Joshua, Anthony

UHN

Andreea Sederias

13-028

Andrea

NCIC

CRC.7

Auer, Rebecca

TOH

Amy Henderson

13-029

Aurora

NCIC

LY.15

Crump, Michael

UHN

Nanthini Tharahan

13-030

Victoria

Synta

9090-14

Leighl, Natasha

UHN

Tuhina Paul-St. Hilaire

13-031

Aurora

Inv Initiated

MAST_01

Fleshner, Neil

UHN

Ranjena Maloni

13-032

Arshia

Genomic Health

05-055 ONCOTYPE DX

Gapski, John

THC

Anne Abraham



Studies in Pre Submission:

13-020

Arshia

Merck

MK-3475

Leighl, Natasha

UHN

Tuhina Paul

 

 

Weill Cornell Medical College

1208012946

Asmis, Tim

TOH

Amy Henderson

 

 

Astex

SGI-110-03

Goel, Rakish

TOH

Amy Henderson

 

 




 

Chan, Kelvin

SHSC

 

 

 

Paladin Labs

Abstral Study

Chow, Edward

SHSC

Lori Holden



Other Potential Studies:


  • Roche BO28405 (“KAITLIN”). Dr. Caroline Hamm will be the Provincial Applicant. 

  • RTOG 1203 “A RANDOMIZED PHASE III STUDY OF STANDARD VS. IMRT PELVIC RADIATION FOR POST-OPERATIVE TREATMENT OF ENDOMETRIAL AND CERVICAL CANCER (TIME-C)”. Hamilton is willing to be Provincial Applicant (submitting in July) unless another centre is ready to submit sooner.



CONTINUING REVIEW APPLICATIONS DUE FOR THE JUNE 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 7 studies involving 16 centre applications (approximately 23 continuing review applications) due by the May 30th deadline for the June 14th, 2013 OCREB Meeting: (i.e., expiring June 14th to July 11th, 2013 inclusive) unless a study closure has been or will be submitted.
Next OCREB teleconference: Friday June 7, 2013 @ 9am

CONTINUING REVIEW APPLICATIONS DUE FOR THE JUNE MEETING

OCREB #

REC

Sponsor

Protocol #

PI

Centre

Centre Contact

Application Type

Expiry Date

06-027

Arshia

OCOG

RAPID

Rachakonda , Ramana

Grand River Hospital

Carol Ballantyne

Provincial

15-Jun-13

06-027

Arshia

OCOG

RAPID

Rachakonda , Ramana

Grand River Hospital

Carol Ballantyne

Centre

15-Jun-13

06-027

Arshia

OCOG

RAPID

Schneider, Kenneth M.

Windsor Regional Hospital

Jane Coulter

Centre

15-Jun-13

06-027

Arshia

OCOG

RAPID

Findlay, Brian Peter

Niagara Health System

Linda Illes

Centre

15-Jun-13

06-031

Arshia

NCIC

CRC.2

Mathews, John

Windsor Regional Hospital

Krista Naccarato

Provincial

15-Jun-13

06-031

Arshia

NCIC

CRC.2

Chouinard, Edmond E.

Cambridge Memorial Hospital

Stephanie Evans

Centre

15-Jun-13

06-031

Arshia

NCIC

CRC.2

Gapski, John A.P.

Trillium Health Centre

Anne Abraham

Centre

15-Jun-13

06-031

Arshia

NCIC

CRC.2

Sicheri, Dolores A.

Thunder Bay Regional Health Sciences Centre

Carol Pelletier

Centre

15-Jun-13

06-031

Arshia

NCIC

CRC.2

Burkes, Ronald Louis

Mount Sinai Hospital

Janet Smith

Centre

15-Jun-13

06-031

Arshia

NCIC

CRC.2

Knight, Gregory J.

Grand River Hospital

Carol Ballantyne

Centre

15-Jun-13

06-031

Arshia

NCIC

CRC.2

Mathews, John

Windsor Regional Hospital

Krista Naccarato

Centre

15-Jun-13

07-038

Victoria

OCOG

PET-CAM

Husien, Mohamed

Grand River Hospital

Carol Ballantyne

Provincial

10-Jul-13

07-038

Victoria

OCOG

PET-CAM

Husien, Mohamed

Grand River Hospital

Carol Ballantyne

Centre

10-Jul-13

08-002

Andrea

MSH

KG080358

Goodwin (MSH), Pamela

Mount Sinai Hospital




Provincial

29-Jun-13

08-002

Andrea

MSH

KG080358

Goodwin (UHN), Pamela

University Health Network

Christopher Ha

Centre

29-Jun-13

08-002

Andrea

MSH

KG080358

Goodwin (MSH), Pamela

Mount Sinai Hospital




Centre

29-Jun-13

09-033

Andrea

Roche

WO20698

Brezden-Masley, Christine

St. Michael's Hospital

Daisy Dastur

Provincial

05-Jul-13

09-033

Andrea

Roche

WO20698

Brezden-Masley, Christine

St. Michael's Hospital

Daisy Dastur

Centre

05-Jul-13

10-055

Aurora

NCIC

IND.195

Sridhar (UHN), Srikala S.

University Health Network

Ida Lee

Provincial

27-Jun-13

10-055

Aurora

NCIC

IND.195

Sridhar (UHN), Srikala S.

University Health Network

Ida Lee

Centre

27-Jun-13

10-055

Aurora

NCIC

IND.195

Winquist, Eric W.

Lawson Health Research Institute(London)

Mary Beth Husson

Centre

27-Jun-13

10-057

Andrea

Bayer

NX0802

Ko, Yoo-Joung (Yooj)

Sunnybrook Health Sciences Centre

Adam Lam

Provincial

04-Jul-13

10-057

Andrea

Bayer

NX0802

Ko, Yoo-Joung (Yooj)

Sunnybrook Health Sciences Centre

Adam Lam

Centre

04-Jul-13




Teleconference 2013-May-03 Page of


Verilənlər bazası müəlliflik hüququ ilə müdafiə olunur ©www.azrefs.org 2016
rəhbərliyinə müraciət

    Ana səhifə