Address: 661 University Avenue, Suite 510
City: Toronto Prov: Ontario Postal Code: M5G 0A3
Tel: 416-977-7599 Fax:1-866-678-6427
How many research peer review committees do you have?
The Ontario Institute for Cancer Research (OICR) supports research through large multi-disciplinary, multi-institutional programs and translational research initiatives. Each program and translational research initiative submits a four year Funding Request which receives initial peer review plus undergoes a mid-term review. OICR currently has eleven programs and two translational research initiatives, however the framework will change in the new strategic plan that will be implemented starting April 2017. Within each program and translational research initiative, there are mechanisms where by research activity is periodically reviewed by a group of “peers” [Program Management Committee and a Scientific Advisory Boards].
The Ontario Cancer Research Ethics Board (OCREB), and an independent initiative created in 2004 by the OICR, provides high quality ethics review and oversight of multi-centre cancer research by an expert provincial cancer-specific research ethics board. Research ethics review is vital to the advancement of ethically sound research. Before individuals can be enrolled in a research study, the study must be approved by a research ethics board, an independent committee composed of medical and scientific experts, ethicists, researchers and healthcare professionals, as well as non-scientific members such as legal and privacy experts and members representing the community. The research ethics board’s role is to ensure that the proposed research adequately protects the rights, safety and well-being of the research participants. Since January 2004, OCREB has fulfilled an important role in the ethics review process for cancer research in Ontario. OCREB is an expert central oncology research ethics board serving nearly every hospital in the province that conducts cancer clinical trials. For more than eleven years, OCREB has been providing rigorous ethics review and oversight of multi-centred cancer trials while streamlining the review process.
Additionally, OICR supports the Coordinating Centre for the Canadian Cancer Clinical Trial Network (3CTN), a pan-Canadian initiative to improve the efficiency and quality of clinical trials in Canada. The focus of 3CTN is to support clinical trial activities at sites conducting 3CTN approved “portfolio” academic trials. Portfolio trials are reviewed by the Portfolio Committee to ensure that cancer interventional studies to receive support from the 3CTN are multi-centre, have an academic sponsor, and importantly, have received external peer review.
In the past, OICR also supported investigator initiated research projects through the Cancer Research Fund and Personalized Medicine Research Fund. The Cancer Research Fund, which included both a Translational Research Panel and a Clinical Trials/Companion Studies Panel, ended in 2009 and was replaced by the Personalized Medicine Research Fund, which subsequently ended in 2012. The aim of the both the Cancer Research Fund and Personalized Medicine Research Fund was to support research in areas of cancer genetics, genomics, biology, treatment and management of cancer patients. They supported studies that addressed predictive and prognostic genetic tests, identified biomarkers and informative diagnostic/treatment monitoring tools, and applications of novel agents and new technologies in early clinical studies.
- Cancer Stem Cell
- Innovation in Target Validation
- Smarter Imaging Program
- Ontario Health Study
- Genome Technologies
- Informatics and Bio-computing
- Drug Discovery
- Imaging Translation Program
- Transformative Pathology
- High Impact Clinical Trials (ended March 31, 2015)
- Health Services Research
- Immuno- and Bio-therapies
- Improved Management of Early Cancer (focus on breast and prostate)
- Pancreatic Cancer Initiative
How many patients, survivors, caregivers and/or family members sit on each committee?
Programs and Translational Research Initiatives’ Funding Request/Mid-Term Review committees: Currently no patients, survivors, caregivers and/or family members sit on any of the program and Translational Research Initiatives Funding Request or mid-term review panels. As OICR prepares for submission of a new 2016-2021 strategic plan, it has an opportunity to consider future involvement of the patient advocate community in not only its peer review committees and Scientific Advisory Boards, but also guidelines for inclusion and mentorship of patient advocates on its programs’ Program Management Committee and a Scientific Advisory Boards.
Program Management Committee and a Scientific Advisory Boards: Although guidelines do not mandate involvement of patient advocate community members, two of OICR’s programs have incorporated patient advocates within their program governance committees.
- High Impact Clinical Trial Program, which began in 2009 and ended on March 31 2015, had involved one patient advocate in its program’s Program Management Committee (Dr. Gene Vayda, retired physician, cancer survivor).
- Smarter Imaging Program and Imaging Translation Program hold joint program Scientific Advisory Board meetings. When these programs first started, the Scientific Advisory Board included two patient advocates. Recently, it has been decreased to include only one patient advocate. Mr. Norm Achen is a long-time patient advocate (former Chair of the Canadian Cancer Society Research Institute Scientific Advisory Boards) and a family member of a cancer patient.
Interestingly, the Informatics and Biocomputing Program, includes one patient advocate on its high risk of esophageal adenocarcinoma project.
OCREB: Two patient advocate community members serve as members of OCREB and attend every OCREB meeting. The community members are cancer survivors or family members/caregivers of individuals with cancer.
3CTN: Patient advocate community members are involved in all committees, where feasible within the
3CTN central coordinating structure and across the pan-Canadian network of cancer research sites. Within the 3CTN central coordinating structure, patient advocate community members involvement consists of one representative in the Portfolio Committee, two representatives in the Steering Committee; one representative on the Scientific Advisory Board, six representatives in the Lay Advisory Group, and the Strategic Council and three strategic teams that are currently seeking representation.
Cancer Research Fund and Personalized Medicine Research Fund: When the Cancer Research Fund and Personalized Medicine Research Fund were active, each review panel had two Patient advocate community members involved.
How often do committees meet?
Programs and Translational Research Initiatives: Funding Request panel reviews meet every four years with mid-term panel reviews occurring just prior to the start of start 2nd year. Program Management Committees meet at least three times a year, while Scientific Advisory Boards meet at least every twelve to eighteen months.
3CTN: All 3CTN central coordinating office committees meet quarterly, or more often as needed.
OCREB: The research ethics board meets monthly to review clinical trial protocol submissions.
Cancer Research Fund and Personalized Medicine Research Fund: The Translational Research Panel and a Clinical Trials/Companion Studies Panel met annually to review small investigator initiated submissions.
What is the role of the patients, survivors, caregivers and/or family members who sit on each committee?
Program Management Committees and Scientific Advisory Boards:
High Impact Clinical Trial Program: The role of the Program Management Committee was to provide recommendations to the Program Director for developing a translational research agenda for the program and in the annual review of individual trial concepts. As a lay member of the Program Management Committee, the patient advocate was specifically tasked to inform the Program Management Committee members with issues of concern and relevance to cancer patients, survivors and their families plus provide experience/expertise on communicating with the public. As a member of the Program Management Committee, the patient advocate was involved in review of proposal submissions to the High Impact Clinical Trial Program. Like all other Program Management Committee and external peer reviewers, Dr. Vayda was responsible for reading and participating in the review of project submissions for funding. Although he was not assigned the task of completing a written report, nor provided a scoring vote during panel deliberation, he was encouraged to partake in all discussions of the project (priority for the program, strategic alignment with OICR, scientific and clinical merit, feasibility, and appropriateness of budget).
Smarter Imaging Program and Imaging Translation Program: As a member of the Scientific Advisory Board, the patient advocate is tasked to support the evaluation of the scientific progress of the program and of the individual projects, and to suggest changes in the scope and direction of the research activities, when necessary. Like all other Scientific Advisory Board members, the patient advocate reviews project progress reports and provides recommendations on going forward.
OCREB: The role of the community member is to represent the participant community that may become involved in the research. Someone who is not affiliated in any way with the institution and who does not engage in research or legal work as their primary activities can provide a fresh perspective on the research proposals under review. The involvement of these members also enhances communication with and accountability to its community. Research ethics boards are encouraged to appoint community members who have been participants in research. Members who know what it is like to be a research participant offer a vital perspective to the review process. Their contribution is particularly important in the review of proposals involving high risk or participants in vulnerable circumstances.
3CTN: Patient engagement within 3CTN central coordinating structures occurs at all levels where feasible. Furthermore, all other pan-Canadian 3CTN cancer sites are determining patient engagement on their 3CTN committees/working groups.
- Steering Committee: As a member of the Steering Committee the lay representative is an integral part in the oversight of 3CTN. The representative participates in Steering Committee meetings and provides input on the activities and processes of 3CTN and assists with identifying categories of lay representative involvement and support strategies within 3CTN, to enable meaningful involvement for the lay representative viewpoint.
- Scientific Advisory Board: As a member of the Scientific Advisory Board the lay representative is an integral part in the formal evaluation of 3CTN. The representative participates in Scientific Advisory Board meetings and evaluation and provides feedback on the activities and processes of 3CTN lay representation within 3CTN to enable meaningful involvement.
- Portfolio Committee: As a member of the Portfolio Committee, the lay representative is an integral part of the oversight of the 3CTN Portfolio and assists the Portfolio Committee to establish and maintain a portfolio of academic trials reflecting clinical trials addressing the important questions to cancer patients and the Canadian health care system. The representative participates in Portfolio
Committee meetings and advocates for, and provides input and assistance to the Portfolio
Committee from the viewpoint of the lay representative.
• Strategic Council and Strategic Teams: the lay representative role on these committees is under development and will include advocating for and providing input and feedback on activities and processes of 3CTN to enable meaningful involvement for the lay representative.
• Lay Advisory Group: lay representatives are engaged in assisting 3CTN with the continued development of patient and public engagement strategy and implementation, tools development such as training manuals, role descriptions, trial information etc.
Cancer Research Fund and Personalized Medicine Research Fund: During the annual review panels, the role of the patient advocate community member was to provide a mechanism for ensuring good communication to public stakeholders and transparency of the peer review process. Although they did not rate applications, they were asked to provide verbal comments on the applications’ lay abstracts, specifically on the extent to which the intent and importance of the proposed research was well explained and in a language clear to members of the general public. During panel deliberations, they were asked questions and provided clarifications on the scientific questions addressed in the proposals. Furthermore, they were asked to provide feedback on the proceedings of the review panel, such as the quality, quantity and variety of science reviewed, objectivity of the discussions, and any other general comments.
What is the term for patients, survivors, caregivers and/or family members on your peer review committees?
Program Management Committee and Scientific Advisory Board:
High Impact Clinical Trial Program: Term for the patient advocates on the Program Management Committee was for the full course of the program (4 years).
Smarter Imaging Program and Imaging Translation Program: Term for the patient advocates on the program Scientific Advisory Board is for the full course of the program (4 years).
OCREB: Term for the community members is between 2-3 years.
3CTN: Terms for all 3CTN committee memberships are for 4 years.
Do patients/survivors present research proposals?
In OICR Program with patient advocates, research proposals are not presented by the patient advocate. However, for OCREB the community members review and provide input on every agenda item and in particular the proposed participant’s materials. They do not present the in-depth summary of the research proposal.
Do patients/survivors have a vote? If not, why not? See above.
OCREB: Yes, the two community members are voting members of OCREB.
How are patients/survivors who sit on research peer review committees chosen?
It can be difficult to find patient advocate community members to serve on committees. They are recruited through a variety of means such as advocacy groups, cancer support groups, clinicians, word- of-mouth. Often a community member completing a term will find his/her own replacement.
Are positions on research peer review committees open to patients/survivors who are not already involved with the organization? If not, why not?
OCREB: Yes. Members cannot be affiliated with OICR.
Is there mentorship available for new incoming patients/survivors on research peer review committees?
Program Management Committee and Scientific Advisory Board:
- High Impact Clinical Trial Program: When the High Impact Clinical Trial Program needed to add a patient advocate, Ms. Karen Arts (then part of the HIGH IMPACT CLINICAL TRIAL Program, currently Executive Director, 3CTN) approached the Canadian Cancer Action Network, who suggested Dr. Gene Vayda. K Arts worked with Dr. Vayda to mentor and integrate him with the High Impact Clinical Trial Program, its Program Management Committee, and his role on the committee and in project submission review.
- Smarter Imaging Program and Imaging Translation Program: Mentorship for patient advocates comes from the Program Leader who is involved in other organizations committed to patient engagement. Additional mentorship and support is provided by the Program Manager.
OCREB: The potential member meets with the Chair of OCREB to discuss the role and observes a meeting before deciding whether or not to join OCREB. New community members are paired with another experienced community member.
3CTN: The 3CTN is implementing several orientation and support strategies across its network. This includes a formal framework that will serve as a road map to assist anyone seeking lay representatives for working groups and committees, a formal orientation and training manual in collaboration with the NCIC-Clinical Trials Group and its lay representative committee, a patient education webpage on the 3CTN website, a collaboration with Network of Network (N2) patient education website, workshops, a lay representative advisory council and additional tools as the network implementation evolves.
Are there resources and materials to help orient new incoming patients/survivors in their position and on the policies and procedures of the peer review committees?
Program Management Committees and Scientific Advisory Boards:
- High Impact Clinical Trial Program: As a past physician, Dr. Vayda found it difficult to limit his review and not provide any scientific/medical input. In an effort to understand if Dr. Vayda’s issues were similar to other patient advocates, and see if there was any literature available to help orient him in his role, or better understand the policies and procedures in the peer review process, Ms. Arts and Dr. Patty O-Hara (PhD, Ethics) conducted a literature review to determine current practices associated with lay representation. They found that information about lay representation and support was limited. This led to the establishment of a lay representative working group and development of a formal framework which is scheduled to be published and made available later this year. It also led to a continued development for a formal lay representation strategy for 3CTN.
- Smarter Imaging Program and Imaging Translation Program: no materials are available. Each new mentor attends program meetings in advance of committing involvement.
OCREB: Each new member attends an education/orientation session and is provided with an orientation manual containing multiple resources, including the OCREB standard operating procedures. New members must then complete research ethics training (tutorial, Tri-council Policy Statement: Ethical conduct for research involving humans) before conducting their first formal review.
3CTN: Recently, 3CTN developed a working group to discuss better engagement between lay and health care providers. From this activity, a Lay Representative Framework was developed to support engagement and involvement of lay/patient advocate. Publication of the Framework is forthcoming, including its use for engagement and involvement of lay/patient advocates. Currently, the 3CTN Lay Advisory Group is assisting 3CTN and its pan-Canadian cancer research sites on developing a patient and public engagement strategy and tools for lay advocates, such as training manuals. Communication of the Framework to national organizations has garnered much interest. The 3CTN together with the Network of Networks (N2) is working to create a Patient Education website. Furthermore, the 3CTN is developing a patient engagement page on its 3CTN website. Education support tools for involvement of patients/advocates in peer review committees will be included.
Where can patients and CCSN find out about opportunities to apply to sit on one of your peer review committees?
Further information on OCREB can be found at http://oicr.on.ca/oicr-programs-and-platforms/ontario- cancer-research-ethics-board
Janet Manzo, Executive Director, Ontario Cancer Research Ethics Board
MaRS Centre, 661 University Avenue, Suite 510, Toronto, Ontario, Canada, M5G 0A3
Tel: 416-673-6636 Toll-free: 1-866-678-6427 ext. 6636 www.ocreb.ca
When is the next opportunity available for patients?
OCREB is currently looking to appoint an alternate community member. Alternate members are expected to attend a minimum of two meetings per year and to attend meetings when/if the regular member is not available. When the regular member’s term ends, substitute/alternate members generally become regular members, but this is not a requirement.