Revised January 16, 2012
PURPOSE
The purpose of the CCMB RRIC is to review all clinical trials (and the associated agreements for those trials) and research studies conducted by CCMB or at CCMB or which involve CCMB data, CCMB patients- or materials from them, CCMB staff (as research subjects), or CCMB resources.
A clinical trial or research study involves human subjects (or samples of tissue or fluid from them). Clinical trials or research studies may:
- evaluate new and/or existing treatments, devices, or behavioral interventions;
- evaluate tests which may assist in the detection, diagnosis, staging, treatment planning, or prognostication of the disease;
- assess the experiences and/or quality of life of the patient (and sometimes other members of their family);
- assess late- or long-term adverse effects of treatment;
- assess prevention strategies;
- assess early detection strategies; or
- involve health outcomes research. [This may involve determining the incidence of a particular disease (overall and in specific subgroups of patients) and the outcome for that disease for the specific group of patients identified in the study, as well as performing a risk factor analysis.]
The specific activities of the CCMB in this regard are as follows:
- Review all clinical trials conducted by or at CCMB (but not limited to) studies which involve CCMB data, CCMB patients- or materials from them, CCMB staff (as research subjects) or CCMB resources
- There is an expedited process for studies conducted by the Department of Medical Physics and the Department of Epidemiology which do not involve any patient contact or the use of tissue(s) or fluid(s) obtained from patients
- Studies run through the CIO office are exempt from review by the CCMB RRIC as they have their own process for obtaining approval from impacted departments unless the study is a local investigator-initiated study or the CIO requests that a study be reviewed by the CCMB RRIC
- Assess the impact of each study on local resources and determine whether the study is feasible and acceptable as written- and propose changes if it is not.
- **Ensure that the research design is sound and that there is an adequate plan in place for data collection and data analysis. Propose changes/assist the researcher in making those changes as required.
- Work with the U of M REB to ensure that adequate safeguards are in place to protect the research subjects
- Ensure that adequate steps have been taken to ensure privacy and confidentiality of patient information and of research studies. [CCMB PHIA form for research; assess the plan for database development; have a signed "supply agreement" (or contract) if the study involves sending patient information and/or sending samples obtained from patients to another centre; all members of the CCMB RRIC sign a confidentiality agreement annually.]
- Educate staff and trainees about the proper conduct of research
- Help ensure that trainees receive adequate mentoring regarding the proper conduct of research
- Provide assistance in research design, the plan for data collection, and the plan for data analysis
- Develop policies and processes to deal with:
- overlapping clinical trials;
- database storage and use;
- and ownership of the information in the databases created, etc.
- Develop and maintain forms, processes, and a website to facilitate all of the above.
- Review the contracts for clinical trials conducted at CCMB
** In its role to protect CCMB resources, staff and patients, the RRIC reserves the right to comment on the scientific rigour and/or value of any study submitted, even if it has been approved by an Ethics Review Board. As such, applicants may be required to modify their proposal.
CONTRACTS SUB-COMMITTEE
A subcommittee of the RRIC (the contracts sub-committee) will review all contracts for clinical trials conducted at CCMB according to a set of criteria to:
- assess the risks and liabilities to investigators, participants and the institution
- and recommend modifications to the contract as appropriate
- assess whether contracts with industry and Cooperative Groups are favorable to investigators and CCMB
- and recommend modifications as appropriate.
Membership of the Contracts Sub-committee:
- Chief Operating Officer
- Chair of the RRIC
- Representative(s) from CIO
- Others on an ad-hoc basis
APPROVALS
- The RRIC secretary will ensure that all of the required approvals are in place before a study is approved by the CCMB RRIC. (See the latest version of the CCMB RRIC study submission form, section 11.0 for details).
- The RRIC secretary will maintain a list of all studies reviewed and approved by the CCMB RRIC (including those which have received expedited approval). All studies activated by CIO will also have an RRIC number assigned to them and will be listed on the RRIC database of "approved studies".
- New as of March 2011: The RRIC secretary will also maintain a list of studies previously approved by the RRIC, which have been revised and resubmitted for reapproval, indicating the current status of those requests.
MEMBERSHIP OF THE RRIC
Membership of the RRIC consists of:
- The President and CEO (ex-officio)
- The Chief Operating Officer (ex-officio)
- Manager of the Clinical Investigations Office (CIO)
- Provincial Director of Research at CCMB (ex-officio)
- Chief of Professional Practice (or designate)
- Director of Pharmacy (or designate)
- Medical Director, CCPN
- Manager of Health Information Services/Privacy Officer of CCMB (or designate)
- Senior Director of Clinical Services (CMO) (if applicable)
- Director of Epidemiology (or designate)
- Director of Cancer Registry (or designate)
Representative from each of:
- Radiation Oncology
- Medical Oncology
- Surgical Oncology
Ad hoc members:
- Department of Medical Physics
- Chair of the Research Committee, Medical Staff Research Association of CCMB
- Director of Psychosocial Oncology
TERMS OF OFFICE OF MEMBERS
The Chair and Vice- Chair of the RRIC will be elected from among the committee members
The Chair will serve a three year term (with an option to extend by one year) and will be replaced by the Vice Chair, who will serve a three year term (with an option to extend by one year) and then assume the role of Chair. The Chair/Vice Chair must be a physician who has been a member of the CCMB RRIC for at least one year, is involved in research, and has good administrative skills.
The term of office for other members of the committee will be re-evaluated every two years (or more often as required).
MEETINGS
Meetings will be held every month except for one month during the summer (July or August).
The Contracts Sub-committee will meet at least monthly and once during July and August at the discretion of the sub-committee
Distribution of materials for RRIC meetings:
- An agenda for each CCMB RRIC meeting will be sent out with the package of information to be discussed at the RRIC meeting at least four days prior to the RRIC meeting (and ideally two weeks prior to the RRIC meeting).
- The contracts to be reviewed at each contract subcommittee meeting will be distributed at least one week prior to the meeting.
- The minutes of each RRIC meeting will be recorded by the RRIC secretary and will be maintained as a permanent record; all of the material submitted for each study and the ongoing written correspondence about it will also be kept as a permanent record.
- The minutes of each meeting will be sent out electronically in a timely fashion after each RRIC meeting and will be included in paper form in the package of material that is sent out to RRIC members in advance of each RRIC meeting
REVIEW OF TERMS OF REFERENCE
CCMB RRIC Terms of Reference will be reviewed at least annually by members of the RRIC.
QUORUM
Quorum is required for all voting decisions and is defined as 50% plus 1.
REPORTING
The Chair reports directly to the as yet un-named senior executive committee.
