Terms of Reference

revised March 31, 2014

PURPOSE

The purpose of the RRIC is to review all clinical 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:
  1. evaluate new and/or existing treatments, devices, or behavioral interventions;
  2. evaluate tests which may assist in the detection, diagnosis, staging, treatment planning, or prognostication of the disease;
  3. assess the experiences and/or quality of life of the patient (and sometimes other members of their family);
  4. assess late- or long-term adverse effects of treatment;
  5. assess prevention strategies;
  6. assess early detection strategies; or
  7. 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:
  1. 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 which do not involve any patient contact or the use of tissue(s) or fluid(s) obtained from patients
    • Studies run through the CTU 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 CTU requests that a study be reviewed by the CCMB RRIC
    1. 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.
    2. **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.
    3. Work with the U of M REB to ensure that adequate safeguards are in place to protect the research subjects
    4. 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.]
  2. Educate staff and trainees about the proper conduct of research
    1. Help ensure that trainees receive adequate mentoring regarding the proper conduct of research
    2. Provide assistance in research design, the plan for data collection, and the plan for data analysis
  3. Support the development of policies and processes to deal with research related issues
  4. Develop and maintain forms, processes, and a website to facilitate all of the above.

**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 (excluding Data Sharing Agreements)

Contracts and contract amendments for clinical trials (including Confidentiality Disclosure Agreements, Work Orders and Clinical Trial Agreements) will initially be reviewed and negotiated with the sponsor by the designated contract reviewer within each department using the Contract Review Guidelines Document located in the Clinical Trials Unit. Following initial negotiations, the Clinical Trials Unit Resource Coordinator, Ethics & Regulatory Affairs will review and provide feedback on the contract to the initial reviewer. Once the contract is acceptable to both the sponsor and the Resource Coordinator, Ethics & Regulatory Affairs it will be sent to the Administrative Assistant to the Chief Operating Officer (COO) for execution. Communication will be sent to the RRIC chair and RRIC Coordinator when a contract has been sent to the COO for signature so an exempt# can be assigned and the contract can be logged in the RRIC database.

WEBSITE SUB-COMMITTEE

A sub-committee of the RRIC (the website sub-committee) will review all aspects of the website on an ongoing basis and provide the RRIC a means to provide up-to-date information and documentation necessary for submission of research studies to the RRIC. Membership of the Website Sub-committee:
  1. Manager of CTU
  2. Manager of Cancer Registry
  3. Project Manager of Cancer Registry/Epidemiology
  4. Communications and Public Affairs Representative
  5. RRIC Coordinator

DATA SHARING AGREEMENT WORKING GROUP

A sub-committee of the RRIC (the DSA sub-committee) will review all Data Sharing Agreements between regular RRIC meetings and will provide feedback within one week or less. Membership of the DSA Sub-committee:
  1. RRIC Chair
  2. Manager of CTU
  3. Manager of Epidemiology
  4. Project Manager of Cancer Registry/Epidemiology
  5. Privacy Officer of CCMB

SUBMISSIONS
  1. The RRIC Coordinator will ensure that all of the required documents are in place before a study is approved by the CCMB RRIC. (See the latest version of the CCMB RRIC study submission form, section 10.0 for details).
  2. The RRIC Coordinator will maintain a list of all studies reviewed and approved by the CCMB RRIC (including those which have received expedited approval). All exempt studies will also have an RRIC number assigned to them and will be listed on the RRIC database of "approved studies".
  3. New as of March 2011: The RRIC Coordinator will 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.
  4. The RRIC Coordinator will maintain a list of contracts and a list of Data Sharing Agreements (DSA). The list of contracts and DSA's will be forwarded to the Chief Operating Officer (COO) c/o their Administrative Assistant twice a year (April and October).

MEMBERSHIP OF THE RRIC

Membership of the RRIC consists of:
  1. Manager of the Clinical Trials Unit (CTU)
  2. Manager of Health Information Services/Privacy Officer of CCMB (or designate)
  3. Manager of Epidemiology (or designate)
  4. Manager of Cancer Registry (or designate)
  5. Director of Pharmacy (or designate)
  6. Representative from Medical Oncology and Hematology
  7. Representative from Radiation Oncology
  8. Representative from Surgical Oncology
  9. Representative from Pediatric Oncology
  10. Representative from Nursing and Hematology
  11. Representative from Screening Program
  12. RRIC Coordinator

Ex-officio members: :
  1. The President and CEO
  2. The Chief Operating Officer
  3. Provincial Director of Research at CCMB
  4. Senior Director of Clinical Services (CMO) (if applicable)

Ad hoc members:
  1. Medical Director, CCPN
  2. Department of Medical Physics
  3. Chair of the Research Committee, Medical Staff Research Association of CCMB
  4. 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. The Vice Chair 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 an individual 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).

Distribution of materials for RRIC meetings:
  1. 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 one week prior to the RRIC meeting.
  2. The minutes of each RRIC meeting will be recorded by the RRIC Coordinator 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 apermanent record.
  3. The minutes of each meeting will be sent out electronically in a timely fashion after each RRIC meeting and will be included in the package of material that is sent out to RRIC members in advance of each RRIC meeting

The website sub-committee will meet at least every six months, or more often if needed.

The DSA working group will review Data Sharing Agreements between regular RRIC meetings and will schedule a DSA sub-committee meeting as required.

CONFLICT OF INTEREST

CCMB RRIC members shall declare any confirmed or potential conflicts of interest at the beginning of each RRIC meeting or prior to discussion of an individual project.

The Chair may ask the member with a confirmed or potential conflict of interest to remove him/herself while the potential conflict and appropriate action are discussed and resolved by the remaining committee members.

Significant potential conflicts that could require a member to be absent during the discussion of a study include:

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.