Research Review Impact Committee (RRIC)

RRIC is a review process conducted by CancerCare Manitoba to assist in governing research compliance at CCMB and the Research Institute in Oncology and Hematology.  

The documents outlined in the table below must be submitted to CCMBRRICCoord@cancercare.mb.ca

* Researchers can submit the RRIC package prior to obtaining the UM Ethics Approval Certificate, providing the UM Research Ethics Submission form is also provided at the time of initial submission.  The Certificate must be forwarded to RRIC as soon as it becomes available.

Studies involving multiple institutions require a formal agreement between the parties. Data sharing, material transfer, study agreements are but some of the types of contracts used in research. A research agreement is an essential study document required as part of the Ethics and RRIC submission process.

While agreements are submitted as part of the RRIC process, they are managed by the CCMB Contracts Officer. RRIC is a conduit for the receipt of agreements that are then tracked and processed by the Research Office.

The RRIC Research Application form does ask whether an agreement is required. The researcher is expected to provide a contact for each party such that the CCMB contracts team can contact them directly.

• If the researcher received an agreement from another institution, the agreement template must be submitted as part of the RRIC submission to the RRIC Coordinator. The CCMB Contracts Officer and/or a Research Officer from the Research Office will work with the investigator and the other parties directly to complete and finalize the agreement in a timely fashion.
• If no agreement was provided by the other party, the CCMB contracts team will select the appropriate CCMB template for use.
• The investigator is no longer required to complete any agreements.

The RRIC team processes submissions on an ongoing basis. Once all criteria for approval have been met, the RRIC coordinator will provide the Investigator with a final “Certificate of Approval”. This means the project can be activated and started at CCMB.

Often, all RRIC documents are in place and have been approved by CCMB, but an outstanding agreement, UM Research Ethics approval or an external institution’s impact approval are still pending. In such circumstances, a “Conditional Approval” is provided by RRIC.This means the study can only start once RRIC has received the last document(s). Once the missing document(s) has been provided to RRIC, a final “Certificate of Approval” will be issued. [Note: some exceptions do exist. The RRIC Coordinator will inform the investigator if/when the possibility to start on a conditional approval arises.]

The Investigator is no longer required to complete a RRIC study amendment form for changes to study personnel.

For study personnel changes occurring throughout your study, RRIC now only requires the following:

• The updated CCMB PHIA for Research Form
• Approval Form for Trainees, if applicable
• Copy of the UM Ethics Change in Study Personnel Form

RRIC will provide the Investigator with approval following its review of the CCMB PHIA for Research Form.

A RRIC Study Amendment form must be completed if/when any change is made to the protocol and/or study, regardless of whether CCMB is impacted or not.

For changes in study personnel, please refer to section Study Personnel Changes

RRIC follows the UM Research Ethics Board’s renewal and expiry guidelines. RRIC must receive the following documents annually for the Investigator to continue conducting research at CCMB or with CCMB resources:

• UM Research Ethics Board (REB) Annual Study Status form
• UM Annual Research Ethics Board (REB) Approval.

Once the study is closed, the Investigator must submit a copy of the UM Research Ethics Board (REB) Final Study Status Report to RRIC.

Aggregate Data -The total number of occurrences within a defined population (stratified by age, gender, or geographic area) or over a given time period. When data are aggregated, groups of observations are replaced with summary statistics based on those observations. Data can only be presented in aggregate form for the purposes of reporting or publication with cell sizes of at least six (6) or more (smaller rates of occurrence or cell sizes of five (5) or less must be suppressed).

Anonymous/Anonymized information - the information never had identifiers associated with it (eg., anonymous surveys) or the information is irrevocably stripped of direct identifiers, a code is not kept to allow future re-linkage, and risk of re-identification of individuals from remaining indirect identifiers is low or very low.

Breach or Breach of Security - any unauthorized access, collection, use, modification, disclosure, destruction, disposal, storage, or loss of information or property held by, in the custody of, or belonging to CancerCare Manitoba, and includes unauthorized access to CancerCare Manitoba premises.

Coded information - direct identifiers are removed from the information and replaced with a code or unique study number. Depending on access to the code, it may be possible to re-identify specific participants (e.g., a list is retained that links the participants' code or study number with the cancer registration number so data can linked back if necessary). If identifiable PHI has been removed & replaced with a unique code PHIA Compliancy does not apply (to the database).

Cohort - a group of individuals having a statistical factor (as disease, age or risk) in common.

Co-investigator(s) - Researcher(s) and other individuals specifically identified in the research submission and identified on the PHIA agreement as requiring access to the research data; an individual who has attended/received PHIA Orientation and has been made aware of the Personal Health Information Confidentiality Policy and the consequence of a breach.

Confidential Information - all information held by, in the custody of, or belonging to CancerCare Manitoba that is not in the public domain.

Data Capture Sheet - pre-designed form/system for the purpose of recording information that can be handled by a computer.

Data Fields - specific information required for the research database. Commonly used to refer to a column in a database or a field in a data entry form.

Data Sharing Agreement (DSA) - A legal agreement that allows for the transfer of research project-specific health information between organizations; the DSA binds the organization and the researchers to their respective responsibilities and obligations for protecting research data.

De-identified - A record in which identifying information is removed and through which a link to a particular individual cannot be established.

Demographics - The qualities (such as age, sex, and income) of a specific group of people: a group of people that has a particular set of qualities.

Direct Identifier - information that identifies a specific individual through direct means (e.g., name, social insurance number, personal health information number (PHIN)).

Identifiable information - any information created, used, or received that relates to:

1. the past, present, or future medical condition of an individual;
2. the provision of health care to an individual; or
3. the past, present or future payment for the provision of health care to an individual with respect to which there is reasonable basis to believe the information can be used to identify the individual.

Information Manager: - A person or body that:

1. processes, stores or destroys PHI for a trustee, or
2. provides information management or information technology services to a trustee.

Non-identifiable - Data that have never been labelled with individual identifiers or from which identifiers have been permanently removed, and by no means can a specific individual be identified.

Password/password protected - A sequence of characters that allows entry into a restricted system.

Personal Health Information Act (PHIA) - Manitoba Law that regulates the collection, use, disclosure, security and destruction of "personal health information" by "trustees". It has important implications for health researchers.

Personal Health Information - Recorded information about an identifiable individual that relates to:

1. the individual's health, or health care history, including genetic information about the individual,
2. the provision of health care to the individual, or
3. payment for health care provided to the individual, and includes
4. the PHIN and any other identifying number, symbol or particular assigned to an individual, and
5. any identifying information about the individual that is collected in the course of, and is incidental to, the provision of health care or payment for health care;

Principal Investigator/Researcher: - a person who is a student, teacher or researcher either enrolled at or employed by any of the following institutions:

1. universities as defined in the Universities Act, R.S.B.C. 1996, c. 468,
2. colleges, university colleges, and provincial institutes as defined under the Colleges and Institutions Act, R.S.B.C. 1996, c. 52,
3. the open university continued under the Open Learning Agency Act, R.S.B.C. 1996, c. 409,
4. any other institutions offering public post-secondary education services that may be described in the statutes above, and
5. other comparable institutions in other jurisdictions worldwide.

Prospective cohort study - follows a group of similar individuals (cohorts) over time who differ with respect to certain factors under study, to determine how these factors affect rates of a certain outcome.

Record - information in any form, including written, photographed, recorded or stored on any storage medium or by any means.

Research Data - facts, observations or information on which an argument, theory or research objectives are based. Data may be raw or analyzed, experimental or observational. that does not permit individuals to be identified is considered to be data.

Program of Research - A sustained research endeavor that includes one or more projects and which is generally shaped by broad objectives. Research proposals for a program of research usually describe an area of research rather than a discrete, time limited project. RRIC will consider applications for Programs of Research (the 'Program') with the understanding that individual projects within the Program must be reviewed on a project by project basis.

Prospective cohort study - follows a group of similar individuals (cohorts) over time who differ with respect to certain factors under study, to determine how these factors affect rates of a certain outcome.

Record - information in any form, including written, photographed, recorded or stored on any storage medium or by any means.

Research Data - facts, observations or information on which an argument, theory or research objectives are based. Data may be raw or analyzed, experimental or observational. that does not permit individuals to be identified is considered to be data.

Research Project - A time-limited research endeavor with specific objectives and/or research questions.

Retrospective Chart/Record Review - evaluates patient information that is existing at the time the project is submitted to the research committees for initial review. A post-treatment assessment of services on a case-by-case or aggregate basis after the services have been performed.

Secure Network Environment: - A dedicated server/network that does not allow external access. A computing system that enforces boundaries between computer networks using secure firewall that limits the exposure of a computer from unauthorized modification, destruction, or disclosure.

Study I.D. Number - a generated number or code unique to each record to replace identifiers. Depending on access to the code, it may be possible to re-identify specific participants (e.g., a list stored separately that links the participants' code with cancer registration numbers so data can be linked back if necessary).

Summary Table - analytical results and derived information generated using the data that does not directly identify an individual. This includes but is not limited to research notes taken from the data, and aggregations of the data including maps, tables and graphs.

Variable - a characteristic of a statistical unit being observed that may assume more than one of a set of values to which a numerical measure or a category from a classification can be assigned.

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:

• the RRIC member is a principal or co-applicant, or a collaborator
• the RRIC member is from the same research group or department, or is in a supervisory role or administrative position to the applicant
• the RRIC member is a close personal friend or relative of the principal or co-applicant
• the RRIC member has collaborated on scholarly project(s) (e.g., grant, manuscript, presentation) with the applicant or co-applicant within the past five years
• the RRIC member has marked current or past scientific or personal differences with the applicant

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.