Guidelines

All revisions, additions or deletions to studies previously approved by the Research Resource Impact Committee (RRIC) are considered amendments and must be submitted to the CCMB RRIC, University of Manitoba REB, and all other relevant regulatory bodies, for review to ensure that the research remains scientifically and ethically sound and departments are notified of any changes in resource requirements.

The Principal Investigator (PI) is responsible for ensuring that amendments are submitted to the RRIC for review and written approval is received prior to implementation.

Study amendments will be reviewed between meetings by the RRIC chair and impacted departments and can be submitted to the RRIC Coordinator at any time. If the amendment includes significant changes, the chair may require submission to the full committee at their next monthly meeting. The decision of whether an amendment qualifies for expedited review rests with the RRIC chair.

The RRIC generally considers sub-studies, ancillary studies, rollover studies, continuation studies, and extension studies as new studies, however, the decision of whether they qualify for review as amendments rests with the RRIC chair.

All revised study documents must have version dates that reflect the most recent amendment/administrative change submission.

Once the amendment has been approved, a signed copy of the amendment form will be returned to the PI with the outcome of the review.

For questions about the amendment form and submission process, please contact RRIC Coordinator at 204-787-4170. The Study Amendment Form is available in the Forms section of the web site.

Please download the following pdf to review the RRIC Requirement for Written Research Proposal for Chart Review.

Reference Materials
CCMB Policy 02.015

Guidance Document explaining the process for contract submission and approval is available by contacting the RRIC Coordinator at 204-787-4170.

revised October 25, 2013

Note: Data Sharing Agreements can also be referred to as Supply Agreements or Material Transfer Agreements.

1. A Data Sharing Agreement (DSA) is required for a study when data and/or samples will be sent from CancerCare Manitoba (CCMB) to another centre and no contract exists between CCMB and the other centre that addresses those issues.
2. There may be instances where more than one DSA is required. For example: Samples sent to one location and clinical data going to another location. A separate DSA is required for each centre.
3. If a DSA is required, the Research Resource Impact Committee (RRIC) Coordinator will note and track this in the RRIC database.
4. If a DSA is submitted when the study package is submitted to the RRIC for review at the next RRIC meeting, the DSA will be reviewed at the RRIC meeting with the corresponding study.
5. If a DSA is required, but was not included in the original submission package, the RRIC coordinator will notify the PI (or designate) that a DSA is required.

Important: In both # 4 and #5 above, the PI (or designate) must complete the required fields in the DSA, however no signatures are to be obtained until the agreement has received approval by the RRIC.

6. Once received by the RRIC Coordinator, the DSA will be reviewed by a small working group (the DSA review subcommittee of the RRIC). The timeline for review of the DSA by the working group will be one week or less.
7. Once the DSA has been reviewed by the working group, the RRIC Coordinator will advise the PI/designate whether any changes are required. If changes are required, the PI/designate will make the changes and send the revised DSA to the RRIC Coordinator, who will ask the working group to review the revised DSA.
8. Once the RRIC deems that the DSA is ready for signature, the RRIC Coordinator will request that the PI/designate obtain the signature from the signatory for the recipient (the institution receiving the data and/or samples from CCMB patients).
9. If the recipient requests changes to the DSA, the PI/designate will communicate this to the RRIC Coordinator who will send the requested revisions to CCMB’s Chief Operating Officer (COO) or designate c/o their Administrative Assistant. The COO/designate will review the requested revisions and seek legal counsel as required. When the DSA agreement is acceptable to both parties, both the recipient and COO will sign the DSA. The COO’s Administrative Assistant will return the fully executed DSA to the RRIC Coordinator who will distribute the signed DSA to the relevant individuals once the study (and DSA) is approved by the CCMB RRIC.
10. If changes to the DSA are not requested by the recipient, once they have signed the DSA, the RRIC Coordinator will send it to CCMB’s COO/designate c/o their Administrative Assistant for the institution signatory. The COO’s Administrative Assistant will return the fully executed DSA to the RRIC Coordinator who will distribute the signed DSA to the relevant individuals once the study (and DSA) is approved by the CCMB RRIC.

Exempt Study form applies only to the following one group:

• Departments of Medical Physics

This form must be completed for all studies that do not meet the criteria for full review by the RRIC.

Criteria for full Review by the RRIC:

Your study:

• Involves the review of patient charts (electronic or paper)
• Involves any type of contact with participants (including surveys and questionnaires)
• Involves the use of tissue or body fluids
• Has significant impact on CCMB resources (staff, equipment, or other) and which may adversely affect the availability of those resources for routine patient care

If the answer to all the above questions is "no", then please complete the Exempt Study Form to apply for an exemption.

If study participants are CancerCare Manitoba patients or significant others for whom participation in the study may cause anxiety or emotional distress, it is recommended that the following paragraph be included in the information for participants. Sign off from the Director of Patient and Family Support Services will also be required.

"Participation in this study may be upsetting or distressing to you as you recall your own illness experience, or the experience of your family member. If you would like to talk to someone about this, there is support available through CancerCare Manitoba Patient and Family Support Services. Please call 204-787-2109 or toll free 1-800-561-1026, or ask the research study staff to refer you."

Manitoba's Personal Health Information Act (PHIA) was legislated June 28, 1997. CancerCare Manitoba, as a trustee, shall protect personal health information by adopting reasonable administrative, technical, and physical safeguards that ensure the confidentiality, security, accuracy and integrity of the information.

As a trustee, CancerCare Manitoba will limit on amount of information used or disclosed. Every use and disclosure by a trustee of personal health information must be limited to the minimum amount of information necessary to accomplish the purpose for which it is used or disclosed.

It is important that research studies comply with the Act to:

1. Limit collection of identifiable personal health information. Participant should be assigned a study number. All efforts to de-identify shall be made.
2. If study participant personal health information will be disclosed, obtain signed consent from participant.
3. Limit access to study information. Researchers should be aware of the Personal Health Information Act, and sign a pledge of confidentiality.
4. Safeguard study information that has been collected. Consider, how will this information be stored ie. Stored in a locked filing cabinet, not removed off premises, computer is password protected, computer data encrypted? CD/disk use and storage, use of USB keys. Information must be protected.
5. How long will the data be retained, and how will it be destroyed once the study is completed.

PHIA Orientation & Pledge Forms (Note: The PHIA orientation and pledge forms are only required if you have not received prior PHIA training)

If you answered "no" to question 8.3 on the RRIC Submission form and/or question 8 on the PHIA form for research, please complete the PHIA Checklist and PHIA Pledge. All completed forms must be submitted to the Health Information Services Privacy Office (ON2092 - 675 McDermot Avenue)

• PHIA Guideline
• PHIA Checklist
• PHIA Presentation
• PHIA Pledge

The 200 word abstract provided on the Scientific Merit Pre-ScreenForm should include the following:

1. Background and Impact

Why is it important to do this study?

2. Objectives

What are the objectives of the study?

Example:

A) To examine differences in the allocation of treatment A versus treatment B for individuals diagnosed with colorectal cancer from 2010 to 2013.
B) To compare overall survival between individuals diagnosed with colorectal cancer by treatment type.
C) To compare the rate of recurrence between individuals that received treatment A versus treatment B.

3. Study Design

What is the study design you plan to use?

Example:

This study will use a retrospective cohort design.

4. Participants/Subjects

Who will be included in the study?

Example:

This study will include all individuals diagnosed with colorectal cancer from 2010 to 2013 that received treatment A or treatment B.

5. Outcomes for each objective

What are the outcomes for each objective?

Example:

The outcomes for each objective are as follows:
Objective A - Allocation of treatment
Objective B - Overall survival
Objective C – Recurrence

6. Data

What data is required and where will you get it?

Example:

Individuals with colorectal cancer will be identified using the Manitoba Cancer Registry. Tumour characteristics, treatment, and date of death will be identified from the Manitoba Cancer Registry. Recurrence will be determined by reviewing the CancerCare Manitoba electronic medical record (Aria).

7. Analysis

What analysis will be used for each objective?

Example:

The following analyses will be used for each objective:
Objective A - Logistic regression predicting treatment selection
Objective B - Cox regression predicting overall survival
Objective C - Competing risk analysis predicting recurrence

8. Sample size

What is your estimated sample size? Note – you will want to include power calculations for each outcome in your full study proposal.

Example:

Based on estimated from the MCR, there are 500 individuals that received either treatment A or treatment B from 2010 to 2015.