820 Sherbrook Street Winnipeg, Manitoba, Canada R3A 1R9  
telephone: 204-787-3661; 1-877-499-8774  

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Dept of Research

 

 

Department of Research

The Department of Research is located in the Thorlakson Building at HSC:

HSC Department of Research
MS7 - 820 Sherbrook Street
Winnipeg, Manitoba, Canada R3A 1R9

Reception Phone: 204-787-2404  |  Fax: 204-787-4547

Director of Research: Dr. John Wilkins
Manager, Research Administration: Maria Loureiro

HSC DEPARTMENT OF RESEARCH:
The Department of Research was established to ensure that research studies performed at the Health Sciences Centre are scientifically sound and ethical (through the review and approval of the University of Manitoba Research Ethics Boards) and to determine the impact of research projects on the institution’s resources and/or staff.

Vision:
To achieve excellence in research through the provision of infrastructure and support to investigators; promote cross-disciplinary cooperation, and the preservation of ethics and partnerships between stakeholders in the advancement of clinical / healthcare science.

Mission:
To encourage and support programs of clinical / healthcare research at the Health Sciences Centre, which advance the state of medical knowledge, enhance the health of residents of Manitoba and support the development of technology transfer and commercial application opportunities within Manitoba. To achieve this Mission, the Department of Research strives to provide a safe, comfortable and supportive infrastructure for research while integrating accepted ethical values as expressed by the University of Manitoba (U of M) Research Ethics Board.

Research Studies at the Health Sciences Centre – Submission Process:
All research studies (Clinical Research studies which are sponsored by pharmaceutical companies, Grant-funded, and Investigator-driven studies) undertaken at the HSC must be submitted to Department of Research for review and approval before commencement of the study at HSC, to determine if and how any research study has an impact on HSC and its staff, and to ensure costs generated by research studies are recovered.

Patient Privacy:
All research studies are to be conducted in accordance with the Personal Health Information Act of Manitoba (PHIA).

How Is Research Reported To / Approved By HSC?
The HSC Research Impact Approval Form is to be completed and submitted to the Protocol Officer with the required copies of the protocol, etc. Instructions are included in the form, which can be found in the Public Folders of MS Outlook, under the Research Department Folder.

A Contract Research Surcharge Agreement for pharmaceutically-sponsored studies must be completed and signed. This form is available in the Public Folders of MS Outlook, under the Research Department Folder. The Specific Purpose Account application form must be completed if funds are to be held at HSC. It is located in the Public Folders of MS Outlook, under the Finance/All Finance Forms section.

If you do not have access to HSC MS Outlook or have any questions regarding the HSC Impact process or forms, contact the Protocol Officer (787-4968).

Research contracts for all studies conducted at HSC are be to written as a three party agreement – between the sponsor or granting agency/ investigator/ and institution. All contracts are to be submitted to the Protocol Officer (787-4968) for institutional review and signature.

Ethics submissions for all research studies must be made to University of Manitoba Research Ethics Board (UMREB). The current version of the REB Submission Form must be completed. Proof of Ethics approval must be received by the Protocol Officer before research can commence at HSC. Information on the submission process for the UMREB is available at their website: http://www.umanitoba.ca/medicine/ethics/.

Financial Transactions through Research Accounts
The Financial Analyst for the Department of Research monitors all financial transactions that are processed through the HSC Research Accounts. If you need information or have questions regarding research accounts, contact the Financial Analyst (787-1948).

Assistance with the Ethics submission process for clinical research trials:
The HealthTrials office, as part of the Department of Research, will assist Investigators and study sponsors with the preparation of site specific Subject Information and Consent Forms and Ethics submissions for research studies on which overhead is applicable. Contact healthtrials@hsc.mb.ca (or 787-2084) for more information.

Institutional Overhead / Study Budgets:
Institutional overhead (currently 20%) is charged on clinical trials sponsored by pharmaceutical companies. Some departments charge an additional overhead. Investigators should check with their department to determine if there is an additional departmental overhead. Ensure that the correct overhead amount is included in the preparation of the study budget. It should be calculated and added to the “per patient” cost in the study budget.

A sample budget template for research studies is available, which can be used as a guide. For further information, contact healthtrials@hsc.mb.ca.

Grant Funding Competitions For Investigator-Driven Research Projects

HSC Department of Research Personnel Awards administered by the HSC Foundation:
The HSC Foundation awards a General Grants Competition, Allied Health Awards, Nursing awards, the Opportunities Fund, and the DeWiele-Topshee and Olenick awards. Check the Public Folders, the HSC Focus, Corporate Office General Announcements. For additional information contact the HSC Foundation office at (204) 787-2022 or their web page:  www.hscfoundation.mb.ca.

Standard Operating Procedures (SOP) for Good Clinical Practice at the Investigative Site:
An SOP template specific to the Health Sciences Centre is available for research groups. It is based on Good Clinical Practice Guidelines, the Code of Federal Regulations, Health Canada Therapeutic Product Directorate Guidelines, and the ICH Harmonized Tripartite Guideline (Good Clinical Practice: Consolidated Guideline).

For more information, go to: www.hsc.mb.ca/healthTrials_SOP.htm
To view the template, contact healthtrials@hsc.mb.ca

Transportation of Dangerous Goods
For information on upcoming training for researchers, contact healthtrials@hsc.mb.ca.

Health Canada
Health Canada approval is required for many research studies.

For more information, go to their web page: www.hc-sc.gc.ca/index-eng.php

Health Canada requires that research study documents are retained for 25 years after study completion. For information on long term storage of research documents for studies conducted at HSC contact healthtrials@hsc.mb.ca.

Department of Research – Who to contact:

bullet For questions regarding Research and/or Research Space on MS7, John Buhler Research Centre 8th Floor (JBRC8), and General Hospital GF2 contact the Manager, Research Administration (787-4175).
 
bullet For MS7 general inquiries and room bookings for MS7 and JBRC8 boardrooms, monitor/meeting rooms, call the Secretary/Reception (787-2404).
 
bullet For questions regarding HSC Impact call the Protocol Officer (787-4968).
 
bullet For questions regarding Research Accounts call the Financial Analyst (787-1948).
 
bullet Contact HealthTrials: healthtrials@hsc.mb.ca (or call 787-2084 or 787-2046) for:
 
bullet information on project administration services for clinical trial research subject to contract research overhead – including assisting Investigators and Coordinators in the preparation of submissions to the University of Manitoba Research Ethics Board (preparation of site-specific consent forms, protocol/amendment submission, liaison with sponsors, etc.).
 
bullet questions regarding budget preparation
 
bullet research-related educational opportunities
 
bullet general questions regarding research and regulatory documents for any type of research study

FREQUENTLY ASKED QUESTIONS:

  1. Why is overhead charged?
    Overhead is charged on clinical trials sponsored by pharmaceutical companies to support the costs of general services provided for research projects at HSC, and the facility itself. Most institutions and clinics include overhead as a study expense. This extra amount charged is in addition to the study cost per patient. It should be calculated and added to the “per patient” cost in the study budget. Most sponsors expect that overhead will be included in the study budget.
     
  2. What is involved in the HSC Impact Approval Process?
    An outline of the Impact Approval Process is as follows:
bullet Impact Approval Form is completed and submitted (along with protocols) to the Protocol Officer in the Department of Research for review. This process can occur simultaneously with the Research Ethics Board submission. The form is available in HSC Public folders, Research Department, or by contacting the Protocol Officer at 787-4968.
 
bullet Information regarding use of HSC services and resources is requested, to determine if any area will be impacted by the research. (Examples: Types of tests, number of visits, number of participants and where the study visits will take place, PHIA Agreement, etc.).
 
bullet The Protocol Officer consults with the Research Impact Committee when the application is received. Committee members represent pharmacy, medical records, laboratory, radiology, nursing units, and operations (i.e., physiotherapy, occupational therapy, printing, etc.).
 
bullet Once impact has been identified, costs will be sent to the investigator. These costs must be reviewed and approved by the investigator.
 
bullet The study will be approved once all identified impact and costs are accepted, and a copy of the final Ethics approval has been received.

 

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Date of last revision:  March 31, 2011