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St. Boniface General Hospitalvalues and promotes clinical research. The review process of the SBGHResearch Review Committee (RRC) is to ensure that clinical research conductedat SBGH is adequately funded; has received appropriate SBGH departmental approval;meets the applicable regulatory, ethical, and good clinical practiceguidelines; and has received appropriate peer review. Manitoba provincial legislation on PersonalHealth Information (PHIA) stipulates that an institutional review committee isrequired to approve the disclosure of personal health information for researchpurposes. It is also a mandatory requirement of the RRC to have all PrincipalInvestigators involved in clinical trial / therapeutic interventions researchat SBGH to give written confirmation that the Principal Investigator andResearch staff have read and are willing to comply with the Office of ClinicalResearch Standard Operating Procedures. To guide the review process, theRRC utilizes the Good Clinical Practice: Consolidated Guideline published byHealth Canada, the Tri-Council Policy Statement: Ethical Conduct for ResearchInvolving Humans, and the HealthCare Ethics Guide of the Catholic Health Association of Canada. Inaddition, the RRC is responsible for ensuring that clinical research complieswith the Personal Health Information Act of Manitoba (PHIA) and theMental Health Act of Manitoba. Operation of theCommittee (2007 Termsof Reference)
The Chair of the RRC communicates with the Principal Investigator following thereview of the research submission. In response to any submission, the RRC may: - grant approval,
- grant approval pending revisions, clarification or receipt of further documentation,
- not grant approval.
Every effort is made to provide awritten response within four weeks after the submission to the RRC has beenmade. If consensus cannot be reached byRRC, the matter is resolved by a vote of the RRC members. If RRC approval is not granted,the Principal Investigator may apply for an appeal process. The PrincipalInvestigator has an opportunity to consult with the Chairperson of the RRC orto arrange to appear at a meeting of the RRC for discussion. In the event thatsuch a consultation does not resolve the outstanding issues, an appeal meetingto ensure fair and due process is established by the RRC. This appeal meetingis chaired by the Executive Director, Clinical Programs and includes the Chairof the RRC as a non-voting member. If a clinical study has beenapproved by an external REB and has not been granted approval by the RRC due toa difference in opinion between committees, the decision of the SBGH RRC isbinding for any research carried out at St. Boniface General Hospital. The response letter from the RRCnotes the specific study (code number and date) under consideration and allitems reviewed. The approval letter from the RRC may be withheld until allrequired documentation has been received and reviewed by the RRC. What must be reviewed bythe RRC
Any research study that involves human subjects (clinical research) and / oraccess to personal health information for research purposes must be approved bythe RRC in writing prior to implementation of any research procedures orprocesses, and prior to the utilization of any hospital resources. The RRC does not need to review: - Chart review studies and chart audits that are not related to research projects.
- Journal articles and publications arising from chart audits and chart reviews.
These are to be submitted to theattention of the Executive Director, Clinical Programs. - Pre-clinical Research (any non-human research, such as animal or "bench" laboratory work). These are to be submitted for review as required by your department.
Completing the RRC Forms
For assistance with RRC submissions or for generalquestions regarding the conduct of clinical research at St. Boniface GeneralHospital contact the Office of Clinical Research.
Tel (204) 235-3623, Fax (204) 237-9860
Submissions to the RRC must be directed to:
The RRC Chairperson
c/o Recording Secretary
N1004, St. Boniface General Hospital
409 Taché Avenue
Winnipeg, MB R2H 2A6
Complete all sections as required on the forms, including indicating thoseareas that are not applicable to your study with the designation "NA" in thoseareas where this applies. Clickhere for a list of RRC submission dates.
Part A, B, and C (REB Submission form) is to becompleted by all Investigators or his/her study coordinator and submittedto the appropriate Ethics Board . The copy with the original signatures of thePrincipal Investigator and Department Head should be sent to the REB and acopy to the RRC. Retain a photocopy for your files. Part D(RRC Submission form) is to be completed by all applicants submitting to the SBGH RRC. Theoriginal copy is to be sent to the SBGH RRC. You should not provide acopy of this section to the REB as it is for SBGH resource utilization only.You are required to obtain all of the signatures for all departments involvedin providing patient care or other services as part of the research study. Pleasealso refer to the section "Documents to be reviewed by the Committee" for additionalinformation.
In the event that the procedures or tests required during your study are partof normal patient care, please note this on the forms in the applicable areas.You are required to identify and request costing for all research relatedservices, tests, clinic visits, and patient care that is beyond thenormal standard care. It is the responsibility of the Investigator to ensurethat there is sufficient funding available to cover additional services andpatient visits. The departments where additional services are provided willrequire reimbursement of funds from the Investigator. You are required toprovide a complete copy of your budget (your SBGH costs as well as the Sponsorbudget) as part of the application process. See the attached budget templateas an example. An Agreement for Access to Personal HealthInformation For Research Purposes form is required for each and every study.Please complete and sign the form as part of the RRC submission. The RRC willobtain the signature from the SBGH Representative on your behalf once they haveapproved the study. Final RRC approval will not be granted unless this part ofthe form has been received by the committee. The forms and all requiredsignatures and documents must be provided to the RRC at least one week prior tothe scheduled meeting date. The departmental signatures often take a few daysor longer, so be sure to circulate early for signatures. Costing of variousservices to support the clinical trial also may take a few days. Signatories for Part D: - Pharmacy Services - Don Mestdagh
If Pharmacy Services are requiredcontact the Research Pharmacist directly for more information by calling237-2117. - All SBGH Labs - Anne Hielkema
If Lab services at SBGH will beimpacted the attachedform must be completed and supporting documentation must be submitted tothe Research Lab Technician. Additional information can be obtained by calling235-3935. - Health Records - Shirley Guinn
Where access is required to health records, proposals (REB Form, RRC Form, and a copy of the protocol) must be submitted to SBGH Health Records Department along with a completed Request for Access to Health Records and / or Statistical Data form. If you need assistance in identifying health record numbers or preparation of statistical datadata, you will need to also complete a St. Boniface Hospital Study / Data Request Form . For information on Research Retrieval Fees or additional information can be obtained by calling 237-2405.
- Patient Registration - Debi Wilson
The Program Directors (Nursing Staff Utilization): - Medicine - Heather Carlsson-Reid
- Geriatric Day Hospital - Ed Ziesmann
- Surgery - Lance Barber
- Mental Health - Ed Ziesmann
- Emergency Program - Shirley Herlick
- Oncology - Karen Fletcher
- Women and Child Health - Lisa Albensi
- Family Medicine - Heather Carlsson-Reid
- Rehab / Geriatrics - Ed Ziesmann
- Palliative Care - Shirley Herlick
- Cardiac Sciences - Sheila Bowles
The Program Directors (non-Nursing Staff Utilization): - Occupational Therapy - Fiona McIntyre
- Physio / Communication Disorders - Contact Ed Ziesmann
- Social Work - Faye Ostrove
- Nutritional Services - Gabriella Benedictson
- Psychology - Dr. Lorne Sexton
- Rehabilitation - Ed Ziesmann
- Pastoral Care - Fr. Gerry Ward
- Facility Support - Sean McCarthy
Clinical Directors /Academic Department Heads / Section Heads at SBGH: - Diagnostic Imaging - Dr. B. McClarty
- Department of Medicine - Dr. K. Humphreys
- Department of Surgery - Dr. R. Guzman
- Department of Anesthesia - Dr. T.W.R. Lee
- Cardiac Anesthesia - Dr. S. MacKenzie
- Clinical Director, Cardiac Sciences - Dr. A. Menkis
- Cardiology Department Head & EKG - Dr. James Tam
- Mental Health - Dr. M. Enns
- Family Medicine - Dr. J. Boyd
- Palliative Care - Dr. M. Harlos
- Oncology Program - Dr. C. Olweny
- Women and Child Program - Dr. M. Helewa
- Women's Health - Dr. M. Morris
- Pediatrics - Dr. S. Kovnats
- Emergency Department - Dr. A. Chochinov
- Laboratory Medicine - Dr. A. Kabani
- Ultrasound - Dr. Fern Karlicki
- Nuclear Medicine - Dr. Anne Peterdy
- Nuclear Medicine (fMRI) - Dr. Bill Leslie
- Geriatric Day Hospital - Dr. E. Boustcha
- CCMB - L. Friesen (if study only at SBGH)
Overhead Exemption
An Institutional 20% overhead is obtained as additional financing from theIndustry Sponsors conducting research. The overhead is used by SBGH to providesupport of institutional research-based infrastructure expenses. Research that is not Industryfunded is exempt from the 20% overhead. This includes MRC funded studies,personal academic research, some non-profit grant agency funding, researchfunded by internal departmental funds etc.. It is important that, if youbelieve that your study proposal is overhead exempt, you provide a copy of thecontract from the funding source and rationale for why the study is exempt, orclearly explain the source of the funding if there is no external fundingagency. Indicate if you believe your study to be overhead exempt on the spaceprovided on the form. This exemption from overhead does not exempt costrecovery of expenses for resources utilized for research purposes. Note: The Institutionalsignatory on Investigator Agreements and any legally binding contract clinicaltrial contracts for SBGH must be the Director of Research Innovation andRegulatory Affairs. All Investigator Agreements / Clinical Trial Contracts mustallow for this institutional signature. A copy of the final, signed (includingSponsor), Investigator Contract / Agreement must be provided to the Officeof Clinical Research for archiving purposes. The Office of Clinical Research isavailable for any consultation or review of contracts prior to the Investigatorsigning. Contact 237-2226 for more informationregarding clinical research contracts. Communications with theCommittee
The RRC may audit or review the progress of a clinical study at any time. Anotification of a pending audit will be communicated to the PrincipalInvestigator in writing. Periodic chart reviews of patients who areparticipating as study subjects may be conducted without prior notification ofthe Principal Investigator. Any changes to the protocol thatimpact on hospital resource utilization must be submitted by the Investigatorto the RRC for review and approval. Copies of annual study approvalletters from the REB, including local SAE reports, must be submitted to the RRCfor information purposes on an annual basis. The Investigator must inform theRRC as well as the REB and the Sponsor of any protocol deviations that may havesignificant impact on subject safety. Where a study is discontinuedprematurely or extended beyond the stated timeframe, the Investigator mustinform the RRC in writing of the reason(s). On behalf of the RRC , the Officeof Clinical Research (OCR) will monitor study enrollment for record keepingpurposes. Investigators are required to report enrollment numbers as requested. Documents to be reviewedby the Committee
Prior to the enrollment of subject's into a clinical study, the Investigatormust obtain documented approval by the RRC. In order to give approval, the RRCneeds to review the documents listed below. - Protocol:
The protocol submitted to the RRC must be the same protocol, including attachments, that was provided to the REB for approval.
Please ensure the protocol is dated. - Protocol Amendments:
Protocol amendments for a previously approved study should be provided, along with copies of the revised REB approval letter and revised consent forms, to the RRC for information purposes. If the RRC has questions regarding any amendments, the Investigator will be contacted for clarification. - Investigator Brochure:
The Investigator Brochure (IB), which contains all the relevant information known prior to the onset of a clinical study, may be reviewed by the RRC. The IB is required only if the RRC requests a copy from the Investigator. - Data Collection Forms:
If requested by the RRC, the forms used to collect data (e.g. questionnaires, diaries) may be reviewed to ensure that they conform with the protocol. - Consent Procedures:
The procedure for obtaining informed consent is described in OCR 202 (Manual of Standard Operating Procedures For Clinical Trial Investigators). - Informed Consent Form:
A copy of the REB approved consent form / information sheet must be submitted. Any subsequent changes to the consent form / information sheet which occur as a result of changes to the protocol or any new discoveries, must be submitted, by the Investigator, along with the REB approval letter.
Please ensure the consent form is dated. - Advertisements:
Advertisements used to recruit subject's are seen as an extension of the informed consent and selection process. Copies of any advertisements (including posters and text for newspaper / newsletter ads), plus REB approval for the advertisements, must be submitted to the RRC. - Suitability of Investigator and Facilities:
To maintain suitability of all Investigator study sites, signed curriculum vitae and medical licenses must be kept current. A signed copy of the Investigator(s) CV(s) as well as the CVs of any research support staff must be submitted to the Office of Clinical Research and made available for review by the RRC if requested. - Regulatory Authority Review of Approval:
The Investigator is to provide evidence of HPB, FDA, or other regulatory authority approval of the investigation substances or devices. The Investigator should request these documents from the study Sponsor. Medical devices may require a letter of approval from Biomedical Engineering at SBGH. - Investigator Agreement (IA) / Contract:
The Director of Research Innovation and Regulatory Affairs is required to sign all Investigator Agreement's/Contracts as the SBGH Institution representative. A final photocopy of the IA must be provided to the Director of Research Innovation and Regulatory Affairs and the Office of Clinical Research (contact 237-2226 for more information). A copy of the IA must be made available to the RRC if requested. - Budget:
Complete details of the clinical study budget must be provided to the RRC. The original budget from the Sponsor must be included along with details of all hospital resources required to support the clinical trial. Ensure that all related costs, including salaries, compensation to patients, fees for medical record retrieval, equipment, tests, stationary and photocopying are included. Costing of pharmacy services and laboratory services must be obtained, in writing, from these service areas. A 20% overhead charge is levied by SBGH for all Industry Sponsored research and must be identified, when it is applicable, on the budget form. - RRC Submission form:
A completed RRC submission form (Part D above), including original signatures, must be submitted to the RRC. - REB approval letter:
St. Boniface General Hospital will require that Investigators provide a copy of the REB approval letter and approved consent form with the RRC application. If approval has not yet been granted by an REB, the Investigator should submit the proposed consent form and provide the REB meeting date of when the clinical research proposal will undergo REB review. Once the REB approval letter has been granted, a copy of the letter and a copy of the final approved consent form must be forwarded to the RRC. It is important to note that approval by a REB does not automatically authorize implementation of the study.
The Investigator is to maintain a record / file to show what was sent to the RRC for approval. - Committee Documentation to be Archived:
The following items must be archived: - all correspondence with the RRC (by the RRC and Investigator);
- the RRC letter(s) of approval for the clinical study (by the RRC and Investigator)
- the RRC membership list and meeting minutes (by the RRC only).
To obtain copies of any of thefollowing documents, please contact: Office of Clinical Research
St. Boniface General Hospital
Tel (204) 235-3623
Fax (204) 237-9860 or click on one of the linksbelow...  |
