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Office of Clinical Research

 

About

The Office of Clinical Research (OCR) is a unique clinical research support service offered by the St. Boniface Hospital in a collaborative partnership with the University of Manitoba. The Office of Clinical Research is proud to offer several years of combined academic and industry research experience to Investigators, local companies, and other agencies requiring research support and consultation. Staff of the OCR utilize their diverse research skills and experience in the provision of a host of services that include:

  • protocol/proposal development
  • single and multi-site project management
  • pre-clinical consultation
  • regulatory affairs support
  • research submissions
  • auditing, and
  • a multitude of research administrative support services

The OCR is proficient at operating with a team-oriented approach when handling requests and the benefit to the Investigator and Industry is the experience of a seamless research process. Basic research, academic research, Investigator-driven and Industry-sponsored research needs are the driving force that keeps the OCR on the leading edge of current research initiatives in Manitoba and across Canada. We encourage you to contact us for more information on how we can assist you with your academic research pursuits as well as industry contracts.

Continuing Education

The Office of Clinical Research offers a variety of education-based opportunities to enhance your knowledge and understanding of the processes involved in Clinical Research. For more information including, dates, times, location and costs for workshops please contact the Office of Clinical Research at (204) 237-2226.

Research Review Committee

St. Boniface Hospital values and promotes clinical research.

The review process of the SBH Research Review Committee (RRC) is to ensure that clinical research conducted at SBH is adequately funded; has received appropriate SBH departmental approval;meets the applicable regulatory, ethical, and good clinical practice guidelines; and has received appropriate peer review. Manitoba provincial legislation on Personal Health Information (PHIA) stipulates that an institutional review committee is required to approve the disclosure of personal health information for research purposes. It is also a mandatory requirement of the RRC to have all Principal Investigators involved in clinical trial / therapeutic interventions research at SBH to give written confirmation that the Principal Investigator and Research staff have read and are willing to comply with the Office of Clinical Research Standard Operating Procedures.

To guide the review process, the RRC utilizes the Good Clinical Practice: Consolidated Guideline published by Health Canada, the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, and the Health Care Ethics Guide of the Catholic Health Association of Canada. In addition, the RRC is responsible for ensuring that clinical research complies with the Personal Health Information Act of Manitoba (PHIA) and the Mental Health Act of Manitoba.

Operation of the Committee (2007 Terms of Reference and Membership List)
The Chair of the RRC communicates with the Principal Investigator following their view of the research submission. In response to any submission, the RRC may:

  1. grant approval,
  2. grant approval pending revisions, clarification or receipt of further documentation,
  3. not grant approval.

Every effort is made to provide a written response within four weeks after the submission to the RRC has been made.

If consensus cannot be reached by RRC, 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 Principal Investigator has an opportunity to consult with the Chairperson of the RRC or to arrange to appear at a meeting of the RRC for discussion. In the event that such a consultation does not resolve the outstanding issues, an appeal meeting to ensure fair and due process is established by the RRC. This appeal meeting is chaired by the Executive Director, Clinical Programs and includes the Chair of the RRC as a non-voting member.

If a clinical study has been approved by an external REB and has not been granted approval by the RRC due to a difference in opinion between committees, the decision of the SBH RRC is binding for any research carried out at St-Boniface Hospital.

The response letter from the RRC notes the specific study (code number and date) under consideration and all items reviewed. The approval letter from the RRC may be withheld until all required documentation has been received and reviewed by the RRC.

What must be reviewed by the RRC

Any research study that involves human subjects (clinical research) and / or access to personal health information for research purposes must be approved by the RRC in writing prior to implementation of any research procedures or processes, 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 the attention 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 general questions regarding the conduct of clinical research at St-Boniface Hospital contact the Office of Clinical Research.
Tel (204) 237-2226, Fax (204) 237-9860

Submissions to the RRC must be directed to:
The RRC Chairperson
c/o Recording Secretary
N1004, St-Boniface Hospital
409 Taché Avenue
Winnipeg, MB R2H 2A6

Complete all sections as required on the forms, including indicating those areas that are not applicable to your study with the designation “NA” in those areas where this applies.

Click here for a list of RRC submission dates.

Part A, B, and C (REB Submission form) is to be completed by all Investigators or his/her study coordinator and submitted to the appropriate Ethics Board . The copy with the original signatures of the Principal Investigator and Department Head should be sent to the REB and a copy to the RRC. Retain a photocopy for your files.

Part D (RRC Submission form) is to be completed by all applicants submitting to the SBH RRC. The original copy is to be sent to the SBH RRC. You should not provide a copy of this section to the REB as it is for SBH resource utilization only. You are required to obtain all of the signatures for all departments involved in providing patient care or other services as part of the research study. Please also refer to the section “Documents to be reviewed by the Committee” for additional information.

In the event that the procedures or tests required during your study are part of normal patient care, please note this on the forms in the applicable areas. You are required to identify and request costing for all research related services, tests, clinic visits, and patient care that is beyond the normal standard care. It is the responsibility of the Investigator to ensure that there is sufficient funding available to cover additional services and patient visits. The departments where additional services are provided will require reimbursement of funds from the Investigator. You are required to provide a complete copy of your budget (your SBH costs as well as the Sponsor budget) as part of the application process. See the attached budget template as an example.

An Agreement for Access to Personal Health Information 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 will obtain the signature from the SBH Representative on your behalf once they have approved the study. Final RRC approval will not be granted unless this part of the form has been received by the committee.

The forms and all required signatures and documents must be provided to the RRC at least one week prior to the scheduled meeting date. The departmental signatures often take a few days or longer, so be sure to circulate early for signatures. Costing of various services to support the clinical trial also may take a few days.

Signatories for Part D:

  • Pharmacy Services – Sheri Dyck

If Pharmacy Services are required contact the Research Pharmacy directly for more information by calling 235-3501.

  • Asper Clinical Research Institute Services – Dr. B. Ramjiawan

If Asper Clinical Research Institute Services at SBH will be impacted, attached form must be completed and supporting documentation must be submitted to the Office of Clinical Research. Additional information can be obtained by calling 258-1044.

  • All SBH Labs – Alissa Leforte

If Lab services at SBH will be impacted the attached form must be completed and supporting documentation must be submitted to the Research Lab Technician. Additional information can be obtained by calling 235-3935.

  • Health Records – Contact Office of Clinical Research

Where access is required to health records, proposals (REB Form, RRC Form, and a copy of the protocol) must be submitted to SBH 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 data, you will need to also complete a St. Boniface Hospital Study / Data Request Form. Once RRC approval is obtained, complete the Request for Heath Records Form and return completed form to Health Records.

  • Patient Registration – Debi Wilson

The Program Directors:

  • Medicine – Jennifer Bjarnarson
  • Critical Care – Jennifer Bjarnarson
  • Geriatric Day Hospital – Jason Hillier
  • Surgery – Lance Barber
  • Mental Health – Jennifer Taylor
  • Nephrology – Diane Genyk
  • Emergency Program – Nina Williams
  • Women and Child Health – Heather Nowak
  • Family Medicine – Jason Hillier
  • Rehab / Geriatrics – Jason Hillier
  • Palliative Care – Jason Hillier
  • Cardiac Sciences – Reid Love
  • Occupational Therapy – Jennifer Taylor
  • Social Work – Ela Partyka
  • Nutritional Services – Gabriella Benedictson
  • Psychology – Dr. Lorne Sexton
  • Rehabilitation – Ed Ziesmann
  • Spiritual Care – Ela Partyka
  • Facility Support – Sean McCarthy
  • Diagnostic Imaging – Brenda Badiuk

Clinical Directors /Academic Department Heads / Section Heads at SBH:

  • Diagnostic Imaging (not including MRI)- Dr. B. Maycher
  • MRI – Dr. B. McClarty
  • Department of Medicine – Dr. N. Hajidiacos
  • Department of Surgery – Dr. R. Guzman
  • Department of Anesthesia – Dr. C. Christodoulou
  • Cardiac Anesthesia – Dr. S. MacKenzie
  • Clinical Director, Cardiac Sciences – Dr. A. Menkis
  • Cardiology Department Head & EKG, Echo – Dr. Colette Seifer (acting)
  • Mental Health – Dr. J. Sareen
  • Family Medicine – Dr. J. Boyd
  • Palliative Care – Dr. M. Harlos
  • Women and Child Program – Dr. M. Helewa
  • Pediatrics – Dr. S. Kovnats
  • Neonatology – Dr. R. Alvaro
  • Emergency Department – Dr. R. Steigerwald
  • Laboratory Medicine – Dr. A. Kabani
  • Ultrasound – Dr. A. Goubran
  • Nuclear Medicine – Dr. A. Peterdy
  • Nuclear Medicine (fMRI) – Dr. Bill Leslie
  • Geriatric Medicine – Dr. C. Van Ineveld
  • Nephrology – Dr. M. Verrelli
  • Intensive Care Medical/Surgical (ICMS) – Dr. G. Eschun

Overhead Exemption

An Institutional 20% overhead is obtained as additional financing from the Industry Sponsors conducting research. The overhead is used by SBH to provide support of institutional research-based infrastructure expenses.

Research that is not Industry funded is exempt from the 20% overhead. This includes MRC funded studies, personal academic research, some non-profit grant agency funding, research funded by internal departmental funds etc.. It is important that, if you believe that your study proposal is overhead exempt, you provide a copy of the contract from the funding source and rationale for why the study is exempt, or clearly explain the source of the funding if there is no external funding agency. Indicate if you believe your study to be overhead exempt on the space provided on the form. This exemption from overhead does not exempt cost recovery of expenses for resources utilized for research purposes.

Note: The Institutional signatory on Investigator Agreements and any legally binding contract clinical trial contracts for SBH must be the Director of Research Innovation and Regulatory Affairs. All Investigator Agreements / Clinical Trial Contracts must allow for this institutional signature. A copy of the final, signed (including Sponsor), Investigator Contract / Agreement must be provided to the Office of Clinical Research for archiving purposes. The Office of Clinical Research is available for any consultation or review of contracts prior to the Investigator signing. Contact 204-258-1044 for more information regarding clinical research contracts.

Communications with the Committee

The RRC may audit or review the progress of a clinical study at any time. A notification of a pending audit will be communicated to the Principal Investigator in writing. Periodic chart reviews of patients who are participating as study subjects may be conducted without prior notification of the Principal Investigator.

Any changes to the protocol that impact on hospital resource utilization must be submitted by the Investigator to the RRC for review and approval.

Copies of annual study approval letters from the REB, including local SAE reports, must be submitted to the RRC for information purposes on an annual basis.

The Investigator must inform the RRC as well as the REB and the Sponsor of any protocol deviations that may have significant impact on subject safety.

Where a study is discontinued prematurely or extended beyond the stated time frame, the Investigator must inform the RRC in writing of the reason(s).

On behalf of the RRC , the Office of Clinical Research (OCR) will monitor study enrollment for record keeping purposes. Investigators are required to report enrollment numbers as requested.

Documents to be reviewed by the Committee

Prior to the enrollment of subject’s into a clinical study, the Investigator must obtain documented approval by the RRC. In order to give approval, the RRC needs 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 SBH.
  • Investigator Agreement (IA) / Contract:
    The Director of Research Innovation and Regulatory Affairs is required to sign all Investigator Agreement’s/Contracts as the SBH 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 SBH 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 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:

    1. all correspondence with the RRC (by the RRC and Investigator);
    2. the RRC letter(s) of approval for the clinical study (by the RRC and Investigator)
    3. the RRC membership list and meeting minutes (by the RRC only).

To obtain copies of any of the following documents, please contact:

Office of Clinical Research
St. Boniface Hospital
Tel. (204) 237-2226
Fax. (204) 237-9860

or click on one of the links below…

Statistical and Research Services

The Office of Clinical Research, in collaboration with our statistical consultant, offers a wide range of statistical services and expertise that may be of assistance to medical researchers in any phase of the research process.

Research and statistical support is available in the following areas:

1. Research Support

  • Assisting or conducting literature reviews.
  • Consulting regarding research design and methodology.
  • Consulting regarding statistical design and statistical tests.
  • Facilitating the ethical review process with respect to design and statistical concerns.

2. Statistical and Data Analysis

  • Data input to computer software programs (SPSS and SAS).
  • Analysis and interpretation of data.
  • Preparation of statistical reports, tables and figures.
  • Recommendation of appropriate statistical software programs for research.

3. Writing

  • Writing scientific articles and research papers.
  • Editing manuscripts for submission to journals or conferences.
  • Reviewing and critiquing journal articles.
  • Preparing grant submissions.
  • Preparing internal departmental reports and documents.

4. Teaching and Education

  • Teaching statistical theory to staff, residents and medical students.
  • Presenting data analysis and research results.
  • Attending education rounds, conferences and other research forums.

Accessing Statistical Support Services

If you would like more information about statistical support services for your study, please contact the Office of Clinical Research.

Requests for OCR statistical services are prioritized on the basis of time considerations, nature of the statistical request and availability of research grant funds.

Related Links

The Office of Clinical Research is pleased to offer you the following links that might be helpful in conducting your research:

General

Frequently Asked Questions

Clinical Trials

This information is written for you, your family, and your friends, to help answer some questions that you may have about taking part in a research study or a clinical trial at St. Boniface Hospital.

You should discuss this information and any other information about the study you may be in with your study doctor, study nurse, or study staff.

You need to make sure that all your questions have been answered.

What is Clinical Research ?

Clinical research is research done on humans to help us learn about which procedure, technique, tool, drug, vaccine, or medical device (i.e. a pacemaker) is better and safer. All clinical research must be approved by the St. Boniface Hospital Research Review Committee and is reviewed to ensure that the research provides quality care to you as the patient.

Some research studies focus on quality of life or the psychological impact of a disease or social issue. This type of research may not involve treatment, but may use interviews and questionnaires instead.

You will not be enrolled in clinical research without your knowledge or consent. It is always up to you to decide if you want to take part in research.

What is Informed Consent ?

Informed consent means that you are given information so that you can understand what is involved in any research study. You will be told:

  • what the known risks and benefits are,
  • what the most common side effects are and,
  • what you will be asked or must do in the research study.

You can speak to family and friends and then decide if you want to be in the research study or not.

You will be told about what treatments are being tested and what other options that might be available to you other than being in the research study. You will need to ask the study doctor, study nurse, or study staff about any part of the consent that is not clear to you. You can refuse to take part in a research study. Your treatment or care will not be affected.

If you are involved in a research study, you will be told about new findings and you will be given any new information that may affect your willingness to take part in the trial. When you sign a consent form, you do not need to stay in the study or give up any legal rights you have. You can still withdraw from the study at any time. You do not need to give a reason.

Why is Clinical Research important ?

New discoveries and advancements in health care and science are the results of research. By doing research, we are able to learn which procedures and treatments work better, and are safe. The results of research studies will direct which procedures and treatments become widely available. The results of research may also change the way we care for patients.

Do I have to be in a Research Study to get the care & treatment I need ?

No. All of the treatment options that would normally be available to you should be discussed with your study doctor or study caregiver. We will explain all treatment options to you so that you can make your own mind up about any treatment that is experimental. You will receive the same close attention and treatment that you would if you were not in a study.

What do I do if I change my mind ?

You always have the right to withdraw from a research study.

If you are in a study that involves treatment, we suggest that you discuss any plans to leave with your study doctor so that you can be placed into another treatment plan. In some cases, leaving the study quickly might affect your health. Therefore, you should not stop your treatment without calling your study doctor. If you have an implanted device as part of a research trial, leaving the study may require taking out the device. This must be discussed with your study doctor.

Who do I call if I have a problem ?

It is important that you contact your study doctor, the study nurse, or the study staff if you have any health problems or have an accident while you are taking part in a study or in the months after it. This is very important. If you have a health problem, this may be the result of being in the research study or it may not, but your study doctor will need to help sort that out. You might need to be taken off the study treatment or have a change in your treatment.

You should let those caring for you know that you are in a research study. If you are hospitalized or have other medical treatment while you are in a treatment based research study, they can get details of your study treatment from your study doctor. Even if you have a car accident or a fall and hurt yourself, you still need to let the study doctor know.

The names and phone numbers for the study doctor and study staff are included in the consent form for any research study. Use these to contact the study staff in the event that you need to speak with someone.

You should keep a copy of these numbers with you at all times.

If you would like to know about your rights as a research subject, you can contact the Research Ethics Board at the University of Manitoba at 789-3389.

If you wish to speak with a St. Boniface Hospital Patient Relations Officer please call 237-2306.

How do I know a Research Study is safe ?

Taking part in any research study may involve risks that we do not know. Laboratory studies must be done first before a research medication or device is given to humans. Reports of all of the research done for medications and devices must be given to Health Canada each year. Health Canada can then decide if their research should continue. Also, the drug or device company must send a report to Heath Canada immediately when a serious injury occurs.

Who has access to my Medical Chart ?

The people and agencies that may have access to your medical chart are listed in the consent form. Access to any of your personal health information is protected by law in the Personal Health Information Act of Manitoba.

Who will look after me when I am taking part in a Research Study ?

Most study doctors have experienced research nurses and research support staff working with them. All of the staff involved in the research study will have special training in how to conduct the research study and any common side effects, that may be associated with being in the research study. You will receive the same close attention and treatment that you would if you were not in a study.

Will I ever know what Study Group I was in or what treatment I received ?

In some cases, you may be told which study group you are in as soon as you agree to be in the research study. In other cases, the study doctor may be told only once all of the research information is reviewed. Sometimes this information is not ready until many months after the study is over. You will need to ask your study doctor if the results will be given to you.

Will I ever know the results of the Study ?

The results of a study are often published. The results of new drug or device studies must always be sent to Health Canada. Once the studies are done, Health Canada will review the results before it allows the drug company or device maker to sell the product.

Should I take part in a Research Study ?

Whether to be in a study or not is for you to decide. We suggest that you take your time to review all of the information given to you. You should also talk with your family and friends, if you feel that it will help you decide. Only once you feel that you have had all of your questions answered should you consent to be in a study. Be sure to keep a copy of the information and consent form. You should feel free to contact the research staff if and when any other questions come up; that is why their names and contact numbers have been given to you.

General

Are representatives from the sponsor (i.e. Drug Companies) & their monitors required to sign a ‘Visitors on Business’ form ?

According to recommendations made by the WRHA PHIA Committee in January 2010, representatives from a sponsoring company who will be reviewing medical records for clinical research monitoring and auditing purposes, are required to sign a “Visitor on Business” form. The original form is to be kept in the Investigators research files and a copy given to sponsor’s representative if requested. For a copy of the form please click on the link “Visitors on Business Form”.

Is written consent for screening a chart required?

Screening of Charts:
The research nurse who works within the specific clinical department pre-screens those departmental clinic charts for the Investigators’ clinical patients and identifies those patients who may be eligible for studies (usually based on basic inclusion exclusion criteria, diagnosis). The charts are then flagged to remind the Physician to ask the patient is it is OK for the research nurse to approach them to discuss participation in a study.

If the research nurse is involved in the patient’s care and is therefore aware of their medical condition, etc., then this process is satisfactory. The process needs to be described on the REB submission, and be sure to include the fact that the nurse provides care to this patient in the clinical department.

The research nurse approaches the patient after a staff member has asked patient permission. The research nurse verbally asks the patient permission to review their chart to see if they may be eligible for the study. No written consent is obtained.

If the research nurse is working with a Principal Investigator who has privileges with the WRHA, and the research nurse has signed a PHIA Pledge of Confidentiality, then documented consent is acceptable (the research nurse documents that the patient has provided verbal consent).

If the research nurse were from another RHA, or government department / agency, etc., then we would require written consent for the “trustee” to disclose the PHI to the research nurse.

In some situations, it might be reasonable for Research Nurses / Coordinators to review personal health information (“PHI”) of patients without first asking patient consent. This would only apply to a situation where a patient is seeking health care from physicians who provide that health care and also conduct research that might be a treatment option for the patient.

In such instances, access to the PHI would be solely for the purpose of determining whether or not the patient meets basic inclusion criteria for the study in order to determine if the study represents a treatment option for that individual. The research nurse / coordinator could inform the physician that the patient may be eligible for the study treatment option so that the physician can then discuss the study with the patient during their clinic appointment.

The research nurse / coordinator must:

  • be employed by the hospital
  • paid by the hospital
  • work directly with a group of physicians within the specific program or service (i.e. Vascular Surgery)
  • have a job description with the facility specifying their clinical research role

In these situations, the research nurse / coordinator would only have access to the PHI that would be forwarded in the normal course to the physician for the purposes of the clinical consultation with that patient. This does not include PHI held in other hospital departments or where the hospital Medical Record would have to be pulled for this purpose.

Access to PHI in Critical Care / Emergency Departments:
The research nurse is working in a critical care / emergency area and the patient is not able to provide consent for chart screening for eligibility criteria. Is the nurse allowed to review the patient chart to see if they are eligible and then contact the Investigator. These patients are identified to the research nurse by house staff and the Investigator would have to be called in for enrolment and final determination of suitability for the study.

This scenario is explained in the document titled “The application of the Personal Health Information Act of Manitoba (PHIA) in a Research Ethics context“.

In some exceptional situations, it may be potentially beneficial for individuals to be approached as quickly as possible to discuss the research study. In these situations, it may be appropriate to allow access to the patient’s PHI prior to discussions between the individual and researchers. Example:

“Stroke Study:
There is no good treatment for embolic stroke at present. A new IV drug is being tested to prevent brain damage from stroke. The new drug may offer a chance to the patient that would otherwise not be provided. Drug must be started within 6 hours of onset of stroke symptoms. Symptom onset occurs at home, patient must physically get to hospital, be triaged and diagnosed. Already much time has elapsed. Researcher is aware of patient, but cannot begin screening process until permission is given via clinical staff for study staff to approach patient. This process may involve the family and patient asking many questions about the study and may interfere both with their time together and with clinical staff assessing the patient for direct care. Under these stressful circumstances, the patient/family may simply decline and not be provided with an opportunity to potentially receive better treatment. This situation could be avoided if the study staff gained access to the chart to see if the patient is even a candidate for the study.”

The need for access to the patient’s PHI without consent needs to be clearly documented on the REB Submission Form and they will take this into consideration when reviewing the protocol for approval.

Contact Us

Dr. Bram Ramjiawan, Ph. D.
Director, Research Innovation And Regulatory Affairs
(204) 235-3206

Lorie Forbes
Admin. Manager
(204) 258-1044
lforbes@sbgh.mb.ca

Angela Ramjiawan
Research Support and Grants Officer
(204) 237-2226
aramjiawan@sbgh.mb.ca

Office of Clinical Research
St. Boniface Hospital
409 Tache Avenue, Room #N1004
Winnipeg, Manitoba, Canada
R2H 2A6
Tel. (204) 237-2226
Fax. (204) 237-9860