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Clinical Trials
This information is written for you, your family, and your friends, to help answer some questions that you may have about participating in a research study or a clinical trial at St. Boniface General Hospital.
This information, along with the specific General Clinical TrialsThis information is written for you, your family, and your friends, to help answer some questions that you may have about participating in a research study or a clinical trial at St. Boniface General Hospital.
This information, along with the specific 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 General 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. Top 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 are 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. Top 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 ones 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. Top 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. Top 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.
Top 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 General Hospital Patient Relations Officer, please contact Lorraine Bisson at 237-2306.
Top 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. Top 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. Top 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. Top 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. Top 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 a year. Once the studies are done, Health Canada will again review the results before it allows the drug company or device maker to sell the product. Top 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. Top GeneralAre 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".
Top 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.
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