Oncology Research Consent Form Information
When you agree to become a Stage I Clinical Trial volunteer, you will be asked to read and sign a Consent Form that provides information about the trial and what to expect.
NEW! BC Cancer Agency Consent Form Template - This document is a 15-page template, updated 23 February, 2007, with instructions for researchers regarding the information they must provide about the trial, and the wording they must use. This is a real eye-opener and a *must* for every potential Phase I Trial volunteer to read. This document was received in hard copy and each page has been scanned. The pages are presented exactly as they were scanned, in jpeg format. The pages can be reached in order by clicking here (Page opens in a new window, and there is a "next" link at the top of each page to take you to the next page): Go to Page 1.
BC Cancer Agency Consent Form Template - 23 February, 2007
NOTE: You will find an older (2005) version of the Consent Form posted below for you to compare and note changes / improvements.
Sample Information & Consent Form with notations (PDF) - This is a copy of the standard Information & Consent Form with added notes such as questions to ask before you volunteer (PDF document, opens in new window).
Sample Information & Consent form without notations (PDF) - This is a copy of the standard Information & Consent Form used in Stage I Clinical Trials in BC, without added comments (PDF, opens in new window). This form was in use as of December 2005.
 You will require the Free Adobe Reader to view PDF files. You can download it by clicking here.
Questions you should ask after you have read the
INFORMATION AND CONSENT Form
When the Principal Investigator (PI) for the Phase 1 Study is identified and their details are given to you, ask if this person is actually a resource for you or just another administrative entity. If the PI is actually one of the members of your Phase 1 Team assigned to oversee your data, ask to meet with the PI and ascertain directly from that person exactly what your relationship is; is that person someone you can turn to if you do not feel that your concerns are being addressed?
Emergency Contact Numbers
You are not a medical person. Plus, you are coping with a totally new experience. Therefore, you are not equipped to determine if your situation is an 'emergency' or not. Tell your Phase 1 Team that you are going to define 'emergency' as anything that occurs that is not 'normal' for you. Ask for assurance that the person with whom you will be connected with when using an 'emergency' number has the authority to respond immediately; even if it happens to be 2 o'clock in the morning.
Most Responsible Physician
Determine exactly who is your Most Responsible Physician (MRP). If your MRP is going to be away or he is assigning another doctor to oversee your care, ask that you be informed of this prior to the change over. Ask if the new MRP is a fully qualified physician or a student doctor. If the MRP is a student, then ask for the name of the supervising oncologist and their contact number.
Background
Health Canada - is this government body involved directly in the Phase 1 study? Does someone from Health Canada follow through with the information it collects to assure quality of care to the participants? As of September, 2007, Health Canada does not keep a guiding hand on the Clinical Trial process.
Purpose of the Study
Understand that 'the purpose of the study' is to determine the Maximum Tolerated Dosage (MTD) that can be tolerated by a human being; that human being is YOU. Ask your Phase 1 Team doctor what adverse side effects (AE's) it is possible for you to experience should you end up in the MTD cohort.
Ask for complete details on the side effects experienced by each member of the cohort preceding you.
Ask if the remedies suggested in the Consent Form are the only ones available or are there additional ways to counteract the possibility of your encountering severe side effects - which the researchers call Severe Adverse Events (SAE's).
Plan of Treatment
How will I be "watched very closely?" Will the doctors look at me or just my lab results? Do the lab tests I am submitting to constitute the primary monitoring mechanism for determining my well being?
How often will I actually have a physical, 'head-to-toe', assessment made of my person during this trial?
In the 'normal' scheme of things, how often does the MRP plan to meet with me to discuss my situation?
Are there any services for emotional, psychological or spiritual support available to me or my caregiver?
If I do not feel that my concerns are being addressed fully by my Phase 1 Team, who can I turn to for a second opinion?
Possible Side Effects estimations
How are these percentages arrived at if this is the first time this drug has been given to human beings?
Alternatives
This section is not on point as it has already been determined that no alternative treatments of any sort are possible.
Confidentiality
Does Health Canada keep complete records of all Phase 1 clinical trials conducted in Canada? (Eg. The name of each study; where the study occurs; and the outcome for each member of each cohort; etc). While in this section of the Consent Form, Health Canada is mentioned along with the FDA, in reality Health Canada is not closely involved. Canadians are well aware of the FDA and its power in the U.S. and we tend to assume that we have a similarly 'hands on' equivalent in Canada. It turns out that Health Canada is much less involved with clinical trials in Canada than the FDA is with trials in the United States.
Is there any legal need for me, as the trial subject, to refrain from communicating my Phase 1 trial experience to others?
Rights as a Participant
If I leave the trial, are my patient records, generated during the trial, readily available to my community health providers?
This document assures me that my right to take legal action, that might result from a grievance that I or my estate could have with your institution, is not impacted by my signing the 'Information and Consent 'form/contract. Am I assured that this institution will make available, to me or my estate, an address for each member of my care team? Further, that this institution will require of the Phase 1 care team that their addresses will be accessible to me or my estate for a period of 2 years?
You will require the Free Adobe Reader to view PDF files. You can download it by clicking here.
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