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Standard Phrases to Describe Important Aspects of Informed Consent for Full Board Protocols


Description of the limits of confidentiality. the researcher may be asked to explain this at greater length (e.g., child abuse, self-harm) in some studies.
Your personal information will be kept strictly confidential except as required or permitted by law.

For Phase I, II, or III clinical drug trials:
Representatives of the sponsoring company and/or Health Canada, as well as representatives from the CHEO Research Ethics Board have access to your child’s personal information.  A Quality Improvement Reviewer may review your child’s medical records under the supervision of the Investigator and staff, to ensure that all research standards and guidelines/regulations are met.
 
For clinical drug trials funded by NIH (U.S.):
Representatives of the sponsoring company or government regulators such as the Food and Drug Administration (U.S.) and Health Canada as well as representatives from the CHEO Research Ethics Board have access to your child’s personal information.  A Quality Improvement Reviewer may review your child’s medical records under the supervision of the Investigator and staff, to ensure that all research standards and guidelines/regulations are met.
 
For studies subject to the U.S. Food and Drug Regulations, the statement verbatim must be included:
"A description of this clinical trial will be available on http://www.clinicaltrials.gov/, as required by U.S. Law.  This Web site will not include information that can identify you.  At most, the website will include a summary of the results.  You can search this Web site at anytime." 
 

Anonymity should be described in simple terms.
You will not be identified in any publication or presentation of this study. Any personal information about me that leaves the hospital will be coded so that I cannot be identified by name.

If a person’s photo is to be published in full.
Although my name will not be published, my child’s photo may be published in full. As a result, my child’s identity cannot be protected fully.

Assurances should be given that the decision to participate or not in the study will not affect the care the individual receives at CHEO.
Your decision to participate or not in this study will not affect the care you receive at CHEO.

Participants should be informed that participation is entirely voluntary, that they are free to withdraw from the study without penalty or loss of any benefit to which they would otherwise be entitled.
You are free to withdraw from the study at any time and there will be no penalty to you or your child.

Participants should be informed on their right to request the withdrawal of information or specimens, and any limits on the feasibility of that withdrawal.
If you no longer want your samples to be used in this research, you should tell your study doctor.  Your study doctor will notify the Sponsor, who will ensure the samples are returned to the hospital from which they were obtained if needed, or destroyed.  If tests have already been done on your sample(s) it will not be possible to withdraw those results.  However, no further testing will be done.

Participants should be informed of their responsibilities while on study.
If you choose to participate in this study, you will be expected to:
  • Tell your study doctor about your current medical condition;
  • Tell your study doctor about all prescription and non-prescription medications and supplements you are taking.  Check with your study doctor before starting, stopping or changing any of these;
  • Tell your study doctor if you are thinking of participating in another study;
  • Return any unused study medication;
  • Return any diaries and/or questionnaires to the research team;
  • Tell your  study doctor if you become pregnant or father a child while participating on this study.
Participants should be informed of their expected duration of participation in the study.
Your treatment will last for about [specify time] if you are randomized to [specify - Group A].  If you are randomized to [specify - Group B] your treatment will last for [specify time - x months].  You will be asked to come back to the hospital [specify time - x days] after [specify-your last dose of study treatment]. You will then be asked to come back every [specify time]. You may be seen more often if your study doctor deems it necessary.  The Researcher(s) would like to keep track of your health for [specify time] to look at the long-term effects of your participation in this study. 
 
Participants should be given any new information that might influence their decision to participate in the study (as applicable)
We will inform you of any new information that might influence your decision to continue to participate in this research project.

For biology or genetic studies, participants should be given feedback regarding any result that may be relevant to their health or that of family members.
If the study uncovers information that might be helpful to your current or future health, the study doctor would offer to discuss these findings with you. The study doctor would first advise you of any risks and benefits of sharing this information with you. If necessary, the study doctor will recommend consultation with a genetic counsellor and repeat testing in a clinical (not research) laboratory.

Information regarding the participant’s right to compensation should be included (as applicable).
In the event that you or your child suffer injury as a direct result of participating in this study, normal legal rules on compensation will apply.  Medical care will be provided to you or your child.  By signing this consent form you are in no way waiving your legal rights or releasing the investigator and the sponsor from their legal and professional responsibilities.

What are the costs of taking part in this study?
You will not be charged for any test or research procedure required for this study. Taking part in this study may, however, lead to added drug-related costs to you or your insurance company. This is because your insurance company or governmental drug insurance programmes (for example, Ontario Drug Benefit Program or Trillium fund) may not fully reimburse your drug-related costs. This would occur whether or not you decide to participate in this study (you will still have to pay for the some of the drugs used in treating your child). You can ask to speak with the CHEO oncology pharmacist about these added costs. No patient will be excluded from this study based on their ability to pay for additional drug costs. Everything possible will be done to help you access reimbursement from your insurance company or other third party payer.

The process of randomization should be described (as applicable).
You will be 'randomized' into one of the study groups described below. Randomization means that you are put into a group by chance. Neither you nor your doctor can choose the group you will be in. You will have an equal (one in [specify] ) chance of being placed in any group. The purpose of randomization is to ensure that those receiving the [specify -study medication] and those receiving [specify- placebo] are identical in every other respect. That way, we can know for certain that any differences that we observe between the two groups are due to the study medication and nothing else.

A lay explanation of placebo (as applicable).
A placebo is an inactive substance, which may look like medicine but contains no medicine - a "sugar pill" with no treatment value. A placebo is used in research to compare the effects of a given treatment (in this case the drug, [specify]) against no treatment at all. We use placebos to better understand the psychological effects of medication; for example, like the expectations that patients develop of medication.

A lay explanation of clinical equipoise (as applicable).
Participants should be advised that the risks and inconveniences of the study are believed to be equivalent across the different study arms (a clinical equipoise), e.g., ‘The purpose of this study is to compare two or more treatments. Based on our current knowledge, we do not know if any (either) of the treatments being studied are significantly better than the other(s) in terms of either effectiveness or side effects. The study would be stopped if we learned that this was not in fact, true.’
 
An objective and fair explanation of the benefits of participating in the research (as applicable).
It is possible that this study will help develop a new therapy for others with … (specify condition). However, the therapy being offered through this study is experimental. You cannot be certain that there will be any direct benefits to you or your child.
 
An explanation that there may be unforeseeable risks of participation.
It is possible that you may experience side effects from participating in this study.  Some side effects are known and are listed below, but there may be other side effects that are not expected. 
 
Any effects on fertility and possible teratogenic risks must be described in full for both males and females (as applicable).
  • If there is a risk of sperm mutation then: If the drug under study presents a possible risk of sperm mutation & the directive that the participant should not father a child while on the study medication then the following statement: 'It is recommended that females and males who are sexually active, take precautions to avoid pregnancy during treatment. You must notify the physician if pregnancy occurs during the course of this study. Patients on the study should discuss these risks with sexual partners of the opposite sex. Adolescents will be given appropriate information about methods of birth control. For more information about reproductive risks you may contact the study physician.”
  • Teratogenic risks i.e., 'It is recommended that females and males who are sexually active, take precautions to avoid pregnancy during treatment. You must notify the study doctor if pregnancy occurs during the course of this study. Patients on the study should discuss these risks with sexual partners of the opposite sex. Adolescents will be given appropriate information about methods of birth control. For more information about reproductive risks you may contact the study physician.”
An explanation of the risks of blood draws/venipunctures
Blood drawing causes some pain and may cause bruising, bleeding or infections at the site of the needle stick. Care will be taken to avoid theses complications. Analgesic (numbing or pain blocking) cream can be used to decrease the pain and discomfort of blood tests.

An explanation of the possible use of blood or tissue samples should be given.  Participant should be given the opportunity to consent separately to the samples being used for related research usages (as applicable).
The blood / tissue samples obtained for this study are to be used for the express purpose of the research question(s). We would like your permission to use any remaining blood/tissue obtained from you or your child to answer related research questions. ___yes ____no.

An explanation of the risks to insurability relating to genetic testing.
There is a small risk of a release of information from your research records. Health and research records have been used against patients and their families. For example, in Canada, insurance companies may deny insurance to patient's with a certain illness or those that have a genetic risk of disease. Your hospital medical records cannot, however, be released unless required or permitted by law or if you sign a release of information. The researchers of this study will protect your research records so that your name, address and phone number will be kept private.

The chair of the research ethics board and the role of the committee should be explained.
The CHEO Research Ethics Board (REB) has reviewed and approved this research project. The REB is a committee of the hospital that includes individuals from different professional backgrounds. The Board reviews all research that takes place at the hospital. Its goal is to ensure the protection of the rights and welfare of people participating in research. The Board’s work is not intended to replace a parent or child’s judgment about what decisions and choices are best for them. You may contact the Chair of the Research Ethics Board, for information regarding patient’s rights in research studies at (613) 737-7600 (3272), although this person cannot provide any health-related information about the study.
 
Participants must be given an opportunity to obtain a copy of the results.
At your request, you can receive a copy of the study results at the end of the study.
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