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Standard Phrases to Describe Important Aspects of Informed Consent for Minimal Risk Protocols

 

Anonymity should be described in simple terms.
I 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Although my name will not be published, my child’s photo may be published in full.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 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.
 
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. Particpants 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 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.
 
In presenting the research project to staff, the following points must be included:
  • Staff is being asked to complete questionnaires as part of a research project.
  • The project does not involve quality assurance/improvement, and as such, participation is entirely voluntary and not work-related.
  • Full anonymity is assured. The decision to participate or not will in no way be shared with others.
 
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