Tri-Council Policy Statement

To Whom it May Concern: I am writing to you in regard to my application to the research ethics board for ethics approval under the Tri-Council Policy Statement on research involving human beings. I am seeking approval of an action study for cancer prevention. An action study is a study of lifestyle factors, to see if these choices could potentially be a factor in helping to prevent cancer. This clinical experiment will focus on gaining new knowledge and understanding on the association between development of cancers and physical activity. This observational study will focus on individual’s with high risk of developing cancer. High risk individual’s may include people with precursor lesions, diagnosed cancer, or individual’s with specific exposures

Disclosure is when the subject is given thorough exposure of all relevant information. During this action study, each volunteer will be given information on the purpose of the experiment, how initial fitness level will be marked, what the increased fitness program will include and any relevant background information before the experiment begins. In addition to this, any information gained during the experiment and thorough disclosure of the process while it is happening will be given to the subjects. Comprehension will be required of all the subjects of the experiment as well. I will ensure that the patient understands all the information that is given during the disclosure of all relevant information. During this experiment I will ensure each volunteer understands that we are conducting this experiment to gain knowledge and understanding on the association between development of cancers and increased physical activity level. Through conversation I will also make sure each subject understands the procedure of the initial assessment, the intense physical fitness program and observations of the effects on biomarkers. Voluntariness is the process we are going to take to gain subjects for the action study. This means each person must voluntarily give verbal consent or refusal of participation in the experiment, without any significant duress. For this experiment, only subjects who volunteer to give consent after

Any advances in research gained about the effect on increasing physical activity in high-risk for cancer individuals on their biomarkers, will be made available to the public and government. For research participants, the benefits may be indirect or direct. An example of the potential of direct benefits from this experiment is if a participant’s risk of developing cancer is lowered as a result of their increased physical fitness. Indirect benefits of this experiment will come from advancements in knowledge that may benefit the group of high-risk individual, to which all of the subjects belong. From this, the knowledge will become available to society as a whole. Also, our research yeam will be conscious of the opinions and expectations of the subjects with regards to these benefits. In addition to this, before the research begins the medical team will openly discuss the expectations of possible benefits with the