MYTHS AND INFORMED CONSENT
Myth and Reality
You may find it helpful to know some of the most common misperceptions about informed consent and clinical trials. Even if these do not represent your thinking about informed consent, they can serve as a helpful reminder of what the process is really about before you go through it.
Myth: Informed consent is designed primarily to protect the legal interests of the research team.
Reality: The purpose of the process is to protect you and other participants by providing access to information that can help you make an informed choice. It also is designed to make you aware of your rights as a participant.
Myth: The most important part of this process is signing the informed consent document.
Reality: Actually, the heart of this process is your ongoing interaction and discussions with the research team and other medical personnel-before, during , and after the trial. The document is designed to get this conversation started.
Myth: My doctor knows best; he or she can tell me whether or not I should consent to participate.
Reality: Your doctor is likely to be a valuable source of advice and information, but only you can make this decision. No one-not even medical experts-can predict whether a treatment, screening, prevention, or supportive care method under evaluation in a trial will prove successful. The informed consent process is designed to help you weigh all of the information and make the right choice for you
Myth: Once I sign the consent form, I have to enroll and stay enrolled in the trial.
Reality: That's not true. Even after you sign the form, you are free to change your mind and decide not to participate. You also have the right to leave a clinical trial at any time for any reason, without forfeiting access to medical treatment.
Myth: Medical personnel are busy, so I can't really expect them to keep me informed as the trial progresses or listen to my questions.
Reality: The research team has a duty to keep you informed, make sure that you understand the information they provide, and answer your questions. If you ever feel that you are not getting what you need, do not hesitate to speak up. You will be given the name and phone number of a key contact person who can answer your questions throughout the course of the trial. Keep in mind that people like you are making this research possible through their willingness to participate.
INFORMED CONSENT FORM
Alaska Bio Canines is seeking volunteers to provide breath samples for this research.
Why is this research being done?
It is known that diseases, non-cancerous and cancerous, have unique odors undetectable by humans, but recognized by a dog's extraordinary sniffing ability. Dogs are trained to use their sense of smell to help us in many areas of life, from finding missing persons, to bomb detection to alerting a diabetic that their blood sugar is abnormal.
This research project is expanding on prior research using breath to detect breast cancer. There is no perfect screening tool for cancer. This project intends to show if prior research can be repeated and provide a high level of sensitivity and specificity in detecting breast cancer. In other words how often can dogs pick the cancer breath correctly as well as choosing only the cancer breath in breath samples that may closely resembles cancer scent.
How long will the research last?
What we ask of you is to provide information on a questionnaire and sign this consent form before collecting your breath samples. This process will take about 15 minutes of your time. We anticipate that the research project will take two years to complete.
How many people will be studied?
We need 60 people with newly diagnosed breast cancer and 100 people (controls) with non-cancerous breast changes such as breast cysts, fibrocystic changes, inflammatory changes or dense tissue. These are changes your doctor will have told you about after an exam or testing.
What happens if I say Yes, I want to be in this research?
If you agree to be in this research project, you will blow into a breath collecting tube. If you are able to do so we will collect 5-10 different breath sample tubes on your visit. All samples will be labeled with a number and labeled as cancer or non cancer. No other identifier such as your name will be marked on these samples.
What are my responsibilities if I take part in this research?
If you take part in this research, you will be responsible to provide breath samples and information that includes your age, gender, smoking status, type of cancer, stage of cancer, and any other major medical conditions.
What happens if I do not want to be in this research?
Participation is voluntary. You may decide not to take part in the research or you may agree now and stop later without this being held against you.
Is there anyway being in this study could be bad for me?
There is no risk to providing breath samples, however if you decide after providing your samples that you are uncomfortable with your decision, you may stop and we will discontinue your participation in the study. As personal information about you will be stored as part of the study, there is also a risk that participation could result in loss of confidentiality. However the Principal Investigator (PI) will maintain a secure password protected database. The database will include the number labeled breath samples along with gender, smoking status (smoker or nonsmoker), type and stage of cancer, and any other major medical conditions such as hypertension, diabetes, thyroid disease. The research team, the Sponsor of the study, the regulatory agencies and the Institutional Review Board (IRB) that reviews this study will have access to study records, including your consent forms. No information will be released that personally identifies you, except as specifically by required law.
Conflict of Interest
Mary (Dolly) Lefever, the person responsible for the conduct of this research study, volunteers for Alaska Bio Canines. Alaska Bio Canines is a non-profit corporation formed to conduct this study and may have financial interest in this research study. You are under no obligation to participate in this research study.
Will being in this study help me in any way?
There are benefits to you and others from your taking part in this research. By providing breath samples you are contributing to research that is looking for noninvasive screening methods to detect breast cancer.
What happens to the information collected for the research?
Efforts will be made to limit use or disclosure of your personal information including research and medical records to the people who have need to review this information. We cannot promise complete confidentiality. Organizations that may inspect your information include the IRB representatives responsible for management or oversight of this study. If we access protected health information (i.e. your medical record), you will be asked to sign a separate form to give your permission.
What else do I need to know?
There is no charge for you to participate in this study. Neither you nor your insurance carrier will be charged for you taking part in this study. All costs associated with the study will be paid by Alaska Bio Canines, a nonprofit organization. You will not be compensated for participation. Your willingness to participate is very much appreciated. We hope to see canines used as a secondary screening method within Alaska at some future point.
If you have any questions about this study, your rights as a research subject, to offer input or if you think you have experienced a research related injury, please contact Dolly Lefever, the PI, at (907) 223-9927 or by email at firstname.lastname@example.org. If you have concerns or complaints you do not want to discuss with the PI, you can call the IRB (Ethical and Independent Review Services (E&I) at 1-800-472-3241 or e-mail at email@example.com E&I is the IRB that reviewed this study.
Signature Block for Capable Adult
Your signature documents your permission to take part in this research. It is your alternative not to participate in this study. You do not give up your legal rights by signing this form. You will be given a copy of this signed form for your records.
Signature of subject Date
Printed name of subject
Signature of person obtaining consent Date
Printed name of person obtaining consent