Appendix A
CONSENT TO PARTICIPATE
An investigation by the Centers for Disease Control and Prevention to determine the risk of food allergic reactions from corn products containing Cry9C.
The Centers for Disease Control and Prevention is conducting an investigation to gather information from people who reported adverse health events after eating corn products containing the genetically engineered protein, Cry9C. Since you reported an adverse event, we would like you to be part of this investigation. Your participation is completely voluntary. Refusing to participate is your right and there is no penalty for doing so. The choice is yours. Before you decide, you should know what is involved and have all your questions answered.
Purpose
We will interview and collect blood samples from as many of the people who reported adverse reactions as possible. The combined results of the interviews and blood tests will help us better understand whether or not corn products containing Cry9C protein can potentially cause food allergic reactions and what the risk to individuals might be.
What will it involve?
If you agree, we will take a blood sample right now. It should take about 5-10 minutes. We will take the sample (1 or 2 teaspoons) from a vein in your arm. We will label your blood sample with a unique identification number instead of using your name or other personal information.
A new blood test is being considered for development to detect antibodies against the genetically engineered protein Cry9C. Because of the need to quickly gather information from individuals who reported adverse reactions to corn products containing Cry9C, we are asking questions and collecting blood samples now, even though the blood test is not yet available. If the blood test is not available for use by 31 March 2001 all blood samples will be destroyed, including yours.
If the test is developed, your blood will be tested only for the presence of Cry9C antibodies; it will absolutely not be tested for anything else at any time (such as HIV testing, genetic testing, or drug testing). After the Cry9C antibody testing is complete, any left-over blood will be destroyed.
Cost
There is no cost to you.
Benefits
The goal of this investigation is to help answer the question of whether or not corn products containing the genetically engineered protein Cry9C can potentially cause allergic reactions when eaten by people. The information may help determine if this product is safe for use in human foods and this may indirectly benefit you. Also, if the blood test is developed, we will notify you of your test results if you desire to know.
Risks
The only risk is that you may have some mild, brief discomfort when we take blood from your arm. A small bruise may also appear. The individual who will take your blood is trained and experienced and will do everything possible to minimize your discomfort.
Confidentiality
We will keep your test results and what you tell us confidential to the extent allowed by law. We will notify you of your blood test result if you wish to know, and a summary of all the test results will be given to the U.S. Food and Drug Administration. We will not tell anyone else what your test result is.
To protect your privacy, we will not put your name on the questionnaire or blood sample but will use a unique identification number instead. We will also keep all the investigation records and blood sample results in locked files and only investigation staff will be allowed to look at them. When we talk or write about the investigation, we will not include your name or other facts that might identify you.
We are putting your name, telephone number, and address on this consent form now so that we can notify you of your test results and to document your willingness to participate. We will keep this consent form in a locked file separate from the questionnaires and blood test results.
For more information
We will give you a copy of this form to keep. We would be happy to answer any questions about the study or a problem or injury related to the investigation. You may contact the principal investigators, Dr Brad Winterton and Dr Dori Reissman, at the Centers for Disease Control and Prevention at 404-639-2530. If you have any questions now or in the future about your rights as a participant in this investigation, you may contact the CDC Deputy Associate Director for Science at 800-447-4784, mailbox number 329-4518. Leave a message with your name and number and someone will call you back.
Voluntary participation
It is your choice whether or not to participate in this investigation. There is no penalty if you choose not to participate.
Download [PDF, 23 Kb] and print the consent form.
