Template Language
Consent for Genetic Research
The following template language should be attached behind the signature page of the primary study consent form and be included in the consecutively numbered pages of the consent (i.e., primary consent page 1 of 5, 2 of 5, 3 of 5, genetic screening rider pages 4 of 5 and 5 of 5).
If the study is primarily designed for genetic testing, this template language should be included in the primary consent form rather than be presented as a rider.
The purpose of this study is to look at genes (DNA) and how they affect health and disease. Genes are the instruction manual for your body. The genes you get from your parents decide what you look like and how your body behaves. They can also tell us a person’s risk for certain diseases and how they will respond to treatment.
You are being asked to give a [Insert type of sample, e.g. blood, urine, etc.] for genetic research. What we learn about you from this sample will not be put in your health record. [If applicable insert: Your test results will not be shared with you or your doctor.] No one else (like a relative, boss, or insurance company) will be given your test results. Your sample will only be used for research at Meharry Medical College and will not be sold.
A single [blood sample of X teaspoons or tablespoons will be drawn from a vein in your arm using a needle; cheek swab sample will be obtained by(indicate method); urine sample will be obtained by (indicate method); extra biopsy tissue will be obtained by (indicate method); or other (indicate what) sample will be obtained by (indicate method).] This will take about X minutes/hour of your time.
If applicable insert:
Blood samples – You may feel bothered or pained from the needle stick. You may have a bruise or the site may get infected. It is rare, but some people faint.
Otherwise insert all risks, inconveniences or discomforts associated with specific type of sample collection
One risk of giving samples for this research may be the release of your name that could link you to the stored samples and/or the results of the tests run on your samples. This may cause problems with insurance or getting a job. To prevent this, these samples will be given a code. Only the study staff will know the code. The name that belongs to the code will be kept in a locked file or in a computer with a password. Only (investigator’s name and/or other’s names) will have access to your name.
Your sample will be used to make DNA that will be kept for an unknown length of time (maybe years) for future research. The sample will be destroyed when it is no longer needed.
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Commercialization Language Options - Insert one of the following::
Alternative Language #1:
Your samples may be used to make new products, tests or findings. These may have value and may be developed and owned by the study staff, Meharry Medical College, and/or others. If this happens, there are no plans to provide money to you.
Alternative Language #2:
Your samples will be used for research only and will not be sold or used to make products that could be sold for money.
Insert the following statement if TRUE:
Your samples and information about you may be shared with others to use for research. To protect your privacy, we will not release your name.
You will not receive any benefit as a result of the tests done on your samples. These tests may help us learn more about the causes, risks, treatments, or how to prevent this and other health problems.
Insert if genetic portion is optional
Giving samples for research is your free choice and you may be in the study even if you do not want your samples used or stored for gene research.
At any time, you may ask to have your sample destroyed. You should contact PI Name or study staff at insert address/phone number to have your sample destroyed and no longer used for research. We will not be able to destroy research data that has already been gathered using your sample. Also, if your identity was removed from the samples, we will not be able to locate and destroy them.
There will be no costs to you for any of the tests done on your samples. [Insert if applicable: You will not be paid for the use of your samples.]
Please check Yes or No to the questions below:
My blood/tissue sample may be used for gene research.
My blood/tissue sample may be stored/shared for future gene research
in ______.
My blood/tissue sample may be stored/shared for future gene research for other health problems (such as cancer, heart disease, etc).
Signature:___________________________________ Date:___________
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Pregnancy Language for Female and Male Adults
The following paragraph should be included in consent forms if there is a risk to either the mother or fetus sufficient to exclude pregnant women from participation and avoid pregnancy or fathering a child during the course of the study.
This treatment may hurt an unborn child. If you take part in this study, you and any person you have sex with must use approved birth control such as birth control pills, birth control shots, IUD, diaphragm, or condoms while you are in this study. If you become pregnant or father a child while you are in this study, you must tell your doctor at once. Also, women must not breast feed while in this study. If you are a woman and are able to become pregnant, you will have a (insert the appropriate measurement: blood or urine) test to make sure that you are not pregnant before you receive treatment in this study.
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Privacy and Confidentiality Information Template Language
For Minor
You are required to list the FDA as a governmental authority in the template language if your study includes investigational drugs or devices.
Note: HIPAA does not require authorization for use or disclosure of Protected Health Information in the minor’s Informed Consent Document.
Privacy: Older Child (13-17):
All efforts, within reason, will be made to keep the data in your research record private but we cannot promise total privacy. The data we collect on you may be shared with others (for example, [insert example]) if you or someone else is in danger or if we have to do so by law.
Privacy: Younger Child (7-12):
What you tell me will not be shared with (your school/your parents) unless you or someone else is in danger.
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Study Withdrawal: to be inserted into section 11
This language is optional for therapeutic trials:
If you decide to stop being part of the study, you should tell your study doctor. Deciding to not be part of the study will not change your regular medical care in anyway.
This language is optional for non-therapeutic trials:
If you decide to stop being part of the study, you should tell your study doctor.
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Reimbursement > $600 for Research Participation
This language should be included in all research consents that involves a reimbursement of $600 or greater.
You may receive up to (insert dollar amount or compensation) for taking part in this study. This amount may be taxable and will be reported to the Internal Revenue Service (IRS).
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HIV Testing
You will be tested for HIV (AIDS virus) during this study. If test results show that you have the virus that causes AIDS, the study staff will tell you the results and refer you to the health department to confirm the test results and give you someone to talk to about this disease. We will talk with you before and after testing, and your test result will be given to you only in person. You should know that the study staff must give your name to the Tennessee Department of Health if you test positive because this is the law. If others find out you have this virus, it may cause mental stress, unfair treatment from other people, problems with being able to get insurance or find a job, or other unknown problems. It is important to seek medical care if you have HIV.
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Expected Cost Exposure for Cancer Trials
There is no cost to you for the study drug(s), (insert drug name). But, you or your insurance company will be paying for any added costs to give this study drug, such as IV tubing, costs to prepare the drugs, clinic costs, and maybe other costs. All bills for standard of care tests (things you would have done even if you were not taking part in this study) will be billed to you or your insurance company. You will be billed for all co-payments or costs that your insurance company does not pay for. You have the right to ask what it will cost you to take part in this study. You may wish to contact your insurance company to discuss the costs further before choosing to be in the study as there may be added costs that you will be billed for if you agree to be in the study. Some insurance companies may not pay for standard medical care done in a research study. You may choose not to be in this study if your insurance does not pay for the costs and your doctor will discuss other treatment plans with you.
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