Standard Language - Office of the Vice President for Research



UT IRB Standard Consent Document LanguageContents TOC \o "1-3" \h \z \u Standard Language PAGEREF _Toc529283736 \h 1Audio, Video, Image Release:2Certificate of Confidentiality PAGEREF _Toc529283738 \h PAGEREF _Toc529283739 \h 2Department of Justice Funding PAGEREF _Toc529283741 \h 2Exceptions to confidentiality: Harm to self or others and child/elder abuse. PAGEREF _Toc529283742 \h 3MRI Incidental Findings Procedures for the Imaging Research Center at UT Austin3Pregnancy while on study drug3UT Compensation above $600.00 PAGEREF _Toc529283744 \h 3Sample Language PAGEREF _Toc529283745 \h 3Allergic Reaction Risks PAGEREF _Toc529283746 \h 3Blood Draw Risks PAGEREF _Toc529283748 \h 4Blood Pressure & Heart Rate PAGEREF _Toc529283750 \h 4Bone Marrow Aspirate/Biopsy PAGEREF _Toc529283747 \h 4Computerized Tomography (CT) Scan4DNA4DXA Scan4Echocardiogram4EEG PAGEREF _Toc529283757 \h 5Electrocardiogram (ECG)5Magnetic Resonance Imaging (MRI) scan5PET Scan5X-Ray5Definitions6Standard LanguageAudio, Video, Image Release:The results of this study may be published or presented at a scientific meeting. The researchers will ask for separate written permission to include your [name, pictures, and/or recordings] or other information that could identify you.Certificate of ConfidentialityTo help us protect your privacy we have obtained [or insert: will apply for] a Certificate of Confidentiality from the National Institutes of Health. With this Certificate, the researchers cannot be forced to disclose information that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings. The researchers will use the certificate to resist any demands for information that would identify you, except as explained below. The certificate cannot be used to resist a demand for information from personnel of the United States Government that is used for auditing or evaluation of federally funded projects or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA). A Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, employer, or other person obtains your written consent to receive research information, then the researchers may not use the Certificate to withhold that information. A description of this study will be available on as required by U.S. Law. This web site will not include information that can identify you. At most, the web site will include a summary of the results. You can search this web site at any time.Department of Justice FundingPrivate, identifiable information will only be used for research and statistical purposes. However, if you indicate future criminal intent, the researchers are required by law to report this to authorities. [Any other intended disclosures for research purposes must be explicitly identified in the informed consent document including what will be disclosed, under what circumstances, and to whom].Project findings and reports prepared for dissemination will not contain information that can reasonably be expected to be identifiable. [If findings in a project cannot, by virtue or sample size or uniqueness of subject, be expected to totally conceal subject identity, this must be included in the informed consent.] [If the study is funded by the National Institute of Justice, insert:] At the end of the study, a copy of all the data (without any information that could identify you) will be submitted to the National Archive of Criminal Justice Data.Exceptions to confidentiality: Harm to self or others and child/elder abuse.Under certain situations, we may break confidentiality. If during the study, we learn about child or elder abuse or neglect, or that someone is a clear, serious, and direct harm to self or others, we may report the information to the appropriate authorities, including the police, the Texas Department of Family and Protective Services, and/or an emergency medical facility. MRI Incidental Findings Procedures for the Imaging Research Center at UT AustinDuring the MRI scans, there is a small chance that the researchers may see a problem that might be medically important. This is unlikely. If the researchers see a potential problem, they will send your images to the Imaging Research Center’s Medical Director and a qualified radiologist. If the radiologist sees anything that might be medically significant, the Medical Director will contact you by phone to discuss the findings. Our research team, including the radiologist and The University of Texas at Austin are not responsible for any medical exam or treatment. Since the scans themselves are not equivalent to a medical MRI, the images will not be shared with you or your physician.Pregnancy while on study drug[If any of the treatments or procedures have not been well studied in pregnant women, insert:] If you are or may become pregnant, [insert name of study treatment or procedure] might involve risks to the embryo or fetus that are currently unforeseeable.UT Compensation above $600.00Payment received as compensation for participation in research is considered taxable income to the research subject. If payment to an individual is equal to or exceeds $600 in any one calendar year, The University of Texas at Austin is required to report this information to the Internal Revenue Service (IRS). If the compensation you receive from participation in this research in combination with all other compensation received from The University of Texas at Austin is equal to or exceeds $600 in the current calendar year, you must provide IRS 1099 related information. Sample LanguageAllergic Reaction RisksOccasionally, people may have allergic reactions to medications that may require medical treatment. A severe allergic reaction could be life threatening. Examples of an allergic reaction can include: a rash, shortness of breath, wheezing, difficulty breathing, sudden drop in blood pressure, swelling around the mouth, throat, or eye, fast pulse, and sweating. If any of these reactions occur, you should get immediate help. When you are able, contact the study doctor if you have any of these or any other side effects during your participation in the study.Bone Marrow Aspirate/BiopsyBone marrow will be removed from [insert location, e.g., hip, breastbone]. Your study doctor will discuss this procedure with you in detail. You may have pain at the biopsy site that will require pain medication. You may experience bruising after the procedure is completed and you may experience soreness in the area afterwards. Bleeding and infection are rare side effects of bone marrow aspirate/biopsy. Blood Draw RisksBlood samples will be taken from a vein in your arm during the study. The taking of a blood sample may cause some discomfort and bruising, and there is a potential for infection. Other risks, although rare, include dizziness and fainting.Blood Pressure & Heart RateAn inflatable cuff will be placed on your arm and a machine will measure your blood pressure and heart rate, after you have been sitting down for 10 minutes. You may experience mild discomfort in your arm when the cuff is inflated. Computerized Tomography (CT) ScanA CT scan is an X-ray that is transmitted onto a computer that gives clearer pictures of the inside of your body. DNA Your genes are made up of DNA. DNA is short for deoxyribonucleic acid. A gene, or DNA, contains information that determines in part the traits such as eye color, height, or disease risk, that are passed on from parent to child. DXA ScanA DXA is a type of x-ray used to measure bone strength. During this test, x-ray pictures of your body will measure how much fat and muscle are present. You will lie flat on a table and a machine will take pictures of different areas of the body. This test will last about 15 minutes.Procedures such as CT scans, x-rays and/or radioactive drugs will be used during this research study to see how you are doing. The cumulative radiation exposure from these tests is considered small and is not likely to adversely affect you or your disease. However, the effects of radiation add up over a lifetime.? It is possible that having several of these tests may add to your risk of injury or disease. When deciding to enter this study, think about your past and future contact with radiation. Examples of contact with radiation include x-rays taken for any reason or radiation therapy for cancer treatment.Electrocardiogram (ECG)This is a painless test that shows how your heart works (takes a picture of the electrical activity of your heart). To have the ECG, you will lie on a bed/couch for several minutes and small sticky pads will be put on your chest, shoulders and hips. The machine will measure the electrical activity of your heart. We may need to clip small patches of your hair in these areas. These sticky pads may cause skin irritation and it may cause some discomfort when they are removed. EchocardiogramA gel will be spread on your chest, and then the transducer will be applied. You will feel a slight pressure on your chest from the transducer. You may be asked to breathe in a certain way or to roll over onto your left side. This test is not painful. Electroencephalogram EEGAn electroencephalogram (EEG) measures the electrical activity in the brain (brain waves) using electrodes (small metal discs or sensors) placed on the head with gel. The test does not hurt and usually takes about an hour. The gel used to put the discs on your head is sometimes sticky and the discs may scratch a little bit.Magnetic Resonance Imaging (MRI) scanAn MRI scan is an imaging procedure that uses a magnet and radio waves to take pictures of the inside of your body. An MRI scan is painless and will not expose you to radiation. A known risk is that the magnet could attract certain kinds of metal. Therefore, we will carefully ask you about metal within your body (this includes certain dyes found in tattoos). If there is any question about potentially hazardous metal within your body, you will be excluded from participation in this research study. We will also keep the examining room locked so that no one carrying metal objects can enter while you are in the scanner. During this test, you will lie in a small closed area inside a large magnetic tube. Some people are scared or anxious in small places (claustrophobic). The MRI scanner makes loud banging noises while taking a measurement, therefore, earplugs or specially designed headphones will be used to reduce the noise. The MRI scan will last about [insert amount of time].PET ScanPositron emission tomography (PET) scan is a test that uses radioactive glucose (sugar) and a computer to create images of how organs and tissues in the body are functioning. Abnormal cells in the body use glucose at a different rate than normal cells and this allows the scanner to create a detailed picture of how your body is working.Procedures such as CT scans, x-rays and/or radioactive drugs will be used during this research study to see how you are doing. The cumulative radiation exposure from these tests is considered small and is not likely to adversely affect you or your disease. However, the effects of radiation add up over a lifetime.? It is possible that having several of these tests may add to your risk of injury or disease. When deciding to enter this study, think about your past and future contact with radiation. Examples of contact with radiation include x-rays taken for any reason or radiation therapy for cancer treatment.X-RayProcedures such as CT scans, x-rays and/or radioactive drugs will be used during this research study to see how you are doing. The cumulative radiation exposure from these tests is considered small and is not likely to adversely affect you or your disease. However, the effects of radiation add up over a lifetime.? It is possible that having several of these tests may add to your risk of injury or disease. When deciding to enter this study, think about your past and future contact with radiation. Examples of contact with radiation include x-rays taken for any reason or radiation therapy for cancer treatment.You must not have an x-ray if you think you could be pregnant. DefinitionsDose: Increases in dose, frequency, or duration of administration, compared to labeled dosing regimens, can significantly increase the risk in a study using a marketed drug. It is also possible that a decrease in dose could significantly increase risk. For example, administering a sub-therapeutic dose of an antiviral drug to study subjects could induce resistance in the subjects, thus rendering a subsequent therapeutic dose of the drug ineffective in treating the virus. The significance of changes in dose (in particular, increases in dose) can vary across therapeutic areas. For example, the cancer treatment guidance provides some latitude for conducting studies of high-dose cancer treatments without an IND because oncologists are generally familiar with the implications of high-dose regimens. In other clinical settings, use of higher doses than are recommended in labeling may be much more likely to significantly increase the risk or decrease the acceptability of the risk. ()Patient Population: The acceptability of known and unknown risks can vary across different treatment populations (see § 312.2(b)(1)(iii)). The population chosen for study could be at increased risk compared to the approved use population for a variety of reasons, such as increased age, different disease or stage of disease, concomitant illness, decreased renal or hepatic function, or concomitant therapy. For example, a drug with significant toxicity can be approved for use in a population with a life threatening or severely debilitating disease because the risk of toxicity is acceptable in that population. Use of that drug in a clinical investigation in a population that is not so ill (e.g., to evaluate the drug for prevention of disease or symptomatic relief), however, would present a different risk-benefit situation in which the known risks might not be acceptable. When use of the drug in a specific patient population decreases the acceptability of the known risks, the study would have to be conducted under an IND as required under 21 CFR part 312. ()Route of Administration: A change in the route of administration can introduce a significant new risk. For example, there could be a significant increase in risk if a marketed drug for oral administration is converted to a dosage form that is to be administered by injection or intravenous, intrathecal, or inhalation route. These other routes of administration introduce concerns with increased local concentrations, sterility, pyrogenicity, hypersensitivity (e.g., airway reactivity), variations in metabolism, and other issues not present with oral administration that can significantly increase the risk, or decrease the acceptability of the risk, associated with use of the drug. () ................
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