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Contraceptive Measures for Females/Males
Contraceptive Measures for Males
Definition of DNA
Definition of RNA
Drug and Food Interactions
Expensive Treatment
Genetics/DNA Banking
HIV Testing
Reportable Communicable Diseases
Research Related Injury
MRI
CT-Scan
Bone Aspiration
Payments to Subjects Over $600
Peripheral Neuropathy
Sample Retention
Studies Involving Students and Employees
Radiation Risk
Redisclosure Statement
Risk Management - Durham Regional
Risks of Blood Drawing
Blood Product Transfusions
Liver Biopsy
Endoscopy
Sedation
Skin Biopsy
Mouse Antibody
Risks of General Anesthesia
Statement of Consent

Contraceptive Measures for Females/Males
(To Be Used If Women Of Childbearing Potential Are Eligible)
Being a part of this study while pregnant may expose the unborn child to significant risks, some of which may be currently unforeseeable. Therefore, pregnant women will be excluded from the study. If you are a woman of childbearing potential, a blood pregnancy test will be done (using 1 teaspoon of blood drawn from a vein by needle-stick), and it must be negative before you can continue in this study. If sexually active, you must agree to use appropriate contraceptive measures for the duration of the study and for (specify if applicable) months afterward. Medically acceptable contraceptives include: (1) surgical sterilization (such as a tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD). Contraceptive measures such as Plan B (TM), sold for emergency use after unprotected sex, are not acceptable methods for routine use. If you do become pregnant during this study or if you have unprotected sex, you must inform your study physician immediately.

Revised 2/4/2011


Contraceptive Measures for Males
Your participation in this research may damage your sperm, which could cause harm to a child that you may father while on this study. Such harm may be currently unforeseeable. If you are sexually active, you must agree to use a medically acceptable form of birth control in order to be in this study and for (specify if applicable) months afterward. Medically acceptable contraceptives include: (1) surgical sterilization (such as a vasectomy), or (2) a condom used with a spermicide. Contraceptive measures such as Plan B (TM), sold for emergency use after unprotected sex, are not acceptable methods for routine use. You should inform your partner of the potential for harm to an unborn child. She should know that if pregnancy occurs, you will need to report it to the study doctor, and she should promptly notify her doctor.
 
Revised 2/4/2011

Definition of DNA for Consent Forms
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.
 
 

Revised 10/19/10

Definitions of RNA and Protein for Consent Forms
RNA is made from DNA. RNA is short for ribonucleic acid. RNA is a genetic material that has a major role in making proteins. Proteins are the building blocks of your body, cells, and organs.
 
 
Revised 10/19/10

Drug and Food Interactions
(insert this risk statement if applicable to your study)

Drug and Food Interactions:
For your safety, you must tell the study doctor or nurse about all the prescribed medical foods and drugs, herbal products, over-the-counter (OTC) drugs, vitamins, natural remedies, and alcohol that you are taking before you start the study and before starting to take any of these products while you are on the study.

Revised 4/4/2012

Expensive Treatment
The expenses charged to you for being in this study could be unusually high. Therefore, we recommend that you discuss these costs with [insert PI’s name here] or your insurance company before agreeing to be in this study.

Approved 4/13/00


SPECIAL CONSIDERATIONS FOR GENETIC STUDIES & GENETICS/DNA BANKING LANGUAGE
Genetic research studies may present unique risks to human subjects and their relatives. These involve medical, psychosocial and economic risks, such as the possible loss of confidentiality, of insurability and employability, a change in immigration status, potential limits on education options, and social stigmas. Knowledge of one’s genetic make-up may also affect one’s knowledge of the disease risk status of family members.
 
In studies involving genetic testing, several questions need to be addressed, including:
 
  • Will the person’s test results be given to the person or placed in the person’s medical record?
  • Are tests for diagnostic purposes or for research only?
  • Are tests conducted by a Clinical Laboratory Improvement Amendments (CLIA) approved laboratory or a research laboratory?
  • Will disease risk be quantified, including the limits on certainty of the test results?
  • Will any change in a family relationship be disclosed, such as mistaken paternity?
  • Does the subject or family member have the option not to know the results? How will this decision be recorded?
  • Could other clinically relevant information be uncovered by the study? How will disclosure of this added information occur?
  • Do any limitations exist on the subject’s right to withdraw from the research, withdraw data, and/or withdraw genetic material?
  • Is the subject permitted to participate in the research study while refusing to have genetic testing (such as in a treatment study with a genetic testing component)?
  • Will genetic material be stored or shared? If shared, will the subject’s identity be known by the new recipient investigator?
  • Will the subject be contacted in the future by the investigator to obtain updated clinical information?
  • How can the subject opt out of any distribution or subsequent use of his/her genetic material?
 
 
The following Genetic Testing/DNA Banking information is provided as sample text to assist investigators in developing a readable consent form. Please incorporate all applicable sections, and if needed, please alter the text to reflect the details specified by your protocol (for example, if the subject may choose to agree to part of the study but refuse genetic testing or DNA banking, or if you plan to send materials to another investigator with subject identifiers as part of the study).
 
a. Participation in genetic studies: The genetic studies described are for research purposes only. Therefore, you will receive no results from these genetic studies (except as described below). It is not the purpose of these studies to look for or provide you with any medical information or diagnoses relating to your present condition or any other disease or illness. These studies are not being used as diagnostic tests for any disease or illness. Your participation in this research project is not a substitute for your regular medical care or check-ups.
 
b. Research Results: Through this research, we may find that you have an abnormal gene or gene product (RNA or protein) which indicates a risk for developing a disease at some time in the future. These results may also indirectly provide information about your entire family. Some people involved in genetic studies have felt anxious about the possibility of carrying an abnormal gene that places them at risk or that can be passed on to their children. If you have these feelings at any time during the study, you may contact the investigator(s) who will arrange for you to speak with a genetic counselor.
 
c. Incidental Findings: It is possible that this genetic study will identify information about you that was previously unknown, such as disease status or risk. There are no plans to provide this information to you or your physician unless the information indicates that you may be at risk for a disease known at the time of testing to potentially cause premature death if untreated. In that case, we will attempt to notify you using the contact information you have provided, so that you can speak with Dr. ____________ at Duke University Health System (DUHS). DUHS staff will not provide this information in a voice mail, email, or otherwise prior to contacting you. Please notify us of any change in your contact information.
If you do not want to be notified of any incidental findings, please place your initials by below.
_____ Please do not notify me of any incidental findings obtained from this research.
If you prefer, we can ask you at the time of notification whether or not you want to receive incidental findings information. In this case, please place your initials below.
_____ Please ask me at the time of notification whether or not I want to receive incidental findings information.
If at any time during or after the study you change your mind about whether or not you would like to be notified, you can contact us at ________________.
After providing the information to you, Dr. _________ may arrange for you to meet with him/her and/or a genetic counselor or refer you to another appropriate health care provider to review the incidental findings information with you or your physician.
 
Guidance for Incidental Findings: Based on the specifics of the protocol, broader reporting of incidental findings may be appropriate. For example, you may choose to notify the subject of any clinically relevant findings rather than just findings that relate to potentially life-threatening conditions.
 
d. Use and ownership of samples: By agreeing to participate in this research, you authorize DUHS and members of its staff to use your tissue, blood or other samples for the purposes described in this consent form. DUHS will maintain these samples indefinitely or until they are exhausted. These samples are unavailable for clinical (diagnostic) purposes. Therefore, if you need any future diagnostic testing, a new sample will be obtained from you. Tissue, blood, or other samples collected as part of this study may be valuable for scientific, research, or teaching purposes or for the development of a new medical product. DUHS and/or the developers will assert all rights of ownership in the samples and all rights arising from use of the samples. There is no plan to compensate you for any use of the samples.
 
e. Secondary uses of specimens: With your permission, your blood and/or tissue samples may be shared anonymously with other investigators for research purposes. The samples may be used for study of disorders unrelated to the one(s) in your family. Such research will be strictly anonymous, in that no identifying information that would link the samples to you is provided to the researcher. An ethics board will review any such research prior to access being given to your samples. This secondary use will in no way compromise the study of the disorder(s) in your family or the use of your samples as part of this study.
 
f. Availability/withdrawal of samples: You will not have access to the sample once it is obtained. Samples may be stored indefinitely. If you decide to withdraw your permission to use your samples in this research project, please contact the study doctor, _________, in writing and let [him/her] know you are withdrawing your permission for your samples to be stored and used for this or future research. [His/her] mailing address is (list address). At that time, we will ask you to indicate in writing if you want your unused samples destroyed or if your samples (with all identifying information removed that would link the sample to you) could be used in research. Data collected using your sample before your withdrawal will continue to be used as part of the study.
 
g. Right to New Information: We will tell you about new information that may affect your health, welfare, or willingness to stay in this study.
 
h. Potential Risks and the Genetic Information Non-Discrimination Act (GINA): There is a potential risk of loss of confidentiality. Every effort will be made to protect your confidential information, but this cannot be guaranteed. The genetic information obtained as a result of your participation in this research [will/will not] be included in your medical record. Information from which you may be personally identified will be maintained in a confidential, secure location at DUHS, accessible only by authorized members of the study team, and will not be disclosed to third parties except as described in this consent form, with your permission, or as may be required by law.
 
The Genetic Information Nondiscrimination Act (GINA) is a Federal law that will protect you in the following ways:
 
- Health insurance companies and group plans may not request genetic information from this research;
- Health insurance companies and group plans may not use your genetic information when making decisions regarding your eligibility or premiums;
- Employers with 15 or more employees may not use your genetic information when making a decision to hire, promote, or fire you or when setting the terms of your employment.
 
GINA does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance. GINA also does not protect you against discrimination based on an already-diagnosed genetic condition or disease.
 
 
i. Genome Wide Association Studies (GWAS): Genome-wide association studies (GWAS) look at the genetic differences between individuals that may be found in the human genome (the complete set of all human genes) to find out if there is a relationship between certain traits (such as blood pressure, or weight) and the presence or absence of a disease or condition.
 
As part of this study, we will be collecting genetic data about you, and these data will be sent to the National Institutes of Health (NIH) GWAS repository (a repository is a place where data are stored for use in future research). The data will not be labeled with any information that can be used to identify you. GWAS data may be shared with other researchers around the world. Researchers will have to get approval from an ethics board to use this information for research prior to getting access to the data.
 
Guidance for GWAS: Use of this language is appropriate whenever the study is being funded by a grant that requires such language, or you are applying for funding from an agency that requires such language and are seeking a declaration of concordance.
 
 
 
 
Revised 10/19/10

HIV Testing
As part of this protocol, you will be tested for HIV (human immunodeficiency virus, which is the virus that causes the acquired immunodeficiency syndrome [AIDS]). You will be notified of the results of the testing, and counseled as to the meaning of the results, whether they are positive or negative. If the test indicates that you are infected with HIV, you will receive additional counseling about the significance of your care and possible risks to other people. We are required to report all positive results to the North Carolina Division of Public Health. The test results will be kept confidential to the extent permissible under the law. If you do not want to be tested for HIV, then you should not agree to participate in this study.

 

Revised 9/17/10


Reportable Communicable Diseases
As part of this protocol, you will be tested for [name of infectious organism], which causes [describe what it causes]. You will be notified of the results of the testing, and counseled as to the meaning of the results, whether they are positive or negative. If the test indicates that you are infected with [name the organism}, you will receive additional counseling about the significance of your care and possible risks to other people. We are required to report all positive results to the North Carolina Division of Public Health. The test results will be kept confidential to the extent permissible under the law. If you do not want to be tested for [name of organism], then you should not agree to participate in this study.
 
 
 
 
 
 
 
(For additional information go to the website of Epidemiology in North Carolina.)
 
 
 

Revised 9/17/10


Research Related Injury
Standard Language for Studies NOT Commercial/Industry Sponsored:
Immediate necessary medical care is available at Duke University Medical Center in the event that you are injured as a result of your participation in this research study. However, there is no commitment by Duke University, Duke University Health System, Inc., or your Duke physicians to provide monetary compensation or free medical care to you in the event of a study-related injury.
For questions about the study or research-related injury, contact Dr. (insert PI's name here) at (insert PI's number here with area code) during regular business hours and at (insert PI's 24-hour number here with area code) after hours and on weekends and holidays.
 
For Commercial/Industry Sponsored Studies:
Following are three optional formats for the Research Related Injury section of the Informed Consent for use in Commercial/Industry Sponsored studies. This language is provided for general reference; the optional format selected must coincide with the terms and conditions of the Contract between Duke and the Sponsor. Before submitting the Informed Consent to the IRB, contact the Agreement Manager in OCRC to discuss the correct option to be used and any special contractual conditions that may apply to this section of the Consent. 

Option 1: When the Sponsor Provides for Payment for Research-Related Injury (not conditioned on first billing third party payers)

Immediate necessary medical care is available at Duke University Medical Center in the event that you are injured as a result of your participation in this research study. However, there is no commitment by Duke University, Duke University Health System, Inc., or your Duke physicians to provide monetary compensation or free medical care to you in the event of a study-related injury. The study sponsor,Company X, will reimburse you or the provider of services for the medical care you receive for your injuries provided all aspects of the study protocol have been followed correctly.

For questions about the study or research-related injury, contact Dr. (insert PI's name here) at (insert PI's number here with area code) during regular business hours and at (insert PI's 24-hour number here with area code) after hours and on weekends and holidays. 

Option 2: When the sponsor conditions its obligation to pay for Research-Related Injury on a primary effort to obtain payment from a third party payer

Immediate necessary medical care is available at Duke University Medical Center in the event that you are injured as a result of your participation in this research study. However, there is no commitment by Duke University, Duke University Health System, Inc., or your Duke physicians to provide monetary compensation or free medical care to you in the event of a study-related injury.

If you are a Medicare, Medicaid or Tricare patient or you have no health insurance, and you are injured as a result of your participation in this research study, the study sponsor, Company X, will reimburse you or the provider of services for the medical care you receive for your injuries provided all aspects of the study protocol have been followed correctly. Medicare, Medicaid or Tricare will not be billed for these injuries.

If you have commercial (private) insurance, and you are injured as a result of your participation in this research study, your insurance provider will be billed for medical care you receive for these injuries. For any such costs that are not covered by your insurance provider, the study sponsor, Company X, will reimburse you or the provider of services for the medical care you receive for your injuries provided all aspects of the study protocol have been followed correctly.

 For questions about the study or research-related injury, contact Dr. (insert PI's name here) at(insert PI's number here with area code) during regular business hours and at (insert PI's 24-hour number here with area code) after hours and on weekends and holidays. 

Option 3: When the sponsor makes no provision for payment for research-related injury (our standard paragraphs with addition of “the study sponsor, Company X”)

Immediate necessary medical care is available at Duke University Medical Center in the event that you are injured as a result of your participation in this research study. However, there is no commitment by Duke University, Duke University Health System, Inc., your Duke physicians or the study sponsor, Company X, to provide monetary compensation or free medical care to you in the event of a study-related injury.

For questions about the study or research-related injury, contact Dr. (insert PI's name here) at(insert PI's number here with area code) during regular business hours and at (insert PI's 24-hour number here with area code) after hours and on weekends and holidays.

Revised: 05/26/08


Standard Language for Risks from MRI
Magnetic resonance imaging (MRI) uses a magnet and radio waves to make diagnostic medical images of the body. There have been no ill effects reported from exposure to the magnetism or radio waves used in this test. However, it is possible that harmful effects could be recognized in the future. 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.

The study involves entering a large room in which a magnet is present. You will be placed on a narrow bed and then slid into a small tunnel approximately 6 feet in length and 25 inches in diameter. You will be asked to lie still for about one hour on this bed. You will hear a loud machine-like noise. You may be asked to have a harmless monitoring device applied during the study. During the study, you can have voice contact and physical contact with someone in attendance if you desire.


Standard Language for Risks from CT-Scan

Computed Tomography (CT) is a way to make x-ray images of the inside of the body. The CT scanner is a doughnut-shaped machine that uses x-rays to create computer pictures that show structures inside your body more clearly than regular x-ray pictures. During the procedure, a technologist will take you into the CT scan room where you will lie down on the patient table (usually on your back) inside of the CT machine. You should get comfortable because it is very important that you not move during certain parts of the test.

CT examinations differ depending on the part of your body being studied. For example, if your abdomen is being studied, a series of pictures will be taken from your lower chest to your lower pelvis. During the study, you will be asked to hold your breath so that the pictures will not be blurred. The machine will make some noise, and the table will move during the scan. Also, you may receive signals from the technologist or from the machine about your breathing. Before or during the study, you may be given an injection of a contrast liquid in your vein to allow the radiologist to obtain clearer images of your organs. If you have any discomfort during the test or after the injection, be sure to tell the technologist.


Standard Language for Risks from Bone Aspiration

A bone marrow aspiration is a procedure in which an area of the hip (either one hip or both hips) is numbed and a small sample of bone marrow is withdrawn. When the local anesthesia (numbing medication) is given, you may initially feel a burning sensation in your skin and bone surface for several seconds. During the procedure, you may temporarily feel pressure and/or pain of varying degrees. If necessary, you may ask your physician for additional local anesthesia or a medication to ease your stress. You also may experience bleeding, and/or bruising after the procedure is completed and you may experience soreness in the area for a few days afterwards. Rarely, infection can develop.


Payments to Subjects Over $600

Payment received as compensation for participation in research is considered taxable income to the research subject. If payment to an individual exceeds $600 in any one calendar year, Duke University is required to report this information to the Internal Revenue Service (IRS). Research subject payments to a non-employee of Duke University exceeding $600 during any calendar year will result in a 1099 (Miscellaneous Income) form being issued to the individual and a copy sent to the IRS.


Standard Language for Risks from Peripheral Neuropathy

Peripheral neuropathy is damage to the peripheral nerves which are a large communications network that carries information from the brain and spinal cord to every other part of the body. This can cause weakness, numbness, abnormal sensations such as prickling, tickling, burning, or tingling and pain in the arms, hands, legs, and/or feet.


Standard Language for Retention of Samples

Your sample(s) will be kept and stored at _______ by_______. Maintaining confidentiality is important to ______ (sponsor). All samples will be kept and stored in a secure place. Your sample will be identified by a unique barcode, which means that your name will not be on the sample. However, this barcode can be linked to your unique study identification number, age, gender, ethnic background. Besides protecting your confidentiality this barcode system will allow the sponsor to destroy your sample in case you change your mind. Your sample will be kept for ____ years. After that time, the sample will be destroyed by methods in accordance with laboratory or institution procedures.


Standard Language for Studies Involving Students and Employees

(Insert after withdrawal language) Nonparticipation or withdrawal from this study will not affect your job status if you are a Duke employee and will not affect your grades if you are a Duke student.


Radiation Risk Language
Please refer to the Radiation Safety Committee Website:

www.safety.duke.edu/radsafety/consents/default.asp

There you can find pre-computed "canned" statements for popular studies, or you can try out the on-line "Radiation Risk Computer". The "computer" is useful for creating customized statements when multiple diagnostic procedures are involved.


Redisclosure Statement

For sponsor generated studies - The sponsor may share data:
This information may be further disclosed by the sponsor of this study, [Sponsor Name]. If disclosed by the sponsor, the information is no longer covered by the federal privacy regulations.

For PI funded studies:
If this information is disclosed to outside reviewers for audit purposes, it may be further disclosed by them and may not be covered by the federal privacy regulations.


Risk Management-Durham Regional

For questions regarding your rights as a subject in research you may call the Durham Regional Hospital Risk Management Office at (919) 470-8531.

Risks of Blood Drawing
Venipuncture – Taking blood from a vein in your arm by needle stick

Risks associated with drawing blood from your arm include momentary discomfort and/or bruising. Infection, excess bleeding, clotting, or fainting are also possible, although unlikely.

Revised 1/10/01


Standard Language for Risks from Blood Product Transfusions

As part of your medical treatment, you may need to receive transfusions of blood products. These products come from healthy volunteers from the general population who choose to donate blood for the use of patients. Blood donors and blood products are carefully screened and tested to minimize the risk of transmitting any infectious disease or problems, but it is impossible to eliminate all risks. However, not receiving a transfusion when needed can carry a great risk of serious injury or death.

If your treatment schedule and general health allow, you may arrange for friends or family members to donate blood for you, but, since many products must be matched to your own blood type to be used, blood donated by relatives/friends may not be suitable for your use. Therefore, receiving blood products from Duke Hospital Transfusion Service may be best for you. Alternatives to transfusion such as hemoglobin substitutes are not in general use at this time.

Standard Language for Risks from Liver Biopsy

For patients undergoing liver biopsy, there may be increased risk in certain circumstances. When doctors perform your liver biopsy, they do so by passing a needle into the liver usually through your side. Doctors are usually able to get a large enough piece of liver to examine under the microscope by taking a single biopsy of the liver. However, in some patients, only a small piece is retrieved (not enough to look at under the microscope) and in this case, a second specimen from the liver is taken for clinical diagnosis. However, after the first attempt, if there is enough for clinical purposes, but not for research purposes, a second piece will be taken for research purposes. Thus, by participating in this study, in a small fraction of patients undergoing liver biopsy (less than 5% of all patients), there will be a chance that a second piece of liver will be taken for research purposes. The additional risk of an additional liver sampling is approximately 1 in 1,000 for increased bleeding, and 1 in 2,000 for other complications such as puncture of a lung or colon. These complications are managed by observation and, in some circumstances, surgery.

Standard Language for Risks from Associated with Endoscopy
Risks associated with endoscopy include aspiration (choking and/or gagging), sore throat, bleeding, and infection. Major complications occur in a small number of people who have endoscopy. The endoscope could puncture or pierce the intestines (less than 1 in 1,000 chances). This could require additional treatment or surgery.


Standard Language for Risks from Sedation
The risks of sedation include an allergic reaction, aspiration (fluid going into the lungs), and over-sedation. In addition, the IV used may cause a bruise. Occasionally, an infection develops at the IV site.


Standard Language for Risks from Skin Biopsy
Skin biopsy is generally a non-hazardous procedure; however, possible hazards may include: 1) reaction to anesthetic (numbing medicine), 2) excessive bleeding, 3) bruising, 4) infection and 5) excessive scarring. While the local numbing medicine xylocaine is almost entirely free from allergic properties (such as causing hives), an allergic reaction is possible, and you will not be given xylocaine if you have a history of such a reaction. The xylocaine will be given by a small injection into the skin at the site of the skin biopsy. To speed healing, one or two stitches (also known as sutures) will be placed, which will be removed 5 - 7 days later. During the healing process, you will be asked to keep the biopsy site clean and dry, and to apply antibiotic ointment. Infection rarely occurs and is largely prevented by the use of an aseptic (or sterile) biopsy technique and proper wound care. If infection does occur, you will be instructed to keep the wound clean and to apply warm, wet compresses for 15 minutes, three times a day, until the infection subsides. If the infection persists, antibiotics may be prescribed.
Only 10-15 minutes will be required for the biopsy procedure. After the anesthesia wears off, there will be some soreness at the biopsy site that will last for a few hours. A small scar will develop at the site of the biopsy.


Standard Language for Risks from Mouse Antibody
This drug is a protein made from mouse cells. There is the possibility that persons who participate in this research will develop antibodies to mouse proteins. If antibodies are formed, they may reduce the effectiveness of medicines developed from mouse proteins, though this is unlikely to occur. The antibodies may also interfere with certain laboratory tests. Medicines that contain mouse proteins are used to treat diseases such as rheumatoid arthritis, Crohn's disease, and cancer. This means that there is a very small possibility that you may not be able to receive other medicines in the future that contain mouse proteins or that the effectiveness of the medicines may be diminished. You should tell your doctors in the future that you have received a drug that contains mouse proteins.


Risks of General Anesthesia
Risks of general anesthesia include nausea, vomiting, blood vessel injury, nerve injury, lung injury, heart attack, allergy to drugs, brain damage, and death.
Approved 6/8/00


Statement of Consent
"The purpose of this study, procedures to be followed, risks and benefits have been explained to me. (Or for studies involving children over age 6 – to my child and me.) I have been allowed to ask questions, and my questions have been answered to my satisfaction. I have been told whom to contact if I have questions, to discuss problems, concerns, or suggestions related to the research, or to obtain information or offer input about the research. I have read this consent form and agree to be in this study, with the understanding that I may withdraw at any time. (Or for studies involving children – I have read this consent form and agree for my child to be in this study, with the understanding that I may withdraw my child at any time. [For studies involving children over age 6 – We have discussed the study with my child, who agrees to be in the study.]) I have been told that I will be given a signed and dated copy of this consent form."
 


For Studies Involving Gadolinium-Based Contrast Material
For Adults:
 
A rare but serious adverse reaction has been observed in patients that received a gadolinium-based contrast material during MRI examinations, a reaction called nephrogenic systemic fibrosis (NSF). Patients with kidney disease are at increased risk of developing NSF. NSF may cause skin thickening, joint pain and/or swelling. In rare cases NSF can lead to lung and heart problems and cause death. To minimize the likelihood that you will be affected, you will have a blood test to measure your kidney function. If your blood test is abnormal, you will not be permitted to receive gadolinium.
 
For Children:
 
A rare but serious adverse reaction has been observed in patients that received a gadolinium-based contrast material during MRI examinations, a reaction called nephrogenic systemic fibrosis (NSF). Patients with kidney disease are at increased risk of developing NSF. NSF may cause skin thickening, joint pain and/or swelling. In rare cases NSF can lead to lung and heart problems and cause death. To minimize the likelihood that your child will be affected, your child will be evaluated by the Pediatric Radiologist to ensure that your child meets Duke Pediatric Radiology standards to receive gadolinium. If your child does not meet those standards, gadolinium will not be used.
 


If Subject Regains Decision-Making Ability (For the LAR Consent Form)
If, during the course of the study, the subject regains the ability to make decisions he/she will be asked to read this consent form and decide whether to continue participation.


LAR Language When There Is No Prospect of Direct Therapeutic Benefit to Participant
(For the LAR Consent Form)
"I am the representative of the subject and am acting on behalf of the subject. I am not aware
of any factor that might create a conflicting interest for me in this role (for example, something
that might bring me personal benefit). I consent to the subject's participation in this study."


Conflict of Interest Disclosure
Use this standard language below when the PI has a conflict of interest management plan for corporate relationships such as speaking, consulting, advisory board, etc. This statement can be modified as appropriate to accurately reflect the investigator's conflict of interest (such as equity, stock, or ownership in a company). If another member of key personnel has a conflict of interest management plan, this statement should also be appropriately revised to reflect that conflict of interest:
 
 
"Dr. _________ has received personal compensation from the sponsor of this study in the past for his/her work on ____________________ and may receive personal compensation from the sponsor in the future."
 
 
Standard language for when the PI is the inventor of the technology being used in the study:
 
 
"Dr. ___________ [and other study team members] has/have developed the technology that is being used in the study. If the technology is commercially successful in the future, the developers and Duke University may benefit financially."

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