Suggested Consent Language

Blood Draw. You will have (amount) of blood taken (number of times drawn, and frequency). The blood will be taken from (name the location, i.e., arm). The total amount of blood taken for the whole study will be (amount in teaspoons or tablespoons).

Risks from Blood Draw. The risks of taking blood include pain, a bruise at the point where the blood is taken, redness and swelling of the vein and infection, and a rare risk of fainting.

Bone Marrow Biopsy. A small piece of bone with bone marrow (the soft, sponge-like tissue in the center of most bones) will be taken from the ___ (name the location of the biopsy). First you will be given anesthetic to numb the area and reduce the pain. Then a special wide needle will be pushed into the center of the bone and twisted to remove the sample of bone with the bone marrow inside it.

Bone Marrow Aspiration and Biopsy. A small piece of bone with bone marrow (the soft, sponge-like tissue in the center of most bones) and liquid bone marrow will be taken from the ____ (name the location of the aspirate and biopsy). First you will be given anesthetic to numb the area and reduce the pain. Then a special wide needle with a syringe attached will be pushed into the center of the bone. A sample of the liquid bone marrow will be removed with the syringe and then the needle will be twisted to remove the sample of bone with the bone marrow inside it.

Risks from Bone Marrow Biopsy (and/or Bone Marrow Aspiration). This procedure may be very painful; however, the pain only lasts for about 15 to 30 seconds. The ____ (bone) area may be sore for a day or two. It is possible, but not likely that you could get an infection or have a large amount of bleeding. In very rare cases, people might have an allergic reaction to the numbing medicine. The allergic reaction could include rash/hive, flushing of the face, itching, wheezing and tightness in the throat.

Bone Scan. During a bone scan the doctor will inject (through an IV in your vein) radioactive substance. A short time later, a machine measures how much radiation has been taken into the bones. The test does not hurt but you may have to stay in a certain position to get a good picture.

Risks from Bone Scan. This test uses a small amount of radiation. The total amount of radiation you receive is equal to _______ mrem.   The contact with radiation in this study is thought to be small. 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.

Caliper Test. A tool called a caliper (like a pincher) grasps a small fold of flesh on the back of the arm, shoulder blade, or waist to measure the amount of body fat.

Risks from Caliper Test. There might be a little pain or discomfort from a pinch.

CT Scan. A CT scan — also called CT or computerized tomography — is an X-ray procedure where a high-speed computer is used to make multiple images or pictures of your body. You will be asked to lie still on a table and at time may have to hold your breath for a few seconds in order to avoid blurring the pictures. You may hear a slight buzzing, clicking and/or whirring sounds as the CT scanner moves around your body.  You will receive information on how to get ready for this procedure.

CT Scan With Contrast. [Including applicable text from CT Scan] You will also be given a contrast dye (describe how the contrast agent is administered) to create a clearer picture.

Risks from CT Scan. 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.

Risk of IV Contrast Agent. If an intravenous contrast material is used, you will feel a slight pin prick when the needle is inserted into your vein. You may have a warm, flushed sensation during the injection of the contrast materials and a metallic taste in your mouth that lasts for a few minutes. Occasionally, a patient will develop itching and hives, which can be relieved with medication. If you become light-headed or experience difficulty breathing, you should notify the technologist or nurse, as it may indicate a more severe allergic reaction.

Risks of Oral/Enema Contrast Agent. If the contrast material is swallowed, you may find the taste mildly unpleasant; however, most patients can easily tolerate it. You can expect to experience a sense of abdominal fullness and an increasing need to expel the liquid if your contrast material is given by enema. Usually, this feeling does not last long.

DEXA Scan. A DEXA 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.

Risks from DEXA scan. 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.

EEG. An 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.

Risks from EEG. The gel used to put the discs on your head is sometimes sticky and the discs may scratch a little bit.

EKG. An electrocardiogram (EKG) is a test that gives us a measure of the heart’s electrical activity. You will be asked to lie flat on a table and several small electrode pads (like stickers) will be placed on the body. This test takes about 10 minutes.

Risks from EKG. The test may cause some redness or itching where the pads are placed.

Genetic Research. Researchers want to learn about the role of genes (or inherited traits) in health and disease. Genetic research may discover genes, find out how genes work, or help researchers learn how to use what we know about genes to treat or prevent disease.

Risks from Genetic Research. Disease testing and genetic research may produce results about your medical condition.  One question for you to consider is whether you should know the results of the testing and research.  Knowing the results has risks.  The results may cause you anxiety and other psychological distress.  Also, if you tell the results to your doctor, they may become part of your medical record.  If released, the information could lead to health or life insurance discrimination, job or social discrimination.  Knowing the results could also affect your future relationships with family members

If applicable add: Because your family members are also part of this study, there is a risk that the results may show that some are your family members are not genetic relatives.  There is also a risk that other family members may learn private genetic information about you.)  Not knowing results also has risks.  It could mean that you will not have enough information regarding the need for treatment or the availability of a cure for a particular disease.

HIV Test. For this research study, you will be tested for HIV. HIV is the term used for the virus that produces HIV infection and may ultimately lead to AIDS. Your blood will be taken to test for HIV. The study doctor must follow the Illinois AIDS Confidentiality Act (An Illinois law that sets up how HIV testing must be done and protects the confidentiality of information about someone’s HIV status.)

You must be told that you are being tested for HIV and give consent. By signing this consent form and agreeing to be in this research, you are agreeing to the HIV testing.

The test involves taking _____ml (teaspoons) of your blood.

You have a right to know the results of the test.  If you test positive you will be given more tests to confirm the results of the first test.  If you are HIV positive, the study doctor will also give you a list of referrals for further information and counseling.

Risks from HIV Testing. There is the risk that you may find out that you are HIV positive. These results may be emotionally upsetting and may cause you psychological distress.

Confidentiality and Privacy Rights. The study doctor must report positive HIV tests to the Illinois Department of Public Health (IDPH). The IDPH keeps track of all persons in the state with positive HIV tests. The database that keeps track of this information is coded so that your name does not appear with your HIV status. You are given a unique identification number. This helps keep your name private.

Suggested language (select whichever is appropriate):

• Some of the questions asked may be upsetting, or you may feel uncomfortable answering them.  If you do not wish to answer a question, you may skip it and go to the next question.
• Some of the questions asked may make you angry, emotionally upset or stressed out now or at a later time.  If this occurs, you can contact the following person for help (insert appropriate person’s name and contact information).  If you do not wish to answer a question, you may skip it and go to the next question.
• There could be a risk of discomfort and harm (to psyche, reputation, employability, insurability, social status, criminal or civil liability) that may occur as a result of participation.  If you do not wish to answer a question, you may skip it and go to the next question.
• If the study staff finds evidence that suggests that you have been physically or sexually abused, they are required by law to report this to local law authorities.
• If the study staff finds evidence of child abuse or neglect, they are required by law to report this to local law authorities.
• We will not ask you about child abuse, but if you tell the interviewer about child abuse they are required by law to report your name to the state authorities
• The study staff may be required by law to report to appropriate NU authorities any information you provide that indicates sexual misconduct, including sexual assault, sexual exploitation, dating violence, domestic violence, stalking, and sexual harassment.  Therefore, we cannot promise you complete confidentiality of any information you share about experiences of sexual misconduct.

• In this study, you will be asked about (illegal activities, sensitive information) (specify these). We will keep information about you as confidential as possible, but complete confidentiality cannot be guaranteed. On rare occasions, courts have subpoenaed (required release) research records.

If a Certificate of Confidentiality will be obtained, use the following language:

• In this study, you will be asked about illegal activities or highly personal behavior.  The principal investigator has a Certificate of Confidentiality from the federal government.  Your study records cannot be subpoenaed (released to courts at their request), and we will only release your study records if you ask us in writing.

Certificate of Confidentiality. A Certificate of Confidentiality helps protect the privacy of human research participants enrolled in biomedical, behavioral, and other forms of sensitive research. Certificates protect against compulsory legal demands, such as court orders and subpoenas, for identifying information or identifying characteristics of a research participant. For additional information about Certificates of Confidentiality see https://grants.nih.gov/policy/humansubjects/coc.htm 

For scientific reasons, this consent form does not include complete information about the  research questions or topics being tested. You will be fully debriefed following your participation in the research.

OR

We cannot tell you every detail of this study ahead of time, but if you are willing to participate under these conditions, we will explain the procedure to you fully after your participation.

1. Your health information we may collect and use for this research includes:
   Mental health information
2. Delete “Unless you revoke your consent, it will not expire” and replace with:
   This consent expires on _______. After this date, Northwestern University may not gather new information about you, use or disclose your personal health information collected in this study for any purpose other than the research study described in this consent unless it obtains permission to do so from you

MRI. This study uses (functional, spectroscopic, structural, vascular — describe the type of MRI that will be done) magnetic resonance imaging (MRI) to look at the (name the area of the body that will be examined—e.g. brain, liver, shoulder). (Name the type of MRI again) magnetic resonance imaging is a type of scan that uses magnetic fields and radio waves to make a picture of the (name the area of the body) (include a description of what you are looking for such as function, chemicals, anatomy, or blood flow).

fMRI. This study uses functional magnetic resonance imaging (MRI) to look at the brain. Functional magnetic resonance imaging is a type of brain scan that uses magnetic fields and radio waves to make an image of changes in blood flow in your brain while you do certain tasks.

In order to make sure the MRI procedure will be safe, you will be asked to fill out a screening form before starting the study. It is important that you tell the researchers in this study if you have any history of:

• Metal fragments in your eyes or face.
• Implantation of any electronic devices such as (but not limited to) cardiac pacemakers, cardiac defibrillators, cochlea implants or nerve stimulators.
• Surgery on the blood vessels of your brain or the valves of the heart
• Claustrophobia (fear of enclosed places)
• Body piercing or tattoos

You will be given instructions outside the MRI scanner about the scanning. Next you will be asked to lie still on the MRI patient table and your head will be placed in a specially-designed head holder. Your head will be cushioned by a firm foam pillow. The table will then slide into the enclosed space of the MRI scanner. Some people feel tired, uncomfortable or claustrophobic (afraid of small spaces) in the MRI scanner. The MRI scanning session will take (put in length of time) minutes to complete once you are in the scanner. (Note: if more than one session will be needed be sure this is stated—e.g., two sessions in the scanner for 20 minutes each.)

The information from the MRI scanner is only useful if you are able to complete the whole imaging session, and hold your head very still the whole time. Therefore you will be encouraged to hold as still as possible, and to let the investigators know if you are uncomfortable in any way as soon as possible after the imaging session begins.

The front of the head-holder will be open, which lets you look through a special mirror and see pictures presented to you on a projection screen near your feet. Sounds may also be presented to you using specially designed headphones. You will be asked to hold your head as still as possible and to respond to the pictures or sounds by pushing a button or thinking quietly to yourself.

The MRI scanner makes loud banging noises while taking a measurement, so either ear plugs or specially designed headphones will be used to reduce the noise. The researchers will be in communication with you through an intercom system to tell you how the study is going.  The earplugs or headphones should not get in the way of communicating with the researchers.

MRI with Gadolinium. [Including applicable text from MRI] During the MRI we plan to inject a contrast agent (dye) into your veins. You will feel a slight pin prick when the needle is inserted into your vein. You may have a warm, flushed sensation during the injection of the contrast materials and a metallic taste in your mouth that lasts for a few minutes. Occasionally, a patient will develop itching and hives, which can be relieved with medication. If you become light-headed or experience difficulty breathing, you should notify the technologist or nurse, as it may indicate a more severe allergic reaction.

(If Gadolinium is being used, state whether or not its use is experimental in this study.)

The contrast agent to be used contains gadolinium and is called ______ (insert brand to be used). It is/is not approved for use by the Food and Drug Administration (FDA) for its use in this study.   The dose to be given is _______ and is/is not within FDA approved guidelines.

Before we give you this contrast agent, we will ask you about any history of kidney problems or liver transplant.  Also, within 24 hours of the MRI, we will draw some blood (INSERT AMOUNT MLs and TSPs) to test the health of your kidneys by laboratory tests. If your medical history suggests a recent significant change in kidney function and/or the result of this blood test show that you currently have significantly reduced kidney function, you will not be eligible to participate in (the study or the part of the study that uses gadolinium- choose whichever is applicable) and you will be asked to follow-up with your primary care physician.

Risks of MRI (or fMRI). Some people cannot have an MRI because they have some type of metal in their body.  For instance, if you have a heart pacemaker, artificial heart valves, metal implants such as metal ear implants, bullet pieces, chemotherapy or insulin pumps or any other metal such as metal clips or rings, they cannot have an MRI.  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, so either ear plugs or specially designed headphones will be used to reduce the noise.

If the test is being done only for research purposes then add: The MRI pictures from this study will not be in a form readable by either you or your doctor. Therefore, a copy of the MRI pictures or the results of your individual study will not be given either to you or your doctor. While the MRI pictures in this study are not formally reviewed by a radiologist, if in the course of processing the images we notice any abnormality that would be possibly important to your health we will tell you and a doctor you name.

Risk from MRI and Gadolinium. [Including applicable text from Risks from MRI] The use of gadolinium-based contrast agents in patients who already have severely reduced kidney function or who have had a recent (within 4 weeks) kidney or liver transplant is uncommonly (less than 10%) associated with a possibly fatal disease involving the skin, muscle and internal organs.  This disorder is called nephrogenic systemic fibrosis (NSF).  As stated in the earlier sections of the consent form, you will have blood drawn to test your kidney function and will be asked if you have any history of kidney problems or have had a kidney and/or liver transplant.

Deposits of gadolinium remain in the brain of some patients who have undergone MRI scans with gadolinium for a prolonged time after the last administration. Deposits of gadolinium have also been reported in skin and bone. It is unknown whether these gadolinium deposits are harmful or can lead to adverse health effects.

The dose and frequency of the contrast agent we are giving you is standard/higher than normal (choose which is applicable).  We do/do not expect any additional risk to be posed to you beyond those already described above.  These risks include ______ (complete if there are additional risks).

You should avoid receiving additional gadolinium within 24 hours before or after the dose given in this research study.

MUGA Scan. A MUGA Scan (Multiple Gated Acquisition Scan)  takes images of the beating heart to see how well your heart is pumping blood. A small amount of radioactive material will be injected into your vein and bind to your red blood cells (blood cells that carry oxygen throughout your body) in order for the special camera to take pictures of how the blood moves through your heart. You will be asked to lie very still during this scan, because any movement can cause the images to be blurry.

Risks from the MUGA Scan and Radioactive Tracer. 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.

PET Scan. Positron 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.

Risks from Pet Scan. 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.

Pharmacogenetic Testing. Not all medicines work for all people and not all people have the same good or bad effects from a medicine. This is because a person’s genes affect the way they respond to drugs. This study involves pharmacogenetic testing to see if there are any genes that would affect how the study drug will work. (Describe the amount of blood to be withdrawn and at what timepoints; or tissues to be obtained)

Risks from Blood Withdrawal for Pharmacogenetic Testing. The risks of the pharmacogenetic testing are the same as having a blood test, which include pain, a bruise at the point where the blood is taken, redness and swelling of the vein and infection.

Placebo. This study compares an active drug to a placebo. A placebo is an inactive substance made to look/taste like an active medicine. You will either get the study drug/product, ________(name of drug/device) or a placebo. Researchers use a placebo to see if the study drug works better or is safer than not taking anything.

Risks from Placebo  (If appropriate for your study). For studies that don’t let you take the standard treatment, there is the risk that you will not get either the study drug/device or your normal medicine/treatment so your ______ (condition/specific symptoms) may get worse.

Taking part in this research study will not improve your housing or correctional program assignments. Your taking part in this research study will not improve your chance of parole or release.

This study involves asking sensitive questions relating to _____ (describe).

Suggested language (select whichever is appropriate)

• Some of the questions asked may be upsetting, or you may feel uncomfortable answering them.  If you do not wish to answer a question, you may skip it and go to the next question.
• Some of the questions asked may make you angry, emotionally upset or stressed out now or at a later time.  If this occurs, you can contact the following person for help (insert appropriate person’s name and contact information).  If you do not wish to answer a question, you may skip it and go to the next question.
• There could be a risk of discomfort and harm (to psyche, reputation, employability, insurability, social status, criminal or civil liability) that may occur as a result of participation.  If you do not wish to answer a question, you may skip it and go to the next question.

Spinal Tap. During a spinal tap (also called a lumbar puncture) a small needle is put into the lower back through the space between the bones below where the spinal cord ends to get spinal fluid. Spinal fluid is the fluid that moves around the brain and spinal cord. You will:

a) be given medications to numb the pain and blur the memory before the test since it is painful.

b) be sedated during the test.

Risks from Spinal Tap. Risks with spinal taps are extremely rare but always possible. The risks may include swelling of the spinal cord, discomfort from the needle stick, infection, bleeding or headache.

ADD: risks of medicine used to numb or to sedate.

Spirometry Test. Spirometry tests how your lungs work by measuring how much and how fast air moves out of your lungs. You will wear a nose clip and forcefully blow into a tube hooked to a machine.

Risks from Spirometry Test. Spirometry may make you cough or feel lightheaded. This will go away shortly after the test is finished.

Chest X-Ray. A chest x-ray uses radiation to takes pictures of the heart, lungs, airway, blood vessels and the bones of the spine and chest. You may be asked to remove your clothes and were a gown during this test. You will need to stand very still in order not to blur the x-ray picture and may be asked to hold your breath for a few seconds while the x-ray is being taken.

Risks from Chest X-Ray. 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.

A description of this clinical trial will be available on http://www.ClinicalTrials.gov, 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.

This research is covered by a Certificate of Confidentiality from the National Institutes of Health. This means that the researchers cannot release or use information, documents, or samples that may identify you in any action or suit unless you say it is okay. They also cannot provide them as evidence unless you have agreed.  This protection includes federal, state, or local civil, criminal, administrative, legislative, or other proceedings. An example would be a court subpoena.
 
Identifiable information that could still be disclosed beyond the research team: The Certificate does not stop reporting that federal, state or local laws require. Some examples are laws that require reporting of child or elder abuse, some communicable diseases, and threats to harm yourself or others.  The Certificate cannot be used to stop a sponsoring United States federal or state government agency from checking records or evaluating programs. The Certificate does not stop disclosures required by the federal Food and Drug Administration (FDA).  The Certificate also does not prevent your information from being used for other research if allowed by federal regulations.
 
Researchers may release information about you when you say it is okay. For example, you may give them permission to release information to insurers, medical providers or any other persons not connected with the research.  The Certificate of Confidentiality does not stop you from willingly releasing information about your involvement in this research. It also does not prevent you from having access to your own information.

Phase I. A phase I study is the first use of a new drug in humans. In a phase I study the new drug is tested in escalating doses in a series of small groups of people in order to find the highest dose of study drug that does not cause harmful side effects.

Benefits from Phase I. You should not expect any direct benefit from participating in this study.  Taking part in this study may help scientists to better understand how the study drugs work.