Consent Language

Procedure Language

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For this procedure, an area Name the location of the aspirate and biopsy is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle.

Risk Language

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You could have pain, bruising, bleeding, redness, low blood pressure, swelling, and/or infection at the site of the aspiration. An allergic reaction to the anesthetic may occur. A scar may form where the sample was removed. 

Procedure Language

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Risk Language

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

Procedure Language

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Risk Language

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Graft versus Host Disease (GVHD) is a side effect of bone marrow or stem cell transplantation. In cases of GVHD, the new marrow treats your body as "foreign" and launches an attack against it. Medications are given to prevent or reduce the chances of it, and to treat GVHD if it does occur. The most common sites are the skin, liver, and gastrointestinal tract. Symptoms can range from mild to severe, and when severe, GVHD can be fatal. Medications are given to prevent or reduce the chances of it, and to treat GVHD if it does occur.

This research is covered by a Certificate of Confidentiality from the Federal government. This means that the researchers may not disclose information or biospecimens that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, nor can the information or biospecimens be used as evidence, unless you have consented to this disclosure. Information or biospecimens protected by this Certificate cannot be disclosed to anyone else who is not connected with the research unless you have consented to the disclosure. More specifically, identifiable information or biospecimens will not be shared with your medical providers who are not involved in this research unless you authorize the study to disclose information to them, or if it is used for other scientific research, as allowed by federal regulations protecting research subjects.

Information about your study participation will not be in your MUSC medical record. This means that neither your research participation nor any of your research results will be included in any MUSC medical record. A Certificate of Confidentiality does not prevent you from voluntarily releasing information about yourself or your involvement in this research. If you want your research information released to an insurer, medical care provider, or any other person not connected with the research, you must authorize the researchers to release it.

The Certificate of Confidentiality will not be used to prevent disclosure as required by federal, state, or local law. Examples of required disclosure include: child abuse and neglect, or harm to self and others, but there could be others.

Finally, a Certificate may not be used to withhold information from the Federal government needed for auditing or evaluating Federally funded projects or information needed by the FDA.

If this study has a Certificate of Confidentiality and no information about the subject’s participation in the research and/or will be place in the in Medical Record, use the verbiage below:

Certificate of Confidentiality No Alias No Information in Medical Record

This research is covered by a Certificate of Confidentiality from the Federal government. This means that the researchers may not disclose information or biospecimens that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, nor can the information or biospecimens be used as evidence, unless you have consented to this disclosure. Information or biospecimens protected by this Certificate cannot be disclosed to anyone else who is not connected with the research unless you have consented to the disclosure. More specifically, identifiable information or biospecimens will not be shared with your medical providers who are not involved in this research unless you authorize the study to disclose information to them, or if it is used for other scientific research, as allowed by federal regulations protecting research subjects.

Information about your study participation will not be in your MUSC medical record. This means that neither your research participation nor any of your research results will be included in any MUSC medical record. A Certificate of Confidentiality does not prevent you from voluntarily releasing information about yourself or your involvement in this research. If you want your research information released to an insurer, medical care provider, or any other person not connected with the research, you must authorize the researchers to release it.

The Certificate of Confidentiality will not be used to prevent disclosure as required by federal, state, or local law. Examples of required disclosure include: child abuse and neglect, or harm to self and others, but there could be others.

Finally, a Certificate may not be used to withhold information from the Federal government needed for auditing or evaluating Federally funded projects or information needed by the FDA.

If this study has a Certificate of Confidentiality and information about the subject’s participation in the research and/or research results will be place in the in Medical Record, use the verbiage in the link directly below:

Certificate of Confidentiality No Alias Information in Medical Record

This research is covered by a Certificate of Confidentiality from the Federal government. This means that the researchers may not disclose information or biospecimens that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, nor can the information or biospecimens be used as evidence, unless you have consented to this disclosure. Information or biospecimens protected by this Certificate cannot be disclosed to anyone else who is not connected with the research except if you have consented to the disclosure, including for your medical treatment; or if it is used for other scientific research, as allowed by federal regulations protecting research subjects.

A Certificate of Confidentiality does not prevent you from voluntarily releasing information about yourself or your involvement in this research. If you are an MUSC patient you have an MUSC medical record. If you have never been an MUSC patient, a MUSC medical record will be created for the purposes of this study. Results of research tests or procedures will be included in your MUSC medical record. All information within your medical record can be viewed by individuals authorized to access the record. We will make every effort to keep confidential all research information in the medical record that identify you to the extent allowed by law; however, there is the possibility that your research information will be disclosed.

The Certificate of Confidentiality will not be used to prevent disclosure as required by federal, state, or local law. Examples of required disclosure include: child abuse and neglect, or harm to self or others

Finally, a Certificate may not be used to withhold information from the Federal government needed for auditing or evaluating Federally funded projects or information needed by the FDA.

If this study has a Certificate of Confidentiality and an “alias” medical record will be created specifically for the need to order medical tests via EPIC, use the verbiage in the link directly below:

Certificate of Confidentiality and Alias Medical Record

This research is covered by a Certificate of Confidentiality from the Federal government. This means that the researchers may not disclose information or biospecimens that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, nor can the information or biospecimens be used as evidence, unless you have consented to this disclosure. Information or biospecimens protected by this Certificate cannot be disclosed to anyone else who is not connected with the research except if you have consented to the disclosure, including for your medical treatment; or if it is used for other scientific research, as allowed by federal regulations protecting research subjects. 

A Certificate of Confidentiality does not prevent you from voluntarily releasing information about yourself or your involvement in this research. If you want your research information released to an insurer, medical care provider, or any other person not connected with the research, you must provide consent to allow the researchers to release it.

The Certificate of Confidentiality will not be used to prevent disclosure as required by federal, state, or local law. Examples of required disclosure include: child abuse and neglect, or harm to self and others, but there could be others.

If no information will be in the medical record:

Information about your study participation will not be in your medical record. This means that neither your research participation nor any of your research results will be included in any MUSC medical record.

OR: 

If information will be placed in the subject’s medical record at MUSC using alias coding, include the following:

If you are an MUSC patient you have an MUSC medical record. If you have never been an MUSC patient, a MUSC medical record will be created for the purposes of this study.

In order to protect your privacy, you may be assigned a different name or other identifier so that there will be no information in your medical record about your study participation. Your information will be coded in a way that does not identify you as a participant in this study to anyone outside of the research team. This means that neither your research participation nor any of your research results will be included in any MUSC medical record.

Finally, a Certificate may not be used to withhold information from the Federal government needed for auditing or evaluating Federally funded projects or information needed by the FDA.

Note: Alias Medical Record means that an appropriate de-identification process is required. The PI is responsible for consulting with the Epic Research Team to determine the appropriate process for de-identification and study designation in the SPARC Request system as well as the legal medical record. For more information please see Research Documentation in the Legal Medial Record (PDF).

This research is covered by a Certificate of Confidentiality from the Federal government. This means that the researchers may not disclose information or biospecimens that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, nor can the information or biospecimens be used as evidence, unless you have consented to this disclosure. Information or biospecimens protected by this Certificate cannot be disclosed to anyone else who is not connected with the research except if you have consented to the disclosure, including for your medical treatment; or if it is used for other scientific research, as allowed by federal regulations protecting research subjects.

A Certificate of Confidentiality does not prevent you from voluntarily releasing information about yourself or your involvement in this research. If you want your research information released to an insurer, medical care provider, or any other person not connected with the research, you must provide consent to allow the researchers to release it.

The Certificate of Confidentiality will not be used to prevent disclosure as required by federal, state, or local law. Examples of required disclosure include: child abuse and neglect, or harm to self and others, but there could be others.

If no information will be in the medical record:

Information about your study participation will not be in your medical record. This means that neither your research participation nor any of your research results will be included in any MUSC medical record.

OR:

If information will be placed in the subject’s medical record at MUSC using alias coding, include the following:

If you are an MUSC patient you have an MUSC medical record. If you have never been an MUSC patient, a MUSC medical record will be created for the purposes of this study.

In order to protect your privacy, you may be assigned a different name or other identifier so that there will be no information in your medical record about your study participation. Your information will be coded in a way that does not identify you as a participant in this study to anyone outside of the research team. This means that neither your research participation nor any of your research results will be included in any MUSC medical record.

Finally, a Certificate may not be used to withhold information from the Federal government needed for auditing or evaluating Federally funded projects or information needed by the FDA.

This research is covered by a Certificate of Confidentiality from the Federal government. This means that the researchers may not disclose information or biospecimens that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, nor can the information or biospecimens be used as evidence, unless you have consented to this disclosure. Information or biospecimens protected by this Certificate cannot be disclosed to anyone else who is not connected with the research except if you have consented to the disclosure, including for your medical treatment; or if it is used for other scientific research, as allowed by federal regulations protecting research subjects.

A Certificate of Confidentiality does not prevent you from voluntarily releasing information about yourself or your involvement in this research. If you are an MUSC patient you have an MUSC medical record. If you have never been an MUSC patient, a MUSC medical record will be created for the purposes of this study. Results of research tests or procedures will be included in your MUSC medical record. All information within your medical record can be viewed by individuals authorized to access the record. We will make every effort to keep confidential all research information in the medical record that identify you to the extent allowed by law; however, there is the possibility that your research information will be disclosed.

The Certificate of Confidentiality will not be used to prevent disclosure as required by federal, state, or local law. Examples of required disclosure include: child abuse and neglect, or harm to self or others.

Finally, a Certificate may not be used to withhold information from the Federal government needed for auditing or evaluating Federally funded projects or information needed by the FDA.

Procedure Language

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Risk Language

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If you need to have a chest X-ray taken, you will be exposed to a small amount of radiation.

Samples Linked to Participant

Samples Unlinked to Participant

As part of this study, we would like to store ____ (type of specimen - blood, urine, tissue, etc.) specimens collected from you for future research on ____ (condition). This future research may be conducted by ____ (PI’s name) or by other researchers who obtain IRB approval for their research. This research may/ will not (choose which is correct) involve genetic studies. There are several things you should know before allowing your (tissues, cells, urine, and/or blood) to be studied or to be stored.

1. The specimens will be labeled with a code that only study personnel can link back to you. Researchers outside of this study will not be given a link between the code number and your name or any other identifying information. While we hope this will prevent any potential loss of privacy or confidentiality, we cannot make any guarantees.
2. In addition to your name, other information about you might be connected to your sample. For instance, information about race, ethnicity, sex, your medical history, and so forth might be available to investigators studying your specimen. Such information might be important for research or public health. It is possible that this information (including genetic information) might come to be associated with your racial or ethnic group.
3. The specimens obtained from you in this research may help in the development of a future commercial product. There are no plans to provide financial compensation to you should this occur.
   
   If no re-contact is planned:
   
4. In this study, investigators will not tell you what they find out about you, nor will they contact you if a test becomes available to diagnose a condition you might have or later develop.
   
   Or, if potential re-contact is planned:
   
5. Investigators in this study may try to re-contact you in the future to find out about your health. If you are contacted and want to know what the investigators have learned about your samples, you should understand that the following are the kinds of things the investigators or your health team might tell you:
   1. Information is too preliminary to give you particular details, but you will receive a newsletter informing you about the results of the project.
   2. For any future research, we may contact you with a new consent form giving you additional information.
   3. If including genetic testing also add the info below:
   4. You carry a gene for a particular disease that can be treated.
   5. You carry a gene for a particular disease for which there is no current treatment. This news might cause severe anxiety or other psychological distress, depending on the severity of the disease.
   6. You carry a gene for a disease and might consider informing relatives that they, too, might carry the gene. It can be very difficult to decide whether to share such information with relatives. Genetic counselors can help sort out the various options in such a case.

You may request at any time that your research samples be removed from storage and not be used for future research. If you decide you want your samples removed, you may contact _____ (PI’s name) via written communication at the following address: _____________. Once the request is received, and if your samples have not already been used for other research, they will be destroyed. If you do not make such a request, your specimens will be stored indefinitely or until completely used.

If storage of specimens is an optional part of the study, include the following, as well as initial lines to document participants’ choice: You do not have to agree to allow your blood and urine specimens to be stored in order to be part of this study.

Initial your choice below:

___ Yes, I agree to allow my samples to be kept and used for future research.

___ No, I do not agree to allow my samples to be kept and used for future research.

As part of this study, we would like to store ____ (type of specimen, blood, urine, tissue, etc.) specimens collected from you for future research on _____ (condition). This future research may be conducted by ____ (PI’s name) or by other researchers who obtain IRB approval for their research. This research may/ will not involve genetic studies. The specimens will be de-identified/anonymized. This will protect your confidentiality and anonymity; it will also have other consequences:

1. It will be impossible to withdraw these samples from any future research project. Your sample cannot be destroyed if it has been de-identified and can no longer be traced back to you.
2. Results of any future research will not be given to you or your doctor.
3. Even though your name and other personal identifiers will not be connected to the sample, other information about you might still be connected. For instance, information about your race, ethnicity, sex, your medical history, and so forth might be available to investigators studying your specimen. Such information might be important for research or public health. It is possible that this information (including genetic information) might come to be associated with your racial or ethnic group.
4. The specimens obtained from you in this research may help in the development of a future commercial product. There are no plans to provide financial compensation to you should this occur.

If storage of specimens is an optional part of the study, include the following, as well as initial lines to document participants’ choice: You do not have to agree to allow your blood and urine specimens to be stored in order to be part of this study.

Initial your choice below:

___ Yes, I agree to allow my samples to be kept and used for future research.

___ No, I do not agree to allow my samples to be kept and used for future research.

Procedure Language

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Risk Language

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The contrast material used for an MRI exam, called gadolinium, does not contain iodine and is less likely to cause side effects or an allergic reaction. It is, however very important to know if you have ever had any allergic reaction (hives, swelling to the face, throat, lips, or tongue, itching, or difficulty breathing) to fish/shellfish. A previous allergic reaction makes you at risk for an allergic reaction to the dye. The contrast is eliminated by your kidneys, and for that reason your doctor will check blood work prior to the exam to make sure that your kidneys are working well. Gadolinium contrast agents may increase the risk of a rare, but serious, disease called nephrogenic systemic fibrosis in people with severe kidney failure. Nephrogenic systemic fibrosis triggers thickening of the skin, organs, and other tissues. There is no effective treatment for this serious, debilitating disease. The intravenous contrast sometimes causes a warm painless sensation at the time it is given.

Procedure Language

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During the procedure you may be placed in a moderate level of conscious sedation during which you will be able to respond purposefully to verbal commands. The drugs used to put you in this state of moderate consciousness are Name the drugs to be administered.

Risk Language

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The risks of a biopsy can include bleeding, pain, and infection. To reduce these risks, the site of the biopsy will be numbed, and sterile techniques will be used. Your doctor will discuss with you the safest method and location to perform these biopsies.

If you have a CT Guided Biopsy you will be exposed to a small amount of radiation. Such doses of radiation may be potentially harmful, but the risks are so small that they are difficult to measure. If you have already had many CT scans, you should discuss this with the researchers before agreeing to be in the study. If you are especially concerned with radiation exposure, you should discuss this with the researchers.

Procedure Language

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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 not to 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.

Risk Language

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Note to Researcher Preparing the Informed Consent If contrast material is used, the risks from the contrast material are serious and need to be included.

Procedure Language

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Risk Language

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DXA scans are commonly performed and considered safe. During the scan, you are exposed to a very low amount of radiation. The amount of radiation is less than one tenth of the amount used during a normal chest X-ray and equivalent to one day of exposure to natural background radiation. The amount of radiation used during a DXA scan is considered safe for adults but can cause damage to unborn babies.

Procedure Language

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Risk Language

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While you take part in this study, you may be at risk for side effects that may be mild, moderate or severe. You should discuss these with your doctor.

Many side effects go away shortly after the treatment stops, but occasionally, side effects can be serious, long lasting, or permanent. It is not possible to tell which side effect will affect you or how mild or severe the side effect might be. We can only tell you what other people have experienced.

It is very important that you notify your study doctor right away about any side effects, problems, or unusual experiences you may have while taking the medication involved with this study. This will decrease the chance that the side effects continue or become worse. Sometimes there are other medications that we can give you to make lessen the side effects or make you more comfortable.

Study Drug Name may cause some, all or none of the side-effects listed below:

More Likely (X percent to Y percent):

Less Likely (X percent to Y percent):

Rare (less than or equal to X percent) :

There may be other side effects of the drugs that we do not know of yet.

Procedure Language

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Risk Language

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The ECG procedure may cause some mild discomfort during the placement and removal of the leads to and from the skin. You may also experience some local irritation, redness, or burning in the areas where the leads are attached.

Procedure Language

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Risk Language

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Risks associated with endoscopy include aspiration (choking and/or gagging), sore throat, bleeding, and infection. Infection and bleeding risks may increase if the procedure involves removing a piece of tissue for testing (biopsy) or additional therapeutic procedures. 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, hospitalization or surgery.

Procedure Language

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Risk Language

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The exercise test(s) may cause headache, nausea, fatigue, muscle soreness, dizziness, or shortness of breath. Exercise tests may cause chest pain, chest tightness, or a change in vital signs.

Procedure Language

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Risk Language

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Risks of general anesthesia include nausea, vomiting, blood vessel injury, nerve injury, lung injury, heart attack, allergy to drugs, brain damage, and death.

Procedure Language

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DNA: Your genes are made up of DNA. DNA is short for deoxyribonucleic acid. 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. RNA: RNA is short for ribonucleic acid. RNA is a genetic material that has a major role in making proteins. Proteins: Proteins are the building blocks of your body, cells, and organs. Genetic research – Research to identify genes that cause or contribute to a disease or trait is an increasingly important way to try to understand the role of genes in human disease.

Risk Language

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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 (private information), loss of insurability and employability, paternity, and social stigmas. Knowledge of one’s genetic make-up may also affect one’s knowledge of the disease risk status of family members. Genetic research raises difficult questions about informing you and other subjects of any results, or of future results. Some people feel anxious about the possibility of having a defective gene that would place them or their children at risk. Some people want to know what is found out about them; others do not. The risks of knowing include anxiety and other psychological distress. The risks of not knowing what is found include not being aware if there is treatment for the problem being studied. But these risks can change depending on whether there is a treatment or cure for a particular disease and on how clear the results are. If there is a medical reason to seek specific information from you, your doctor will tell you this. A process called “genetic counseling” is often appropriate in such cases; you should ask your doctor or nurse about this if you have any questions.

South Carolina law, mandates that your genetic information obtained from any test or from this research, be kept confidential. Our state law prohibits an insurer using this information in a discriminatory manner against your or any of your family in issuing or renewing insurance coverage for you or your family. Our state law further prohibits our sharing your genetic information with anyone except in a few narrow circumstances, one of these being a research project of this type, approved by the Institutional Review Board and then we must take all steps to protect your identity. You will still be responsible for paying for health care, however. The Medical University of South Carolina will not be responsible for such costs, even if care is needed for a condition revealed during research or clinical testing.

Additional Applicable Language

Genetic Information Non-Discrimination Act (GINA)

Genetic Research: Use for studies that involve genetic testing of the subject’s DNA, RNA, chromosomes, proteins, or metabolites that detects genotypes, mutations, or chromosomal changes. While the protections of the Act apply in the US whether this language is included or not, the subject needs to know when they are not protected under the Act (see last paragraph).

Genetic Research: Use for studies that involve genetic testing of the subject’s DNA, RNA, chromosomes, proteins, or metabolites that detects genotypes, mutations, or chromosomal changes. While the protections of the Act apply in the US whether this language is included or not, the subject needs to know when they are not protected under the Act (see last paragraph).

A federal law, called the Genetic Information Nondiscrimination Act (GINA), generally makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. This law generally will protect you in the following ways:

• Health insurance companies and group health plans may not request your genetic information that we get from this research.
• Health insurance companies and group health 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 that we get from this research when making a decision to hire, promote, or fire you or when setting the terms of your employment.

Be aware that this new federal law does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance, nor does it protect you against genetic discrimination by all employers.

Genome Wide Association Studies (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. For protocols that are considered Genome-Wide Association Studies (GWAS), MUSC must certify that plans for the submission of genotype and phenotype data from GWAS to the NIH meet the expectations of the policy. For applicable protocols, include the following:

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 this data.

Payment to Participants

Payment for study visits will be made using a pre-paid debit card, called a ClinCard. It works like a bank debit card and you may use the card to purchase goods or services everywhere Debit MasterCard is accepted. You will be given a ClinCard at the beginning of the study. Each time you receive payment for participation in this study, the money will be added to the card, as outlined in the payment schedule above. Details of the debit card system are explained on an additional sheet.

ClinCard is administered by an outside company called Greenphire. Greenphire will be given your name, address, SSN and date of birth. They will use this information only as part of the payment system, and it will not be given or sold to any other company. Greenphire will not receive any information about your health status or the study that you are participating in. Bankcards can only be issued to an adult. If you are younger than 18 years, payments to you may be issued to your parent, in trust for you.

(Optional) Reimbursement for travel costs, such as lodging and meals, will be made directly by MUSC via check.

ClinCard ICF Tip Sheet

Procedure Language

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Risk Language

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We are performing imaging solely for the research purposes described above. It is not a clinical scan intended for diagnostic or therapeutic purposes. If you want your scan to be reviewed by a physician so that the physician can look for medical issues, you can request a copy of your scan. We will provide an electronic copy at no charge.

Procedure Language

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Risk Language

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If a study involves infectious disease testing include the following risk language: Per South Carolina law, if you test positive for Name the qualifying disease, the results of your test must be reported to the South Carolina Department of Health and Environmental Control.

Procedure Language

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Risk Language

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There is a risk of infusion reaction associated with administration of the study drug via IV infusion. The symptoms are similar to allergic reactions and may be clinically indistinguishable. They are generally mild-to-moderate in severity and usually occur within the first couple of hours, most often with the first infusion. If you have a very serious infusion reaction, there is a risk of death.

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The questions that will be asked may be sensitive in nature and make you feel uncomfortable. You may be asked personal questions that you find distressing. You may refuse to answer any question(s) that you do not wish to answer.

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The 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.

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There is a risk of loss of confidentiality of your information that is used in this study.

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This drug is a protein made from mouse cell. 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.

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Magnetic resonance imaging (MRI) uses a magnet and radio waves to make diagnostic medical images of the body. 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 hear a loud machine-like noise.

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There have been no ill effects reported from exposure to the magnetism or radio waves used in this test. 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. Please inform the study staff if you have a history of claustrophobia (extreme anxiety in close spaces). This may also be a contraindication to participation in the study.

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Peripheral neuropathy is damage to the nerves that can cause weakness, numbness, abnormal sensations such as prickling, tickling, burning or tingling and pain in the arms, hands, legs, and/or feet. This may get better or be permanent.

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If you are in the group that receives placebo, your condition will go without active treatment for indicate the number weeks.

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We do not know if the study drug will affect mother’s milk or an unborn fetus. Therefore, breast-feeding and pregnant women are not allowed to take part in the study. If you are pregnant or become pregnant, there may be risks to the embryo or fetus that are unknown at this time. [Note to PI] If there are specific known risks for your treatment, please include. Women who can become pregnant must take a pregnancy test before the start of the study.

You should not father a child while on this study as the treatment may indirectly affect an unborn child. If you are sexually active and are at risk of causing a pregnancy, you and your female partner(s) must use a method to avoid pregnancy that works well or you must not have sex.

Unless you cannot have children because of surgery or other medical reasons, you must be using an effective form of birth control before you start the study. You must also agree to continue to use an effective form of birth control for [Insert number] month/s after taking the study drug.

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If you are or become pregnant and test positive for illegal drugs, it is a law that the South Carolina Department of Social Services (DSS) must be notified. You and your family will be evaluated by the agency. You could be ordered to mandatory drug treatment, lose custody of your children, or be jailed.

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Some of the questions the researchers ask you may be upsetting, or you may feel uncomfortable answering them. If you do not wish to answer a question, you can skip it and go to the next question.

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The amount of radiation to which you will be exposed is relatively small (for example, less than the amount from 3 chest x-rays). Such doses of radiation may be potentially harmful, but the risks are so small that they are difficult to measure. If you have already had many x-rays, you should discuss this with the researchers before agreeing to be in the study.

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As a result of participating in the study, you will receive a significant amount of radiation. The amount is similar to that received in many standard procedures that use x-rays (such as a cardiac catheterization), but is far more than you would receive from natural daily exposure or in the normal course of treatment, and carries at least a theoretical risk. If you are especially concerned with radiation exposure, you should discuss this with the researchers.

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The treatment you receive may prove to be less effective or to have more side effects than the other study treatment(s) or other available treatments.

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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.

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Skin biopsy is generally a low risk procedure; however, possible risks may include: 1) reaction to anesthetic (numbing medicine), 2) excessive bleeding, 3) bruising, 4) infection, and 5) excessive scarring.

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. An allergic reaction (such as hives) to the numbing medicine is possible.

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Commonly reported side effects are as follows: local skin irritation with light itching/tingling/ burning, mild headache, or nausea. There have also been rare cases of mild burns at the procedure site.

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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 patient.

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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 in order to be used, blood donated by relatives/friends may not be suitable for your use. Therefore, receiving blood products from MUSC may be best for you. Alternatives to transfusion such as hemoglobin substitutes are not in general use at this time.

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The experimental treatments may have unknown side effects. The researchers will let you know if they learn anything during the course of the study that might make you change your mind about participating in the study.

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During the washout period, your symptoms of [list symptoms] may get worse. You may also experience new symptoms directly attributable to stopping the medication itself. Please discuss the washout period with the study doctor.