VA Consent Form

Department of Veterans Affairs VA RESEARCH CONSENT FORM

Subject Name : Date:

Title of Study :

Principal Investigator: VAMC: New Mexico VA Health Care System

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Page 1 of 14 HRRC#: XX-XXX Version: XX/XX/XX

FOR OFFICIAL USE ONLYAPPROVED: EXPIRES:

The University of New Mexico Human Research Review Committee



Title of Study :


Insert Study TitleIntroduction

You are being asked to participate in a research study that is being done by Insert Name of PI, who is the Principal Investigator and Insert one co-investigator or state "his/her associates", from the Department of Department Name. This research is studying Insert study goal.

INSERT BRIEF BACKGROUND HERE

Instructions - Introduction of Background

Select the CAPITALIZED words INSERT BRIEF BACKGROUND (located above) Replace with the following information:

o Previous studieso Number of people who have had interventiono Whether intervention has been used for this conditiono Clearly define what is experimental o FDA approved-if so for whato State if Phase I, Phase II, etc. and use the following definitions:

o Phase I studies help determine a safe dose for the new drug.o Phase II studies enroll a limited number of a target population to determine safety and efficacy.o Phase III studies compare the experimental drug to standard treatment.o Phase IV studies are done after the drug has received FDA approval to help determine the drug’s

long term safety, benefit and side effects.

You are being asked to participate in this study because Insert reason. Insert # of subjects locally people will take part in this study at the New Mexico VA Health Care System. (Add University of New Mexico, if applicable). Insert # of subjects study-wide if multi-site will participate across the United States. Insert Sponsor Name is funding this study.

This form will explain the research study, and will also explain the possible risks as well as any possible benefits to you. We encourage you to talk with your family and friends before you decide to take part in this research study. If you have any questions, please ask one of the study investigators.

What will happen if I decide to participate?

If you agree to participate, the following things will happen:






Title of Study :


INSERT “WHAT WILL HAPPEN” ANSWERS HERE – EXAMPLES OF LANGUAGE FOLLOW

o Explain each procedure, preferably in separate bullets, in the order that they will occur. Procedures can also be listed by study visit or by using a study calendar. A sample calendar is provided on the HRRC website. Modify as appropriate. Please reference the calendar in this section if used.

o Describe randomization procedure, if applicable (e.g. 50/50 chance, or “tossing a coin”). If being randomized into more than two groups, “picking numbers out of a hat.”

o Identify what drugs/devices/procedures are experimental. o State how long each visit takes, total amount of specimens to be taken in teaspoons or tablespoons.o Only include research related procedures here, and, if necessary, attach standard of care procedures in an

appendix. If applicable, add a statement that standard/routine clinical procedures are addressed in an appendix.

o If optional testing is being done (e.g. biology studies, tissue banking), this should be included using YES/NO checkboxes and initial lines. If using a separate consent form for optional testing, refer to that document.

o Provide information regarding what will happen at the end of the study, long term follow up, etc.o State where study procedures will take place.

You will be assigned by chance (like a flip of a coin) to receive either X or placebo, so you will have an equal chance of receiving either treatment. You will be asked to take 1 pill three times a day before meals. You will be shown how to record dosing times in a medical diary. Neither you nor the study doctor will know which medication you are taking as they are identical in appearance. However, this information is available in case of an emergency. You will continue to take this medication for up to 3 months. Your doctor may adjust the medication dose depending upon how you are doing.

You will have a physical examination and your medical records will be reviewed. The following information will be collected: …

You will be asked questions regarding your current medications. You will be asked to complete a questionnaire that asks about your feelings (such as “Do you feel depressed today?”) You may refuse to answer any questions at any time. This questionnaire will take about 30 minutes to complete.

X cc of blood (approximately 2 teaspoons) will be drawn with a needle from a vein in your arm and a urine sample (1 tablespoon) will be collected for laboratory testing.

Testing will be done to check blood count, kidney and liver function; an EKG (electric tracing of the heart) will






Title of Study :


be done.

All blood and urine collected for this research study will be sent to a central laboratory (state name of lab, city and state). Your name and medical record number will be removed from the sample and labeled with a unique code number before being shipped.NOTE: If results of lab tests will be communicated to subject/caregiver, this should be stated here.

Magnetic Resonance Image (MRI): During the study you will be required to undergo 5 magnetic resonance imaging (MRI) examinations of your head. An MRI is a procedure which gives a picture of the brain that can determine the areas affected by MS. An MRI will be done at your screening visit and at visit months 6, 12, 24 and at a follow-up visit, 3 months after study completion. If the MRI results are unclear, you may be asked to have an additional MRI done. During the MRI examination, you will lie on a table confined to a small space inside a cylindrical machine which uses magnetic fields and radio waves to take special pictures of the brain. In order to obtain good pictures, it is important that you do not move during the procedure. The examination will last approximately one hour. Special positioning supports will keep your head from moving. Although you may not talk during the MRI procedure, you will be able to communicate with the technician by pressing a call button or similar device. The radiologist at the facility at which the procedure is conducted will read the MRI. If any abnormalities are found that necessitate further follow up, the radiologist will alert Dr. Corey Ford and he will correspond the information to you with a referral, if you so wish.

During the MRI you will receive a solution through a needle placed in your arm. This solution is a liquid preparation of a substance called gadolinium, which improves the quality of the MRI. This will help determine how your brain is affected by MS.

NOTE: HRRC policy requires that readable neuroradiological images are read by a neuroradiologist and abnormal findings are communicated back to the subject and/or the subject’s physician. This information should be included here.

How long will I be in this study?

Participation in this study will take a total of Insert total # of hours required for participation hours over a period of Insert total # of days or weeks required for participation.

What are the risks or side effects of being in this study?

INSERT RISKS HERE.






Title of Study :


There are risks of stress, emotional distress, inconvenience and possible loss of privacy and confidentiality. For more information about risks and side effects, ask your study doctor.

Examples of Language - Risks

You may have side effects while on the study. Everyone taking part in the study will be followed carefully for any side effects. However, doctors do not know all the side effects that may happen. Side effects may be mild or very serious. Your study doctor may give you medicines to help lessen the side effects. In some cases, side effects can be serious, long lasting, or may never go away. There is also a risk of death. Many side effects go away soon after you stop taking DRUG NAME.

You should report to your study doctor any side effects you experience while taking part in the study.

Risks and side effects related to the DRUG NAME OR DEVICE NAME are listed below: o Frequent (Greater than 20%) Side Effects Include: LIST SIDE EFFECTS HEREo Occasional (Between 2-20%) Side Effects Include: LIST SIDE EFFECTS HEREo Rare (Less than 2%) Side Effects Include: LIST SIDE EFFECTS HERE

If the frequency of the side effect is unknown, state so. Risks of standard drugs being used for the subject’s clinical care should be included in an appendix, if necessary.

If appropriate to the study, include the following risk statement(s) and delete unnecessary text:o Randomization risks: You will be assigned to a treatment program by chance, and 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.

o Blood drawing risks: Drawing blood may cause temporary pain and discomfort from the needle stick, occasional bruising, sweating, feeling faint or lightheaded and in rare cases infection.

o Allergic reaction: With any drug there is a risk of allergic reaction. Symptoms may include but not be limited to trouble breathing, fast heart rate, rash, dizziness, and swelling. If you experience any of these symptoms, you should contact your study doctor immediately.

o Radiation (x-ray) risks: The amount of radiation you will be exposed to depends upon the type and number of procedures you will have as part of this research study. Procedures such as chest x-rays or x-rays of your arms and legs expose you to small amounts of radiation with very slight risk. CT scans and nuclear medicine examinations expose you to much larger doses of radiation and are associated with an increased risk. If procedures with high-dose radiation are part of the protocol, please include language provided by Dr.






Title of Study :


Philip Heintz in the radiation dose letter. If you are concerned with radiation exposure, you should discuss this with your study doctor.

o CT scan risks: CT scans involve the risks of radiation (see above). In addition, if contrast material (iodine dye) is used, there is a slight risk of developing an allergic reaction, from mild (itching, rash) to severe (difficulty breathing, shock, or rarely, death). The dye may also cause kidney problems, especially if you have diabetes, are dehydrated or have poor kidney function. The study doctors will ask you about any allergies or medical conditions before the procedure.

o An MRI machine acts like a large magnet, so it could move iron-containing objects in the room during your examination. Precautions have been taken to prevent any such event from happening and injuring you. You cannot have an MRI if you have a pacemaker or any metal in your body, such as an aneurysm clip, ear implant, or nerve stimulator. MRI examination releases radio waves, which are very noisy. Earplugs will be given in order to ease discomfort. You may experience brief claustrophobia (fear as a result of being in a small, enclosed space) and anxiety during the MRI procedure. If your doctor feels it is necessary, you may be given medication to increase your comfort during MRI procedure.

Radio and magnetic waves associated with MRI examinations are not associated with any known adverse effects. Gadolinium, the substance given during each MRI examination, will be given by injection into a vein in your arm. This may cause some minor pain, and may cause some bruising near the area of the injection. The gadolinium may also cause the following: headache, nausea, and vomiting. Rarely, it may cause dizziness, rash, itching, numbness or a tingling feeling in the hands or feet (less than 10% chance). Allergic reactions to gadolinium occur in less than 0.01%.

Persons with severe kidney disease, liver transplants and newborn children may develop a rare debilitating condition called Nephrogenic Systemic Fibrosis after they receive gadolinium. This disorder affects the skin, and may involve the lungs, liver, muscles and heart. Therefore, if you have advanced kidney disease you will not be allowed to participate.

o Reproductive Risks: You should not become pregnant or father a baby while on this study because the drugs in this study can affect an unborn baby. If you become pregnant, the treatments or procedures might involve risks to the embryo or fetus, which are currently unknown. Women should not breastfeed a baby while on this study. If you are of child bearing potential, it is important to understand that you need to use birth control while on this study. Check with your study doctor about what kind of birth control methods to use and how long to use them. Some methods might not be approved for use in this study. If you were to become pregnant while on this study, the sponsor may ask to obtain information from you even after the study has ended.

o HIV testing risks: Being tested for HIV may cause anxiety regardless of the test results. A positive test indicates that you have been infected with HIV virus, but no one knows for sure when, if ever, you will






Title of Study :


become sick with AIDS or a related condition. Receiving positive results may make you very upset. If other people learn about your positive test results, you may have trouble obtaining insurance or employment. If your test is negative, there is still the possibility that you could be infected with the HIV virus and test positive at some time in the future. Also, it is always possible that the test results could be wrong.

o Unknown risks: The experimental treatments may have side effects that no one knows about yet. They may also have unknown risks to a fetus or embryo.

o Genetic research: There are risks of loss of privacy, getting insured, being employed, and stigmatization (treated badly due to your genetic testing results).

NOTE: Use only for placebo-controlled studies.o Placebo risks: If you are in the group that receives placebo, your condition will go without an active

treatment for INSERT LENGTH OF TIME. You will be monitored closely and if your condition worsens while on placebo, you may be taken off the study and put on standard medications.

o Provide examples of the following:o Privacy Risks (legal, employment and social).

What are the benefits to being in this study?

INSERT ANY BENEFITS THAT THE SUBJECT MAY RECEIVE FROM PARTICIPATING. COMPENSATION IS NOT A BENEFIT AND SHOULD NOT BE MENTIONED HERE.

Examples of Language - Benefits

There may or may not be benefit to you from participating in this study.

If there may be benefit to the subject, such as improvement from study drug, include with benefits.

If there is no benefit to subject, state: There will be no benefit to you from participating in this study. However, it is hoped that information gained from this study will help in the treatment of future patients with STATE CONDITION OR OTHER SOCIETAL BENEFIT.

What other choices do I have if I do not want to be in this study?

Your participation in this study is completely voluntary. LIST ALTERNATIVE CHOICES HERE






Title of Study :


Examples of Language – Other Choices

If alternative treatments are available as a non-research option, state specific options. Please revise this section as needed to make applicable to your study.

You do not have to participate in this study to receive treatment for your condition. STATE IF STUDY MEDICATION IS AVAILABLE ASIDE FROM RESEARCH. If you choose not to participate in this study, you could choose to receive SPECIFIC ALTERNATIVE TREATMENT INFORMATION or no treatment. You should discuss all available treatment options and their risks with your doctor.

How will my information be kept confidential?

We will take measures to protect your privacy and the security of all your personal information, but we cannot guarantee confidentiality of all study data.

Information contained in your study records is used by study staff and, in some cases it will be shared with the sponsor of the study. The University of New Mexico Health Sciences Center Human Research Review Committee (HRRC) that oversees human subject research, federal agencies such as the Department of Veterans Affairs Office of Research Oversight, Office of Inspector General, Office of Human Research Protection, Government Accounting Office and the Food and Drug Administration and/or other entities that may have access will be permitted to access your records. There may be times when we are required by law to share your information. However, your name will not be used in any published reports about this study. A copy of this consent will be kept with your medical record.

INSERT ADDITIONAL STATEMENTS REGARDING CONFIDENTIALITY HERE.

Examples of Language – Confidentiality

Information and/or specimens collected as part of the study will be labeled with your initials and a study number; Information (without your name) will be entered into a computer database/locked file cabinet in the Principal Investigator’s office (or state other secured location). INSERT PI and his associates will have access to your study information. Data will be stored according to the VA Record Retention Schedule in a secure environment with limited access on the NMVAHCS campus.

Medical information created by this study may become part of your hospital medical record. Information that does not become part of your medical record will be stored in your study file.






Title of Study :


If a certificate of confidentiality will be obtained, include the following statement: To help us further protect the confidentiality of your data, the investigators have obtained a Confidentiality Certificate from the Department of Health and Human Services (DHHS). With this certificate, the investigators cannot be forced (for example by court subpoena) to disclose research information that may identify you in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings. Disclosure will be necessary, however upon request of DHHS or other federal agencies for audit or program evaluation purposes.

You should understand that a Confidentiality Certificate does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. Note however, that if an insurer or employer learns about your participation, and obtains your consent to receive research information, then the investigator may not use the Certificate of Confidentiality to withhold this information. This means that you and your family must also actively protect your own privacy and the confidentiality of your data.

Finally, you should understand that the investigator is not prevented from taking steps, including reporting to authorities, to prevent serious harm of yourself or others.

For studies involving genetic testing of tissue samples, also explain who will be permitted access to the information and codes.

For behavioral studies, revise as appropriate (i.e. delete reference to FDA).

What are the costs of taking part in this study?

Some veterans are required to pay co-payments for medical care and services provided by the VA. These co-payment requirements will continue to apply to medical care and services provided by the VA that are not part of this study. INSERT COSTS OF TAKING PART IN STUDY HERE.

Examples of Language – Costs

Explain whether the subject will be charged for any study procedures or treatments, and which ones. In this section, be specific on what is and is not covered by insurance and/or sponsor.

You will not be charged for any study procedures or treatments. The costs of Insert name of study drug , the physical exam, blood tests, MRIs and office visits required by the research will be covered by the study. You or






Title of Study :


your third party payer will be responsible for the costs of your standard medical care and birth control.

You will not be billed for the cost of tests and procedures directly associated with this study. However, you or your third party payer (i.e. insurance company) are responsible for all other costs related to your clinical treatment.

What will happen if I am injured or become sick because I took part in this study?

In the event of illness or injury, you may contact {Name of PI} during the day at (insert phone/pager #) or contact {Name of PI or other POC}, after hours at (insert phone/pager #). You may also contact the VANMHCS Emergency Department at (505-265-1711 ext. _2793/2929) for emergencies ONLY. If you sustain physical injury as a result of participation in this investigation, if you are eligible for medical care as a Veteran, all necessary and appropriate care will be provided. If you are not eligible for medical care as a Veteran, humanitarian emergency care will nevertheless be provided at no cost to you if your injury is related to your participation in the study. However, you have not released the UNM or VA from liability for negligence. Further information can be obtained by calling the Office of Regional Counsel, 505-256-2780INSERT INFORMATION IF SPONSOR OF THIS STUDY MAY COVER COSTS OF REQUIRED MEDICAL CARE DUE TO USE OF STUDY DRUG/DEVICE HERE.

Will I be paid for taking part in this study?

INSERT COMPENSATION INFORMATION HERE

Examples of Language – Compensation

Explain how the participant will be compensated (if any) for their time and inconvenience. Include amount, form of payment and timing of payment. State if payments are prorated based on length of participation or if there will be no compensation.

In return for your time and the inconvenience of participating in this study, you will be paid $20 for each clinic visit (a total of up to $100 if you complete the study). If you do not complete the study, you will be paid $20 for each clinic visit you completed. You will be mailed a check approximately (3) weeks after the study has ended.

Compensation is considered taxable income.

How will I know if you learn something new that may change my mind about participating?






Title of Study :


You will be informed of any significant new findings that become available during the course of the study, such as changes in the risks or benefits resulting from participating in the research or new alternatives to participation that might change your mind about participating.

Can I stop being in the study once I begin?

You have the right to choose not to participate now or to stop participating at any point in this study without affecting your future health care or other services to which you are entitled.

PROVIDE SPECIFIC INSTRUCTIONS ON HOW TO WITHDRAW CONSENT.

INSERT, IF APPLICABLE, CIRCUMSTANCES UNDER WHICH AN INVESTIGATOR AND/OR SPONSOR MAY WITHDRAW THE SUBJECT WITHOUT HIS/HER CONSENT

Instructions– Withdrawal

Explain any procedures for withdrawal if the subject chooses to leave the study early. If there are certain requirements for withdrawal, such as tapering of medication or safety follow-up, these need to be explained. Explain anticipated circumstances under which the participant’s participation might be terminated by the investigator or Sponsor without regard to participant’s consent.

Who can I call with questions or complaints about this study?

If you have any questions, concerns or complaints at any time about the research study, Enter PI name, degree , or his/her associates will be glad to answer them at Enter telephone number and time/days available by phone. If you would like to speak with someone other than the research team, you may call the UNMHSC HRRC at (505) 272-1129 or the NMVAHCS Research Office at (505) 256-2810.. Who can I call with questions about my rights as a research subject?If you have questions regarding your rights as a research subject, you may call the UNMHSC HRRC at (505) 272-1129. The HRRC is a group of people from UNM and the community who provide independent oversight of safety and ethical issues related to research involving human subjects. For more information, you may also access the HRRC website at http://hsc.unm.edu/som/research/hrrc/.






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RESEARCH SUBJECTS’ RIGHTS: You have read or have been read all of the above. Dr. has explained the study to you and answered all of your questions. Someone has explained what the study is about and how and why it is being done. You have been told of the risks or discomforts and possible benefits of the study. You have been told of other choices of treatment available to you (or the person you represent).

You understand that you do not have to take part in this study, and your refusal to participate will involve no penalty or loss of rights to which you are entitled. You may withdraw from this study at any time without penalty or loss of VA or other benefits to which you are entitled. The results of this study may be published, but your records will not be revealed unless required by law.

In case there are medical problems or questions, you have been told you can call Dr. at during the day or contact {Name of PI or other POC}, after hours at (insert phone/pager #). . If any medical problems occur in connection with this study the VA will provide emergency care.

You voluntarily agree to participate in this study. You will receive a signed and dated copy of this consent form.

_____________________________ _____________________/________

Name of Subject (print) Signature of Subject Date

_____________________________ _____________________/________Name of Witness (print) Signature of Witness Date

_____________________________ _____________________/_____________Name of Investigator Obtaining Consent (print) Signature of Investigator Obtaining Consent/Date

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Title of Study :


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Page 14 of 14

Health & Medicine

VA Consent Form