Title of Research Study

Insert checked box when formatting for IRB review for the site where research will occur:

¨ MOUNT SINAI BETH ISRAEL ¨MOUNT SINAI ST. LUKE’S

¨ MOUNT SINAI ROOSEVELT

CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY

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IRB (HS#) #: Form Version Date:

[Follow all instructions in red. Delete optional text that does not apply to your study and delete all instructions from the completed consent document.

Title:

Name:

Physical Address: [. This will usually the location where the subject should go for study visits; otherwise it can be the PI’s office address]

Mailing Address: [e.g. Street address, city ,state ZIP]

Phone: [e.g. 212-XXX-XXXX; this number should reach the research team directly, not be just a general clinic or department number]

A research study is when scientists try to answer a question about something that we don’t know enough about. Participating may not help you or others.

People volunteer to be in a research study. The decision about whether or not to take part is totally up to you. You can also agree to take part now and later change your mind. Whatever you decide is okay. It will not affect your ability to get medical care at [choose the site(s) that apply]: Mount Sinai Beth Israel, Mount Sinai St. Luke’s, and Mount Sinai Roosevelt.

Someone will explain this research study to you. Feel free to ask all the questions you want before you decide. Any new information that develops during this research study which might make you change your mind about participating will be given to you promptly.

[For any study that will be registered on ClinicalTrials.gov, add the following paragraph:]

Basic information about this study will appear on the website http://www.ClinicalTrials.gov. There are a few reasons for this: the National Institutes of Health (NIH) encourages all researchers to post their research; some medical journals only accept articles if the research was posted on the website; and, for research studies the Federal Drug Administration calls "applicable clinical trials” 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.

The purpose of this study is……[Tell the subject the purpose of the research. Explain the background of the research problem IN LAY TERMINOLOGY. For example, explain to the subject the current therapies for the disease and why they are not satisfactory. For non-therapeutic studies, explain the scientific problem. Describe how this research will attempt to solve the problem.]

You may qualify to take part in this research study because ………. [Fill in the circumstance or condition that makes subjects them eligible for the research, for example, “you are a healthy individual.” or “you have diabetes and you take insulin.” These descriptions should be brief and not the entire inclusion/exclusion criteria.]

Funds for conducting this research are provided by ……… [indicate name of financial sponsor(s) [or, for unfunded studies, which part of Mount Sinai Health System (BI, SL or R)] as applicable, and indicate the relationship of the financial sponsor to the study if any (e.g., manufacturer of the drug or device).]

Your participation in this research study is expected to last .... [months/weeks/years, until a certain event.]

The number of people expected to take part in this research study at this site is ……. [if it is multisite study, also indicate:] The total number of people expected to take part in this research study is…

If you agree to participate in this research study, the following information describes what may be involved.

[Tell the subject what to expect using lay language and simple terms. As appropriate, include the following items:

·  What is being performed as part of the research study

·  List experimental procedures and therapies and identify them as such

·  List frequency of procedures and tests. Consider providing a time-line description of the procedures that will be performed. If practical, prepare a time-line chart or schematic to accompany descriptions of procedures and tests for studies that require more than 1 or 2 steps/visits

·  Protocol-dictated drugs or biologics to be used

·  Protocol-dictated devices to be used

·  Hospitalizations, outpatient visits and telephone or written follow-up

·  Length and duration of visits and procedures

·  If blood will be drawn, indicate the amount in teaspoons, tablespoons, or ounces

·  With whom the subject will interact

·  Where the research will be done

·  When the research will be done

·  What is being performed according to the standard of care, when providing context is necessary

·  What procedures are part of regular medical care that will be done even if the subject does not take part in the research, when providing context is necessary]

[NYS Civil Rights Law Section 79-I covers confidentiality of records of genetic tests. Compliance with the law is required if the research involves the research use of genetic testing (including DNA profile analysis) to diagnose the presence of a genetic variation linked to a predisposition (meaning the subject is asymptomatic) to a genetic disease or disability in the subject or the subject’s offspring, add the following statements:

·  A statement whether samples will be used for future genetic tests

·  A statement indicating that the individual may wish to obtain professional genetic counseling before signing the informed consent

·  A statement that a positive test result is an indication that the individual may be predisposed to or have the disease or condition being tested for and may wish to consider further independent testing, consult their physician or pursue genetic counseling

·  A general description of the disease or condition being tested for

·  The level of certainty, if any, that a positive test result for a disease or condition serves as a predictor of such disease.

·  The time period during which the sample will be stored when the sample will be destroyed, or if no time limit is specified, a statement that the tissue will be stored for as long as deemed useful for research purposes.

·  A statement that no tests other than those authorized will be performed on the biological sample]

[For research involving random group assignment, describe the chances of being assigned to any one group. For example:] The study treatment you get will be chosen by chance, like flipping a coin [use the term “pulling names out of a hat” for the case of more than 1:1]. Neither you nor the study doctor will choose what study treatment you get. You will have a(n) ……….. [equal/one in three/etc.] chance of being given each study treatment. [For double-blinded studies, add] Neither you nor the study doctor will know which study treatment you are getting. This information could be obtained in an emergency, however. [For single blinded studies, add:] You will not be told which study treatment you are getting, however your study doctor will know.

If you decide to take part in this research study you will be responsible for the following things: … … [Describe the subject’s responsibilities. Explain what commitment you expect from the subject. For example: taking prescribed medications, use of effective birth control, avoidance of certain medications, attendance at study visits, etc.]

[If there are no anticipated costs or payments to the subjects, add:] You will not be paid for participating in this research study. Being in this research study will not lead to extra costs to you. [If time or travel costs to be assumed by subjects, add:] You will not be reimbursed for your travel or time that may be required for study visits. [If the research may result in additional costs to the subjects, add:] Taking part in this research study may lead to added costs to you. [Describe what these costs are, if known]

[When subjects will be paid, add:] If you agree to take part in this research study, we will pay you ……… [indicate amount] for your time and effort. [Indicate if the amount is pro-rated for research visit completion and what form the form of the payment will be (e.g. cash, gift card, Greenphire’s ClinCard). Provide a general indication of when the payment will be provided.

For ClinCard payments, use the following:

Payments in Research

(Example): The total payment for participating will be based on the visits you complete. You will receive $------per visit for a possible total of $------. (This would be customized for each study and some studies may require additional information).

You will be given a Greenphire ClinCard, which is a specially-made debit card for clinical research payments. After you have completed a visit, the specific payment for that visit will be approved and added onto your card. The payment will be available within 24 hours. It can be used wherever Mastercards are accepted. You will be given additional information on how the card works.

Research personnel will collect information about you, including your name, address, social security number, and date of birth and will enter it into the Greenphire system. Your information will be kept confidential. Greenphire collects your social security or individual taxpayer identification number as required by the Internal Revenue Service (IRS) for participants receiving payment in research as this is considered taxable income. If payment exceeds $600 in any one calendar year, Mount Sinai Beth Israel, Mount Sinai St. Luke’s, or Mount Sinai Beth Israel is required to report this information to the IRS. A 1099 (for U.S Citizens) or a 1042 (for nonresident aliens) Miscellaneous Income form will be issued to you by the institution and a copy sent to the IRS. You may have to pay tax on the money you receive for your participation in this research study.

Lost or Stolen ClinCards:

You will be given this card only once while you are in the study. If your card is lost or damaged, please contact the study coordinator for assistance. The first lost card will be replaced at no charge to you. To replace an additional lost card, you will be charged $7.00. The fee will be deducted from the balance available on the card when it was lost. Unused funds will be loaded onto a new card and the original card will be cancelled.

If the card is stolen please call (866)952-3795 for ClinCard’s Customer Service and also notify the study coordinator.

If you are being reimbursed for travel, food, or other study-related expenses, these funds will also be reimbursed to you through the ClinCard. You will not have to pay income tax on expense reimbursements.” (State if receipts are needed in this case and if there is a maximum reimbursement).

Only if NO payment of any kind will be provided to subjects as part of their participation may this statement be removed or if ClinCard will be used:] Tax law may requirethe Mount Sinai Finance Departmenttoreportthe amount of payment you receive from Mount Sinai to the Internal Revenue Service (IRS) or other agencies, as applicable.Generally this reportingwould take place if youreceive payments that equal$600 or more from Mount Sinai in a calendar year. Youwould beresponsible for the payment of any tax that may be due.

[If any reimbursement will be provided for expenses the subject will incur, such as transportation, indicate what evidence of the expenses the subject needs to provide (receipts). Further guidance is available from the Finance Department.]

[For Department of Defense (DOD) research that targets military personnel and where subjects will be paid, add:] You should check with your supervisor before accepting payment for participation in this research.

[For studies involving prisoners, add:] If you are released from jail before you finish this research study, you should take steps to get insurance or Medicaid coverage. Regular office visits and standard treatment will be billed to you and/or your health insurance. You may continue in the research study after your release from prison. If you move out of the area, we will help you make arrangements to be followed by a physician.

[If there are possible benefits to individual subjects from the research, add:] It is important to know that you may not get any benefit from taking part in this research. Others may not benefit either. However, possible benefits may be … …. [Describe the potential benefits of participation but do not overstate them. First describe any direct benefits to the subject, then any benefits to others. If benefits from participation may not continue after the research has ended, explain that here. For example, an investigational drug provided for free may not be available at the end of the research or may no longer be provided free if the drug becomes available for marketing. Monetary reimbursement for participation is not considered a benefit and should be described the Costs/Payments section.]