CONSENT FORM TEMPLATE - U of FL

University of Florida – Gainesville or Jacksonville

Note: This document contains only the language requirements for the institution. It is not a complete template.

This institution requires the University logo on the first page of the consent form.

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Use WIRB standard headings – plus

PROTOCOL NO.:

WIRB® Protocol #

Include the Institution Tracking #

The institution tracking # is only applicable to GAINESVILLE; JACKSONVILLE does not use tracking numbers. All consent forms for Gainesville sites must include an Institution Tracking Number. This number is located on the RAC Billing Compliance Risk & Informed Consent Financial Language Assessment under the heading “RAC Log/Institutional #”. The RAC form will also contain information for each consent form that has been submitted for the research. If you do not have information for all of the submitted consent forms, contact the site and request an additional/updated form.

Add the following lines immediately after the standard headings:

Name of person seeking your consent: ______

Place of employment & position: ______

Name of Participant (“Study Subject”)

______

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What will be done only because you are in this research study?

Include submitted or existing text from WIRB study specific template - plus

Florida requires hepatitis, HIV, AIDS, and some STD reporting. Also suspected child abuse if that were something that might be found because of study activities. The site will include the following language for reportable diseases, and will modify the text for suspected child abuse:

State law requires the study staff to report the results of positive tests for [reportable disease] to a local health agency.

If a MRI is done the site will add the following text, do not include if it is not submitted:

Magnetic Resonance Imaging (MRI) is a procedure which allows your doctors to look at internal body parts using a scanner that sends out a strong magnetic field and radio waves. This is a routine medical procedure and is safe for most people. However, if you have any type of metal implanted in your body, you may not be able to have the MRI. Someone will ask you questions before you have your MRI. You will not be able to have the MRI if you have any pacing devices (such as a heart pacer), any metal in your eyes, or certain types of heart valves and brain aneurysm clips. Because of the small space inside the MRI scanner, you may require a sedative to help you relax if you are uncomfortable in close spaces. If you do need a sedative, you will not be able to drive a car or perform similar tasks for 4 to 6 hours afterwards because of drowsiness. In addition, the MRI scanner produces a “hammering” noise which has been reported to have produced hearing loss in a very small number of patients. You will be given earplugs to help reduce this risk. You will be monitored during the entire MRI procedure.

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What are the possible discomforts and risks?

The submitter will include the language selected from the choices below as required by HURRC. WIRB is not to add this language IF NOT SUBMITTED!

If radiation is involved as a research procedure, the UF Human Use of Radioisotopes and Radiation Committee (HURRC) requires standard language about the risks. Select from the choices below. The investigator should have done the mrem and days calculations already, and should fill in the appropriate contact name and phone number. Assistance for acquiring the information can be obtained from the Jacksonville Radiation Safety Committee, at (904) 244-4580 or the Gainesville Radiation Safety Committee at (352) 392-7359. The submitter will include the language selected from the choices below as required by HURRC. WIRB is not to add this language IF NOT SUBMITTED!

DIAGNOSTIC PROCEDURES USING RADIOACTIVE MATERIAL:

This research study involves exposure to radiation from [the site will insert type of procedure(s)]. The amount of radiation exposure you will receive from this procedure is equivalent to an exposure to your whole body of [the site will insert effective dose calculated in B-5 from “Study Design”] mrem. A comparable exposure is equivalent to [the site will insert number of days] days of the amount a natural background radiation exposure people in the United States receive each year. The risk from radiation exposure of this magnitude is too small to be measured directly, and is considered to be low when compared with other everyday risks. The study doctor will provide you with a contact person if you would like more information about radiation exposure. This contact person is [insert contact name and phone number].

USE FOR DIAGNOSTIC – X-RAY, FLUOROSCOPY, CT/CAT SCANS OR MAMMOGRAPHY PROCEDURES:

This research study involves exposure to radiation from x-rays. The amount of radiation you will receive from the procedure exposes a part of your body to a higher level of radiation than the rest of your body. The risks from radiation to only part of your body are considered to be less than risks from whole body exposure. The radiation exposure from the procedure is typically [the site will insert effective dose calculated in A-5 from “Study Design”] mrem. A comparable exposure is equivalent to [the site will insert number of days] days of the amount of natural background radiation exposure people in the United States receive each year. The risk from radiation exposure of this magnitude is too small to be measured directly, and is considered to be low when compared with other everyday risks. The study doctor will provide you with a contact person if you would like more information about radiation exposure. This contact person is [insert contact name and phone number].

The Board may include the following statement: “However, the exposure risk is cumulative over a lifetime, and the total should be kept as low as possible.”

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How could the researchers benefit from this research study?

The sponsor is paying the University of Florida for conducting this research study. In general, presenting research results helps the career of a scientist. Therefore, the study doctor may benefit if the results of this study are presented at scientific meetings or in scientific journals.

Pre-Board include the following on the consent form if a conflict of interest is submitted:

Note to Board: If any conflict of interest exists, include appropriate language here.

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If you choose to take part in this study, will it cost you anything?

This text must be submitted by the site. If the language is not submitted send an email to the site requesting the information.

Gainesville Only: See the UF RAC Form for the language required by the University.

Jacksonville Only: The site will submit the required language. Check the submitted consent form.

The following paragraphs are examples of the text that will be submitted:

Study [Drugs/Devices]

[The site will insert the name of the study drug or device] and its [the site will include: infusion/administration/implant/explant/replacement] will be provided at no cost to you while you are participating in this study.

The following phrase will be added by the site if the infusion/administration /implant will be billed out even though the study drug/device is provided. However, the cost of [infusing/administering/implanting/explanting/replacing] the [insert name of study drug or study device] will be billed to you or your insurance company. You will be responsible for paying any deductible, co-insurance, or co-payments for these services, and for any non-covered or out-of-network services.

The cost of [insert name of drug or device], all other treatments [and its/their infusion/administration/implant/explant/replacement] will be billed to you or your insurance company. You will be responsible for paying any deductible, co-insurance, or co-payments for those services, and any non-covered or out-of-network services. Some insurance companies may not cover costs associated with research studies. Please contact your insurance company for additional information.

Study Services

One of the following study services paragraphs that best describes how study services will be paid will be added by the site:

The Sponsor will [pay for/provide] all [medical services/activities] required as part of your participation in this study. There will be no cost to you. If you receive a bill related to this study, please contact [insert Principal Investigator’s name and phone number, and if applicable, study coordinator’s name and phone number].

The Sponsor will [pay for/provide] all [medical services/activities] required as part of your participation in this study as described above in the question “What Will Be Done Only Because You Are In This Research Study”. If you receive a bill for these services, please contact [insert Principal Investigator’s name and phone number, and if applicable, study coordinator’s name and phone number].

The Sponsor will [pay for/provide] the following study-required [medical services/activities] at no cost to you:

1. [ALL protocol-required services that are being paid for or provided by the sponsor will be listed by the site]

If you receive a bill for these services, please contact [insert Principal Investigator’s name and phone number, and if applicable, study coordinator’s name and phone number].

Items/Services Not Paid for by the Sponsor

One of the following study services paragraphs will be added by the site:

[Any/All] other medical services provided to you that are not directly required by this study will be billed to you or your insurance company in the usual manner.

[Any/All] other medical services you receive would have been provided to you even if you were not in this study. These services will be billed to you or your insurance company in the usual manner. You will be responsible for paying any deductible, co-insurance, or co-payments for those services, and for any non-covered or out-of-network services.

This paragraph will be added by the site only if there are services that will be billed to insurance/patient.

Some insurance companies may not cover costs associated with studies. Please contact your insurance company for additional information.

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Will you be paid for taking part in this research study?

Include submitted or existing text from WIRB study specific template – plus (if applicable)

Include this language if a subject is being paid more than $75 to participate in the research:

If you are paid more than $75 for taking part in this study, your name and social security number will be reported to the appropriate University employees for purposes of making and recording the payment as required by law. You are responsible for paying income taxes on any payments provided by the study. If the payments total $600 or more or you are a nonresident alien, payment will be processed through the University of Florida Accounts Payable department and the University must report the amount you received to the Internal Revenue Service (IRS). The IRS is not provided with the study name or its purpose. If you have questions about the collection and use of your Social Security Number, please visit: http://privacy.ufl.edu/SSNPrivacy.html.

The site will include the following language when a subject is being paid for participation in the research through the University: Your payment for participation in this research study is handled through the University of Florida’s Human Subject Payment (HSP) Program. Your information which will include your name, address, date of birth, and SSN (depending on amount of money you are paid) is protected. Access to the (HSP) Program site is limited to certain staff with the assigned security role. You will be randomly assigned a specific identification (ID) number to protect your identity.

The study team will provide you with an informational form called the Prepaid Card Facts document. If you have any problems regarding your payment call the HSP Office (352) 392-9057.

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What if you are injured because of the research study?

This text must be submitted by the site. If it is not submitted send an email to the site requesting the information.

Gainesville Only: See the UF RAC Form for the language required by the University.

Jacksonville Only: The site will submit the required language. Check the submitted consent form.

If the sponsor is paying:

1. The injury occurs during your participation in the study.

2. The injury results directly from the study [drug/device/product] or study-required procedures that you would not have received as part of your routine medical care.

Other appropriate caveats that match the sponsor’s contract may be added. They must be written at an 8th grade reading level.

Some EXAMPLES are:

· the injury is not the result of the natural course of your disease or some other underlying condition;

· the study doctor and/or study staff have followed the study procedures;

· the study doctor and/or study staff have met all their obligations to the sponsor;

· the injury is not listed above in the section covering discomforts and risks.

The sponsor and the Principal Investigator will determine whether your injury is related to your participation in this study.

No additional compensation is routinely offered. The Principal Investigator and others involved in this study may be University of Florida employees. As employees of the University, they are protected under state law, which limits financial recovery for negligence.

Please contact the Principal Investigator [insert Principal Investigator’s name and 24-hour phone number] if you experience an injury or have questions about any discomforts that you experience while participating in this study.

If the sponsor is not paying

[This minimal risk text will be included by the site if appropriate: Since this is a data collection/registry/observational study, there is a very low risk of study-related injury, However,] If you are injured as a direct result of your participation in this study, only the professional services that you receive from any University of Florida Health Science Center healthcare provider will be provided without charge. These healthcare providers include physicians, physician assistants, nurse practitioners, dentists or psychologists. Any other expenses, including Shands hospital expenses, will be billed to you or your insurance provider.