The external IRB will probably approve one or more consent template documents for the study. You are responsible for adding language required by the University of Miami to the consent template. The IRB should then approve a consent document that includes the required language.
The following language must be included in the consent document, when appropriate:
If subjects are being compensated:
If you receive $600 or more during a calendar year from the University for participating in research, you may receive a 1099 for tax reporting purposes. Reimbursements for travel and other expenses are not included in this amount.
If the research collects specimens:
The University of Miami may retain, preserve, or dispose of these specimens and may use these specimens for research, which may result in commercial applications. You will not receive money for donating blood, urine or tissue samples nor will you receive money from any future proceeds as a result of this research project.
Compensation for Injury Language
[Non-Sponsored studies that involve greater than minimal risks:]
If you are hurt or get sick because of being in this study, treatment will be available in most cases. If you have insurance, your insurance company may or may not pay for these costs. If you do not have insurance, or if your insurance company refuses to pay, you will be expected to pay. Funds to compensate for pain, expenses, lost wages, and other damages caused by injury are not available. This policy does not prevent you from trying to obtain compensation through the legal system
[Sponsored studies that involve greater than minimal risks:]
If you are hurt or get sick as a result of being in this study, in most cases treatment will be available. If you experience an injury as a result of the study drug or procedures, the Sponsor will cover the cost of treatment of these injuries. Funds to compensate for pain, expenses, lost wages, and other damages caused by injury are not available. This policy does not prevent you from trying to obtain compensation through the legal system. [Include the following, if applicable, otherwise delete.] If the sponsor pays any of your medical expenses, we may be required to give the sponsor your name, date of birth, and Medicare ID or social security number.
If one or more members of the research team has a reportable financial relationship
[Study doctor] has disclosed that he/she has a personal interest related to this study.
Please ask any questions to assure yourself that this relationship has not overly influenced the conduct of this research study. If you require further information, please contact the study doctor or the University of Miami Human Subject Research Office at 305-243-3195 to ask questions or discuss concerns.
Note: The language above is an example. If the Conflict of Interest Committee requires language that is different, that required language must be substituted for the above language.
Include if research information will be added to University of Miami Medical Record
If you are, or have been, a patient at a University of Miami facility, you will have a University of Miami medical record. We use an electronic medical record system known as UChart, which improves access to information important to your medical care. UChart will show that you are in a research study and a copy of this signed consent form will be included. Some or all of your research information may be placed in UChart to provide as complete a record as possible. Included in this information are information about investigational drugs, devices, biologics, or anything else that may interfere with our clinical treatment or place you at greater risk of harm if used separately or together with other substances or activities. Including this information in the electronic medical record system is intended only to give information to caregivers providing treatment for you while you are on this study.
This information will be available to University of Miami doctors, nurses and other authorized staff who may not be part of the research team but who are involved in providing you medical care, or who are otherwise allowed to access your information. The confidentiality of the results and other documents in UChart will be governed by laws, such as HIPAA, that concern medical records. We suggest that you tell any non-University of Miami doctors that you are in a research study and that more information may be made available to them at your request. The research team may use your information to notify you of appointments, send you appointment reminders, or schedule additional appointments.
Include if the study involves HIV, hepatitis B, or hepatitis C testing with subjects who have not already been diagnosed with those conditions:
As part of the study you will be tested for __(condition)__. Florida regulations require health care providers/laboratories to report new cases of HIV, AIDS, hepatitis infection and some STD to the county health department. If you test positive for one of these infections we are required by law to report your personal identifiers such as name, sex, date of birth, address and phone number, and other identifying information. Information about these new infections is used to track these diseases statewide and nationwide. Other than this required reporting, your results will be kept confidential to the extent permissible under the law. The health department may contact you with resources for counseling and medical care, if you need them and want them.
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