Sponsor Shall Provide Payment for Reasonable and Necessary Medical Expenses Incurred By

Compensation for Injuries to Subjects during a Clinical Trial:

Contract and Consent Form Language

Key Issues to Determine and Explain to Subject:

⁪ Who decides whether Subject’s injury is related to the Study?

⁪ Will third-party payors be billed for injuries?

⁪ If third-party payors will be billed for injuries, will Subject will be reimbursed for co-pays and/or deductibles?

⁪ Will Sponsor’s payment for treatment of injuries be sent directly to treating provider or directly to Subject?

⁪ What exceptions are there to Sponsor’s obligation to pay (e.g., investigator negligence, subject’s failure to follow physician/investigator directions)?

⁪ IF Sponsor will not pay for treatment of injuries, explain that UCHC will not assume any payment obligations.

⁪ Will Sponsor pay for expenses related to lost wages, emotional distress, or other non-medical expenses (usually not)? If not, explain this is not the sponsor’s intent. Do not use exculpatory language such as, for example, the sponsor will not pay for lost wages, emotional distress etc.

Note: Contract language will often be silent on one or more of these points. The Informed Consent Form (ICF) language (1) should not promise anything on behalf of the Sponsor that is not explicitly stated in the contract as an obligation of the Sponsor, and (2) should inform the Subject of any important limitations or qualifications on the Subject’s right to compensation for injuries, whether the payment/compensation comes from UCHC or from Sponsor.

While there are many possible permutations of the above elements, it is essential that there be consistency in the provisions of the ICF and the clinical trial agreement relating to the Sponsor’s obligation to pay for treatment for study-related injuries to subjects. Four examples of contract language and corresponding ICF language follow.

Examples of Contract Language and Corresponding ICF Language for Sponsor-Initiated Studies: (These are listed in order of preference for UCHC, beginning with the most preferable.)

1. Sponsor Payment, No Third Party Billing

Contract Language

Corresponding Consent Language

2. Sponsor Payment, Unless Injury Caused by Negligence of UCHC or Subject

Contract Language

Sponsor agrees to reimburse Subject for the cost of all diagnostic procedures, medical treatments, inpatient or outpatient drugs, hospitalization, and other care needed to help the subject recover promptly from any injuries sustained as a direct result of participating in the Study, as reasonably determined by Sponsor, except to the extent the injuries or expenses are attributable to the negligence or willful misconduct of any person in the employ of Institution [or of the injured Subject, in his/her failure to follow instructions of the Institution/Investigator]. No provider of treatment for Subject injury shall be required to bill any entity other than Sponsor in lieu of or as a precondition to Sponsor payment for medical costs in the event of Subject injury.

Corresponding Consent Language

3. Subjects’ Insurance is Billed for Injuries, but Sponsor Agrees to Pay for Co-pays and Deductibles, and for Care for the Uninsured

Contract Language

In the event of injuries to a Subject as a direct result of the Subject’s participation in the Study, Institution, if it treats the Subject for such injuries, is responsible for submitting appropriate requests for payment or reimbursement of treatment expenses to the Subject’s insurer or other third-party payor. Sponsor shall agree to reimburse Subjects for any co-pays or deductible amounts as may be required by an injured Subject’s insurer or other third party payor. If a Subject has no source of payment for reasonable and necessary treatment expenses incurred by Institution (if the Subject is treated at Institution) or by Subject himself/herself (if the Subject is treated elsewhere) and if Sponsor reasonably determines that the Subject’s injuries are a direct result of participating in the Study, then Sponsor shall pay all reasonable and necessary treatment expenses related to that injury. Notwithstanding the foregoing, Sponsor shall not provide payment for any expenses that result from the negligence or misconduct of the Institution or the Principal Investigator or from the Study subject’s failure to follow any instructions given to him or her by the Institution or Investigator.

Corresponding Consent Language

All research involves a chance that something bad might happen to you. This may include the risk of personal injury. In spite of all safety measures, you might develop a reaction or injury from being in this study. If such problems occur during the course of the study, you must contact your study doctor immediately. The University of Connecticut Health Center has not set aside funds to pay you for any such reactions or injuries, or for the related medical care. The University of Connecticut Health Center, or anyone else who treats your injuries, will bill your health plan or insurance company (if you have one) for these expenses. If [Company] determines that your injury is a direct result of your participation in this research, and if your injury is not the fault of the University of Connecticut Health Center or its staff and is not due to your own failure to follow the study doctor’s instructions, then any co-pays and deductibles will be paid by [Company]. If you have no health insurance, all reasonable treatment expenses will be paid by [Company],. Financial compensation for such things as lost wages, disability or discomfort due to the injury is not routinely available and is not offered by [Company]. However, by signing this form, you do not give up any of your legal rights.

4. Subjects’ Insurance is Billed for Injuries, but Sponsor Agrees to Pay for Co-pays and Deductibles, and for Care for the Uninsured, but with Significant Exceptions and Carve-Outs [ NOTE: THIS ALTERNATIVE IS NOT PREFERRED DUE TO BROAD CARVE-OUTS]

Contract Language

If a Subject is injured in the course of a Study as a direct result of Subject’s participation in the Study, then for treatment of such injuries, Sponsor agrees to pay for co-pays and deductibles incurred by Subjects and for Subjects with no insurance or other source of third-party payment for medical expenses, agrees to pay all reasonable and necessary treatment expenses; provided, however, that Sponsor’s obligations under this Section shall not apply to the extent that any such costs or such illness or injury is attributable to: (i) the failure by Site, any affiliated Site participating in the study, any participating Investigator, or any of their Study personnel, contractors or other indemnities: (a) to comply with the terms of the pertinent Study Protocol, Study Agreement, or any written instructions (including, without limitation, package inserts, where appropriate) relative to the use of any drugs or devices used in the performance of a Study, or (b) to comply with applicable FDA or other governmental requirements; or (ii) any negligent or wrongful act or omission, or willful malfeasance, on the part of Site, any affiliated Site participating in the Study, any participating Investigator, or any of their Study personnel, contractors, or other indemnities involved in the performance of a Study; or (iii) a Study subject’s primary disease or any concurrent disease not exacerbated or caused by the administration of the Sponsor’s investigational Study drug in accordance with the Study Protocol; or (iv) a Study subject’s failure to comply with instructions contained in the Informed Consent executed by such subject or communicated to the subject by Study personnel.

Corresponding Consent Language

All research involves a chance that something bad might happen to you. This may include the risk of personal injury. In spite of all safety measures, you might develop a reaction or injury from being in this study. If such problems occur during the course of the study, you must contact your study doctor immediately. [The University of Connecticut Health Center has not set aside funds to pay you for any such reactions or injuries, or for the related medical care. The University of Connecticut Health Center will bill your health plan or insurance company (if you have one) for these expenses. [Company] has agreed to pay for the cost of any co-pays and deductibles under your insurance plan, and if you have no health insurance, [Company] will pay for all reasonable and customary medical treatment of the injury, if [Company] determines that your injury is a direct result of the proper administration of the Study Drug or of procedures performed only because of the Study. [Company] will not, however, pay for any of your co-pays and deductibles or other medical expenses, if your injury is in any way the fault of the University of Connecticut Health Center, if you or the University of Connecticut Health Center fail to comply with instructions relating to the Study, or if your injury is the result of your disease and was not made worse by the Study Drug. This means that in many cases, [Company] may be unwilling to pay for your medical expenses if you are injured or become ill during this Study. In addition, financial compensation for such things as lost wages, disability or discomfort due to the injury is not routinely available and is not offered by [Company]. However, by signing this form, you do not give up any of your legal rights.

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