Subject Injury Language for Informed Consent Documents Submitted to the UPMC CTO

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Subject Injury Language for Informed Consent
Documents Submitted to the UPMC CTO

• Dennis P. Swanson, R.Ph., M.S
• Director, UPMC Clinical Trials Office
• July, 2006

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Default Criteria Industry-Sponsored Clinical
Trial of an Investigational Drug/Device

• Who should, in general, be ultimately responsible
  for covering the costs of treating a
  research-related injury?
• Research subjects insurance/research
  subject
• UPMC or University
• Industry sponsor

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Default Criteria Industry-Sponsored Clinical
Trial of an Investigational Drug/Device

• Should the industry sponsor be responsible for
  covering the costs associated with
• only emergency treatment of the
  research-related injury or.
• both emergency and long-term treatment of
  the research-related injury?

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Default Criteria Industry-Sponsored Clinical
Trial of an Investigational Drug/Device

• Should the industry sponsor be responsible for
  covering the costs of treating an injury
  resulting from the administration of the
• investigational drug/device
• protocol-defined procedures performed
  specifically for the purpose of the clinical
  trial or
• both of the above?

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Default Criteria Industry-Sponsored Clinical
Trial of an Investigational Drug/Device

• In general, the sponsors contract language and
  the informed consent document should indicate
  that the sponsor will cover the costs of
  treatment (immediate and long-term) of an injury
  caused by the investigational drug/device or any
  protocol defined procedures performed
  specifically for the purpose of the research
  study.

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Model Consent Language Industry-Sponsored
Clinical Trial of an Investigational Drug/Device

• This research study involves the evaluation
  of an experimental drug (or device). If you
  should suffer an injury related to the evaluation
  of this drug (or device) in this research study,
  you should contact immediately the study doctor
  listed on the first page of this consent form.
  Necessary medical care will be provided to you.
  It is possible that the costs of this medical
  care may be billed to your insurance company.
  However, in the event that your insurance company
  does not pay these costs, or you do not have
  insurance, the sponsor of this research study,
  (specify name), will cover the costs. There is
  no plan to provide you with other payments for or
  related to your injury. You do not give up your
  legal rights by signing this form.

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Default Criteria Industry-Sponsored Clinical
Trial of an Approved Drug/Device for an Off-Label
Indication

• Who should, in general, be ultimately responsible
  for covering the costs of treating a
  research-related injury?
• Research subjects insurance/research
  subject
• UPMC or University
• Sponsor

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Default Criteria Industry-Sponsored Clinical
Trial of an Approved Drug/Device for an Off-Label
Indication

• Should the industry sponsor be responsible for
  covering the costs associated with
• only emergency treatment of the
  research-related injury or.
• both emergency and long-term treatment of
  the research-related injury?

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Default Criteria Industry-Sponsored Clinical
Trial of an Approved Drug/Device for an Off-Label
Indication

• Should the industry sponsor be responsible for
  covering the costs of treating an injury
  resulting from the administration of the
• investigational drug/device
• protocol-defined procedures performed
  specifically for the purpose of the clinical
  trial or
• both of the above?

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Default Criteria Industry-Sponsored Clinical
Trial of an Approved Drug/Device for an Off-Label
Indication

• In general, the sponsors contract language and
  the informed consent document should indicate
  that the sponsor will cover the costs of
  treatment (immediate and long-term) of an injury
  caused by the off-label use of the drug/device
  or any protocol-defined procedures performed
  specifically for the purpose of the research
  study.

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Model Consent Language Industry-Sponsored
Clinical Trial of an Investigational Drug/Device
for an Off-Label Indication

• This research study involves the evaluation of
  a FDA-approved drug (or device) for an
  experimental use. If you should suffer an injury
  related to the evaluation of this drug (or
  device) in this research study, you should
  contact immediately the study doctor listed on
  the first page of this consent form. Necessary
  medical care will be provided to you. It is
  possible that the costs of this medical care may
  be billed to your insurance company. However, in
  the event that your insurance company does not
  pay these costs, or you do not have insurance,
  the sponsor of this research study, (specify
  name), will cover the costs. There is no plan to
  provide you with other payments for or related to
  your injury. You do not give up your legal
  rights by signing this form.

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Default Criteria Industry-Sponsored Clinical
Trial Evaluating One or More FDA-Approved
Drugs/Devices for their Approved Indication

• Who should, in general, be ultimately responsible
  for covering the costs of treating a
  research-related injury?
• Research subjects insurance/research
  subject
• UPMC or University
• Sponsor

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Industry-Sponsored Clinical Trial Evaluating One
or More FDA-Approved Drugs/Devices for their
Approved Indication

• The informed consent language should be
  consistent with the corresponding provisions of
  the sponsors contract.
• Consult with UPMC Clinical Trials Office re.
  sponsors contract language.

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Model Consent Language Industry-Sponsored
Clinical Trial of FDA-Approved Drugs/Devices for
Approved Indication

• This research study involves one or more
  FDA-approved drugs (or devices) being evaluated
  for their FDA-approved use. If you should suffer
  an injury related to the evaluation of this drug
  (or device, or these drugs/devices) in this
  research study, you should contact immediately
  the study doctor listed on the first page of this
  consent form. Necessary medical care will be
  provided to you. The costs of this medical care
  will be billed to your insurance company in the
  usual manner (as per the cost of an injury that
  you may suffer from any FDA-approved drug). In
  the event that your insurance company does not
  pay these costs or you do not have insurance, the
  costs of injury treatment will be billed directly
  to you. If you have concerns about this, you
  should discuss these concerns with the study
  doctor. There is no plan to provide you with
  other payments for or related to your injury.
  You do not give up your legal rights by signing
  this form.

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Default Criteria Industry-Sponsored Registry

• Is there a requirement for compensation for
  injury language in consent forms for registry
  studies that are limited to the collection of the
  patients-subjects medical record information
  related to the medical use of a FDA-approved drug
  or device?
• No
• Yes

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Model Consent Language (if required by
IRB-of-record) Industry-Sponsored Registry

• Your participation in this study is limited
  to the collection of your medical record
  information related to the medical use of
  (specify drug or device). Thus there is no risk
  of physical injury associated with your
  participation in this research. If you should
  suffer an injury related to the medical use of
  this drug (or device), necessary medical care
  will be provided to you in the usual manner and
  the costs of this medical care will be billed to
  your insurance company in the usual manner.
  There is no plan to provide you with payments for
  or related to your injury. You do not give up
  your legal rights by signing this form.

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Examples of Inappropriate Consent Form Statements

• Statements That Do Not Reflect Default Criteria

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Scenario Industry-Sponsored Clinical Trial of
Investigational Drug

• Medical care will be made available to you to
  treat any physical injury you suffer as a direct
  result of the administration of the study
  medication or procedures. It will be necessary
  for you to cooperate in obtaining any proceeds
  from insurance or other third party coverage that
  may be available to you for such medical care.
  No money or other form of compensation (such as
  for lost wages or discomfort) will normally be
  offered to you for such injuries, however you do
  not waive any legal rights by signing this form.
• Be aware that your health care payer might
  not cover the costs of study-related injuries or
  illnesses. To ask questions about any of this,
  talk to the study doctor or study staff.

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Examples of Inappropriate Consent Form Statements

• Statements That Incorporate University IRB Model
  Language and Do Not Reflect Default Criteria

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Scenario Industry-Sponsored Clinical Trial of
Investigational Device

• University of Pittsburgh researchers and their
  associates who provide services at the UPMC
  recognize the importance of your participation in
  their research studies. ---
• Emergency medical treatment for injuries
  solely and directly related to your participation
  in this research study will be provided to you by
  the hospitals of the UPMC. It is possible that
  UPMC may bill your insurance provider for the
  costs of this emergency treatment, but none of
  these costs will be billed directly to you. If
  your research-related injury requires medical
  care beyond this emergency treatment, you will be
  billed for the cost of this follow-up care unless
  otherwise specifically stated below. No
  additional statements included.

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Scenario Industry-Sponsored Clinical Trial of
Investigational Device

• University of Pittsburgh researchers and
  their associates who provide services at the UPMC
  recognize the importance ---
• Emergency medical treatment for injuries
  solely and directly related to your participation
  in this research study will be provided to you
  ---
• Sponsor has not arranged to pay for the
  costs of injuries or the expenses of treatment of
  injuries resulting from your participation in
  this research study.

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Scenario Industry-Sponsored Clinical Trial of
Investigational Drug

• If you are physically injured by the study
  drug or properly performed procedures and you
  have followed the directions of the study
  personnel, Sponsor will cover medical expenses to
  treat this injury. Sponsor has no plan to provide
  you with additional financial compensation. This
  includes no financial support for lost wages,
  disability, pain or discomfort.
• Emergency medical treatment for injuries
  solely and directly related to your participation
  in this research study will be provided to you by
  the hospitals of the UPMC. It is possible that
  UPMC may bill your insurance provider for the
  costs of this emergency treatment, but none of
  these costs will be billed directly to you. If
  your research-related injury requires medical
  care beyond this emergency treatment, you will be
  billed for the cost of this follow-up care unless
  otherwise specifically stated below.

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Examples of Inappropriate Consent Form Statements

• Confusing or Non-Informative Statements

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Scenario Industry-Sponsored Clinical Trial of
Investigational Drug

• Medical treatment will be provided at no
  cost to you for a research-related injury. The
  term research-related injury means physical
  injury caused by the product or procedures
  required by the study which are different from
  the medical treatment you would have received if
  you had not participated in the study.
• If you are injured in this research study,
  UPMC Shadyside Hospital will provide professional
  medical care at no expense to you. However, UPMC
  Shadyside Hospital does not plan to pay for
  hospital expenses. Hospital expenses will be
  billed to you or your insurance company. No
  other compensation is routinely offered by UPMC
  Shadyside Hospital.

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Scenario Industry-Sponsored Clinical Trial of
Investigational Device

• The sponsor of this study will reimburse the
  UPMC for medical expenses incurred by any injury
  that may occur as a result of your participation
  in the study. You, or your third party payer
  (insurance carrier) may be billed for procedures
  that are considered standard of care for your
  condition and are associated with this research
  study. Your insurance company may not pay for
  treatment associated with a research related
  injury, and your participation could affect your
  insurance coverage.

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Scenario Industry-Sponsored Clinical Trial of
Investigational Drug

• Every reasonable effort to prevent injury to
  you from participation in this study will be
  made. In the event of medical complications as a
  result of being in this study, treatment will be
  provided. Depending on certain factors, the
  costs of treatment may be covered by the
  University of Pittsburgh Cancer Institute (UPCI)
  or Sponsor. UPCI and Sponsor do not normally
  provide any other form of compensation for
  injury.

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Scenario Industry-Sponsored Clinical Trial of
FDA-Approved Drug for Approved Use

• In the event that your participation in this
  study results in a medical problem, treatment
  will be made available. Your doctor will explain
  the treatment options available and where
  information and such treatment can be obtained.
  The costs of any such treatment will not be
  reimbursed, nor will any other financial
  compensation be offered.

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Examples of Inappropriate Consent Form Statements

• Statements that Incorporate Restrictive Conditions

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Scenario Industry-Sponsored Clinical Trial of
Investigational Device

• If an injury occurs as a direct result of the
  administration of the device, necessary medical
  care will be made available. However, neither
  free medical treatment nor any financial
  compensation for any illness or injury will be
  routinely provided unless the study sponsor,
  Sponsor, in its discretion, approves payment for
  such medical care. Payment or compensation,
  financial or otherwise, will not be routinely
  offered or made from any source. You do not give
  up any of your legal rights by signing this form.

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Scenario Industry-Sponsored Clinical Trial of
Investigational Drug

• If any injury occurs to you as a direct
  result of your participation in this study, the
  study sponsor will pay for any immediate care
  and/or treatment not covered by your health
  insurance, provided that you have followed the
  instructions of your doctor.

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Scenario Industry-Sponsored Clinical Trial of
Investigational Drug

• Any medical expenses related to medical
  treatment due to serious adverse (bad or harmful)
  events or side effects from the study drug will
  be covered by Sponsor.

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Scenario Industry-Sponsored Clinical Trial of
FDA-Approved Drug for Approved Use

• The subject, or the subjects insurance
  carrier, will be billed for standard medical
  procedures provided throughout the study.
  Unexpected side effects are those which are not
  listed in the consent form. The sponsor will pay
  for the cost of medical treatment for unexpected
  side effects if (i) the sponsor and study doctor
  agree that they were caused by the study drugs
  and (ii) the side effects are not the result of
  the negligence of the study doctor or
  institution.

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Examples of Inappropriate Consent Form Statements

• Unnecessary Inclusion of Statements

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Scenario Post-Marketing Surveillance Registry

• If you get sick as a direct result of taking
  part in this study, the same emergency care that
  is available to the general public is available
  to you. You and/or your health care payer will
  be responsible for paying for this treatment. No
  compensation is routinely available from the
  sponsor other than that provided by law. The
  sponsor will not routinely pay for treatment that
  is paid for by a third party. You do not give up
  your legal rights by signing this form.
• Note that your health care provider might not
  cover the costs of study-related injuries or
  illnesses.

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Procedures to Address Inappropriate Consent Form
Statements

• Research coordinators Review current draft
  statements and red-line recommended revisions
  prior to initial submission of materials to UPMC
  CTO
• UPMC CTO Preliminary consent form review
• Research coordinators Submit necessary revisions
  to responsible IRB at time of initial submission
  of IRB materials