Intended for healthcare professionals

Letters

Paying for research related injuries in the US

BMJ 2006; 332 doi: https://doi.org/10.1136/bmj.332.7541.610 (Published 09 March 2006) Cite this as: BMJ 2006;332:610
  1. Mark Hochhauser, readability consultant (MarkH38514{at}aol.com)
  1. Golden Valley, MN 55422 USA

    EDITOR—That the United Kingdom considers clinical trial patients to be covered by consumer contract law puts it at odds with the United States.1 2 Because the US Food and Drug Administration (FDA) does not consider the informed consent process to be a contract between researchers and subjects, US subjects are not protected by consumer laws.

    Standard consent form language tells US subjects that “By signing this consent form you do not waive any of your legal rights” but does not describe those rights. In 11 years on an institutional review board I've seen only one consent form state that “You have the right to obtain legal advice if you're injured in this study.”

    For subjects injured in US clinical trials, many consent forms state that “Treatment for research related injury will be made available. Costs associated with this treatment will be billed to your insurance company. Costs not covered by your insurance company will be your responsibility.”

    Because of insurance deductibles, co-payments, and lifetime benefit limits, injuries in clinical trials could be a costly experience for some injured subjects. US patients without health insurance probably shouldn't try to enrol in clinical trials.

    Other consent forms note that sponsors will pay to treat research related injuries, but only costs “that are a direct result of taking the study medication and are not covered by your medical or hospital insurance coverage, provided you have followed all the instructions of the study doctor and his or her staff.”

    Or: “If you are physically injured by the study drug or properly performed study procedures and you have not caused the injury by failing to follow the directions of the study personnel, the sponsor will cover the reasonable medical expenses necessary to treat the injury. No other compensation such as lost wages or payments for emotional distress is offered by the sponsor, but you do not waive any legal rights by signing this consent form.”

    So injured subjects will have to prove they're not responsible for their researchrelated injuries.

    The most bizarre disclaimer was “In the event of a treatment-related injury, [the sponsor] will reimburse you only for medical expenses for the treatment of bodily injuries that are not mentioned in this consent form as potential side effects and that are directly caused by the use of [the study drug]… Compensation for medical expenses shall not be deemed an admission of fault or liability by [the sponsor] or affiliates.”

    Our institutional review board has rejected some of these reimbursement schemes because we don't believe subjects should be expected to take on financial risks to reduce the pharmaceutical industry's new drug development costs.

    Footnotes

    • Competing interests None declared.

    References

    1. 1.
    2. 2.
    View Abstract