Desmond Laurence, PhD
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Research professionals who follow the United Kingdom's Department of Health guidelines when recruiting volunteers for clinical
trials could find they have acquired personal liability for compensation claims from injured subjects.
Closed openness
In 1991, the United Kingdom's Department of Health commendably stated that potential subjects in clinical trials must "be
told in advance of all known risks and be made aware that there could also be unforeseen risks, and of the possible difficulties
in obtaining compensation."1
The words "possible difficulties in obtaining compensation" undoubtedly refer primarily to non-negligent harm. In the United
Kingdom, courts will not award compensation for nonnegligent injury, unless a prior legally binding agreement provides for
it. Non-negligent harm is a cost inherent in medical research. Trial sponsors and research professionals clearly are free to propose
that the cost be borne by the injured subjects themselves. But as a matter of law, subjects must be told plainly what they
are letting themselves in for.
Despite this, the Department of Health, through its own Central Office for Research Ethics Committees (COREC), advocates the
following words for use in information provided to potential patient volunteers: "[the sponsor] will [emphasis added] pay compensation for [non-negligent harm]. Any payment would be without legal commitment (please ask if
you wish for more information on this)."2
This formula is not straightforward. The clear legal commitment given in the first sentence is undone by the legal sleight
of hand in the second. The Department of Health's 1991 policy statement calls for openness and full information, but its actions
in 2006 are obscurantist.
Legal issues
Surprisingly, at least in the United Kingdom, researchers often suppose that the law leaves ethical questions to the discretion
of researchers. But they are wrong. The Department of Health's doublespeak, adopted in the United Kingdom by trial sponsors
and widely allowed by Research Ethics Committees, is odious to UK law.
I have shown elsewhere3 that in the UK, a patient's agreement to take part in a clinical trial is a legal contract, which consumer law requires to
be expressed in "plain language."4
Under UK consumer law, it is unlawful even to recommend a term for use in consumer contract documents if the term is not open
and fair. The Department of Health has no power to set aside consumer law for itself; nor has it the power to absolve any
other person from the duty to comply with the law.
A potential subject who "wishes for more information" (on the Department of Health's fast-talking about non-negligent harm)
is likely to ask the research professional who is about to counter-sign the consent form on behalf of the trial sponsor. Research
professionals who venture to make reassuring comments may later find themselves personally responsible for their amateur legal
advice.
The United Kingdom's systematic disinforming of potential subjects in clinical trials probably has no parallel in the United
States,5 but research professionals working in the United Kingdom may want to seek their own legal advice. For a legal time bomb
is ticking.
References
1. NHS Management Executive. HSG(91)5. Local Research Ethics Committees. Priority and Health Service Division (PHS4D) Department
of Health, London (1991).
2. Central Office for Research Ethics Committees. Guidelines for researchers. Consultation version 22 November 2005; para
19. What if there is a problem? http://www.corec.org.uk/applicants/help/docs/Guidance_on_Patient_Information_Sheets_and_Consent_Forms.doc/ (accessed 6 December 2005).
