No Plain English for UK Subjects

August 1, 2006

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-08-01-2006, Volume 0, Issue 0

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.

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.

Desmond Laurence, PhD

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? www.corec.org.uk/applicants/help/docs/Guidance_on_Patient_Information_Sheets_and_Consent_Forms.doc (accessed 6 December 2005).

3. D.R. Laurence, "Patients in Clinical Trials Are Protected by Consumer Regulations," BMJ, 331, 110 (9 July 2005).

4. Office of Fair Trading. Unfair Terms in Contracts: What Is an Unfair Term?, www.oft.gov.uk/Consumer/Unfair+terms+in+contracts/what+are+unfair+terms.htm (accessed 5 December 2005).

5. M. Hochhauser, "Paying for Research Related Injuries in the US," BMJ, 332, 610 (2006).