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Informed consent - legal issues from the sponsor's perspective (part II)
Introduction
The clinical trial Consent Form and Plain Language statement (Consent Form) plays an important role in informing and recruiting potential subjects to a clinical trial. The task of drafting such a document varies from company to company and usually falls upon various individuals within the sponsoring company. Often, the Australian based subsidiary will use a template of the Consent Form from their Overseas parent company.
The International Conference on Harmonisation Tripartite guidelines (ICH guidelines) can assist in drafting the Consent Form. However, compliance with the ICH guidelines does not necessarily ensure that the Consent Form thoroughly covers the rights and responsibilities of the sponsoring pharmaceutical company.
Although the sponsor is not a signatory to the Consent Form, it may nonetheless be responsible for the undertakings it provides, by virtue of various guidelines and legislative requirements. The sponsor is responsible both ethically and legally for the undertakings it provides, albeit indirectly, to the subject through the Consent Form.
In the previous issue, this paper discussed the potential liability issues for a pharmaceutical sponsor in the face of a poorly drafted Consent Form. This issue aims to alert the sponsor to certain legal pitfalls that they might unwittingly encounter should the Consent Form ever be legally challenged.
Legal actions that may be brought against the sponsor
Often, the Institutional Ethics Committee (IEC) may resolve issues arising between a patient and the sponsoring pharmaceutical company. A confidential agreement or settlement between the subject and the sponsor may keep the issue out of the public domain.
However, it is possible that the patient may bring legal action against the sponsor in the event of a dispute arising over the Consent Form. The patient may also pursue remedies under the common law and the Trade Practices Act 1975 (TPA).
TPA Issues
Clinical trials have the necessary 'commercial character' required for the application of the TPA generally. In particular, undertakings provided in the Consent Form are subject to sections 51AA, 52 and 53(g) of the TPA. In broad terms, these provisions prohibit a corporation engaging in trade or commerce which is unconscionable or misleading or deceptive. Although the TPA applies to corporations only, reciprocal state legislation applies to 'non-corporations' such as private individuals and institutions.
Section 51AA prohibits unconscionable conduct and applies where one party to an agreement is at a special advantage vis-à-vis the other as a result of the exploitation of the other party's weakness (due to illness, ignorance, inexperience, impaired faculties, language difficulties). Section 52 prohibits conduct that is misleading or deceptive or is likely to mislead or deceive. Section 53(g) prohibits a corporation making a false or misleading representation concerning the existence, exclusion or effect of any condition, warranty, guarantee, right or remedy.
Consequently, a sponsor which uses an unfair or misleading Consent Form or fails to properly notify a patient of a change in circumstance relating to the Consent Form (or the trial itself) could be found liable under the TPA.
Negligence and Part VA TPA
Common law negligence refers to actions (or omissions) which cause damage unintentionally but carelessly to someone to whom a duty of care is owed. There is little doubt that a sponsor of a trial owes a duty of care to patients in the trial and potentially also to dependants (including unborn foetuses of patients). It would be reasonably foreseeable that a breach of the sponsor's duty of care to the subject in the context of a clinical trial could result in damage. Thus, a sponsor must inform subjects of any change in circumstances relating to the trial or the Consent Form where it is reasonably foreseeable that failure to so inform could lead to damage.
Under Part VA of the TPA, sponsors and/or manufacturers are strictly liable for any adverse consequences or damage suffered by parties who have used their product. Goods are said to have a defect if their safety is not such as persons are generally entitled to expect. However, sponsors will have a defence under Part VA where 'the defect could not have been discovered given the state of scientific or technical knowledge when the manufacturer supplied the goods'.
Conclusion
Clinical trials are, in a sense, the life blood of the research-based pharmaceutical industry. As such, from a company's perspective, goodwill, consideration of ethical issues and compliance with relevant legislation and acceptable codes of clinical practice should provide a strong framework to maintain its reputation and assist in the ongoing recruitment of patients.
When drafting Consent Forms, sponsors must be vigilant and aware that patients and their physicians rely upon the undertakings provided in the consent forms. Companies must be consistent with their message in the conduct of trials while maintaining co-operative relationships with all the parties involved.
If you require further information regarding legal issues in clinical trials,
please contact Vasantha Stesin BSc, LLM on +613 9613 8398.
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