Double standards in clinical practice ethics

Human research ethics committees (HRECs) are now firmly entrenched in the research environment. Clinical research, including quality improvement activities, can only be performed and published with HREC approval. Clinical practice, however, is not subject to such approval, yet the risk of harm (to the individual and to society) from clinical practice may be considerable.1 Are researchers being held to a higher standard than clinicians? Has our concentration on ethical standards for clinical research led to an ethical blind spot for clinical practice?

Instances of research-related harm led to the development of ethics committees.2 Rightly, such committees have considerable control over research. However, this control does not extend to clinical practice ethics at their institutions.

Systematic follow-up of treated patients (research) needs ethics approval, yet clinicians can use new techniques and new prostheses (practice) without such approval, provided they do not wish to publish their results. Researchers cannot seek informed consent from a non-English- speaking patient without an interpreter or appropriately translated documents, but clinicians often obtain consent for surgery from the same individuals without these provisos.3 The ethical standards for independent assessment of the effectiveness of a procedure, therefore, are higher than those required for performing the procedure.

Clinical governance over clinical practice exists, but it may not prevent harm or ensure optimal outcomes. Governance in the form of morbidity and mortality meetings and incident reporting occurs after the event, and is largely dependent on voluntary reporting. Although present, guidelines for introducing innovations rely on self-regulation and are subject to individual interpretation.4 When does the modification of an instrument, device, surgical approach or any diagnostic or therapeutic technique become innovative, and therefore subject to formal analysis by research, rather than fall within the realm of professional judgement? For example, several minimally invasive approaches for hip replacement surgery currently exist, but surgeons do not usually request oversight when introducing these techniques. Nor is it usually asked of them, despite evidence of increased complications.5

Even the prospective governance provided by regulatory bodies for device and drug approval may not ensure effectiveness. Approval does not imply effectiveness — it implies only that a drug or device is safe and at least equivalent to current treatments. Mistakes are still made and bias in the assessment and approval of new drugs is well documented.6 In this context, placebo trials are not deemed necessary and neither are large-scale equivalence trials. Mostly, devices only require theoretical and laboratory support to show that they perform as intended in order to be approved. For some procedures, like autologous stem cell injections, testing of effectiveness is not required as stem cells fall outside the regulatory framework reserved for implants and devices.

For research, however, the standards are different. The rationale of the research is subject to scrutiny and research protocols should be beyond reproach. The researcher must seek approval to measure outcomes involving any patient contact and where publication is expected. We suggest that rather than researchers requesting ethics approval for patient follow-up, those charged with clinical governance should demand that clinical outcomes be measured. We feel that not measuring the outcomes of interventions is unethical.

There is a difference between the ethics of research (for the potential benefit of society and future patients) and the ethics of clinical practice (for an individual’s benefit),7 but this does not explain the double standard. Ethical standards for clinical practice are arguably stricter than those for research, yet they are not overseen by ethics committees. The guiding principle covering new or untested techniques in clinical practice is to “do no harm”; if there is uncertainty about a treatment, it should not be performed. Research ethics are such that if uncertainty exists, scientific enquiry should evaluate effectiveness, balancing the (largely individual) harms against any (largely societal) benefits.8

Increased oversight and regulation of clinical practice might delay the introduction of potentially beneficial treatments.9 But surely this is better than inadequately tested treatments becoming so entrenched that it is deemed “unethical” to test them against a control? Ironically, the delay occurs when these interventions are being withdrawn from standard practice because of ineffectiveness or harm.1,10

The ethical standards required for research are indeed higher than for clinical practice. We need to lower the ethical oversight required for some clinical research (particularly for low-risk, quality improvement activities), and raise the ethical oversight of clinical practice. Otherwise the ethical blind spot for clinical practice will persist, while the ethical oversight of its evaluation will remain restrictive.