Ethics committees (IRBs in the US) are now firmly entrenched in the research environment such that clinical research can only be performed with their approval. Clinical practice, however, is not subject to such approval, yet in many cases the risk of harm (individually and to society) from clinical practice is greater. 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?
Rightly, the ethics committee has considerable control over research. Their role is to minimise the risk of harm from clinical research. Examples of such harms exist, and these examples (including WWII atrocities) led to the formation of ethical standards for research. However, the committees only have control over what is submitted to them, and they tend not to concern themselves with clinical practice at their institution. For example, the follow up of treated patients (research) needs ethics approval, but clinicians can perform new techniques and implant new prostheses (practice) without ethics approval.
Drugs versus devices
The requirements for drugs to be approved prior to clinical use are that it be safe and at least equivalent to current treatments. Mistakes are still made and the bias in the assessment and approval of new drugs is well documented (Ben Goldacre’s book Bad Pharma for a general overview, and the antidepressant story here). For implants and devices the requirements are lower (history here, documentation of the differences (for the US) here). Placebo trials are not necessary. Large scale equivalence trials are not necessary. Mostly, devices require theoretical and lab support to show that they perform as intended. For some procedures, like autologous stem cell injections (in Australia anyway), you don’t need anything, just a syringe and a centrifuge and you can open up for business. For techniques that do not involve devices or drugs, like new surgical techniques, you just need to try it out a few times and there is no requirement for oversight or reporting.
Practice versus research
For research however, the standards are different. For example, if you are doing a procedure that has not been subjected to a trial, or if there are practice variations with an intervention, ethics committee approval is not required to perform the procedure, but it is required to measure the outcomes (if any patient contact is required and publication is expected).
Shouldn’t it be the other way around?
Rather than researchers asking for ethics approval to follow up patients, shouldn’t it be the other way around? Shouldn’t those in charge of ethical standards be demanding that we measure our outcomes? To me, not measuring the outcomes is unethical. And shouldn’t those in charge of ethical standards for an institution cover all clinical activity, not just the research?
Ethics of research vs ethics of clinical practice
There is a difference between the ethics of research and the ethics of clinical practice, but it does not explain the double standard. In fact, the ethical standards for clinical practice are stricter than those for research, yet it is clinical practice that is not covered by ethics committees. For clinical practice, you have duty of care, confidentiality etc. but the guiding principle covering new or untested techniques is to “do no harm”. In other words, if you aren’t sure about the treatment, you shouldn’t be going there. The ethics for research says: if you aren’t sure about the treatment, find out: do the research to measures the outcomes. The ethics for research does not say to “do no harm”, but to “balance the (individual) harms against any (societal) benefits”.
What should happen is that clinicians should not be performing any treatments until they have been tested. What is happening is that clinicians are performing many treatments that have not been adequately tested, and researchers are being hampered from evaluating those treatments.
But if we raise the barriers to clinical practice, we might delay the introduction of beneficial treatments?
Yes, we might. However, what often happens is the opposite: treatments become entrenched such that it then becomes “unethical” to do a controlled trial. This is how we end up with the current problems of overtreatment due to ineffective and harmful treatments. Examples or treatments that were/are common practice and were later shown to be ineffective abound in this blog (platelet rich plasma, vertebroplasty, knee arthroscopy for arthritis, spinal steroid injections, fusions for back pain, the ASR hip replacement). In fact, every surgical procedure that has been subjected to a placebo-controlled trial has failed to show a benefit (here), yet we are told that such surgical trials are unethical.
What if we did a trial of back fusion surgery versus placebo for back pain, and the trial showed no difference (a real possibility). How many people have been harmed and how much money has been spent in the last 50 years on that procedure alone? Would it not have been more ethical to have done trials on a few hundred patients first, if there was a possibility that we could have avoided performing millions of spine fusions in the future?
The bottom line
The ethical standards for research are higher than for clinical practice. We need to lower the ethical standards for clinical research (particularly for things like patient follow up and surveys), and raise the ethical standards for clinical practice. Otherwise we have the current situation whereby I can use the latest metal-on-metal hip replacement without any special consent or approval, but to have independent objective follow up afterwards I need special consent and approval to phone them afterwards. Telemarketers don’t even need that.