The Ethics of Regulating Monetary Incentives within Clinical Trials

A transcript of a presentation I gave today on whether it is ethical to allow people to be paid to participate in clinical trials.

I am going to be giving a short presentation on the use of monetary reimbursements and incentives within clinical trials, specifically looking at Australian policy. Currently in Australia, participants involved in clinical trials cannot be offered any monetary incentives for taking part in the study. Reading from section 2.2.10 of the ‘National Statement on Ethical Conduct in Human Research” we have:

“It is generally appropriate to reimburse the costs to participants of taking part in research, including costs such as travel, accommodation and parking. Sometimes participants may also be paid for time involved. However, payment that is disproportionate to the time involved, or any other inducement that is likely to encourage participants to take risks, is ethically unacceptable.”

This policy I feel is unjustified, it shows no respect for the individual’s right to autonomy and in fact is cleverly designed to undermine such autonomy.

Before we get into the details of such an argument we will start by just looking at why such ethical concerns exist.

Generally when we talk about the possibility of people being paid incentives to participate in clinical trials we are mainly concerned with healthy people who are being recruited into Phase I clinical trials. While ailed people can also often be paid incentives to participate in clinical trials, Phases II and III, these trials are designed to benefit their position. In a Phase I trial the success of the treatment would have no effect on the potential participants and so ethical concerns are raised, understandably, when these participants are paid incentives to take part, that is, risk their health for no medical gain on their own behalf.

Generally when investigating such policies one would gather as much statistically relevant data as possible to help show exactly what are the issues at hand are. Unfortunately in this case there is not really any accessible data outlining percentages such as persons who have suffered adverse effects against total number of person involved in clinical trials. Without such data it is difficult to speculate on the actual risks that participants are putting themselves at except by analysis on an individual case by case basis.

In 2007 after being successfully administered to animals, TGN1412, an anti-inflammatory drug being developed to treat leukemia and arthritis, was tested on 6 healthy volunteers in a Phase I drug trial. These participants were offered a sum of 2000 pounds to take part in the study resideding in the UK where current policy allows such monetary incentives. The administered doses were 500 times less than the determined safe dose in animals but due to unforeseen complications the 6 participant’s conditions rapidly deteriorated, resulting in four of them suffering massive internal organ failure.

As with any misfortunate event like this the media jumped on it. Sensationalized stories appeared in many papers and online news outlets depicting events with little concern for the truth. First let’s look at an excerpt from an article published in the Times:

“Ms Marshall said that her boyfriend felt ill 80 or 90 minutes after being given an oral or injected dose of the

Now the Times are generally considered a fairly reputable news outlet. Unfortunately articles like this are not what you find when you initially Google the event. Instead you get stories like this:

“After being injected with the anti-inflammatory drug TGN1412, patients began tearing their shirts off, screaming that their heads were going to explode. One patient's head swelled to triple its normal size, and patients were soon passing out, vomiting, or screaming in sheer terror.”

Now don’t get me wrong this was a very unfortunate and sad event for these people and their families. Four of the men were in a critical condition, with one ending up in a coma for several weeks and another having suspected cancer as a result of the drugs effect. But it is too easy for the media to point the blame at the medical institutions and for people to jump to the conclusion that these men should have not been paid to be human guinea pigs.

At first glance this opinion does seem to be justified with many of the men expressing that the money was a driving factor in their involvement. “It’s such good money for a student” One of the patients stated, “It goes a long way”.

But upon further investigation it becomes clear that the monetary incentives were not the problem here. Instead it soon becomes apparent that the real issue lies with how these trials are advertised and ‘sold’ to the participants. These trials are often advertised like a holiday, using cavalier language and very little focus on the potential risks.

A Research ethicist is quoted as saying, “They failed to adequately disclose the degree of uncertainty around a first- in –man’s trial. The risks were well known. They’re not disclosed in the consent form” http://www.sskrplaw.com/lawyer-attorney-1472884.html

For these companies it really is all about enticing people in. Money does act as a powerful incentive but it is not the real concern here. The concern is the deception that the recruitment companies are employing.

Now imagine a hypothetical situation with a government that has no policy on monetary incentives and no laws protecting the participant’s right to informed consent. You can imagine that there would be a rise in clinical trial participation and thus consequently a rise in people who suffer adverse effects to these trials. The media would catch on as it does and creates a big fuss. The government then is put under pressure to fix the problem. How could it go about this?

If you look at Australia what our government has effectively done is say “these people don’t know what’s good for them and where therefore going to protect them from themselves” and so they have prevented anyone from receiving payments to participate in clinical trials, a clever and deceptive way of preventing participation or at least dramatically reducing participation as who would willing act as a human guinea pig when there is nothing in it for them.

But they have missed the point completely and that is to act ethically, as they so claim to be doing, they need to respect people right to choose, their autonomy. So instead of taking the easy, blanket approach of just preventing incentives, they need to address issues of informed consent. Ensuring that participants are not being deceived by the recruitment companies into thinking they have a sweet risk free deal.

With better enforced polices and proper avenues for prosecuting companies that don’t follow such policies, there should be no issue with people who are informed of the risks and understand the potential dangers from taking payment to participate. This is their choice and if they feel that they can justify the risks to themselves by the potential financial gains then they have the right to do so. This is comparable to miners who receive hazard pay when going underground or working on deep sea oil rigs. The work has substantially greater risks involved but they are financially compensated for taking such risks.

In both cases here it is the government’s responsibility to ensure that they do understand the risk and can make informed decision but not their role to take the decision out of their hands. This I feel is the most ethical approach available to us.

Before I finish up I want to address another issue that I believe is relevant to the situation, and this is the payments that go to the recruitment companies for recruiting participants into a trial. It seems contradictory that the government would establish laws preventing paid participation in clinical trials but have no strong policy regarding the conflict of interest that these recruitment companies obviously possess. This extends even further with doctors in Australia receiving payments upwards of $6000 per patient they recruit into clinical trials. GP’s are trusted by patients to have their best interests in mind but how can this possibly be achieved when such a conflict of interest exists. Just a little food for thought.

In conclusion, the point I am trying to drive home here is that the current policy is deceptively unethical, removing peoples autonomy without them even realizing. As long as people are fully aware of the risks they should have the right to be paid participants in clinical drug trials.