Introduction

Pre-recruitment is the practice of recruiting participants to a list of potential research volunteers in general rather than to a specific research project. Pre-recruitment is beneficial because it makes the conduct of clinical trials more efficient by facilitating the quick and easy recruitment of participants. As such, it is a useful practice which facilitates the conduct of good quality science. This is a relatively common practice in commercial medical research; however, current practices in the UK and perhaps elsewhere clash significantly with what are seen as best practices and ethical guidance with regard to recruiting participants to individual trials, and insofar as this undermines these practices need to be reformed. While I’ll discuss this in the UK context, similar implications hold wherever pre-recruitment is used.

Internationally, clinical trials are now highly regulated, primarily but not exclusively, via research ethics committees.1 The recruitment of research participants is a central focus of ethics committee review.2 These committees have evolved a set of norms to govern the recruitment of research participants:

1. Participants should freely choose to be involved, not be induced, but may be compensated for time and the inconvenience of participating. Typically the amount of compensation shouldn't be emphasised.

2. No coercion is to be used in the recruitment process—for example, the usage of non-emotive language is preferred.

3. Fully informed consent must be obtained—so, for example, the research participant shouldn't be misled with regard to the likely success of the research.3

These well-established norms have likewise been absorbed by industry, with the Association of the British Pharmaceutical Industry (ABPI) stating in its code of practice for clinical trials that the recruitment of research participants to specific individual trials must be approved by an authorised ethics committee.4 And that conditions of that approval will include advertising in a neutral fashion, ensuring that participants have full and balanced information and that they are not coerced.4

Given this, I was surprised to hear my local radio in Staffordshire advertising thusly: “Be a hero, volunteer for medical research and if you are selected you could earn thousands of pounds” which is clearly contrary to the central norms of recruitment to clinical trials. When I looked at the websites of this company and others engaged in pre-recruitment, similar issues came up.ⁱ So, for example, if you look at the website of http://www.trials4us.co.uk, you will see the headline banner is: “We need healthy and patient volunteers for paid clinical trials starting Now” and suggests “As a medical trial volunteer, you are helping to find a cure or simply improve the standard of living for millions of people and sufferers of varying medical conditions worldwide.” It has links to sections on getting paid to participate, and even suggests a referral fee for recruiting friends.ii,5 I'm not picking on http://www.trials4us.co.uk as a lone example; there are several companies recruiting in this fashion. In effect, what these companies are doing is applying traditional marketing techniques to the recruitment of clinical trial volunteers. However, it seems conflicts occur between the appropriate conduct of research and thinking about recruitment of research participants in traditional marketing terms.

These adverts appear to violate the three well-established general requirements of the recruitment of research participants that I outlined above and the industry endorses. They emphasise in emotive language the likely benefits for others of participating, they focus on the financial recompense and portray the research as likely to succeed. So, we would normally deem such recruitment to be unethical, failing to appropriately respect autonomy, and an ethics committee wouldn't allow it. However, pre-recruitment falls into a regulatory loophole, since present regulations apply exclusively to the direct recruitment of participants into specific trials. Since the advert was for general recruitment rather than to a specific trial, there is no formal regulation of this activity. You do not currently need research ethics committee approval to approach people to pre-recruit them, nor is there any formal guidance for this sort of recruitment either from the Health Research Authority (HRA) or from the ABPI.

The present disparity in practices of the pre-recruitment and recruitment of research participants seems problematic—to put it starkly, if you are recruited onto a list of potential participants on the promise of riches and heroism via clinical trials and are then recruited from that list into a specific trial in a much more neutral fashion, your beliefs about the actual trial will be informed by what you were told during pre-recruitment—in other words, you will think you are being heroic and earning lots of money, precisely the views that the current regulations are trying to prevent participants from having. As such, unregulated pre-recruitment runs the risk of making a mockery of the careful standards which have evolved to try and protect people from exploitation and harm in clinical trials. This provides a strong prima facie reason to harmonise our regulations—given that the point of pre-recruitment is to eventually recruit participants to specific trials, we ought to ensure that the norms regarding such specific recruitment are protected by regulating pre-recruitment to the same standard.

Before we rush to regulate pre-recruitment, however, it is worth considering whether there are any significant objections to harmonisation by regulating it. I'll consider two main objections, first that our current standards might be too high and second that these sorts of activities might not be able to be regulated.