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Is the pre-recruitment of research participants potentially an ethical issue in Australia? (David Hunter)

 


I’ve recently published a paper focused on the UK looking at some ethical issues faced by a practice that has developed for the recruitment of research participants there, called pre-recruitment. http://jme.bmj.com/content/early/2015/02/19/medethics-2014-102639.abstract. Given the difficulties recruiting research participants, companies have formed who source research participants for researchers, particularly for pharmaceutical research. They do this primarily by recruiting potential participants onto lists and then selling access to these lists to researchers.

This is hardly a new practice, informally researchers often keep lists and contact details for previous participants so they can recruit them onto future studies which is a form of pre-recruitment in itself. However having become a commercial business worrying trends have emerged in the UK regarding the information provided to the pre-recruited, where they may be promised that they will earn thousands of pounds, help cure cancer and be heroes if they just agree to volunteer.

What is problematic about this is that no research ethics committee in the UK and I suspect none here either would approve a project which made such statements in its recruitment literature. However because this is pre-recruitment it is entirely unregulated. And worse still the research ethics committee reviewing the actual study that draws on this pool of pre-recruited participants will probably not know they have been pre-recruited, nor what information they were given prior to their recruitment to a specific study. This is problematic both because it makes a mockery of the careful provisions we have established regarding informed consent to ensure it is valid (avoiding explicit incentives, emotive language and over promising results) but also because it presents the participants with conflicting information, which turns the consent process into a game they play to get to the results (a fortune, cure for cancer etc) rather than a careful reflection on whether they want to participate.

Like in the UK, presently in Australia the pre-recruitment of research participants is entirely unregulated – specifically the National Statement wouldn’t apply to pre-recruitment since it is not directly the recruitment of research participants though we might think best practice in pre-recruitment would follow the norms established by the National Statement and enforced by Human Research Ethics Committees (HRECs) for the direct recruitment of research participants in Australia.

So how should HRECs respond to pre-recruitment? Pre-recruitment is difficult to regulate both because it is prevalent and because unlike research itself it does not have a public output at the end of it. I’d suggest that the best way forward is for a section on pre-recruitment be added to the National Ethics Form. This should ask if any research participants have been pre-recruited, and if they have copies of the recruitment literature and materials should be provided to the HREC reviewing the research. If the HREC considers that material to be misleading or inadequate it can then turn down the study, or at least require a different recruitment method. This is likely to quickly change the practices of pre-recruitment companies since if researchers can’t get ethical approval if they use pre-recruiters their business model will swiftly fail.

Dr David Hunter
Associate Professor of Medical Ethics
Southgate Institute,
School of Medicine,
Flinders University
David.hunter@flinders.edu.au

This blog may be cited as:
Hunter, D (2015, 11 June) Is the pre-recruitment of research participants potentially an ethical issue in Australia? AHRECS Blog. Retrieved from https://ahrecs.com/human-research-ethics/is-the-pre-recruitment-of-research-participants-potentially-an-ethical-issue-in-australia-david-hunter

facebook catskillmtns says:

Excellent read, I just passed this onto a colleague who was doing some research on that. And he just bought me lunch as I found it for him smile Thus let me rephrase that: Thank you for lunch! “Without friends no one would choose to live, though he had all other goods.” by Aristotle.



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