āSomeone unable to put together a competent ethics submission is almost certainly unable to do competent ethical research.ā
Dr Tim Steiner, Chair, London Multi-centre Research Ethics Committee (MREC)1
āSloppy proposals, in Dr. Mās view, were written by sloppy investigators, who had the potential to threaten the well-being of research participants.ā
Laura Stark2
Amy leads off on an application to Northmoor Local Research Ethics Committee (LREC). The proposed research involves the development of a survey of mental health inpatients. Her main concern centres on the six attempts to contact people to ask them to fill in the questionnaire which is described as āhectoringā: āThere is an issue around recruiting people with mental health problems but six attempts is hounding them.ā Overall, her position is that āIn principle itās a good idea but they need to do a bit of work. In the PIS [participant information sheet] they donāt really say what theyāre going to do and why.ā
The discussion opens up to the rest of the committee. Rose, the RECās statistician, suggests that for her the issue āis whether the results are reliable. I also think a 30% response rate is alright. They could also analyse non response in terms of institutions, but Iām not sure the results will mean anything.ā Amy chips in: āThe other thing is they donāt report the results back to the patients and given they contact them six times to get them to fill out the form, the least they could do is send a report.ā Points begin to emerge as members take turns to criticise the application:
Because the applicant has not come along to the meeting to answer questions, the REC moves on to discussing its final decision. Amy sums up her position (more sceptical than at the start of the discussion): āI think we should say itās unsuitable, so they come back and have a talk about it.ā Referring to the concerns expressed about this research as a waste of money, Frank, the Vice Chair who is running this meeting, reiterates the point: āwe canāt reject it on those grounds ā we need a reasonā.
Yet for some members, concerns about repeated re-contact are not enough to fully reject an application (as opposed to just requiring some changes):
In response, Rose restructures the objection to the proposal, moving beyond issues about re-contact or it being a waste of funding to deeper concerns about the underlying justification: āBut they havenāt given a proper reason for doing it. Improving response rate is not a good enough reason.ā Like the large majority of applications to RECs, this study is finally given a āprovisionalā approval, requiring additional information or some minor changes, before being signed off by the Chair or a small sub-group of the REC.
As this example suggests, the application form and associated pieces of paper are the cornerstone of any REC decision; they provide the raw material for any assessment of the suitability of a piece of research and the trustworthiness (or otherwise) of an applicant. This chapter sets out to explore the way in which RECs draw on written materials submitted by applicants to make initial (sometimes final) decisions about whether to approve a piece of proposed research or not, and, in the process, make judgements about whether an applicant can be trusted to do what they say they will do. A key insight is into the tangled relationship between the idea of written consent to research and the rise of REC review and how consent documents (PIS, informed consent forms) serve as a form of limit to REC trust decisions.
At the most basic level the application form is obviously a source of information about the proposed study, explaining what will be done, to whom, for how long and with what possible risks and potential benefits. As such, this dry, standardised document might be thought of as largely devoid of āsocialā information. Yet for members of RECs, the written application is also an important source of intelligence on the researcher him- or herself. As Adam, a lay member of the Coastal MREC, put it: āIf somebodyās put in a pretty awful application, itās quite clear theyāre not really interested in what the participants might be thinking or feeling ā¦ the fact that they havenāt done the form properly, in a sense is indicative of a cavalier attitude.ā
At the same time, a well-completed application form, and associated material, will reassure a REC of an applicantās trustworthiness. For example, during an assessment of a study of the care of dementia patients, Coastal MREC discusses the methods being proposed, with Adam noting that āgiven the detail they have given in terms of instructions for those people filling out the questionnaires, I donāt think we need to be concerned about the focus groupsā. While the nature of the personal relationship with applicants is an important part of REC decision making (see Chapters 3 and 4), the use of application forms to pass judgements underlines how documents allow a āvirtual relationshipā to development between RECs and applicants. Yet the interpretation of the application and the risk of the intervention sit within a broader social context, including expectations of trustworthiness, which shape the reading of the application, regardless of personal interaction with applicants.
That RECs are bodies that produce, manipulate, and distribute large amounts of paper is acknowledged both by the committees themselves ā Martin, Chair of Northmoor REC, sarcastically calling across the pile of paper in front of him at the beginning of a meeting: āwelcome to the Amazon rainforest preservation societyā ā and by applicants who regularly complain about the amount of paper that is required for an application to a National Health Service (NHS) REC.3 This latter point highlights the paradox that, as is a common feature for changes in the REC system, the original drive for the standardisation of the NHS form was the desire to make things easier for researchers. In the mid-1990s the head of one of the NHS Research and Development (R&D) Directorates ā units with responsibility for oversight and support of research at a regional level ā was a public health epidemiologist who, because of his own research experience, was aware of the difficulty of setting up large studies across different ethics committees and getting contradictory opinions, as well as the challenge of filling in several different application forms. As a consequence, meetings with RECs in that part of the country were organised and their various application forms pulled together. And, as one person involved in this process put it, the result was:
However, when this regional form was adopted at a national level it became, over time, more cumbersome as additional sections and remits were added to it: āIt all got more complicated then because of the research governance agenda, the [Human] Tissue Bill and data protection and genetics. So, it, it became rather mammoth which is sort of gradually being reformed down again, I think, but it was quite difficult to contain it.ā
From a Science and Technology Studies (STS) perspective, thinking about application forms and their role in trust decisions most obviously draws on Steven Shapinās concept of a āliterary technology of trustā. In his classic discussion of Robert Boyleās attempts to persuade his seventeenth-century contemporaries of the value of his experiments with an air pump, Shapin argues that Boyle sought to draw up the rules for scientific reports, creating a āliterary technology: the expository means by which matters of fact were established and assent mobilizedā. The aim of such written reports was to give the reader the impression that they had actually seen Boyleās air pump work ā the experience of āvirtual witnessingā ā essentially creating āa technology of trust and assurance that the things had been done and done in the way claimedā.4
Of course, for some commentators, basing trust decisions on what people write down is unsatisfactory. As the leading US bioethicist Arthur Caplan noted in the early 1980s:
Yet Caplanās position ā unsurprising for a bioethicist, perhaps ā lacks awareness of the social information contained in such documents. While the specific trust-generating elements of Boyleās literary technology (prolixity, iconography, and modesty) may not be relevant to REC application forms, the fundamental point ā that readers of even the most dry and formal written documents make trust decisions about authors ā is a key insight, and one common in broader discussion of regulatory decision making. As Heimer and Gazley note in their work on the regulation of HIV clinics, peopleās ability to complete application forms caused regulators to wonder āIf clinic staff cannot manage such mundane chores as making copies in triplicate ā¦ how can they possibly manage the more complicated tasks of good science and good caregiving?ā6
This chapter makes the case that in the context of research ethics applications, written materials allow the āvirtual witnessingā of both applicantsā character (whether they are arrogant or not, for instance) and, moving beyond just Shapinās argument about convincing accounts of past behaviour (this is how the experiment was done), their future behaviour (how carefully they will seek consent from patients, for instance). This is then used as the foundation for a trust decision about the applicant, to which other forms of trust warrant ā from previous ālocal knowledgeā of an applicant (Chapter 2), or how they present themselves in front of the committee when invited to answer questions (Chapter 3) ā are added. In terms of idiocultural variation between committees, while ethics committeesā assessment of these application forms do vary, the format of NHS REC meetings ā guided as they are by a set of standard operating procedures (SOPs) ā tend to resemble each other.7 While, as a result of the legislation around pharmaceutical trials, the documents and rules surrounding REC review tend to divide between those focused on Clinical Trials of Investigational Medicinal Products (CTIMPs ā ādrugs trialsā) and those focused on all other research, the way in which REC meetings proceed is largely blind to this distinction. Members arrive at the meeting room having been sent the relevant paperwork about a fortnight before, having already formed a first impression about the application. However the RECās discussion goes and whether or not the applicant attends, the form and other written documents serve as an anchor for individual membersā decisions about an application.8 What people actually receive varies according to their role and expertise. All members will get application forms and consent documents (the PIS and the consent form), but only the pharmacist on the committee and the chair are likely to be sent the Investigatorās Brochure (IB: a comprehensive summary of information about a drug) for a drug trial.
Following introductions and any relevant news (proposed policy changes around REC review perhaps), a REC meeting starts by reviewing applications. The committees I observed used a ālead reviewerā system where two members of the committee were flagged as having responsibility to lead discussion on an application. While ot...