The apparently unassailable status of informed consent as an ethical principle in medical research can be traced to series of shocks and crises (McNeill & Pfeffer, 2001). These have caused research to occupy a distinctive moral space in which the expert system (Giddens, 1990) of medical research is treated as less trustworthy than that of medicine (Chalmers & Lindley, 2001). Informed consent, by operationalising people's autonomy and ability to make choices about participation, is seen as the last defence against the risks of research, including those associated with the motives and practices of researchers (Ashcroft, 2001). A requirement that written information be provided is now a near universal feature of research ethics committee approval of procedures for obtaining consent.
Expert systems such as research are existentially troubling because ordinary individuals lack the specialist knowledge necessary to make appropriate judgements about them (Misztal, 1996). A major element of the regulation of medical research has therefore focused on controlling what is disclosed to research candidates. Participant information leaflets (PILs) play an important role here in producing consent as an “auditable moment” with its own documentation and visibility to judicial scrutiny (Ashcroft, 2003), and thus in the management of risks to researchers themselves. Perhaps no element of the submission is as carefully scrutinised as the PIL (Kent, 1997). Nonetheless, a body of work has persistently demonstrated that research participants frequently lack full comprehension, and that their ideas about basic elements of research procedure such as randomisation may be substantially at variance with what would be regarded as “correct” (Appelbaum, Roth, Lidz, Benson, & Windsdale, 1987; Snowdon, Garcia, & Elbourne, 1997).
Much interest to date has focused on responses to information provision in situations where ill people are asked to take part in studies involving some kind of experimental design, especially clinical trials. However, the issues that attend the involvement of healthy volunteers outside of experimental studies have been much neglected (Morris & Balmer, 2006). In this paper, we explore, empirically and theoretically, the role of written information in recruiting healthy unpaid volunteers to research. Our empirical exploration uses accounts from participants in the Genetic Regulation of Arterial Pressure of Humans in the Community (GRAPHIC) study, a genetic epidemiology study. GRAPHIC provides an ideal opportunity to explore the issue of informed consent in a situation where participants were “healthy” volunteers who were not making decisions immediately relevant to their own therapy, and were recruited outside of a clinical setting. If we consider decision-making by healthy volunteers under near-ideal conditions to be normative for models of informed consent to participation in research, an empirically informed understanding of consent in this context offers important empirical and theoretical insights into strengths and limitations of the available theories and practices of information, understanding and consent. Our example thus has relevance not only to medical research, but to other studies—including social science research—conducted in health settings.
A standard account of “informed consent” in bioethics characterises it as meaning that research participants fully understand the nature of scientific rationale and procedure; have insight into a set of risks of various types that might be identified on their behalf by ethicists or regulators; and have motives for participation that are not “false” (National Commission, 1979). Potential research participants are thus produced both as bearers of rights but also bearers of responsibilities: they
Two possible explanations for why misunderstandings occur are prominent in the ethical literature. One is that the information given to potential participants is too incomplete, misleading, or badly written to allow proper understanding; the second is that potential participants fail or refuse to produce the appropriate response to the information (Moreno, 2003). These explanations are well illustrated in the following excerpt:
if informed consent is to achieve its goals of promoting autonomous
A second element of a critique of the “patient education” approach to informed consent would have its origins in sociology, and particularly in medical sociology. In sociological terms, the (standard) bioethical position on informed consent is concerned with the degrading or erosion of agency that might result from participation in research on the basis of a false prospectus. An alternative conception, however, is that insisting that people only take part in research on the terms of those
The GRAPHIC study aimed to develop a phenotyped resource of nuclear families (two parents and two adult children) to assess the impact on blood pressure of candidate gene polymorphisms and environmental factors. All participants in GRAPHIC were recruited as (apparently) “healthy” volunteers outside of a clinical situation, and their first contact with the study was by letter.
Women aged 40–59 years registered with participating general practitioners (GPs) in Leicestershire, UK were contacted by
We conducted a qualitative study of people who had participated in GRAPHIC, aiming to explore views and experiences, with the approval of Leicestershire Research Ethics Committee. GRAPHIC participants who had previously agreed to be contacted about further studies were approached by letter. No more than one participant from any one family was selected, and purposive sampling was used to select participants based on: position within the family (parent/offspring), gender, and willingness to be
Twenty-nine GRAPHIC participants agreed to take part in this qualitative study (16 men and 13 women) of 84 invited. Theoretical saturation was reached, with no new themes emerging after the 11th interview. The parents (18) were between 47 and 61 years of age and the offspring (11) were between 23 and 35 years old. Participants’ occupational backgrounds were varied. All participants were of “white” ethnicity, reflecting the GRAPHIC population.
Participants’ accounts suggested that the invitation
Participants generally indicated that they considered medical/genetic research to be a good thing (28). For some, the potential for medical research was unspecified, but for most included references to improving knowledge/medical science, prevention and treatment of disease, finding cures for diseases, saving/lengthening lives and the prevention of suffering. Genetic research was seen as being especially rich in potential for medical advancement:
I have opinions about it, that it's hugely
What is the purpose of the study? High blood pressure is an important risk factor for strokes and heart attacks. Evidence suggests that the lower a person's blood pressure, the lower the risk of strokes and coronary heart disease. In order to properly understand the genes that control blood pressure, it is important to study a sample of the whole population containing individuals with low, average and high blood pressure. Such research is best done in a family setting so we can assess the
There was no indication that the participants felt under any pressure from the research team to take part GRAPHIC. Instead, accounts contained two principal motivations for taking part. The first, given by all participants (29), was to help others, with the theme of good citizenship highly prominent:
as much as we didn’t have a reason not to take part I suppose, just to be helpful and you know and anything that encourages medical progress you know I think has got to be advantageous to people.
The second motivation for participation was the possibility of some form of (modest) personal gain, either directly through the medical tests conducted as part of GRAPHIC (12) or less directly through the possibility of the research findings benefiting themselves or their family in the future (12). For many participants cardiovascular disease (18) or genetic problems (11) were particularly salient, often because of family history:
I embraced it, I thought it was a wonderful opportunity for my
We emphasise that the information on genes (which we will get from your blood sample) is obtained for research purposes only. At the present time, the significance of the results is unknown and may remain unknown for some time. The study we are doing aims to add to our knowledge of how genes and other factors affect health and blood pressure. We are gathering this knowledge by studying groups of people, and the genetic research is not meant to test your personal medical status. For these
Even though not all GRAPHIC participants attributed meaning in the way that was intended, it would be a mistake to assume that the texts of leaflets are empty of meaning or had no value for participants. As Prior (2003b) argues, documents function in many ways, not all of them directly related to their content. For GRAPHIC participants, the PILs were the primary source of information at the time when they were making the decision about whether to take part. PILs appeared to play the role of the
This study of participants in a genetic epidemiology study explored the meanings given by healthy volunteers to the PIL that was the primary source of their information about the study. Healthy unpaid volunteers being recruited outside of a clinical situation are arguably best placed to read PILs and make decisions under ideal conditions, without experiencing the stress, pressures or conflicts that may attend participation in clinical research involving ill people. Our analysis suggests that
“Informed” consent to research participation, and the role of PILs in achieving “informed” consent, is not simply a technical problem. A more sophisticated approach to understanding the ways in which meaning is attributed to research participation is required, as is a more thorough theorisation of the implications of those meanings for the ethical practice of research, and of the more diverse functions of leaflets. This is likely to require dialogue between the social science, ethics, and
Thanks to the GRAPHIC participants and GRAPHIC staff who gave up their time to help with this study. GRAPHIC was funded by the British Heart Foundation (BHF). This qualitative project was funded by the Healthcare Epidemiology (Leicester) research fund and drew on theorisations developed as part of the ESRC's Science in Society Programme (Project number RES-151-25-0026). Nilesh J Samani holds a BHF Personal Chair. Joelle Kivits was funded by ESRC post doctoral fellowship PTA-026-27-0403. Thanks
Corrigan (2003) challenged these assumptions, arguing that overemphasis on the fully informed rational individual divorces the consent process from its social context and negates the role of social networks in everyday medical encounters, risk perception and decision-making. O'Neill (2003); Hedgecoe (2004); Dixon-Woods et al. (2007) and Felt et al. (2009) indicate limitations of information provision in resolving all ethical questions in medical research; instead they call for an approach to informed consent that takes complexities into account. While medical literature (de Balicourt and Dobsworth, 2013; Kahan et al., 2016) presents trust as an objective issue resolved by transparency, a sociological perspective considers how understandings of trust are produced, embedded and contoured by a complex set of social relations and processes (Brown and Gale, 2018) imbued with competing, contradictory power relations and demands (Braidotti, 2013; Dennis, 2017).
