Rebecca Dresser’s personal experience of cancer diagnosis, in the context of which she faced decisions concerning both routine treatment and research participation, was the instigation for this interesting volume.  Dresser quickly became aware of the trade-offs between research and treatment, and faced the difficulty of making health-based decisions when challenged with the choice of either standard treatment or the proposed research (and the risk she could be assigned to a placebo).  She chose standard treatment over research participation but later reflected that this raised conflict between her personal health and her sense of responsibility to the wider community of patients.  Despite working in the field of medical ethics, the decisions she found herself making were based on personal motivations. Following successful treatment, she began to think in more detail about the experiences of patients and research volunteers, which led to this book.

The book helpfully draws together a hugely diverse literature and challenges notions such as research subjects as compliant partners in the research process. The core contention is that the ethics governing the implementation of research (involving researchers, ethics committees, peer reviews, institutions etc.) largely ignores the people who understand what it is to be research subjects. 

The first Chapter briefly recounts the history leading to the current climate of professionalizing ethical deliberations and how this has tended to exclude research subjects.  Dresser argues, “People who have never been in the research subject’s position are often unaware of the pressures, concerns, and other on-the-ground realities that subjects encounter” (p.4). Despite the language of participation, she maintains that these people are often treated as subjects rather than participants. 

Dresser argues that taking subjects’ perspectives into account, learning from them and involving them early in the process of designing and delivering research can overcome established barriers and embedded misunderstandings which often eventuate in low participation rates.  She contends that a form of deliberative democracy could provide a suitable alternate approach.

A tension which emerges early in the book is the ethical dynamic between the personal stories of individuals against the ethics of the methodological and scientific requirements for researchers. Many researchers recognize the need to be informed by research volunteers, however the requirements of methodology, peer review and other processes do not readily enable this interaction. There is fruitful ground for further work exploring this dynamic.

Chapter 2 examines the educational value of becoming a research subject, especially where researchers themselves experience participation as research subjects.  This underlines the importance of public trust and transparency – including establishing clear boundaries between research and treatment.

Dresser argues that subjects’ views about research and their experiences of participating in research, are particularly important. In Chapter 3 she argues that research ethics has typically not taken account of the everyday encounters which determine how research subjects experience their participation. Participants sometimes find it arduous dealing with the demands of a study when they are already dealing with illness, and patients may lack understanding about the distinction between ordinary medical care and the demands of research participation. This becomes even more complex when parents are asked to make decisions on behalf of their children. 

Where the focus is entirely on outcomes, the well-known problem of ‘subject misbehavior’ arises.  Chapter 4 explores instances where some subjects fail to follow research requirements, some attempt to second-guess which treatment group they are in, and subjects may create risks to themselves or others by providing modified information to researchers that can alter the value of the research outcomes.

Chapter 5 focuses on participants as partners in genetic research.  This is an area where personal stories and vulnerable groups stand out because genetic data are always potentially identifiable.  There has been some history of re-use of bio-specimens in ways subjects had not originally consented to, and ongoing tension concerning to what extent research results are valuable feedback for participants when the results may present little or no value for ongoing treatment.

Terminally ill patients at times request the ‘right to try’ as yet unapproved drugs.  Chapter 6 outlines the arguments around this question.  This chapter perhaps most clearly identifies the distinction between personal stories (cases) and the need for a wider community approach (science and regulation). Despite exploring the issues in some depth, Dresser does not go the further step of establishing that these distinctions are likely built on different conceptualizations of ethics and that understanding these different conceptualizations could provide some helpful guidance.

There are added ethical dimensions when taking research into developing countries.  Chapter 7 unpacks many of the practical issues researchers face in developing countries. This is a useful section of the book, especially if some of the principles can be generalized from developing countries to research with marginalized communities or vulnerable populations more widely. Understanding how subjects think about and experience research and lead to direct tangible improvements.

Chapter 8 provides an interesting outline of how some of the relevant issues are explored by creative writers.  This chapter in many regards seems out of place in overall the line of argument of the book and may be better suited to a stand-alone paper.

Dresser draws the book together (Chapter 9) by making a case for listening to and including subjects into every aspect of the research process so they begin to become participants in the best sense of the term. Throughout the book Dresser frequently turns to the theme of trust – trust of communities in research, trust between researchers and their participants, trust in the process, and the concluding section builds on this theme.

There is an enormous literature related to research subjects’ views and experiences. Dresser has provided a valuable volume drawing on insights from this literature.  It would have been useful also to include non-medical research, but perhaps this remains for a future volume.  Certainly a book I am happy to recommend.

© 2019 Erich von Dietze

Erich von Dietze, Manager, Research Ethics & Integrity, Murdoch University, Western Australia