‘Human Subjects Research Regulation: Perspectives on the Future’ reviewed by Dr Andra le Roux-Kemp

‘Human Subjects Research Regulation: Perspectives on the Future’ edited by I. Glenn Cohen and Holly Fernandez Lynch (MIT Press, 2014).

Human Subjects Research Regulation: Perspectives on the Future is a seminal work
and a must-read for everybody involved in research pertaining to human beings.


9780262027465_0This is a bold statement of mine and you may wonder whether this also includes you. Or, you may have read this statement and immediately disqualified yourself from the targeted audience because you don’t really consider what you do to be ‘human subject research’. A third alternative is that the statement above made you feel even more concerned about the nature of your research, the undefined space between you and your research subjects, and the impact (or not) that your research ultimately has on them.

Should social and behavioural research be regulated in the same manner as biomedical research? Or does research conducted on de-identified tissues from a databank constitute human subject research? And what is the ethical and legal landscape of this ‘twenty-first century university-industrial research complex’? These are also the fundamental concerns of the multi-billion dollar enterprise of human subject research, an enterprise that includes a broad spectrum of role-players and stakeholders, and the modern tenets of which can be traced to the Nuremberg Tribunal that also passed judgement on Nazi physicians and administrators who were involved in horrifying experiments on their captives.

In the USA (the primary geographical focus of this book), a framework for protecting human research subjects and regulating research involving human subjects have existed as early as the 1960s, with formal regulations being published in 1974, and the Belmont Report (Ethical Principles and Guidelines for the Protection of Human Subjects Research) published in 1979. The Belmont Report was intended to ‘establish a framework for drafting future regulations and guidance for the protection of human research subjects’ and ultimately gave form to what is known today as the ‘Common Rule’, the present regulatory framework governing human subject research in the USA (pp. 10-11).This current regulatory system has been criticized for being slow, expensive, inconsistent, overly focused on the formalities of informed consent, and overprotective of research subjects facing only a minimal potential risk (p. 2). (It should be noted that the same criticisms are also raised about the regulatory systems of other jurisdictions and the value of the debate in this publication is therefore not limited to a USA-based audience.) In light of these criticisms, the US Department of Health and Human Sciences released, in July of 2011, the Advanced Notice of Proposed Rulemaking (ANPRM) titled ‘Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators’. The ANPRM outlines seven areas of concern with regard to the current regulatory scheme and proposes six key changes to the current system of human subject research regulation:

  • ‘A new approach to calibrate the review process to the level of risk posed by a particular research project.
  • Facilitating the use of a single IRB (Institutional Review Board) for multisite research.
  • Changing the requirements for documenting and waving informed consent.
  • Putting in place mandatory data security protections for identifiable data, including biospecimens.
  • Harmonising disparate systems for adverse event reporting and facilitating the aggregation of such reports.
  • Extending the regulations to all research at all facilities that receive federal funding from an agency that requires compliance with these protections, rather than exclusively for the research that these agencies actually fund’ (p. 4 and 12).

In addition to these ANPRM recommendations, President Obama’s Commission for the Study of Bioethical Issues made further recommendations in September of 2011 to improve the regulatory protection of research subjects in federally funded research. To date however, the only real effect that all these recommendations have had is to generate a healthy dose of academic debate about what our research entail, whether we should regulate it, and how we should regulate it.

Human Subjects Research Regulation: Perspectives on the Future is a volume of twenty-two essays by thirty-three cross-disciplinary authors tackling all the major issues in the regulation of human subject research in our current ‘twenty-first century university-industrial research complex’. The authors make recommendations, offer solutions and ask hard questions, including what the objectives of research regulation should be, and whether the current regulatory scheme still serves its intended purpose. The book forms part of The Basic Bioethics series by The MIT Press, and makes a valuable contribution to the existing collection of manuscripts, reference works and textbooks that engage with topics related to the philosophy of medicine, advances in genetics and biotechnology, end-of-life care, health and social policy, and the empirical study of biomedical life.

The book is divided into five parts with the two chapters in Part I, focusing on what an appropriate balance would be between protecting research subjects against potential risk, and allowing for important research to be conducted without unnecessary hindrance. Part II deals with the more conceptual question of what an appropriate governance structure for the regulation of research involving vulnerable populations should be (Chapters 4 – 6), and Part III places under the microscope all the role-players and stakeholders involved in human subject research (Chapters 7 – 11). Part IV makes a particularly valuable contribution to the much debated issue of data privacy in the context of biospecimens and tissue banking (Chapters 12 – 17), and the final Part V challenges our conventional ideas about human subject research regulation by asking pertinent and well-timed questions about the underlying assumptions on which the current scheme is based, and the possibly outdated notions that continue to guide our decisions about research, risk, protection, and regulation (Chapters 18 – 22).

A lot of ground is covered in this publication and the editors – I. Glenn Cohen and Holly Fernandez Lynch – deserve special commendation for the cross-referencing between the different parts and chapters of the book, ensuring that the labyrinth of topics (and opinions) that plague the current regulatory scheme for human subject research ultimately speak as a unified voice in questioning existing practices, making recommendations, and offering new perspectives. Some of the Chapters that offered a particularly interesting read are Parasidis’s ‘Classifying Military Personnel as a Vulnerable Population’ (Chapter 4) and Capron’s ‘Subjects, Participants, and Partners: What are the Implications for Research as the Role of Informed Consent Evolves?’ (Chapter 9). Part IV of the book (Chapters 12 – 17) which is titled ‘Specimens, Data and Privacy’ and which deals with biospecimens, biobanks, and its privacy and property-related concerns also deserve special mention for providing a comprehensive overview of the main arguments and decisive questions that need to be considered in formulating an appropriate regulatory scheme for this increasingly important area in human subject research.

For me, a central theme that all authors – some explicitly and others unknowingly – lay bare, is the necessity of returning to the very essence of the human subjects research endeavor and the reason why an appropriate regulatory framework is so important. In debating the content and effectiveness of informed consent forms (pp. 18-20, pp. 143-155), the role and function of IRBs (pp. 109-186), the utility or futility of protecting data privacy in an age where people already disclose so freely on social media (pp. 20-22, pp. 251-263), or in considering whether certain types of research should be exempted from regulation, either because social and behavioural research is fundamentally different from biomedical research, or because the research poses a minimal risk (pp. 27-57), we can easily get lost in legal technicalities, ethical dilemmas, and vested interests as researchers and human subjects in our own right.

The discerning arguments presented by authors like Ana S. Iltis in Chapter 3 (‘Risk Level, Research Oversight, and Decrements in Participant Protections’), Michael McDonald, Susan Cox and Anne Townsend in Chapter 7 (‘Toward Human Research Protection that is Evidence Based and Participant Centered’), and Heidi Li Feldman in Chapter 19 (‘What’s Right about the “Medical Model” in Human Subjects Research Regulation’) caution us, however, to carefully consider the assumptions on which our premises are based, and remind us that appropriate regulation of human subject research is necessary because we are all ultimately fallible human beings, and the future is unknown with regard to the potential risks and benefits our research may hold for our human subjects, their data, and their tissue samples.


Reviewed by Dr Andra le Roux-Kemp, who works on the interstices that exist between the law and other disciplines, specifically the medical sciences, medical anthropology and bioethics. She is an Assistant Professor at the School of Law, City University of Hong Kong (HKSAR), and a Visiting Research Fellow at the School of Law, University of the Witwatersrand (South Africa).

 Correspondence to Andra le Roux-Kemp.

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