Why do you think your paper is highly cited?

My paper takes issue with the current regulatory framework for conceptualizing the ethical standards for human subject research.  From the comments that I have seen, people (primarily bioethicists) who defend the reigning view take issue with my position, and those who find current research regulation to be problematic (primarily researchers) support my criticism.  There are also some who criticize the status quo but think that I go too far.  As I see it, the attitudes and practices that have emerged and that now govern human subject research are based upon a rejection of the idea that anyone has a moral obligation to participate in research and a view that research participation is supererogatory.  The reigning account deems research to be an unusual activity that is and should be distinguished from clinical practice.  This approach holds that research should be performed with the best interests of the individual subject as its primary goal.  In that light, it takes the proper focus of research ethics to be informed consent and the protection of the vulnerable, and, en passant, protecting potential subjects from undue inducements.  Although I fully acknowledge that The Belmont Report and some other documents which are important in the recent history of research ethics include some subtle and intricate discussions of these issues, in my experience the resulting gestalt that Institutional Review Board (IRB) members, potential research subjects, and young investigators have come to share is much as I describe.  I take this combination of positions to inhibit rather than promote research.  Although there have clearly been recent regulatory efforts to remedy some of the problems related to the inhibition of research on “vulnerable” groups, because the background ideology has remained unchanged, the remedies have been largely ineffective.

  Does it describe a new discovery or a new methodology that's useful to others?

“My paper argues for revising our framework for thinking about the ethical conduct of human subject research and for amending the regulations in that light.”

My paper presents a philosophic argument, not a scientific discovery.  I urge a change in attitude toward clinical medicine and human subject research.  Instead of seeing research as a distinct and optional activity, my positive view is that research should be a frequent and common companion of medical practice.  Although the fundamental goal of medicine (i.e., the benefit of the individual patient) and the fundamental goal of research (i.e., the advancement of knowledge with a view toward the benefit of future patients) are distinctly different, the positive view that I advance is (1) that far more of what we count as medical treatment should involve a research component and (2) that clinician researchers are and should be concerned with both goals at once.  The practice of medicine is advanced by research.  When physicians and patients acknowledge and accept that treatment in the context of research offers our best hope for advancing the field, we will be significantly more likely to improve medical knowledge.  To illustrate my positive view, consider the field of organ transplantation as an example.  Given the severe shortage of cadaveric transplant organs together with the growing demand for transplantation and retransplantation, it becomes crucial to learn about conditions that are likely to promote graft and patient survival and factors that are likely to predict organ rejection and other problems.  The model of research joined hand in hand with treatment would consider every organ recipient as a patient and also as a collaborator in the ongoing research effort.  A treatment approach that also embraces research would allow clinician researchers to store and identify specimens and records for later use in projects that have not yet been conceived, to follow up with identifiable previous organ recipients to help confirm (or disconfirm) hypotheses, and to recontact patients when they were needed to help further future research goals.

  Could you summarize the significance of your paper in layman's terms?

My view entails accepting the legitimacy of the social purpose of biomedical research and recognizing a moral duty to do one’s fair share.  Saying that we each have an obligation to participate in biomedical research suggests an attitude toward making the request and toward refusing participation.  It implies that clinicians should invite or even urge patients to participate in research and that patients who refuse to participate have to justify their refusal at least to themselves.  The change that I advocate puts the onus on the opposite side of where it has been, and I take that difference to be quite radical.  My position, however, does fall short of calling for the imposition of research conscription today because, in our society, the benefits of research are not available to the millions of uninsured.  In this light I do not think that informed consent should be the primary focus of research oversight.  Instead, we should emphasize a number of important issues that have to be considered in context.  The ethical acceptability of a study will turn on issues such as an assessment of risks and burdens, judgments of when and for whom they would be reasonable or unreasonable, the provision of a comprehensive plan for research oversight that scrutinizes the research plan, the informed consent process, the actual conduct of studies, as well as the communication between researchers and research subjects.  Because almost everyone and almost all of their loved ones has medical needs at some point in their lives, and because researchers sometimes need to study subjects who are ill, sometimes subjects from different genetic groups, and sometimes entire populations, and because we frequently cannot know in advance which medical needs any particular subject will have in the future, participation in research should be seen as a prima facie social duty.  Medical needs are very widely appreciated.  Yet, the good that medicine can do can only be achieved by studying our bodies.  Whereas other social obligations can be fulfilled in other ways (e.g., by writing a check, by sending a stand-in), at a certain point in biomedical research, there is nothing that we can substitute for us.  Study involves some sacrifice of our flesh, our privacy, our safety, our comfort, and our time.  Because these basic goods are precious to everyone, non-instrumental basic moral principles of equality, universalization, and mutual love require us to give of ourselves as we would wish to receive from others.  For that reason, every one should accept responsibility for doing one’s fair share so as to further the common good from which we expect ourselves and our loved ones to ultimately benefit.  In sum, the fragility of our bodies, the invasiveness of research, our emotional and genetic interrelatedness, the lack of an adequate alternative, and the commonality of the desire to benefit from medical knowledge combine to create this participatory duty.

  How did you become involved in this research?

As a bioethicist, I have become familiar with the literature on research ethics, and for the past several years I have been teaching a graduate seminar on the ethical conduct of human subject research.  I have become increasingly convinced that the regulations and common views on research ethics are conceptually deeply flawed.  Furthermore, I have come to see that the current standards inhibit research and therein oppose the advancement of medicine and the interests of patients.

  What are the social or political implications of your research?

My paper argues for revising our framework for thinking about the ethical conduct of human subject research and for amending the regulations in that light.  The social implication is change; the political implication is more complex.  In spite of all that I have argued, the establishment of the Common Rule system of research oversight was a very significant policy achievement.  It has been hugely successful in preventing research subject abuse and it takes us a significant distance toward the ethical conduct of research.  Human subject research remains an inherently risky business which also makes rethinking research ethics risky.  One hazard comes from the powerful amalgamated political and economic interests in biomedical research which have succeeded in limiting the applicability of the current standards to the signatory agencies (e.g., it does not apply to the EPA) and preventing the Common Rule from becoming a national standard (e.g., it does not apply to research done with entirely privately funding).  These forces can be expected to try to control, distort, and subvert reform efforts.  Another hazard comes from the difficulty of grasping the complexity of what is involved in research ethics and the opposing inclination to seize onto clear, simple, or popular definitions and solutions.  In any effort to rethink and improve upon our current system, it is also very easy to overlook important considerations or to fail to foresee all of the consequences of a well-intentioned change.  In my paper I argued that current policies have the effect of inhibiting research by focusing too much on protection.  Only with an appreciation of both the dangers and the promises of research can we advance our understanding of the ethics of human subject research.

Rosamond Rhodes, Ph.D.
Professor, Medical Education
and Director, Bioethics Education
Mount Sinai School of Medicine
New York, NY, USA