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Posted on January 7, 2020 at 12:57 AM

This post appears by special arrangement with the American Journal of Bioethics.

by David Magnus, Ph.D.

Last year a bioethics colleague from another institution was expressing her frustration and doubts about the direction of the field of bioethics to me. Her concern was what she perceived as the growing trend towards empirical research in American bioethics as exemplified by the direction of my research and the research of Stanford’s bioethics center as well as our peers. While I (obviously) do not share the view that there is a problem with the increasingly empirical turn of our field, it did get me thinking about this journal and publishing in bioethics more generally. Like many of my peers, I often work as part of collaborative teams to carry out empirical research. And I think that is a healthy development for our field, and one of the reasons why our daughter journal, AJOB Empirical Bioethics, is such an important development for bioethics publishing. I also publish more conceptual or normative work, but often shorter pieces that can be published in scientific or medical journals. Journals like The American Journal of Bioethics do occasionally publish empirical pieces, but the vast majority of our Target Articles are substantial (5,000–7,000+ words) normative or conceptual scholarship. Most of the other top journals in the field have a similar focus. This means there is a small but growing disconnect between the types of scholarship being produced by U.S. leaders in bioethics and the top U.S. bioethics journals. This empirical turn is less pronounced in other parts of the world and we are seeing a growing number of submissions from other countries (a positive development).

For the most part, bioethics journals like ours are passive with respect to our content. We wait for articles to be submitted by authors. Occasionally we will encourage a submission, for example when we see a paper at a conference that we really like. But we are largely dependent on others for the range of options that we can choose from. For a journal like ours, we can afford to be highly selective (since only 10–15% of Target Article submissions are accepted). But this can be frustrating when there are developments in science or medicine or topics that we want covered by particular scholars. A few years ago, we decided to address this gap for breaking issues by launching special issues. These issues involved inviting a small number of authors on a breaking bioethics topic and having a streamlined peer review process using the Associate Editors and myself as peer reviewers. We have had special issues on the SUPPORT controversy, brain death and the Jahi McMath case, and the revisions to the Common Rule.

While this was an important development for the journal, it failed to address the concerns expressed by my friend. To that end, this issue includes the first article in a new series we are calling “Frontiers in Bioethics.” The idea behind this is to reach out to prominent scholars in the field who we believe have something important to say about a particular topic. This can include prominent developments in medicine and science or about research that they are carrying out that we find exciting. Similar to our special issues, we will carry out an expedited peer review process in the hope of getting this scholarship out to the field as quickly as possible.

The first article in this series that we are publishing is the result of an invitation to Jeremy Sugarman. Jeremy and other colleagues have been carrying out extremely important work with the NIH Collaboratory on the ethical issues raised by Pragmatic Clinical Trials. I am a big fan of a lot of this work and wanted to offer them a chance to produce a substantial piece of scholarship about the newest developments they were working on.

Their paper in this issue is about a topic both familiar and novel. There is a very robust literature about what the authors term “collateral” findings, which is similar to incidental findings in clinical care or secondary findings in research. In clinical contexts, there are well-worked out approaches to incidental findings in radiology and clinical genetics, including the American College of Medical Genetics standards for returning variants for 59 different genes. Similarly, in research there are often secondary findings, particularly in precision health efforts and a good deal has been written about the limits of the obligations of researchers to return findings to research participants. But to date, no one has really addressed the issue of collateral findings in Pragmatic Clinical Trials. While there is a great deal of variation among pragmatic trials, many trials stand on the border between clinical care and research. In addition, many pragmatic trials (particularly those sponsored by the NIH Collaboratory) are cluster randomized trials that take place under a waiver of informed consent. Establishing a framework for assessment of the obligation to return results to patients who may be unaware that they were participating in research while receiving usual or standard care could be very challenging, particularly if it involves patients who are receiving care at many health care provider organizations. This article is an important contribution to the field, and should be required reading for IRB’s and courses on research ethics.

Interestingly, the final framework of assessment that they propose, which focuses on the “five W’s” (what, when, where, why, and who) represent Aristotle’s ethical framework for defining “involuntary” and hence non-morally blameworthy actions. But Aristotle added a sixth criteria, a sixth “W.” That is “wherewith,” e.g., with what instrument was the action done. The group’s criteria for “why” largely focuses on this issue, but at the neglect of questions about the actual “why” of the research, namely what the purpose of the activity is. These intentional aspects of research are actually fundamental to the distinction between research and clinical care in current U.S. regulations under the common rule. The group largely ignores this issue, but it could be very important for ethically understanding the duties that might arise for researchers involved in pragmatic clinical trials.

We are very pleased to launch this new series of Target Articles and look forward to feedback about our new “Frontiers in Bioethics” series.

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