Greetings! My name is Elisa Hurley, and I am delighted to be joining the PRIM&R family as its new education director. For the past 11 years, I have been teaching and writing philosophical ethics and bioethics. So, when PRIM&R asked me to attend the 2010 Advancing Ethical Research Conference in San Diego prior to starting my new job, I was thrilled. I couldn’t have asked for a better orientation to PRIM&R, or a more fitting introduction to my new role helping PRIM&R continue to strengthen its current educational programs, and develop exciting and innovative new ones. One of the most intriguing and important themes that emerged during the conference was the complicated relationship between regulations and ethics, and how to understand and navigate that relationship.

The relationship between the regulations that govern human subjects research, and the ethical considerations that bear on that research, is complicated. Two of these complexities include:

• Instances when the regulations are silent on an issue that clearly requires oversight committee action; and
• Instances when the regulations appear to actually conflict with an ethical consideration.

Regarding the first, consider the issue of returning research results, the topic of an AER workshop called More on Biospecimen Research: If, When, and How to Return Research Results. As research on biological specimens and genome wide association studies (GWAs) becomes more prevalent, there is a looming question of what to do with results that may have clinical implications for a particular group or individual. Yet, federal regulations are all but silent on this question. It seems that those trying to answer the question find themselves turning to ethics, specifically, looking to the principles that stand at the foundation of the federal regulations—respect for persons, beneficence, and justice.

That is not to say that, once we turn to ethics, the answers come easily. Consider this question asked at the end of the session: Should a participant be allowed to “opt out” of receiving research results that they do not want, when those results are “clinically actionable”? And, does the fact that it is a researcher and not the participant’s personal physician who has the information matter? Some attendees argued that in the culture of genetics research, if an individual makes an informed decision not to be notified of clinically actionable or meaningful findings (such as the presence of BRCA1 mutation) then that decision is respected. Autonomy trumps beneficence. But others in the room disagreed, and thought that providing clinically actionable information to a research participant, even one who may not want to hear it, should be the standard—that is, beneficence trumps autonomy. A second, more troubling dimension of the complicated relationship between ethics and regulations was illustrated by the panel Research on Pregnancy: A Necessary Risk? (see Wendy Tate’s blog post, 45 CFR 46 Subpart B regulations need updating). During the panel, we discussed the federal regulation 45 CFR 46 Subpart B, which provides protections for pregnant women and fetuses involved in research. The complication comes in when we ask: what if this regulation excludes pregnant women from research that may be of benefit to both them and their fetuses? In other words, here is a case where the regulations, though well-intended, seem to come into stark conflict with ethical considerations of beneficence and justice. Should we be worried that the regulations don’t always “cover the ethical bases” adequately, or even sometimes clash with them? After attending AER, I believe we might not need to worry too much about this issue, because so many of those who work on the ground in the research protections field view substantive ethical review as part of their everyday work. In fact, I wonder if making more of this fact might help mitigate some of the misconceptions out there about the purpose of, and place for, research oversight. What do you think?