On-Call Ethics Consultants in Human-Subject Research

May 4, 2015

Framing the Issue: Private Consultants and IRBs

There are some ethical issues that fall outside the purview of an Institutional Review Board (IRB). In October 2014, a Nature article described an example of clinical trial investigators who discovered incriminating information about a pregnant teenage girl and her boyfriend while interviewing them for a trial that looks at teen pregnancy.[1] The two had lied to each other about their ages, but told the investigators the truth. The girl was fifteen and her boyfriend, who was willing to participate in the trial and be a part of the baby’s life, was twenty-four. The investigators called a private ethics consultant for advice. The consultant was a pediatrician who also ran an ethics consultation service. He explained their legal obligations and told the researchers that they “have to report it.” The police investigated the situation. The researchers never heard from the girl or her boyfriend again.

The private consultant was called in because the researchers found themselves in an ethically gray area where all of their options led to problematic outcomes. If they report the couple, then the father may not be involved in the baby’s life, and if they do not report the couple, then they are allowing an illegal act to go unpunished and may be held accountable.

This story sets the stage for a discussion on whether there is a need for private ethics consultants in human-subject research even though research with human subjects must be approved by an IRB. The IRB provides ethical oversight. Its job is to ensure that the research is being conducted in a manner that is in compliance with human-subject research standards. Those standards ensure that the research subject is protected from abuses or harms.

According to the Nature article, advocates of private consultants believe that the advantage is that, unlike IRBs, the consultants can offer non-binding counsel, and are able to discuss a wider range of issues than would be necessary for the regulatory process. Furthermore, the article says that ethics consultants can offer “more creative solutions” than an IRB, as well as provide guidance throughout the study “in a non-confrontational advice-giving capacity.” And, as Marion Danis, chief of the bioethics consultation service at the NIH Clinical Center, points out, they offer “an open space for talking about research ethics in a way that is not driven by the regulatory environment.”[2]

Critics question why there is a need for a separate body from the IRB, and suggest that the bioethicists who serve as consultants be folded into the IRB regulatory structure. Incorporating the bioethicists would ensure that all problems are addressed by the very IRBs that researchers must go through for approval. Those who believe ethics consultants could be a helpful third party counter that consultants serve to complement IRBs, not become a part of them.

The Stanford Model: A Consulting Group in Practice

A 2008 article in the American Journal of Bioethics, co-authored by Mildred Cho who is quoted in the Nature article mentioned above, makes a case for a collaborative research ethics consultancy and describes their experience with implementing such services.[3] Cho is the associate director of the Stanford Center for Biomedical Ethics that uses a team-based approach for ethics consultation services. The aim of their model is to “make ethics advice available to biomedical researchers as the science unfolds.” They believe that this is particularly helpful in research on emerging science where potential issues are more difficult to anticipate prior to conducting the research.

Cho et al. point out that IRBs must focus on the potential harms to the individual research subjects, but that it is not within their scope to address potential societal harms. The Stanford Model, however, has the overall goal of “maximizing the benefits and minimizing potential harms of research to society.” Cho et al. believe it is important that their consulting group sets clear boundaries in that it functions solely in an advisory capacity. It does not necessarily have the authority to make binding decisions on the ethical situation. While they believe the scope of their services does not overlap with governing bodies, such as the US Food and Drug Administration or NIH committees or institutional bodies, including IRBs, their recommendations may affect how the investigator interacts with those bodies. In this respect, they see themselves as serving a complementary role.

Roles and Requirements

A key question is whether or not independent consultants or consulting groups address gaps that are not filled by IRBs or other regulating bodies.

One of the arguments in favor of independent consultants is that they are usually comprised of a group of people with varying backgrounds deliberating on an ethical issue. The diversity of perspectives ostensibly provides a more complete assessment of the problem as well as the potential for more creative solutions. They are not confined by regulatory processes. Furthermore, ethics consultants may complement rather than replace IRBs. IRBs play an important role in compliance, and ethics consultants provide counseling on specific issues that arise during research.

The roles of the IRB and the ethics consultant are reminiscent of the difference between that of a school principal and a school counselor. While this is a bit of an oversimplification, the principal typically enforces the school rules so that students behave within the guidelines of the school. This is for the protection of other students and the faculty. The guidance counselor typically helps students navigate their personal situation in the school setting. Different students may have different personal issues, so the counselor’s job is individualized. All students must be in compliance with the school’s rules, so the principal’s job, while dealing with individual cases of non-compliance, is not to necessarily develop individualized solutions for a student in a difficult personal situation.

If the IRB is analogous to the principal, and the ethics consultant(s) is analogous to the guidance counselor, then one can see where the need for a consultant arises in terms of human-subject research. Human subjects are both members of a particular community, and they are unique individuals in unique situations. As evidenced by the in the examples given in the Nature article, IRBs and the consultants can work together to ensure protection of a particular community and to provide guidance for the individual’s particular situation.

Where these relationships become confusing is when the consultant or consulting group also takes on the role of asking how the research affects society, as in the example that Steven Miles of the University of Minnesota gives, “For innovative research designs, you need some independent person to say, ‘Well, let’s step back and think about this not just from the standpoint of do the regulations permit it, but does it fulfil the spirit of what people want done with the public research enterprise?’” [4]

It would seem that asking these larger societal questions is the place for governmental committees, not private consulting groups. This is where the private consultant may overstep its role in some cases. Is the role of the private consultant that of an on-call advisor for difficult ethical issues that arise during research? Or is the consultant’s job to assess the potential harms and repercussions of new research, such as the role that the Presidential Commission for the Study of Bioethical Issues currently plays, along with that of the President’s Council on Bioethics before it?

The Nature article raises some interesting questions, providing support both in favor of and against private consultant roles in human-subject research ethics. It also briefly raises an important point about the nature of scientific investigation that merits further consideration: There is no motivation for scientists to seek out these ethics consultants unless the scientists face legal repercussions. The advocates for ethics consultations assume that scientists would call upon them when an ethical situation arises during the investigation. In reality, some scientists may only care to obtain the “stamp of approval” from the IRB so that they can carry on their research without legal recourse. There is no reason to assume that every scientist would call upon a consultant when an ethically problematic situation arises, particularly if the questionable information is not published and remains confidential.

[1] Elie Dolgin, “Human-Subjects Research: The Ethics Squad,” Nature, 514, no. 7523 (2014): 418-420. doi: 10.1038/514418a

[2] Ibid.

[3] Mildred K. Cho, et al. “Strangers at the Benchside: Research Ethics Consultants,” American Journal of Bioethics 8, no. 3 (2008):4-13. doi: 10.1080/15265160802109322

[4] Dolgin, “Human-Subjects Research,” 420.