Step 1: Building a Normative Foundation

The principlist approach has been unfairly critiqued by some commentators as a naïve attempt to identify ethical guides that apply in all places at all times. Even early editions of Principles of Biomedical Ethics acknowledged the historical and intellectual context that made it seem important to the authors to identify consensus principles for doing ethics in biomedical settings. Nonetheless, ethical principles — whether they be Beauchamp and Childress' four principles or the Belmont Report's three principles²³ — have too often been applied in ways that ignore their historical and cultural contingency. Unfortunately, IRBs are almost certainly one of the settings where this reductive use of the Belmont Report principles can be observed.^{Reference Vanderpool24} Ethical principles, when used in specific clinical or research ethics cases, can also tend to oversimplify complex situations.^{Reference Churchill, Fanning and Schenck25}

Although ethical principles are a product of their time and may sometimes be misinterpreted and misused in their application to specific cases, they are often useful as a starting point for the development of policy.²⁶ Without guiding principles, the process of policy development can become aimless. Stakeholders may advance specific policy options, but lack an agreed-upon framework to argue for their suitability. This is exactly what seems to have happened when the effort to modernize the Common Rule resulted in significant controversy but little consensus.

Given this tension between the advantages and disadvantages of ethical principles, an effort to reboot the Belmont Report might start with a normative and conceptual effort to examine the role principles themselves might play in the development of new policies. Can we develop an account of principles for research ethics that emphasizes their interpretation in historical and cultural contexts and dispenses with the idea of timeless principles? In our 21st century context, can a finite set of ethical principles even do the ethical work that is needed to develop appropriate research policies? If not, what other types of ethical ideas or approaches might be needed?

In light of the potential advantages of the principlist approach we have identified and its familiarity to IRB members, researchers, and other stakeholders, it is unlikely that principles will be abandoned altogether. Therefore, revisiting the original principles from the Belmont Report is necessary. What historical and literary evidence do we have about the intended scope of these principles? In what ways do recent accounts of these principles reject or reinterpret these principles? A promising thread for this type of work might involve examining the “fitness” of these principles for modern needs. What would it mean for the Belmont principles to “fit” or “fail to fit” with modern needs and sensibilities? How might we evaluate this?

Critical work must also examine whether additional principles are needed to set the stage for a successful process of policy development. Which ethical commitments and ideas falling outside the Belmont principles were evoked explicitly in the debate about the Common Rule revision? Are there other important principles that were implicit in those debates? How do these principles link conceptually with one another and with the Belmont principles?

By their nature, the work to answer these questions will fall primarily to scholars in the humanities and law. In the next section, we consider how stakeholder voices from non-scholarly communities might be incorporated into this process. But that does not mean that this first step should reject inclusivity. On the contrary, efforts to reframe, reinterpret, and reorder the principles will be most successful if they embrace voices from across the humanities. Scholars skilled in the methods of history and literary analysis will prove critical in efforts to understand the efforts of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Experts in religious ethics and philosophy will need to examine the Belmont principles and to consider the potential value of including other principles. Perhaps most importantly, scholars working from feminist and non-Western traditions should lead the way in broadening the set of ethical commitments and ideas considered relevant to policy on research with humans.

This first stage of work cannot be accomplished within the context of a single working group or grant project. Rather, it should be undertaken by a broad community in a variety of settings using a variety of methods. While aspects of this work are already being carried out by groups working on specific topics or within specific disciplines, we lack a sense of working toward a shared goal. We call on the scholarly community interested in research ethics to break out of their silos and broaden their focus. We should ask bigger questions: What normative foundation shall we build for policies on the governance and oversight of contemporary research? What are the critical ethical ideas that need to be included in this framework, and how should the overall framework be constructed?

Step 2: Expanding the Conversation

Work to build a normative and conceptual foundation will need to be tied closely with a systematic effort to empirically re-examine stakeholder views on the principles of research ethics. When the time comes to debate policies, a normative foundation will only prove useful if it accurately reflects the ethical commitments of stakeholders. Therefore, we must capture the perspectives of the many stakeholders in human participant research and assure that the voices of those underrepresented in traditional policy-making processes have an influence on the outcome.

Since the publication of the Belmont Report, the landscape of bio-ethical inquiry has expanded to incorporate a variety of empirical approaches from the social sciences, including surveys, focus groups, and interviews. Of particular interest, empirical work has also illuminated our understandings of the ethical principles articulated in the Belmont Report. For example, Vitak, Shilton, and Ashtorab^{Reference Vitak, Shilton and Ashktorab27} and Nancy Shore²⁸ have studied researcher perspectives on the Belmont principles and their implications for ethical research practices. This excellent work has provided a starting point, but more empirical work is needed to explore the perspectives of a diverse and inclusive set of stakeholders and to allow for engagement and dialogue across the general public, including patient advocacy groups, community and religious leaders, researchers, clinicians, and others. Ideally, any engagement with the stakeholders of the Belmont Report would also include international participants, whose perspectives on solidarity and communal interests may differ from stakeholders in the United States.

The effort to empirically study perspectives on the ethical principles relevant to research with humans will need to focus on not only collecting data, but also engaging stakeholders in meaningful dialogue about these principles. Therefore, we must look beyond the traditional methodologies utilized in bioethics and the social sciences. While surveys and interviews are effective methods for assessing perspectives and attitudes, their utility may be limited in contexts where respondents lack adequate background information. Perspectives on research ethics is likely a topic that will benefit from the use of other methods, like deliberative democracy and the Delphi approach, that integrate more educational opportunities and that invite stakeholders to engage in discussion with one another.^{Reference Elster29}

These methodologies help shift the locus of “expertise” away from academic perspectives, facilitate the integration of new community voices into this process, and place a high value on the experiences of research participants to guide and move the dialogue. This approach is epitomized in the community-based participatory approach to research, which emphasizes the collaboration and participation of community members at all stages of the research process, including the framing of study questions, the collection of data, and the interpretation of research results. These methodologies are especially salient when trying to engage community members who are not only underrep-resented as research participants, but also underrepresented in the scholarly communities that would participate in this process.

While empirical approaches will be crucial to a Belmont reboot, they have limitations. First, our proposed strategy would not capture the perspectives of every stakeholder. Even though community leaders may raise important concerns shared by their constituents, they should not be seen as representing the perspectives of all members of a population group. Second, while gathering public perspectives is crucial to an effort to reboot the Belmont Report, these voices must be integrated into a larger process that accounts for the full range of ethical and policy considerations. The relationship between a normative critique and any empirical methods must be a two-way street, with one approach necessarily informing the other in order to produce ongoing dialogue. Third, the utility of a process to empirically examine public and professional perspectives may be limited if the results from these activities are not effectively communicated to the narrower set of stakeholders responsible for designing and enacting new policies. While empirical studies may encourage engagement and dialogue about the Belmont principles, these studies must be paired with mechanisms to allow others to hear those messages as a part of a process to operationalize findings from this work into policy assessment and development.

Some of these limitations might be addressed by additionally engaging the public in meaningful discourse about Belmont beyond the framework of empirical research, including through public discussion groups, town hall meetings, and the use of online forums. These might provide important opportunities to engage a broader range of stakeholders, some of whom may not be interested in participating in a formal research study.

Step 3: Transcending the Regulations

The final step in our three-part proposal is perhaps the most radical: an explicit call to disentangle policy making from ethical decision making. While we support the eventual development of a new set of regulations to govern research with human participants, and believe the way to pursue this goal is to build those regulations on the foundation provided by a new consensus around normative ethical principles, these policies will still not be sufficient to address all the challenges that will face researchers, IRBs, and study participants in the 21st century. The regulations governing human research do not decide for us what is right or wrong. We will continue to require approaches to operationalize moral decision-making when situations arise that the regulations do not or cannot govern. This means we need to develop and promote best practices beyond that which may be required by regulations^{Reference Rivera30} with a focus on both administrative practices and behavioral norms.^{Reference King, Henderson and Stein31}

These sorts of practices are already under development in a number of contexts. Consider, for example, that biorepositories have been utilizing oversight boards and community advisory boards for a number of years. These practices were certainly not envisioned, much less obligated, under the Common Rule, but they have created important opportunities for stakeholders to make ethical decisions in ways that augment the functions of IRBs. During the effort to modernize the Common Rule, OHRP proposed a “broad consent” solution that would have refocused governance of this type of research on individual consent. However, public comments about this policy made it clear that we lack a shared understanding about what a reasonable person might want to know about potential future uses of their clinical specimens and that neither legal precedent nor the Belmont principles provide a solution. In some ways, the failure of this proposal reinforces the importance of extending the governance and oversight of biorepository research to include stakeholders beyond the IRB.

More is at stake in a reboot of the Belmont Report than simply reforming the Common Rule. If we are to truly modernize the oversight and governance of research with human participants, we will need to expand the scope of policies that will receive attention in this broad effort. As we have noted, biorepositories often delegate ethical decisions to advisory committees with broad stakeholder representation. In community-based participatory research, participants themselves are asked to make decisions like which research questions will be studied and how the research results will be disseminated. As a modern consensus about the ethical foundation for research with humans emerges through normative and empirical work, it will become necessary both to re-evaluate existing practices and to innovate new governance practices.

These practices are likely to continue to include group decision-making, but also might include decision-making by individuals. Current policies create numerous opportunities of this sort: Research coordinators often need to decide how to proceed when they encounter potential participants who appear not to comprehend an informed consent document. Pathologists who operate a biorepository make important decisions about specimen collections. What types of ethical decisions should continue to fall to individuals, and what ethical guidance do they need to make ethically appropriate decisions?