de Melo-Martín, Inmaculada PhD, MS; Palmer, Larry I. LLB; Fins, Joseph J. MD
Why do many see research ethics as a nuisance to investigators and an obstacle to science while clinical ethics has become a central, and welcome, component of the health care landscape? Certainly, physicians, nurses, and patients face ethical disagreements and uncertainties in the health care context.1 But, as recent public debates about conflicts of interests, exploitation of human subjects, and scientific fraud remind us, ethical problems also arise in the context of research. Indeed, federal regulations requiring institutional review board (IRB) reviews for federally funded research are an acknowledgment of the existence of such ethical concerns.2 Furthermore, with the current emphasis on bringing scientific discoveries from the bench to the bedside, more and more physician scientists are facing ethical dilemmas in the clinical research setting. It appears, then, that collaborations between investigators and research ethicists are as essential as those between physicians and clinical ethicists.
Despite its ubiquitous presence and utility in clinical care,3 ethics consultation is, paradoxically, uncommon in the research context. This is, however, not completely surprising. Indeed, although clinical ethics consultations presuppose a collaborative framework where health professionals and ethicists work together to improve patients’ care, the common approach to ethical concerns in research has been primarily a regulatory one. Predictably, researchers tend to see research ethics as adversarial. They equate research ethics with research compliance and see any attempt to evaluate the ethical implications of scientific research as a way to, at best, police science, and at worst, impede scientific progress.
What can academic research institutions do to dispel the belief that research ethics is a hindrance to science? What can they do to foster fruitful partnerships between researchers and ethicists to demonstrate that research ethics, far from being a hassle, can be a valuable asset? We believe that the development and use of research ethics consultation services is a way to alter this state of affairs.
In what follows, we argue that research subjects, investigators, and the institutions that shelter the investigative enterprise are likely to benefit from research consultations services. In the second part of this essay, we offer a description of the efforts that Weill Medical College of Cornell University has made in this direction.
Integrating Ethics into the Fabric of Scientific Research
Seeking more than regulation to promote research integrity
Clinical ethics consultations services were created as a way to assist health care personnel when facing moral quandaries. On the other hand, the focus in scientific research has been to develop oversight mechanisms such as IRBs. Whereas the first approach encourages collaboration and collegiality, the latter promotes an adversarial regulatory dynamic with statutory authority.4 IRBs function as oversight bodies whose main goal is to protect human subjects. In order to do so, they have the authority to approve, require changes, or reject particular protocols. Of course, this is not to suggest such bodies are unnecessary. Our history is replete with infamous cases of research ethics abuses that show the need for such mechanisms.5 This regulatory impulse has grown because of the increasing complexity of biomedical research and the need to maintain the public trust.6 The problem is that despite, and in some ways because of, these efforts, IRBs have been less than successful in creating a climate of heightened sensitivity to the conflicts attendant to conduct of clinical investigation.
Our fundamental point is that a regulatory approach, devoid of deeper ethical analysis, is destined to fail. It trivializes the ethical questions inherent in research and promotes the dubious idea that following regulations is all that is needed to achieve ethically responsible research. Moreover, a regulatory approach is also problematic because it might exacerbate researchers’ impressions that ethics is a matter of merely complying with particular, sometimes obscure and meaningless, bureaucratic procedures, rather than an intrinsic component of the research process. As some studies have shown, such an impression might result in alienated researchers who are more likely to commit scientific misconduct.7
We recognize that some might disagree with our analysis that human subjects protections are largely handled as a regulatory exercise. However, we are not alone in that evaluation of the human subjects protection process. Both the Institute of Medicine (IOM) and the Association of American Colleges have weighed in on this theme.8,9 In 2002, for instance, the IOM performed a comprehensive assessment of the national system for the protection of research participants.8 Its report called attention to the need to refocus the mission of IRBs. The IOM’s fear was that IRBs were more and more burdened with the management of organizational responsibilities, such as compliance with relevant regulations. The IOM argued that reliance on IRBs to accomplish all these protection tasks was a disservice to research participants and recommended that ethics review become IRBs’ main focus.
Research ethics consultations: fostering partnership between scientists and ethicists
The implementation of research ethics consultation services is certainly in line with solving some of the concerns pointed out by the IOM report. From issues related to obtaining valid informed consent, to the need to balance risks and potential benefits, to concerns about conflicts of interest, ethical issues permeate research with human subjects.10 The increasing complexity of biomedical research only makes things more difficult for all involved. Of course, this is not to say that researchers are unethical or that they lack integrity. However, they are not trained to recognize ethical problems and inquiry starts once a problematic situation has been identified. If the problem is not identified as a moral problem, but rather as a technical one, then the response will likely be inappropriate.11 Reasonably, scientific researchers are focused on the scientific and technical issues in research. An ethicists working in collaboration with scientists can ask the questions necessary to help determine what, if any, ethical issues are relevant to the particular research project. Thus we believe that, in this context, an ethics consultation service can be invaluable.
Ethicists, who are skilled in analyzing ethically complex situations, could offer advice and direction when dealing with ethical problems, and could warn about the possible consequences of particular courses of action.12 They are trained to understand logical reasoning, detect fallacies, uncover hidden assumptions, and show unexpected consequences of a particular course of action. They can identify and articulate precisely the value dimensions of specific situations, analyze concepts and clarify meanings, and recognize normative, epistemological, and social issues. Of course, knowledge of values, meanings, and valid argumentation is not sufficient to guarantee the resolution of ethical problems. However, knowledge of moral principles and theories, understanding of ethical and epistemological concepts, ability to argue clearly and rigorously, and knowledge of relevant facts are important features for any analysis. Investigators could thus find this expertise helpful when having to navigate difficult ethical problems.
Concern for the well-being of human subjects also justifies the creation and use of research ethics consultation services. Such services are likely to result in better institutional research policies and more sensitivity on the part of researchers about the ethical complexities of research with human participants. They would also engender broader awareness about impediments to informed consent, fair subject-recruitment, and rigorous conceptual scholarship on research ethics. All these improvements are likely to result in better protection for research subjects. As a result, participants might be more satisfied with the research process.
Research ethics consultation services can also result in productive collaborations between investigators and ethicists. Such collaborations could sensitize scientists to the ethical dimensions of their work. Researchers could also gain insights into the nuances of research ethics in their particular field of investigation. This dialogue between scientists and ethicists could produce more informed professional self-regulation and create an environment that emphasizes a high regard for human subjects.
Equally important is the fact that research ethics consultations could give ethicists the opportunity to immerse themselves in the complexities of scientific design. They could learn about specific scientific facts that are relevant in ethical decision making. After all, good ethics requires good science; value choices should be predicated on a sophisticated knowledge of the scientific dimensions of the work.
Along these lines, ethicists could pursue scholarship on ethical challenges in research related to the particular protocols in which they are involved. For example, if ethicists assist investigators in clinical trials in the emergency department that involve individuals who lack decision-making capacity, ethicists could develop strategies to gain authorization for the proposed intervention.13 Or if the case involves genetic testing, ethicists could reflect on whether and under what conditions researchers have ethical obligations to disclose results.14
However, research subjects, individual scientists, and ethicists are not the only ones who can benefit from these consultations. Academic health centers also stand to gain from them. Research ethicists could be invaluable assets in preparing educational activities to help scientists in dealing with specific ethical issues related to their studies. They also could develop general educational programs on research integrity, but unlike many such sessions, these would be informed by the actual challenges encountered in doing scientific work and creating new knowledge.
Additionally, and perhaps most critically, in seeking to create a learning community that fosters institutional change, it is helpful to encourage and sustain collaborations between scientists and ethicists. Deeper engagement with ethical issues will not only promote shared discourse across the disciplines; it is also likely to lead to improved regulatory compliance. Dialogue between ethicists and researchers can allow for careful elucidation of the reasons for particular rules and for their questioning and refinement as circumstances evolve. Such shared discourse can also foster meaningful discussions on the historical and philosophical grounds of such regulations. These collaborations could result in scholarly work that evaluates the effectiveness of human subjects protection mechanisms and thus advance sound regulatory approaches.
These institutional activities could have a global impact on all aspects of research integrity within an institution because integrity is a characteristic of institutions as well as of individuals. Institutions can foster or hinder all aspects of scientific integrity.15,16 By supporting collaborations between ethicists and investigators, institutions can promote an environment that encourages critical reflection on all aspects of research, from individual projects, to scrutiny of policies and procedures, to assessment of institutional goals, to broader assessments of the sociocultural background. Such work could be vital in an institution’s quest to promote the responsible conduct of research. Given this institutional support for an ethics consultation service sends a clear message about the importance of ethical reflection as an activity related to, but independent of, regulatory mechanisms.
Given that ethics consultation services are not only quite new, but also very rare, we acknowledge that many of these claims about the impact of ethics consultation services are speculative. Nonetheless, because professional ethicists can bring new expertise and new perspectives to the research process, it seems plausible to think that collaborations between researchers and ethicists will be helpful to all stakeholders. Whether we are correct is a matter for future empirical studies. Nonetheless, government agencies such as the National Science Foundation as well as premier scientific journal editors have also recognized the importance of including ethical evaluations from the beginning, rather than waiting for problems to occur.17,18
Research ethics consultation services at Weill Medical College of Cornell University
The idea of a research ethics consultation service at Weill Medical College was the result of the deliberations of the University Research Ethics Advisory Committee (UREAC), a campus-wide committee established in 2002 by former Cornell University President Hunter R. Rawlings III and Medical College Dean Antonio M. Gotto, Jr. UREAC was created to help ensure that the university’s biomedical research involving human subjects met the highest ethical standards. It was intended as a proactive effort at heightening research ethics integrity in the wake of several highly publicized scandals in clinical trials that threatened to erode public trust in biomedical research. UREAC sought to help Cornell University retain and cultivate the public trust necessary to the flourishing (and funding) of biomedical research.
The committee, cochaired by one of us (J.J.F.) and composed of clinical researchers, ethicists, lawyers, and IRB personnel, was given a one-year charge to study the issues and deliver a report. Its task was to outline recommendations consistent with the university’s mission to advance scientific knowledge and maintain public trust. The goals of the committee were to develop innovative strategies to foster human subjects’ safety, maintain investigators’ integrity, and protect the reputation of the medical college and the university as an institution of higher learning. In sum, the goal was to foster both responsible and responsive clinical research.
The yearlong deliberations ended with an institution-wide consensus on a series of recommendations that aimed at advancing biomedical research and maintaining the highest sense of research integrity at Cornell. Among them, the committee recommended that Weill Medical College support the development of a research ethics consultation service. Building on the aforementioned arguments, many of which are drawn from Cornell’s UREAC report, the medical college sought to develop an ethics consultation service based in the division of medical ethics. A clinical research initiative recommended funding for the position, which was provided by the department of research and sponsored programs.
The endeavor began officially in fall 2005 with the appointment of an ethicist with formal training in molecular biology (I.d.M.). She joined another faculty member (J.J.F.) who had expertise in research ethics issues in neuropsychiatric disorders and neuroethics. Although not involved in research consultations, a third member of the division has responsibilities as a research subject advocate, which allows for direct connections not only with researchers, but also with participants.
The members of the research ethics consultation service have faculty appointments in the division of medical ethics and report directly to the division chief, who has overall responsibility for the service. Oversight of its activities is jointly shared by the chairman of the department of public health and the senior associate dean for research.
After the newly recruited ethicist joined the division, Dean Gotto appointed her (I.d.M.) to both IRBs. Subsequently, the division chief wrote letters to all the division heads of the department of medicine, as well as to the department chairs of genetic medicine, and of several centers such as the Iris Cantor Women’s Health Center, the Center for Reproductive Medicine and Infertility, and the Center for Male Reproductive Medicine and Microsurgery. The purpose of the letters was to inform researchers about the new service and encourage them to use it. Several educational programs were also organized to publicize ethics consultations.
The main goal of the ethics consultation service is to create ongoing and dynamic collaborations between researchers and bioethicists and to encourage active scholarship in research ethics and the ethical aspects of scientific investigations. The service attempts to provide guidance to individual investigators and research teams prior to submission of research protocols to the IRB and throughout the process, as ethical and compliance issues arise. In some cases, researchers have been aware of particular ethical difficulties with their research. For example in protocols that involved vulnerable groups, the issue of the validity of informed consent became salient. Collaborations in these cases have resulted in proposals of strategies that were directed to enhance subjects’ autonomy.
Although we believe that collaborations at early stages of protocol development are important, we recognize that developing such collaborations might take time. But collaborations at later stages are also valuable. For instance, in one of our consults, the researcher was made aware of an ethical problem with the selection of participants when the protocol reached IRB review. The association in this case resulted in a protocol that passed IRB review and a manuscript on ethical issues related to subject selection in reproductive medicine, and opened the door to continuing collaboration on research ethics. Likewise, some researchers have been eager to work with us to consider ethical issues that might arise in their future research protocols. They were interested in identifying problems and anticipating possible solutions to research involving regenerative medicine so that they could develop strategies to deal with them at the appropriate time. Thus, in various ways, and at differing points, ethical reflection is coming to be understood as part of the research process.
Approximately eight months after rolling out the consultation service, and as the result of ongoing conversations between members of the division of medical ethics and members of the Institute for Clinical Research (ICR), ethics consultations became a formal part of the ICR process. As part of the medical school’s Office of Research and Sponsored Programs (RASP), the ICR assist investigators in the development, negotiation, and completion of the contract process for all clinical trials. This is a voluntary support process, which allows researchers to discuss concerns related to contracts or grants, budgeting questions, and protocol feasibility review.
The reasons for offering the ethics consultation under this institutional framework were twofold. First, the members of the division of medical ethics hoped that this would bring the new service to the direct attention of researchers. This was important because consultations are completely voluntary, and thus it was a challenge to get investigators to use the ethics consultation services. Second, we believe that including ethics consultations together with other support resources, such as biostatistics assistance to their research, would allow researchers to get to know about the new service and take advantage of it without putting extra burdens on their time.
The ethics consultation service has now become an integral part of this process. Researchers send complete protocols, together with consent forms, to ICR members who forward them to the consultation service’s ethicist prior to the meeting. At the meeting they discuss any ethical concerns that investigators and research coordinators might have. Using this institutional framework, the ethics consultation service has been able to collaborate with over a dozen researchers on different protocols.
As we indicated earlier, this is a new service, and thus there is still not a sufficient volume of consultations to be able to evaluate the program. Nonetheless, the service has been well received by researchers. Once there are a sufficient number of consults, the division of medical ethics will evaluate the service’s efforts to ascertain whether researchers find the service helpful and whether there are measurable differences in the IRB process between protocols for which there has been a consultation and those for which no ethics consultation occurred.
The research ethics consultation service has been an attempt to add a nonregulatory element to the research process. As with ethics consultations in the health care environment, the process is nonconfrontational and nonpunitive. The aim is to inspire trust among researchers and foster collegiality and shared reflection. As we mentioned earlier, consultations are encouraged but completely voluntary. All those involved hope that investigators will engage in the process because they find it helpful to the ethical conduct of their research and not because it is mandated by the medical college or outside regulatory agencies. Also, since the consultation service now occurs in the context of other research support provided by the ICR, this may make the service more appealing to investigators, who do not see this resource as another bureaucratic expectation imposed to satisfy regulatory needs, but as a way to support their research. Of course, research ethics consultations abridge neither the IRBs’ statutory responsibilities for research oversight nor the responsibilities of investigators for the ethical conduct of their research.
As we mentioned earlier, it is too early to know whether the incipient research ethics consultation service will ultimately affect the research practices of Weill Medical College. Nevertheless, the recent appointment of one of the service’s ethicists as vice-chair of one of the medical school’s IRBs shows that the institution is clearly committed to making ethical reflection an essential part of the evaluation of research. Those of us (J.J.F., I.d.M.) who are involved with the service are hopeful that it will yield innovative ways of improving the protection of human subjects, maintain investigator integrity, and assure the university’s many stakeholders that it adheres to the highest ethical standards in conducting research with human participants.
It is likely that the service will be expanded with the hiring of ethicists with knowledge in other scientific areas. Hopefully, by incorporating ethicists with scientific training, researchers will feel more comfortable about possible collaborations. Similarly, by being knowledgeable about particular scientific areas, ethicists are more likely to have the intellectual flexibility necessary to deal with the many scientific details that may have a bearing on the ethical analysis of different research proposals.
Although we believe that regulations are essential for the protection of human subjects, they are certainly not sufficient. As the creation of research ethics consultations services at several institutions show,19 the time is ripe to develop direct and dynamic partnerships between investigators and ethicists. Academic medical centers need to take the lead in fostering an environment that calls for ethical reflection and cultivates trust in the research enterprise. Ongoing collaborations have the potential to bring about a new synergy between regulatory compliance and research ethics. Research ethics consultation services can further the integration of education on ethics into the fabric of research institutions. They can contribute to increased sensitivity among researchers to the ethical implications of their work as well as to the creation of new knowledge about research integrity. More important, the ongoing dialogue between investigators and ethicists can facilitate the development of an organizational culture that is sensitive to the identification and resolution of ethical conflicts. We all stand to benefit.
The authors thank the members of the Cornell University Research Ethics Advisory Committee and Lisa Staiano-Coico, cochair, for their valuable insights and collegiality. Dr. de Melo-Martín acknowledges support for this research from the Tolley Vinick Trust to the Weill Cornell Institute for Clinical Research.