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Although bioethicists and institutions have long provided ethics consultations on an individual basis, research ethics consultation is still a relatively new concept1 as an institutionalized service and has been limited primarily to consultation for clinical researchers.2 With the recent initiation of the Clinical and Translational Science Award (CTSA) program by the National Institutes of Health (NIH),3 most of the 38 CTSA medical institutions are expected to establish some type of formal ethics consultation service designed to facilitate clinical and translational research. As more CTSA awards are made, a rapid increase in the institutionalization and use of research ethics consultation services is likely. Yet while there is increasing recognition of the potential value of such services,4 little systematic analysis has been conducted on the few programs that currently exist. We present here baseline data covering nearly two years of research ethics consultations at our institution to provide an overview of how the Stanford model has evolved, what consultants have learned, and what direction the service is taking.
In November 2005, the Stanford Center for Biomedical Ethics established the Benchside Ethics Consultation Service for clinical and basic scientists.5 The service has been funded in part by a CEER (Center for Excellence in Ethical and Social Implications Research) grant supported by the National Human Genome Research Institute (NHGRI) and the U.S. Department of Energy (DOE), which established the Center for Integration for Research on Genetics and Ethics (CIRGE). CIRGE is located within the Stanford Center for Biomedical Ethics (SCBE) and provides administrative support and partial salary support for consultants.
We envisioned the Benchside Ethics Consultation Service as a pilot program that was initially prompted by unsolicited researcher requests. We included the “bench-side” descriptor to show that it was not limited to clinical researchers and to distinguish it from “bedside” ethics consultation in the hospital. The service’s goals are to integrate ethical considerations into the early phases of research planning, to encourage mutual education of biomedical researchers and ethicists, and to identify patterns of emerging ethical issues in innovative research.6 A core team of consultants consisted of three SCBE/CIRGE faculty: a philosopher, a lawyer, and a biologist, all of whom had knowledge of research ethics. Others on the full six-member team included Stanford faculty with expertise in neuroscience, genetics, epidemiology, and clinical research, as well as research ethics.
During the pilot period of the service (when it was not widely advertised), we collected data on 23 consultations (see Appendix at www.thehastingscenter.org/Publications/IRB) and obtained informal evaluations from consultants and users of the service to assess the program’s needs and effectiveness. Phone interviews, focus groups, and a systematic national survey of potential users of research ethics consultation services were conducted separately; preliminary findings are reported elsewhere.7
Consultations were initiated by a researcher’s in-person, phone, or email request to any member of the full consultation team. The individual consultant who was initially contacted “triaged” the case, deciding whether the request could be resolved on the spot (“curbside consultation”), or whether it required either a meeting of the core team or the core team plus others if additional expertise was needed. In the cases for which meetings with the core team were deemed appropriate, we attempted to hold meetings with the researchers as soon as possible and aimed to provide a written report within 48 hours of the meeting. We also asked researchers whether their request had a specific time frame for resolution, such as a grant deadline. At the beginning of each meeting, we collected information about and discussed the terms of the consultation, defining it as advisory and collaborative rather than assuming decision-making authority. During the course of consultations, we also collected data to help track and evaluate them (see Appendix at www.thehastingscenter.org/Publications/IRB). The information we collected included a researcher’s institutional affiliation, whether the consultation request had a specific time frame, what type of research the consultation was about, whether the consultation was about research involving human subjects, and the stage of research involved (planning, grant-writing, during the project, publication, dissemination, or later).
In these meetings with researchers, we discussed confidentiality in some detail because a pilot survey of Stanford researchers (including graduate students, postdoctoral fellows, faculty, and research staff) revealed that confidentiality was a concern and potential barrier to use of the service.8 We found that researchers were concerned about being “scooped” by competitors, and that junior researchers did not want to be perceived as going over the heads of more senior researchers in obtaining a consultation. Although it would be highly unlikely that consultants would need to discuss specific cases with other researchers, we nevertheless concluded that offering the option of confidentiality was important. We offered confidentiality at a range of levels, from agreeing not to talk about or identify the individual case to being able to discuss any element of the case openly. Nonetheless, we made researchers aware that there were limits to confidentiality. We informed them that if consultants observed researchers engaging in illegal or clearly unethical behavior, such behavior would be pointed out to them and consultants would be obligated to report it to the appropriate authorities. We also asked for permission to have the option to discuss or write up cases for educational purposes after individual and institutional identifiers had been removed.
Although some clinical ethics committees use specific algorithms—such as the four-box method9 or clinical pragmatism10—to gather facts and to arrive at ethically supportable conclusions, we did not adopt similar processes because we did not know the range of issues we would encounter in the pilot phase of the service, and the nature of the consultation team’s activities would not necessarily lead to a discrete decision. However, in all of the cases involving the consultation team, the consultants reached consensus about the ethical and social issues identified and about how to respond to the researchers. Our written reports began with background information and a description of the request, then explored the ethical, social, and other issues involved before offering specific recommendations, if appropriate, to the researcher or research team.
We limited our service to an advisory capacity, rather than carrying out mediation or rendering decisions. In addition, we considered some areas to be outside the scope of the consultation—for instance, those already in the jurisdiction of other governmental bodies such as the Food and Drug Administration, the Recombinant DNA Advisory Committee, and the National Science Advisory Board for Biosecurity, as well as institutional bodies including institutional review boards (IRBs), institutional animal care and use committees (IACUCs), embryonic stem cell research oversight committees (ESCROs), and conflict of interest committees (COICs). The research ethics consultation service also was not designed to address misconduct or resolution of conflicts in scientific process, such as disputes over authorship or intellectual property. These cases are more appropriately handled by an institutional ombudsperson or legal counsel, and research institutions already have procedures specifically mandated for alleging, investigating, and resolving cases of misconduct. Since our own preliminary findings suggested that researchers think of misconduct when they think of ethical issues in research,11 we anticipated receiving requests to address such issues. Our plan was that if any cases fell more appropriately under the jurisdiction of these other bodies, we would refer the cases to the appropriate resource.
The research ethics consultation service has provided 23 consultations to Stanford and non-Stanford researchers on a pilot basis since November 2005. In addition, individual members of the consultation team provided five consultations to agencies in the National Institutes of Health. Of the 23 consultations at Stanford, eight were conducted as meetings of the full team with the investigators who requested the consultation. The rest were conducted by an individual consultant, but almost all of these involved some informal discussions with at least one other member of the full team.
Twenty-three consultation requests were initiated by individual researchers, most of whom were from Stanford. Although Stanford researchers are our intended audience, five of these 23 consultation requests came from researchers at local biotechnology companies, and four came from researchers at other research institutions.
In addition to the 23 cases from individual researchers, individual members of the full consultation team also received five requests from the National Institutes of Health. Some of these requests also included ethicists from other institutions. Although these cases were not handled by the full team, they easily could have been (with permission of the group requesting the consultation) and are indicative of the need for such consultations. These cases came from a variety of institutes, including the National Eye Institute, the National Human Genome Research Institute, the National Cancer Institute, and the National Heart, Lung, and Blood Institute. They included two requests for assistance in evaluating proposals submitted for funding, two requests to evaluate research funded by institutions and already underway, and one request to discuss ethical and societal considerations for a series of projects not yet fully designed. Finally, consultations were most often requested by researchers who were acquainted with or had worked with one of the members of the consultation team or who knew generally of the existence of the SCBE. Four researchers found out about the service via the SCBE or CIRGE Web sites or because of a news article about the consultation service that had been published in a scientific journal in 2006 (see Table 1 at www.thehastingscenter.org/Publications/IRB).12
Because the pilot phase of the consultation service was funded through CEER and because the ethical, legal, and social implications of genetic research are a longstanding programmatic area of the SCBE, we expected consultation requests to focus heavily on genetic research. This happened initially, but other topics became more prevalent over time. Nongenetic topics currently represent nearly half of the total consultations (see Table 2). Although we did not intend to limit the consultation service to human subjects research, all of the consultations focused on research that involved human subjects in some way, including research with human biospecimens. However, issues specific to human subjects research were not the main focus of the consultation in four cases, and the consultations addressed a wide range of ethical concerns, including social issues such as the implications of using particular racial and ethnic labels to describe human populations, conflicts of interests, and reporting research results and incidental findings (see Table 2).
A substantial proportion of consultations were requested prior to the actual initiation of the research project. Some of the consultations were requested by researchers who were in the process of reviewing or reading others’ research. In addition, two consultations were requested to deal with issues raised in the context of writing or revising grant proposals (see Table 3 at www.thehastingscenter.org/Publications/IRB).
Approximately a third of consultations resulted in either full or core team meetings (as opposed to “curb-side” consultations conducted by individual members of the team) and in written recommendations to investigators. In five of seven consultations that involved team meetings, we were able to deliver reports to investigators within the target goal of 48 hours after the meetings. The consultations led to changes in both research process and institutional policy (see Table 4 at www.thehastingscenter.org/Publications/IRB). Most consultations led to one or more changes in the research, including modifications to study design, study procedures, consent forms, or study personnel. Policies were also sometimes affected: two consultation cases led to discussions with institutional officials to clarify the scope of the university research policies (e.g., to whom conflict of interest policies applied). In addition, a consultation led to changes in an editorial written by the researcher, and the researcher and consultant were invited to write a review article about the ethical issue the researcher raised in the consultation.
None of the 23 consultations required reporting of illegal or inappropriate behavior of researchers. In one consultation with a commercial enterprise, consultants were asked to sign nondisclosure agreements, which raised questions about the limits of confidentiality; in the end, no such agreements were signed.
We evaluated the research ethics consultation service to better understand researchers’ experiences with the new program. The pilot evaluation was limited to researchers from Stanford who requested consultations. In doing so, we tailored the evaluation to the type of consultation, i.e., more intensive evaluation techniques like surveys or phone interviews were used for face-to-face consultations in complex cases, and email follow-ups were employed for curbside consultations. Evaluation criteria that we piloted included the degree to which researchers’ questions were answered, the usefulness of recommendations, the anticipated difficulty of implementing recommendations, future improvements to research, and the collaborative nature of the consultation. Based on these post-consultation surveys, phone interviews, and email follow-ups with Stanford researchers, we found that researchers were generally satisfied with the consultations, and they were especially pleased and surprised by our quick response and the specificity of the written recommendations we provided. Researchers indicated that appropriate decisions regarding the issues identified in the consultations were being made, and they appreciated that members of the consultation team were not too “directive” or “rigid.” In general, researchers found the consultations helpful to their research and educational endeavors. Based on researchers’ comments, the central area of improvement for the future development of research ethics consultation is to define and clarify the nature of research ethics consultation and to articulate it to researchers. Some of the researchers who consulted us expressed a desire for information about the framework for the consultation in advance and also requested clarification of the research ethics consultation service’s relationship to the IRB.
Our own informal internal evaluations by members of the consultation team suggested that the current caseload was manageable and, more importantly, interesting from a scholarly point of view. Although almost all cases involved human subjects research, and approximately half of the cases were easily handled as “curbside consultations” (such as questions about whether a particular research project required IRB approval), even these were varied in nature, including questions about financial and even nonfinancial conflicts of interest. Though we anticipated that many researchers would seek advice on how to write informed consent documents for submission to the IRB, this was not the case. Instead, the consultations involved a broader range of subjects, providing a learning experience for consultants about new technological developments and the opportunity to identify related ethical and social issues. In addition, the consultations provided an opportunity to observe patterns in ethical quandaries facing many researchers (such as whether and how to report research findings of clinical significance to individuals).
Our preliminary experiences to date with a research ethics consultation service indicate there is clearly demand for such a service from researchers adept at identifying ethical issues arising at early stages of research. The establishment of consultation services—especially in the context of larger programs that include biostatistical, bioinformatics, and study design consultation for clinical research—will further encourage proactive identification and consideration of ethical issues. Collaboration among research ethics consultants and statistical and other consultants may lead to an increase in ethics consultations because of a larger client pool and because statistical and other consultants could identify ethical or social issues not raised by their clients.
There is also demand outside the university setting, especially from commercial entities and from funding agencies conducting peer review of research. Thus, the consultation service may need to be adapted to accommodate the specific needs of these constituencies, such as confidentiality concerns of commercial entities and matters involving conflicts of interest. Because the consultation service is partially funded by an external grant from the NIH and DOE, this raises conflict questions when consultations are conducted for agencies providing funding to the consultants. How to avoid this type of conflict is not clear, and there does not appear to be consensus among bioethicists and other stakeholders on the issue at this time. One example of discordant views of support for ethics consultation arose in our consultations—a reviewer of a researcher’s grant proposal insisted that an ethicist be included and supported on the grant, while another reviewer of the same grant proposal insisted that to pay an ethicist on the grant would be unethical.
Issues raised in the consultations varied widely but so far have been addressed with basic knowledge of fundamental areas of research ethics, including human subjects research regulations (especially what research requires IRB review), principles and practice of informed consent, and conflict of interest principles and policies. Some more specialized topics also arose, including intellectual property, consent to emergency research, and issues in the use of placebos, sham treatments, and blinding. Questions about research approaches that led to consideration of incidental and clinically-significant findings arose often. Thus, broad and interdisciplinary expertise of consultants would potentially enhance the consultation process and the resulting recommendations. Although the majority of consultations involved human subjects issues, not all did, and we continue to keep the service open to basic science and nonclinical researchers.
Several aspects of the nature of the consultations were surprising. First, the cases represented a wide variety of topics, including social issues such as the implications of using particular racial and ethnic labels to describe human populations. Second, only one consultation raised the issue of possible scientific misconduct regarding a faculty member (which was initially raised to us as a question, and eventually resolved, by the faculty member’s department chair). This was surprising because other studies suggest that misconduct issues ranging from falsification, fabrication, and plagiarism to “normal” misbehaviors are the ethical issues of concern to most scientists.13 In addition, data from our needs assessment studies suggest that some scientists think of misconduct when they hear the phrase “research ethics.”14 Third, we expected more requests for assistance in developing informed consent documents as a way of facilitating IRB review for researchers. While informed consent issues arose in many cases (for example, how to incorporate return of individual genetic results into the consent process), we found that construction of consent forms was not the impetus for any consultations. Fourth, many of the cases raised new and interesting ethical issues because they arose out of cutting-edge research and thus had not necessarily been the subject of wide debate. For example, the frequency of cases involving the issue of when and how to report research results and incidental findings about individual subjects15 indicated the increasing prevalence of this emerging issue. This confluence suggested that further examination of this issue, discussion with researchers, and dissemination of recommendations would be useful. As another example, the commercial entities with whom we consulted had in common a general concern about the responsibilities of for-profit entities to address ethical and societal issues that might arise from the use of their products, again suggesting that this would be a fruitful topic to raise more generally with a larger audience, including other bioethicists and commercial entities.
Without broad advertisement, requests for consultations appear to have depended on the existence of prior personal relationships between researchers and those identified by researchers as “ethicists.” The presence of research ethics consultants on the hospital ethics committee was clearly an avenue through which consultants gained visibility throughout the institution as potential resources for ethics advice. One member of the full consultation team was also an active member of an IRB, and such overlap would also likely increase visibility. Lack of a prior relationship with any members of the consultation team may be a barrier to consultation and suggests that consultation services could better serve a research community if local outreach efforts include face-to-face interactions with researchers. These interactions could take place through meetings with research teams, participation in researchers’ activities such as journal clubs, and teaching activities and lectures, for example. The value of internal, institutional consultation has been suggested for statistical consultation services because such consultations may increase the perception of easy access.16 Advertising may increase the number of “cold calls,” but it seems that fostering individual relationships is also useful to the extent that it builds trust, facilitates understanding of research and ethical issues, and also encourages the exploration of complex ethical issues beyond “getting the consent form right.” On the other hand, when consultants have close relationships with researchers, they may be less willing or able to identify ethical issues arising from the activities of friends and colleagues or to challenge those activities.
Our experience has raised important questions about the purpose, nature, and limitations of a research ethics consultation service. Moreover, several important characteristics of research ethics consultation services still need clarification.17 First, the roles and boundaries of consultants must be defined. Maintaining clarity of boundaries with other institutional bodies, such as the IRB, has thus far not been difficult. The consultation service can serve an educational purpose that is complementary to and does not overlap with the oversight functions of IRBs and other bodies mandated by regulation. However, the allegiance and accountability of the research ethics consultant are not clear. What constitutes a “good” outcome of consultation for diverse institutions and types of researchers and what measures should be used to evalute research ethics consultation services should also be further clarified.
The question of what constitutes core competencies for ethics consultation has been debated and defined for clinical ethics consultation.18 Whether and how core competencies or minimum knowledge, skills, and training can also be defined for research ethics consultation is also a challenge in developing a research ethics consultation service. Finally, creating effective resources and educational materials to enhance the knowledge of both researchers and consultants will be useful. As we move toward potential incorporation of research ethics consultations into the array of services offered by research institutions, these critical questions should be addressed in a coordinated and systematic fashion in order to obtain accurate and reliable answers to them.
This study was supported in part by a grant from the National Institutes of Health/National Human Genome Research Institute and funding from the U.S. Department of Energy (NIH 5 P50 HG 3389). The Stanford University Institutional Review Board approved this study.
Mildred K. Cho, Associate Director, Stanford Center for Biomedical Ethics, and Associate Professor of Pediatrics, Stanford University, Palo Alto, CA.
Sara L. Tobin, Senior Research Scholar, Stanford Center for Biomedical Ethics, Palo Alto, CA.
Henry T. Greely, Deane F. and Kate Edelman Johnson Professor of Law and Professor, by courtesy, of Genetics, Stanford University, Palo Alto, CA.
Jennifer McCormick, Assistant Professor, Biomedical Ethics, Division of General Internal Medicine, Mayo College of Medicine, Rochester, MN.
Angie Boyce, A doctoral student in the Department of Science and Technology Studies, Cornell University, Ithaca, NY.
David Magnus, Director, Stanford Center for Biomedical Ethics, and Associate Professor of Pediatrics, Medicine, and Philosophy, Stanford University, Palo Alto, CA.