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Research Ethics Consultation: Ethical and Professional Practice Challenges and Recommendations Richard R. Sharp, PhD, Holly A. Taylor, PhD, MPH, Margaret A. Brinich, Mary M. Boyle, MPH, Mildred Cho, PhD, Marilyn Coors, PhD, Marion Danis, MD, Molly Havard, MS, David Magnus, PhD, and Benjamin Wilfond, MD
Abstract The complexity of biomedical research has increased considerably in the last decade, as has the pace of translational research. This complexity has generated a number of novel ethical issues for clinical investigators, institutional review boards (IRBs), and other oversight committees. In response, many academic medical centers have created formal research ethics consultation (REC) services to help clinical investigators and IRBs navigate ethical issues in biomedical research. Key functions of a REC service include
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he complexity of biomedical research has increased considerably in the last decade, as has the pace of translational research.1,2 This complexity has generated novel ethical issues for clinical investigators, institutional review boards (IRBs), and other oversight committees.3,4 In response, many academic medical centers have created research ethics consultation (REC) services to help clinical investigators and IRBs navigate ethical issues in biomedical research. RECs are modeled on approaches in clinical ethics, in which specialists in ethics help to address challenging issues in patient care by (1) providing expert analysis of ethical issues and (2) facilitating discussion among health care providers and patients.5 REC services support clinical investigators and IRBs by analyzing ethical issues in research, often recommending practical strategies for managing those difficult issues.3 Please see the end of this article for information about the authors. Correspondence should be addressed to Holly A. Taylor, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, 1809 Ashland Ave., Deering Hall 205, Baltimore, MD 21205; telephone: (410) 614-5358; e-mail: [email protected]. Acad Med. 2015;90:615–620. First published online January 20, 2015 doi: 10.1097/ACM.0000000000000640
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assisting with research design and implementation, providing a forum for deliberative exploration of ethical issues, and supplementing regulatory oversight. As increasing numbers of academic research institutions establish REC services, there is a pressing need for consensus about the primary aims and policies that should guide these activities. Establishing clear expectations about the aims and policies of REC services is important if REC programs are to achieve their full potential. Drawing on the experiences of
a Clinical and Translational Science Award Research Ethics Consultation Working Group, this article describes three major ethical and professional practice challenges associated with the provision of REC: (1) managing multiple institutional roles and responsibilities, (2) managing sensitive information, and (3) communicating with consultation requestors about how these issues are managed. The paper also presents several practical strategies for addressing these challenges and enhancing the quality of REC services.
Key functions of a REC service include assisting with research design and implementation, providing a forum for deliberative exploration of ethical issues, and supplementing regulatory oversight. For example, in studies that involve the collection of biological materials for future genetic research or high-risk medical interventions for which the selection of an appropriate study population is unclear, a REC service can assist investigators in navigating the multiple oversight committees that may be involved or clarify ethical issues for which existing regulatory guidance is limited.4,6,7 Developing thoughtful approaches to ethical challenges in biomedical research can require a significant investment of time, particularly for investigators and IRB members who may not be familiar with recent advances in biomedical science or scholarship in bioethics. REC services provide clinical and translational researchers with access to ethics specialists with the knowledge and expertise needed for addressing complex ethical issues in biomedical research.
of the 46 CTSA institutions supported at the time the survey was conducted, 33 (70%) had established REC services. Many of these academic medical centers also indicated that CTSA funding played an important role in establishing or expanding their REC services.8
The establishment of the Clinical and Translational Science Award (CTSA) Consortium created the impetus for more institutions to develop RECs. A survey by McCormick and colleagues8 found that,
As increasing numbers of academic research institutions establish REC services, there is a pressing need for consensus about the primary aims and policies that should guide these activities. For example, it may be unclear to institutional leadership how the work of REC services differs from the work of IRBs.3,9–11 Similarly, clinical investigators may not be clear about the types of protections that these services have established to protect the confidentiality of information provided as part of a consultation request.12 Without shared expectations among requestors, consultants, and the institutions with which they are affiliated, REC services may be underused. Alternatively, the advice of RECs may be sought when other institutional resources, such as an IRB or conflict-of-interest committee, may be more appropriate. Establishing clear expectations about the aims and policies of REC services is important if
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REC programs are to achieve their full potential. To date, few academic medical centers have shared their experiences providing consultation to clinical investigators.12–16 The CTSA network has provided an opportunity for faculty and staff who provide REC services to examine the types of practices, policies, and procedures that are most effective in meeting the needs of clinical investigators.17 Drawing on our experiences as members of a CTSAsupported committee on research ethics, we present some of the major themes that have emerged from ongoing discussions of the CTSA Research Ethics Consultation Working Group. Specifically, we describe three major ethical and professional practice challenges associated with the provision of REC: (1) managing multiple institutional roles and responsibilities, (2) managing sensitive information, and (3) communicating with consultation requestors about how these issues are managed. We suggest several practical strategies for addressing these programmatic challenges and provide recommendations on how to enhance the quality of REC services. Case Studies
To illustrate several critical programmatic challenges facing REC services, we present a series of case studies (Box 1). These case studies represent situations in which lack of common expectations about REC services may result in potential misunderstandings or conflicts. The complexity of these case studies is intended to highlight both the many practical challenges faced by REC services and the need for creativity in managing sensitive information within the context of a consultative relationship. The analysis of these cases is intended to offer a foundation for recommended solutions. Although many consultation requests are more straightforward, these examples illustrate the importance of anticipating potential challenges. Distinguishing multiple institutional roles Case 1 (see Box 1) illustrates the potential for inconsistent expectations regarding the role of a research ethics consultant. This case highlights a situation in which the goals that an ethics consultant has during a REC
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Box 1 Three Case Studies Illustrating Critical Programmatic Challenges Faced by Research Ethics Consultation (REC) Services, Drawn From Discussions of the Clinical and Translational Science Awards (CTSA) Consortium Research Ethics Consultation Working Group Case 1 A team of researchers propose a multicenter clinical trial of the first use in humans of a novel type of cell derived from human embryonic stem cells. Because of the sensitive nature of this research, both the institutional review board (IRB) and the stem cell research oversight committee (SCRO) want to ensure adequate ethics oversight. The committees strongly recommend that the investigators seek a REC before submitting a protocol for review. The consultant most qualified to conduct the REC is also the ethicist serving on the SCRO. There is concern about conflict of commitment. Key questions: Is it appropriate for a research ethics consultant to serve as both a consultant and a member of the committee that reviews the project? Furthermore, is it acceptable for the consultant to be a reviewer for the project? Case 2 A physician conducting a randomized controlled trial of a new (not Food and Drug Administration [FDA]-approved) medication requests a REC to get advice about ethically acceptable methods to improve subject retention. Discussing strategies that other investigators have adopted to improve retention, the physician expresses skepticism. Subjects who have missed study visits, he tells the consultant, are “really sick from the medication. I doubt they will come back no matter what. In fact, one subject got so ill we told her to go to the emergency department [early the previous week].” The consultant reviews the study’s informed consent form and determines that it does not adequately describe the side effects vis-à-vis the protocol. In addition, knowing that any sponsor requires timely reporting of all “serious, unexpected adverse events” (such as the emergency department hospitalization), the consultant counsels the physician to send a report to both sponsor and IRB as soon as possible. The physician says that he had submitted a report to the sponsor, but not to the IRB, concerned that reports of serious adverse events might lead the IRB to suspend the study temporarily, thus compromising a pending contract to conduct additional studies. Key question: Beyond institutional policies, does the research ethics consultant have a duty to report to the IRB a circumstance that might indicate noncompliance with FDA regulations when participants’ safety may be at risk? Case 3 A manuscript submitted to Science for publication is the product of research led by a junior faculty member, closely assisted by a graduate student. They conducted the research in the lab of a senior faculty member who had almost no involvement on the project. In addition, the lab chief provided minimal guidance on the research approach and reviewed the final draft of the paper. Although authorship and the order of authors was not considered in advance, the junior faculty member feels that the graduate student’s role was significant enough to warrant first authorship and that her own effort should count as senior authorship (last author). The lab chief, however, expects to be senior author on all papers that report research conducted in his lab. The junior faculty member seeks a REC and asks that neither of the senior faculty members be included in the consult or even be told that a consult has been requested. Key question: How can a consultant effectively manage the competing demands of a request for complete confidentiality with the reporting requirements of the REC service expected by the National Institutes of Health, the local CTSA, or other institutional groups?
may come into conflict with other commitments that the ethics consultant may have as a result of participation in other institutional activities. The case considers the implications of a common professional role that research ethics consultants often hold in service to their institution: participating as a member of a committee with research oversight responsibilities (e.g., an IRB, an industry relationship committee, or a stem cell research oversight committee [SCRO]). Research ethics consultants have at least two primary commitments when delivering advice. First, the consultant
is an expert who orients the investigator or study team member to reasonable ethical practices relevant to the request for assistance or dilemma posed. The consultant provides advice regarding relevant ethical norms, institutional policies, regulations, and other considerations pertinent to the issue of concern to the requestor. Typically, the consultant will also make suggestions regarding which practical strategies the requestor might want to pursue to resolve the problem. Second, the consultant is an employee of an institution that supports REC services and thus has a commitment to ensuring that research conducted at the institution meets legal and regulatory
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standards. These multiple institutional roles and professional commitments may not be evident to a clinical investigator who engages a REC service. A key question raised by Case 1 is whether an ethics consultant could encounter conflicts of commitment when simultaneously serving as a member of a REC service and as a member of an oversight committee such as an SCRO. This case highlights several ways in which these professional commitments may come into conflict. First, these multiple roles could affect the advice of the consultant. For example, an ethics consultant who serves on an SCRO may focus his or her advice on approaches that are favored by the SCRO, thereby limiting the educational value or effectiveness of the consult. Second, these multiple institutional roles could affect the requestor. For example, the person seeking REC might frame issues in a particular way, withhold some information, or discuss ethical concerns less candidly if he or she is aware that the consultant also serves as a member of the SCRO. Again, this limits the potential value and effectiveness of the consultation. Alternatively, the requestor may feel compelled to follow the recommendations of the ethics consultant knowing of the dual role the consultant has as a member of an institutional oversight board. Third, the involvement of the consultant in multiple institutional roles could affect the outcome of the oversight committee, in this case the SCRO. For example, if the consultant’s colleagues on an oversight committee are made aware of the advice provided by the ethics consultant, those colleagues might be deferential to those recommendations or feel constrained in evaluating a research protocol as a result of prior advice given by an ethics consultant. Our experience suggests that REC consultants with multiple institutional roles encounter these issues with some regularity. Unless an institution employs a large group of specialists in ethics, it is likely that REC staff will also occupy positions on relevant oversight committees. Consultants and institutions need to acknowledge these dual roles and the potential conflicts of commitment they may create when they establish and staff REC services. Although the individuals staffing REC services may manage these
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conflicts appropriately, it is important to address the appearance of conflict as well. It is especially important to distinguish the consultative activities of a REC service from legal or regulatory review mechanisms. For example, a requestor may believe that a consultant’s service on an SCRO may be useful in expediting committee approval. The distinction between the role of an SCRO and a REC service as described in Case 1 highlights how the two types of activities may need to respond to investigator behavior differently. On the opposite end of the spectrum, requestors may avoid ethics consultation because of concerns that a consultant may be obligated to report unethical behavior to an oversight committee on which that consultant serves. Ideally, each institution has an adequate number of ethics experts to serve as consultants as well as members of oversight committees. Until that time, it is essential that the consultant disclose the multiple roles he or she plays within the institution if those roles are relevant to the consult request. It is important to clarify that the primary role of a REC service is to advise and facilitate ethical understanding on the part of clinical investigators and other participants in research. Requestors should also be informed that if a consultant recommends disclosure of information to the oversight committee on which he or she serves, only in extreme circumstances would the consultant be personally obligated to make that disclosure should the requestor be unwilling to do so himself or herself. Materials describing the REC service to potential requestors should make this clear, and REC consultants should reiterate this orientation prior to initiating any individual consultation. This will reduce the likelihood of inappropriate expectations and the other concerns described above.
research volunteers. A REC service, in most instances, will reconcile these two roles by explaining to the investigator the nature, reasons, and importance of the investigator’s obligation to notify the IRB (and in Case 2, the research sponsor as well). If an investigator is reluctant to disclose information to an oversight committee, the ethics consultant should offer assistance. This might include offering to help the investigator present the relevant information to the committee or to facilitate a meeting at which the disclosure will occur. Only after offering such options, and in the clearest circumstances in which a significant research impropriety has occurred and an investigator refuses to report the event to an appropriate oversight board, should a consultant report these activities directly.
Managing sensitive information in a REC
The obligation to disclose protocol deviations and unanticipated safety concerns resides with the investigator, not the ethics consultant. Although the ethics consultant has no regulatory or legal obligation to protect human subjects, once the impropriety has been identified the ethics consultant can help to facilitate the disclosure. In the unlikely event that an investigator refuses to disclose a serious research impropriety, the ethics consultant should disclose the impropriety directly. In this extreme case, the confidentiality of the investigator is trumped by the professional integrity of the ethics consultant and the consultant’s responsibility to report unethical behaviors to his or her employer. Taking this approach implies that under circumstances such as those described in Case 2, it may be appropriate for the consultant to expand the consultation beyond the initial concerns raised by the requestor. In this case, the consultant should gather additional information from the requestor to determine whether or not reporting to the IRB is warranted. However, consultants may have limited opportunity or authority to pursue these objectives within the scope of their roles as research ethics consultants.
Case 2 (see Box 1) highlights potential tensions that may arise in trying to maintain sharp distinctions between providing advice and investigating potentially problematic research practices. In their work, ethics consultants must find the proper balance between their roles as advisors and as agents of an institution committed to promoting ethical research and preventing harm to
Although the analysis of this case highlights issues of confidentiality, we should emphasize that the most immediate benefit that the consultant can offer to the investigator is practical advice about how to manage this circumstance in an ethical manner. Specifically, the requestor should explore with the investigator the potential need
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to communicate with local regulatory authorities or revise the consent form (e.g., to more accurately characterize the side effects described in the protocol). The consultant can also clarify for the requestor some of the relevant considerations that may suggest a need for the investigator to discuss this matter in greater detail with the IRB. Communication and notification Most REC services collect data about who requests the consultation and the nature of the issue(s) addressed. Collecting data within a REC service is important for enabling quality improvement and assessing the utilization and impact of the service over time. Such information may be of use to both the consultants staffing the REC service and to those to whom the consultants are accountable. Case 3 (see Box 1) provides an example where reporting consultation data, although valuable to the REC program and the institution, could raise concerns for the requestor and limit future use of these services. Although the personal identities of requestors, or the nature of their requests, are not typically sensitive topics, Case 3 illustrates how this information can sometimes raise special concerns. In general, REC services should not distribute summary data on consultative activities that are so specific that doing so could result in personal or professional harm to the requestor. For consultation requests involving particularly sensitive issues, a REC service might adopt a policy that only aggregate data will be shared with others. This approach provides a way to track trends in consultative activities without exposing requestors to significant risks involving loss of privacy. On the other hand, if the purpose of reporting data about requests for REC is to understand the frequency of use and scope of requests, or to evaluate the impact of recommendations made by consultants, then not reporting consultations that involve sensitive topics would undermine those goals. Some of these goals, however, may be achievable without reporting the name of the individual requestor. In this case, because of the nature of the concern, the requestor may even prefer that his or her departmental affiliation not be disclosed, as that would identify the division chief, and thus might make the requestor more readily identifiable as
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well. Excluding the name of the requestor may also make it more difficult to get feedback about the consultation process using postconsultation surveys. Assuming that requests for limited disclosure of personal information constitute a small proportion of REC requests, missing data should not have a significant impact on quality improvement or service documentation activities. It is important to inform requestors about the procedures that the REC service uses to document consultation requests. This approach may allow individuals to opt out of such reporting if they have personal concerns or, if reporting is required, to allow the requestor to reconsider whether to initiate a request. Many requestors will appreciate the brief explanation of the consultation service’s institutional accountability. Allowing requestors and consultants to determine whether to exclude the name of a requestor from any standard data collection activity has the potential to engender trust in the consult service and promote its use. This can be done with limited adverse impact on the broader goals of data collection at institutional levels. Recommendations
The expertise provided by REC services is complementary to the regulatory advice available from institutional oversight committees such as IRBs.13,18 REC services provide a forum in which researchers and oversight committees can examine ethical dimensions of their research and/or issues that may fall outside of explicit regulatory guidance.4,5 Working in partnership with researchers and institutional oversight committees, REC services have the potential to enhance the quality of clinical and translational research.19 As evident in the three case studies presented, ethics consultants are likely to encounter challenges at a professional level when they are involved in consultation activities that intersect with their other institutional roles. Even when consultants do not serve on oversight boards, they must be knowledgeable about federal, state, and local institutional policies relevant to the ethical conduct of research. Consultants should also be familiar with the more detailed operational procedures of relevant
institutional oversight committees (e.g., IRBs, institutional animal care and use committees, SCROs, conflict of interest boards). When institutions establish a REC service, it is important to identify individuals who have the requisite knowledge and skills. All ethics consultants ought to have relevant content expertise. Such expertise can come from course work or personal experience and must be recognized by the consultant’s colleagues. Teaching research ethics to advanced students may be a good indicator of this expertise, as well as prior scholarship on topics in research ethics. Additional criteria might include prior service on an IRB, SCRO, or clinical ethics committee; extensive knowledge of the institution’s administrative policies and research culture; and previous leadership activities related to regulatory compliance or institutional integrity. If an institution has relatively few individuals with the requisite expertise to serve as ethics consultants, an additional committee may need to be created to mediate conflicts of commitment that may arise. In addition to REC consultants, this committee might include senior staff members from the IRB, clinical ethicists, and faculty with extensive research experience. The role of such a committee would be to serve as a sounding board for ethics consultants who find themselves in a situation in which their various professional commitments appear to be in conflict. Such a committee could also serve as a resource for more complex consultations and provide a mechanism for periodic quality reviews. To establish clear expectations about the expertise provided by REC services, and to clarify how these services manage potentially challenging situations in which requestor expectations may be unclear, we offer the following recommendations. We base these recommendations on our personal experiences providing REC in a diverse range of institutional settings. We recognize that the heterogeneity of research programs at academic medical centers may not allow for the universal adoption of the approaches we advocate. To the extent that research institutions may have differing stances or “cultures” regarding the management of intrainstitutional communications about
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sensitive matters, these recommendations are intended as guiding principles to be adapted to the unique circumstances of each institution. • Information about the REC service should be posted and easily accessible. Educational materials and other descriptions of the function, duties, and larger purposes of the REC service should be distributed to potential requestors of REC. At a minimum, these materials should outline the following: who can initiate a consultation request, what information is collected and maintained by the REC, how requestor confidentiality will be maintained, and whether or not anonymous consultation requests are accepted. These policies should also describe the information that will be collected to meet institutional reporting requirements. • Requestors should be informed that some information about consultation requests may be shared with research ethics colleagues or collected for quality improvement purposes. Qualified research ethicists are a limited resource at most institutions. Therefore, institutions should have a policy regarding what, if any, information can be shared with others who are not directly involved in the consultation request. • Requestors should be informed that some information shared during an ethics consultation may require disclosure to an institutional oversight committee. REC services should have a policy describing the types of circumstances in which a research ethics consultant may be required to breach requestor confidentiality—for instance, when the safety of a research participant may be affected or there are legal or regulatory requirements to report behaviors identified during the consultation. • Consultants serving on multiple institutional oversight committees should acknowledge and manage potential conflicts of commitment as appropriate. Institutions should have a policy acknowledging that ethicists may serve in multiple institutional roles and adopt a mechanism to manage these professional conflicts of commitment. For example, a policy might require consultants serving on multiple institutional oversight bodies
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to disclose these multiple roles to requestors or, in some cases, to recuse themselves from subsequent reviews of some research protocols (e.g., if the consultant feels that his or her contribution to the protocol creates a conflict of commitment that would hinder his or her ability to carry out an oversight role).
Conclusion
As more REC services are established and provide assistance to clinical and translational scientists, we believe it is important to work toward the development of standards of excellence. We have presented a set of cases and recommendations that reflect our collective experiences and insights in offering REC services with the intent of promoting dialogue about the aims and structure of REC services. Several additional efforts are under way to compile and analyze experiences with REC.17,20,21 It is only by connecting the many individuals who staff REC services, and leveraging the collective wisdom of consultants across the country, that we can promote the continued development and standardization of this new type of research support activity. This manuscript is an effort to share our experience beyond our CTSA working group and begin a conversation with other interested stakeholders, including deans of research, IRB leaders, and investigators. Funding/Support: This project was supported by the National Center for Research Resources and the National Center for Advancing Translational Sciences of the National Institutes of Health under award number 3UL1RR025014-04S1 (Research Bioethics Consultation Standardization and Data Sharing). Other disclosures: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health (in reference to author M. Danis). Ethical approval: Reported as not applicable. R.R. Sharp is director, Biomedical Ethics Program, Mayo Clinic, Rochester, Minnesota. H.A. Taylor is associate professor, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, and core faculty, Johns Hopkins Berman Institute of Bioethics, Baltimore, Maryland. M.A. Brinich is editor-in-chief, Lakewood Observer, Lakewood, Ohio.
M.M. Boyle is clinical research coordinator, MDS/ MPN Group, Transplantation Biology Department, Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington. M. Cho is professor, Stanford Department of Pediatrics, and associate director, Stanford Center for Biomedical Ethics, Stanford University, Stanford, California. M. Coors is associate professor, Department of Psychiatry, Center for Bioethics and Humanities, Anschutz Medical Campus, Aurora, Colorado. M. Danis is section head, Ethics and Health Policy, Department of Bioethics, National Institutes of Health Clinical Center, Bethesda, Maryland. M. Havard is a medical student, University of Cincinnati College of Medicine, Cincinnati, Ohio. D. Magnus is professor of medicine and biomedical ethics, professor of pediatrics, and director, Stanford Center for Biomedical Ethics, Stanford University, Stanford, California. B. Wilfond is director, Treuman Katz Center for Pediatric Bioethics, Seattle Children’s Research Institute, and professor and chief, Division of Bioethics, Department of Pediatrics, University of Washington School of Medicine, Seattle, Washington.
References 1 Zerhouni E. Medicine. The NIH roadmap. Science. 2003;302:63–72. 2 Zerhouni EA. Translational and clinical science—Time for a new vision. N Engl J Med. 2005;353:1621–1623. 3 Beskow LM, Grady C, Iltis AS, Sadler JZ, Wilfond BS. Points to consider: The research ethics consultation service and the IRB. IRB. 2009;31:1–9. 4 Havard M, Cho MK, Magnus D. Triggers for research ethics consultation. Sci Transl Med. 2012;4:118cm1. 5 Danis M, Largent E, Grady C, et al. Research Ethics Consultation: A Casebook. New York, NY: Oxford University Press; 2012. 6 Marshall MF. Vulnerable subjects and civic professionalism: Would six-sigma research and research ethics consultation solve the vulnerability problem? Am J Bioeth. 2004;4:54–55. 7 Sirotin N, Wolf LE, Pollack LM, Catania JA, Dolcini MM, Lo B. IRBs and ethically challenging protocols: Views of IRB chairs about useful resources. IRB. 2010;32:10–19. 8 McCormick JB, Sharp RR, Ottenberg AL, Reider CR, Taylor HA, Wilfond BS. The establishment of research ethics consultation services (RECS): An emerging research resource. Clin Transl Sci. 2013;6:40–44. 9 Goodman KW, Fiore RN. Toward a comprehensive research ethics consultation service. Am J Bioeth. 2008;8:31–32. 10 McCormick JB, Boyce AM, Cho MK. Biomedical scientists’ perceptions of ethical and social implications: Is there a role for research ethics consultation? PLoS One. 2009;4:e4659. 11 Cho MK, Tobin SL, Greely HT, McCormick J, Boyce A, Magnus D. Strangers at the benchside: Research ethics consultation. Am J Bioeth. 2008;8:4–13. 12 Carter MA, Night SS. From strangers to partners: Emerging forms of research ethics consultation. Am J Bioeth. 2008;8:29–31.
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Article 13 de Melo-Martín I, Palmer LI, Fins JJ. Viewpoint: Developing a research ethics consultation service to foster responsive and responsible clinical research. Acad Med. 2007;82:900–904. 14 Taylor HA, Kass NE. Our two cents: Research ethics consultation at Johns Hopkins Bloomberg School of Public Health. Am J Bioeth. 2008;8:33–35. 15 Cho MK, Tobin SL, Greely HT, McCormick J, Boyce A, Magnus D. Research ethics consultation: The Stanford experience. IRB. 2008;30:1–6.
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16 Resnick DB. Research ethics consultation at the National Institute of Environmental Health Sciences. Am J Bioeth. 2008;8:40–42. 17 Kelley M, Fryer-Edwards K, Fullerton SM, Gallagher TH, Wilfond B. Sharing data and experience: Using the Clinical and Translational Science Award (CTSA) “moral community” to improve research ethics consultation. Am J Bioeth. 2008;8:37–39. 18 DuVal G, Gensler G, Danis M. Ethical dilemmas encountered by clinical researchers. J Clin Ethics. 2005;16:267–276.
19 Chapman AR. The potential contributions of translational research and ethics. Am J Bioeth. 2008;8:64–66. 20 Bean S, Henry B, Kinsey JM, McMurray K, Parry C, Tassopoulos T. Enhancing research ethics decision-making: An REB decision bank. IRB. 2010;32:9–12. 21 Koepsell D, Arp R, Fostel J, Smith B. Creating a controlled vocabulary for the ethics of human research: Towards a biomedical ethics ontology. J Empir Res Hum Res Ethics. 2009;4:43–58.
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Research Ethics Consultation: Ethical and Professional Practice Challenges and Recommendations Richard R. Sharp, PhD, Holly A. Taylor, PhD, MPH, Margaret A. Brinich, Mary M. Boyle, MPH, Mildred Cho, PhD, Marilyn Coors, PhD, Marion Danis, MD, Molly Havard, MS, David Magnus, PhD, and Benjamin Wilfond, MD
Abstract The complexity of biomedical research has increased considerably in the last decade, as has the pace of translational research. This complexity has generated a number of novel ethical issues for clinical investigators, institutional review boards (IRBs), and other oversight committees. In response, many academic medical centers have created formal research ethics consultation (REC) services to help clinical investigators and IRBs navigate ethical issues in biomedical research. Key functions of a REC service include
T
he complexity of biomedical research has increased considerably in the last decade, as has the pace of translational research.1,2 This complexity has generated novel ethical issues for clinical investigators, institutional review boards (IRBs), and other oversight committees.3,4 In response, many academic medical centers have created research ethics consultation (REC) services to help clinical investigators and IRBs navigate ethical issues in biomedical research. RECs are modeled on approaches in clinical ethics, in which specialists in ethics help to address challenging issues in patient care by (1) providing expert analysis of ethical issues and (2) facilitating discussion among health care providers and patients.5 REC services support clinical investigators and IRBs by analyzing ethical issues in research, often recommending practical strategies for managing those difficult issues.3 Please see the end of this article for information about the authors. Correspondence should be addressed to Holly A. Taylor, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, 1809 Ashland Ave., Deering Hall 205, Baltimore, MD 21205; telephone: (410) 614-5358; e-mail: [email protected]. Acad Med. 2015;90:615–620. First published online January 20, 2015 doi: 10.1097/ACM.0000000000000640
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assisting with research design and implementation, providing a forum for deliberative exploration of ethical issues, and supplementing regulatory oversight. As increasing numbers of academic research institutions establish REC services, there is a pressing need for consensus about the primary aims and policies that should guide these activities. Establishing clear expectations about the aims and policies of REC services is important if REC programs are to achieve their full potential. Drawing on the experiences of
a Clinical and Translational Science Award Research Ethics Consultation Working Group, this article describes three major ethical and professional practice challenges associated with the provision of REC: (1) managing multiple institutional roles and responsibilities, (2) managing sensitive information, and (3) communicating with consultation requestors about how these issues are managed. The paper also presents several practical strategies for addressing these challenges and enhancing the quality of REC services.
Key functions of a REC service include assisting with research design and implementation, providing a forum for deliberative exploration of ethical issues, and supplementing regulatory oversight. For example, in studies that involve the collection of biological materials for future genetic research or high-risk medical interventions for which the selection of an appropriate study population is unclear, a REC service can assist investigators in navigating the multiple oversight committees that may be involved or clarify ethical issues for which existing regulatory guidance is limited.4,6,7 Developing thoughtful approaches to ethical challenges in biomedical research can require a significant investment of time, particularly for investigators and IRB members who may not be familiar with recent advances in biomedical science or scholarship in bioethics. REC services provide clinical and translational researchers with access to ethics specialists with the knowledge and expertise needed for addressing complex ethical issues in biomedical research.
of the 46 CTSA institutions supported at the time the survey was conducted, 33 (70%) had established REC services. Many of these academic medical centers also indicated that CTSA funding played an important role in establishing or expanding their REC services.8
The establishment of the Clinical and Translational Science Award (CTSA) Consortium created the impetus for more institutions to develop RECs. A survey by McCormick and colleagues8 found that,
As increasing numbers of academic research institutions establish REC services, there is a pressing need for consensus about the primary aims and policies that should guide these activities. For example, it may be unclear to institutional leadership how the work of REC services differs from the work of IRBs.3,9–11 Similarly, clinical investigators may not be clear about the types of protections that these services have established to protect the confidentiality of information provided as part of a consultation request.12 Without shared expectations among requestors, consultants, and the institutions with which they are affiliated, REC services may be underused. Alternatively, the advice of RECs may be sought when other institutional resources, such as an IRB or conflict-of-interest committee, may be more appropriate. Establishing clear expectations about the aims and policies of REC services is important if
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REC programs are to achieve their full potential. To date, few academic medical centers have shared their experiences providing consultation to clinical investigators.12–16 The CTSA network has provided an opportunity for faculty and staff who provide REC services to examine the types of practices, policies, and procedures that are most effective in meeting the needs of clinical investigators.17 Drawing on our experiences as members of a CTSAsupported committee on research ethics, we present some of the major themes that have emerged from ongoing discussions of the CTSA Research Ethics Consultation Working Group. Specifically, we describe three major ethical and professional practice challenges associated with the provision of REC: (1) managing multiple institutional roles and responsibilities, (2) managing sensitive information, and (3) communicating with consultation requestors about how these issues are managed. We suggest several practical strategies for addressing these programmatic challenges and provide recommendations on how to enhance the quality of REC services. Case Studies
To illustrate several critical programmatic challenges facing REC services, we present a series of case studies (Box 1). These case studies represent situations in which lack of common expectations about REC services may result in potential misunderstandings or conflicts. The complexity of these case studies is intended to highlight both the many practical challenges faced by REC services and the need for creativity in managing sensitive information within the context of a consultative relationship. The analysis of these cases is intended to offer a foundation for recommended solutions. Although many consultation requests are more straightforward, these examples illustrate the importance of anticipating potential challenges. Distinguishing multiple institutional roles Case 1 (see Box 1) illustrates the potential for inconsistent expectations regarding the role of a research ethics consultant. This case highlights a situation in which the goals that an ethics consultant has during a REC
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Box 1 Three Case Studies Illustrating Critical Programmatic Challenges Faced by Research Ethics Consultation (REC) Services, Drawn From Discussions of the Clinical and Translational Science Awards (CTSA) Consortium Research Ethics Consultation Working Group Case 1 A team of researchers propose a multicenter clinical trial of the first use in humans of a novel type of cell derived from human embryonic stem cells. Because of the sensitive nature of this research, both the institutional review board (IRB) and the stem cell research oversight committee (SCRO) want to ensure adequate ethics oversight. The committees strongly recommend that the investigators seek a REC before submitting a protocol for review. The consultant most qualified to conduct the REC is also the ethicist serving on the SCRO. There is concern about conflict of commitment. Key questions: Is it appropriate for a research ethics consultant to serve as both a consultant and a member of the committee that reviews the project? Furthermore, is it acceptable for the consultant to be a reviewer for the project? Case 2 A physician conducting a randomized controlled trial of a new (not Food and Drug Administration [FDA]-approved) medication requests a REC to get advice about ethically acceptable methods to improve subject retention. Discussing strategies that other investigators have adopted to improve retention, the physician expresses skepticism. Subjects who have missed study visits, he tells the consultant, are “really sick from the medication. I doubt they will come back no matter what. In fact, one subject got so ill we told her to go to the emergency department [early the previous week].” The consultant reviews the study’s informed consent form and determines that it does not adequately describe the side effects vis-à-vis the protocol. In addition, knowing that any sponsor requires timely reporting of all “serious, unexpected adverse events” (such as the emergency department hospitalization), the consultant counsels the physician to send a report to both sponsor and IRB as soon as possible. The physician says that he had submitted a report to the sponsor, but not to the IRB, concerned that reports of serious adverse events might lead the IRB to suspend the study temporarily, thus compromising a pending contract to conduct additional studies. Key question: Beyond institutional policies, does the research ethics consultant have a duty to report to the IRB a circumstance that might indicate noncompliance with FDA regulations when participants’ safety may be at risk? Case 3 A manuscript submitted to Science for publication is the product of research led by a junior faculty member, closely assisted by a graduate student. They conducted the research in the lab of a senior faculty member who had almost no involvement on the project. In addition, the lab chief provided minimal guidance on the research approach and reviewed the final draft of the paper. Although authorship and the order of authors was not considered in advance, the junior faculty member feels that the graduate student’s role was significant enough to warrant first authorship and that her own effort should count as senior authorship (last author). The lab chief, however, expects to be senior author on all papers that report research conducted in his lab. The junior faculty member seeks a REC and asks that neither of the senior faculty members be included in the consult or even be told that a consult has been requested. Key question: How can a consultant effectively manage the competing demands of a request for complete confidentiality with the reporting requirements of the REC service expected by the National Institutes of Health, the local CTSA, or other institutional groups?
may come into conflict with other commitments that the ethics consultant may have as a result of participation in other institutional activities. The case considers the implications of a common professional role that research ethics consultants often hold in service to their institution: participating as a member of a committee with research oversight responsibilities (e.g., an IRB, an industry relationship committee, or a stem cell research oversight committee [SCRO]). Research ethics consultants have at least two primary commitments when delivering advice. First, the consultant
is an expert who orients the investigator or study team member to reasonable ethical practices relevant to the request for assistance or dilemma posed. The consultant provides advice regarding relevant ethical norms, institutional policies, regulations, and other considerations pertinent to the issue of concern to the requestor. Typically, the consultant will also make suggestions regarding which practical strategies the requestor might want to pursue to resolve the problem. Second, the consultant is an employee of an institution that supports REC services and thus has a commitment to ensuring that research conducted at the institution meets legal and regulatory
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standards. These multiple institutional roles and professional commitments may not be evident to a clinical investigator who engages a REC service. A key question raised by Case 1 is whether an ethics consultant could encounter conflicts of commitment when simultaneously serving as a member of a REC service and as a member of an oversight committee such as an SCRO. This case highlights several ways in which these professional commitments may come into conflict. First, these multiple roles could affect the advice of the consultant. For example, an ethics consultant who serves on an SCRO may focus his or her advice on approaches that are favored by the SCRO, thereby limiting the educational value or effectiveness of the consult. Second, these multiple institutional roles could affect the requestor. For example, the person seeking REC might frame issues in a particular way, withhold some information, or discuss ethical concerns less candidly if he or she is aware that the consultant also serves as a member of the SCRO. Again, this limits the potential value and effectiveness of the consultation. Alternatively, the requestor may feel compelled to follow the recommendations of the ethics consultant knowing of the dual role the consultant has as a member of an institutional oversight board. Third, the involvement of the consultant in multiple institutional roles could affect the outcome of the oversight committee, in this case the SCRO. For example, if the consultant’s colleagues on an oversight committee are made aware of the advice provided by the ethics consultant, those colleagues might be deferential to those recommendations or feel constrained in evaluating a research protocol as a result of prior advice given by an ethics consultant. Our experience suggests that REC consultants with multiple institutional roles encounter these issues with some regularity. Unless an institution employs a large group of specialists in ethics, it is likely that REC staff will also occupy positions on relevant oversight committees. Consultants and institutions need to acknowledge these dual roles and the potential conflicts of commitment they may create when they establish and staff REC services. Although the individuals staffing REC services may manage these
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conflicts appropriately, it is important to address the appearance of conflict as well. It is especially important to distinguish the consultative activities of a REC service from legal or regulatory review mechanisms. For example, a requestor may believe that a consultant’s service on an SCRO may be useful in expediting committee approval. The distinction between the role of an SCRO and a REC service as described in Case 1 highlights how the two types of activities may need to respond to investigator behavior differently. On the opposite end of the spectrum, requestors may avoid ethics consultation because of concerns that a consultant may be obligated to report unethical behavior to an oversight committee on which that consultant serves. Ideally, each institution has an adequate number of ethics experts to serve as consultants as well as members of oversight committees. Until that time, it is essential that the consultant disclose the multiple roles he or she plays within the institution if those roles are relevant to the consult request. It is important to clarify that the primary role of a REC service is to advise and facilitate ethical understanding on the part of clinical investigators and other participants in research. Requestors should also be informed that if a consultant recommends disclosure of information to the oversight committee on which he or she serves, only in extreme circumstances would the consultant be personally obligated to make that disclosure should the requestor be unwilling to do so himself or herself. Materials describing the REC service to potential requestors should make this clear, and REC consultants should reiterate this orientation prior to initiating any individual consultation. This will reduce the likelihood of inappropriate expectations and the other concerns described above.
research volunteers. A REC service, in most instances, will reconcile these two roles by explaining to the investigator the nature, reasons, and importance of the investigator’s obligation to notify the IRB (and in Case 2, the research sponsor as well). If an investigator is reluctant to disclose information to an oversight committee, the ethics consultant should offer assistance. This might include offering to help the investigator present the relevant information to the committee or to facilitate a meeting at which the disclosure will occur. Only after offering such options, and in the clearest circumstances in which a significant research impropriety has occurred and an investigator refuses to report the event to an appropriate oversight board, should a consultant report these activities directly.
Managing sensitive information in a REC
The obligation to disclose protocol deviations and unanticipated safety concerns resides with the investigator, not the ethics consultant. Although the ethics consultant has no regulatory or legal obligation to protect human subjects, once the impropriety has been identified the ethics consultant can help to facilitate the disclosure. In the unlikely event that an investigator refuses to disclose a serious research impropriety, the ethics consultant should disclose the impropriety directly. In this extreme case, the confidentiality of the investigator is trumped by the professional integrity of the ethics consultant and the consultant’s responsibility to report unethical behaviors to his or her employer. Taking this approach implies that under circumstances such as those described in Case 2, it may be appropriate for the consultant to expand the consultation beyond the initial concerns raised by the requestor. In this case, the consultant should gather additional information from the requestor to determine whether or not reporting to the IRB is warranted. However, consultants may have limited opportunity or authority to pursue these objectives within the scope of their roles as research ethics consultants.
Case 2 (see Box 1) highlights potential tensions that may arise in trying to maintain sharp distinctions between providing advice and investigating potentially problematic research practices. In their work, ethics consultants must find the proper balance between their roles as advisors and as agents of an institution committed to promoting ethical research and preventing harm to
Although the analysis of this case highlights issues of confidentiality, we should emphasize that the most immediate benefit that the consultant can offer to the investigator is practical advice about how to manage this circumstance in an ethical manner. Specifically, the requestor should explore with the investigator the potential need
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to communicate with local regulatory authorities or revise the consent form (e.g., to more accurately characterize the side effects described in the protocol). The consultant can also clarify for the requestor some of the relevant considerations that may suggest a need for the investigator to discuss this matter in greater detail with the IRB. Communication and notification Most REC services collect data about who requests the consultation and the nature of the issue(s) addressed. Collecting data within a REC service is important for enabling quality improvement and assessing the utilization and impact of the service over time. Such information may be of use to both the consultants staffing the REC service and to those to whom the consultants are accountable. Case 3 (see Box 1) provides an example where reporting consultation data, although valuable to the REC program and the institution, could raise concerns for the requestor and limit future use of these services. Although the personal identities of requestors, or the nature of their requests, are not typically sensitive topics, Case 3 illustrates how this information can sometimes raise special concerns. In general, REC services should not distribute summary data on consultative activities that are so specific that doing so could result in personal or professional harm to the requestor. For consultation requests involving particularly sensitive issues, a REC service might adopt a policy that only aggregate data will be shared with others. This approach provides a way to track trends in consultative activities without exposing requestors to significant risks involving loss of privacy. On the other hand, if the purpose of reporting data about requests for REC is to understand the frequency of use and scope of requests, or to evaluate the impact of recommendations made by consultants, then not reporting consultations that involve sensitive topics would undermine those goals. Some of these goals, however, may be achievable without reporting the name of the individual requestor. In this case, because of the nature of the concern, the requestor may even prefer that his or her departmental affiliation not be disclosed, as that would identify the division chief, and thus might make the requestor more readily identifiable as
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well. Excluding the name of the requestor may also make it more difficult to get feedback about the consultation process using postconsultation surveys. Assuming that requests for limited disclosure of personal information constitute a small proportion of REC requests, missing data should not have a significant impact on quality improvement or service documentation activities. It is important to inform requestors about the procedures that the REC service uses to document consultation requests. This approach may allow individuals to opt out of such reporting if they have personal concerns or, if reporting is required, to allow the requestor to reconsider whether to initiate a request. Many requestors will appreciate the brief explanation of the consultation service’s institutional accountability. Allowing requestors and consultants to determine whether to exclude the name of a requestor from any standard data collection activity has the potential to engender trust in the consult service and promote its use. This can be done with limited adverse impact on the broader goals of data collection at institutional levels. Recommendations
The expertise provided by REC services is complementary to the regulatory advice available from institutional oversight committees such as IRBs.13,18 REC services provide a forum in which researchers and oversight committees can examine ethical dimensions of their research and/or issues that may fall outside of explicit regulatory guidance.4,5 Working in partnership with researchers and institutional oversight committees, REC services have the potential to enhance the quality of clinical and translational research.19 As evident in the three case studies presented, ethics consultants are likely to encounter challenges at a professional level when they are involved in consultation activities that intersect with their other institutional roles. Even when consultants do not serve on oversight boards, they must be knowledgeable about federal, state, and local institutional policies relevant to the ethical conduct of research. Consultants should also be familiar with the more detailed operational procedures of relevant
institutional oversight committees (e.g., IRBs, institutional animal care and use committees, SCROs, conflict of interest boards). When institutions establish a REC service, it is important to identify individuals who have the requisite knowledge and skills. All ethics consultants ought to have relevant content expertise. Such expertise can come from course work or personal experience and must be recognized by the consultant’s colleagues. Teaching research ethics to advanced students may be a good indicator of this expertise, as well as prior scholarship on topics in research ethics. Additional criteria might include prior service on an IRB, SCRO, or clinical ethics committee; extensive knowledge of the institution’s administrative policies and research culture; and previous leadership activities related to regulatory compliance or institutional integrity. If an institution has relatively few individuals with the requisite expertise to serve as ethics consultants, an additional committee may need to be created to mediate conflicts of commitment that may arise. In addition to REC consultants, this committee might include senior staff members from the IRB, clinical ethicists, and faculty with extensive research experience. The role of such a committee would be to serve as a sounding board for ethics consultants who find themselves in a situation in which their various professional commitments appear to be in conflict. Such a committee could also serve as a resource for more complex consultations and provide a mechanism for periodic quality reviews. To establish clear expectations about the expertise provided by REC services, and to clarify how these services manage potentially challenging situations in which requestor expectations may be unclear, we offer the following recommendations. We base these recommendations on our personal experiences providing REC in a diverse range of institutional settings. We recognize that the heterogeneity of research programs at academic medical centers may not allow for the universal adoption of the approaches we advocate. To the extent that research institutions may have differing stances or “cultures” regarding the management of intrainstitutional communications about
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sensitive matters, these recommendations are intended as guiding principles to be adapted to the unique circumstances of each institution. • Information about the REC service should be posted and easily accessible. Educational materials and other descriptions of the function, duties, and larger purposes of the REC service should be distributed to potential requestors of REC. At a minimum, these materials should outline the following: who can initiate a consultation request, what information is collected and maintained by the REC, how requestor confidentiality will be maintained, and whether or not anonymous consultation requests are accepted. These policies should also describe the information that will be collected to meet institutional reporting requirements. • Requestors should be informed that some information about consultation requests may be shared with research ethics colleagues or collected for quality improvement purposes. Qualified research ethicists are a limited resource at most institutions. Therefore, institutions should have a policy regarding what, if any, information can be shared with others who are not directly involved in the consultation request. • Requestors should be informed that some information shared during an ethics consultation may require disclosure to an institutional oversight committee. REC services should have a policy describing the types of circumstances in which a research ethics consultant may be required to breach requestor confidentiality—for instance, when the safety of a research participant may be affected or there are legal or regulatory requirements to report behaviors identified during the consultation. • Consultants serving on multiple institutional oversight committees should acknowledge and manage potential conflicts of commitment as appropriate. Institutions should have a policy acknowledging that ethicists may serve in multiple institutional roles and adopt a mechanism to manage these professional conflicts of commitment. For example, a policy might require consultants serving on multiple institutional oversight bodies
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to disclose these multiple roles to requestors or, in some cases, to recuse themselves from subsequent reviews of some research protocols (e.g., if the consultant feels that his or her contribution to the protocol creates a conflict of commitment that would hinder his or her ability to carry out an oversight role).
Conclusion
As more REC services are established and provide assistance to clinical and translational scientists, we believe it is important to work toward the development of standards of excellence. We have presented a set of cases and recommendations that reflect our collective experiences and insights in offering REC services with the intent of promoting dialogue about the aims and structure of REC services. Several additional efforts are under way to compile and analyze experiences with REC.17,20,21 It is only by connecting the many individuals who staff REC services, and leveraging the collective wisdom of consultants across the country, that we can promote the continued development and standardization of this new type of research support activity. This manuscript is an effort to share our experience beyond our CTSA working group and begin a conversation with other interested stakeholders, including deans of research, IRB leaders, and investigators. Funding/Support: This project was supported by the National Center for Research Resources and the National Center for Advancing Translational Sciences of the National Institutes of Health under award number 3UL1RR025014-04S1 (Research Bioethics Consultation Standardization and Data Sharing). Other disclosures: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health (in reference to author M. Danis). Ethical approval: Reported as not applicable. R.R. Sharp is director, Biomedical Ethics Program, Mayo Clinic, Rochester, Minnesota. H.A. Taylor is associate professor, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, and core faculty, Johns Hopkins Berman Institute of Bioethics, Baltimore, Maryland. M.A. Brinich is editor-in-chief, Lakewood Observer, Lakewood, Ohio.
M.M. Boyle is clinical research coordinator, MDS/ MPN Group, Transplantation Biology Department, Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington. M. Cho is professor, Stanford Department of Pediatrics, and associate director, Stanford Center for Biomedical Ethics, Stanford University, Stanford, California. M. Coors is associate professor, Department of Psychiatry, Center for Bioethics and Humanities, Anschutz Medical Campus, Aurora, Colorado. M. Danis is section head, Ethics and Health Policy, Department of Bioethics, National Institutes of Health Clinical Center, Bethesda, Maryland. M. Havard is a medical student, University of Cincinnati College of Medicine, Cincinnati, Ohio. D. Magnus is professor of medicine and biomedical ethics, professor of pediatrics, and director, Stanford Center for Biomedical Ethics, Stanford University, Stanford, California. B. Wilfond is director, Treuman Katz Center for Pediatric Bioethics, Seattle Children’s Research Institute, and professor and chief, Division of Bioethics, Department of Pediatrics, University of Washington School of Medicine, Seattle, Washington.
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