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.
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However, consultants may have limited opportunity or authority to pursue these objectives within the scope of their roles as research ethics consultants. While 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 to communicate with local regulatory authorities or revise the consent form e.
- Research Ethics Consultation: Ethical and Professional Practice Challenges and Recommendations.
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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. 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, while valuable to the REC program and the institution, could raise concerns for the requestor and limit future use of these services.
While 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 is so specific that it 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 well.
Excluding the name of the requestor may also make it more difficult to get feedback about the consultation process using post-consultation 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 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.
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. The expertise provided by REC services is complementary to the regulatory advice available from institutional oversight committees such as IRBs. 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. 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. 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: 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 research ethics consultation 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. Educational materials and other descriptions of the function, duties, and larger purposes of the REC service should be distributed to potential requestors of research ethics consultation.
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At a minimum, these materials should outline the following: These policies should also describe the information that will be collected to meet institutional reporting requirements. 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.
REC services should have a policy describing the types of circumstances in which a research ethics consultant may be required to breach requestor confidentiality, e. 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 to disclose these multiple roles to requestors, or in some cases, to recuse themselves from subsequent reviews of some research protocols e. 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 underway to compile and analyze experiences with REC. 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. 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.
Reported as not applicable. Brinich, Lakewood Observer , Lakewood, Ohio. National Center for Biotechnology Information , U.
A Casebook
Author manuscript; available in PMC May 1. Sharp , PhD, director , Holly A. Brinich , editor-in-chief , Mary M. Author information Copyright and License information Disclaimer. Address correspondence to Dr. The publisher's final edited version of this article is available at Acad Med.
See other articles in PMC that cite the published article. Abstract The complexity of biomedical research has increased considerably in the last decade, as has the pace of translational research. Case Studies To illustrate several critical programmatic challenges facing REC services, we present a series of case studies Box 1. 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. Case 2 A physician conducting a randomized controlled trial of a new not FDA-approved medication requests an REC to get advice about ethically acceptable methods to improve subject retention.
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. 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?
Distinguishing multiple institutional roles Case 1 see Box 1 illustrates the potential for inconsistent expectations regarding the role of a research ethics consultant. Managing sensitive information in a research ethics consultation 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.
Communication and notification Most REC services collect data about who requests the consultation and the nature of the issue s addressed. Recommendations The expertise provided by REC services is complementary to the regulatory advice available from institutional oversight committees such as IRBs.
Marion Danis (ed.), Clinical Research Consultation: A Casebook - PhilPapers
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 research ethics consultation. 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. 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, e.
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.
Research Ethics Consultation
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. Contributor Information Richard R. Translational and clinical science-time for a new vision. N Engl J Med. The research ethics consultation service and the IRB. Triggers for research ethics consultation.
Oxford University Press; Vulnerable subjects and civic professionalism: Would six-sigma research and research ethics consultation solve teh vulnerability problem? IRBs and ethically challenging protocols: Views of IRB chairs about useful resources. The establishment of research ethics consultation services RECS: An emerging research resource.
Toward a comprehensive research ethics consultation service. Biomedical scientists' perceptions of ethical and social implications: Is there a role for research ethics consultation? Strangers at the benchside: Although the NIH experience is unique, this book focuses on cases - and associated lessons - that are generalizable and valuable for the entire clinical research community. This book will be valuable to ethics consultants, clinical investigators, students and teachers, and others desiring insight into clinical research ethics and ethics consultation.
Head, Unit on Vulnerable Populations, Dept. Oxford University Press is a department of the University of Oxford. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide. Academic Skip to main content.
Choose your country or region Close. Ebook This title is available as an ebook. To purchase, visit your preferred ebook provider. Reinforces the theoretical concepts of research ethics while simultaneously bringing them to bear on actual cases from the routine conduct of clinical research with human subjects. These consultations have provided the consultants at the NIH Clinical Center with rich experiences identifying, analyzing, and addressing the ethical concerns - routine and rare - that arise when conducting clinical research.