Clinical and Translational Research Ethics: Training Consultants and Biomedical Research Personnel

Arnold, Jason F.; Boan, Andrea D.; Lackland, Daniel T.; Sade, Robert M.

doi:10.1080/15265161.2017.1401172

Cited by 7 publications

(7 citation statements)

References 8 publications

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“…T o create a successful RECS, it is important to assess whether the institution has (or can hire) the appropriate employees to act in the role of a research ethics consultant. While there is no agreed‐upon list of competencies needed for this position, there is a growing concern that more education and training programs are needed to address competency in research ethics 19 . As more of these consultation services are being established in this area, some scholars have argued for the development of standards of excellence akin to the competencies that the American Society for Bioethics and Humanities (ASBH) has outlined for ethics consultants who address ethics issues in the clinical care setting 20 …”

Section: What Knowledge Skills and Abilities Are Necessary?mentioning

confidence: 99%

Creating a Research Ethics Consultation Service: Issues to Consider

Taylor

Porter

Paquette

et al. 2021

Ethics & Human Research

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This article provides pragmatic advice for organizations interested in creating a research ethics consultation service (RECS). A robust RECS has the potential to build capacity among investigators to identify and consider the ethical issues they encounter while conducting their research. Determining whether to establish an RECS should begin with an institutional‐needs assessment that includes three key questions: What are the current resources available to research teams to navigate ethical concerns that arise from their research? Is there a demand or perceived need for more resources? Is there institutional support (financial and otherwise) to establish and maintain an RECS? If this results in the decision to establish the consultation service, relevant institutional stakeholders must be identified and consulted, and personnel with the requisite skills recruited. The next step is to establish an RECS and build the infrastructure to process and respond to requests. The RECS's long‐term sustainability will depend on a stable source of funding and a mechanism to receive constructive feedback to ensure that the service is meeting the institutional needs it set out to address.

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Section: What Knowledge Skills and Abilities Are Necessary?mentioning

confidence: 99%

Creating a Research Ethics Consultation Service: Issues to Consider

Taylor

Porter

Paquette

et al. 2021

Ethics & Human Research

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“…Another important point is competency of research ethics consultants; its significance essentially depends on the quality of research ethics consultation. Several previous reports have raised questions and concerns about how clinical research ethics consultants should be trained (Arnold et al, 2018; Fost, 2018; Paquette & Ross, 2018). However, studies addressing the education of research ethics consultants remain scarce to date.…”

Section: Research Agendamentioning

confidence: 99%

Research Ethics Consultation in Nursing Studies

Kane

Sakaguchi

Chuma

et al. 2021

Journal of Empirical Research on Human Research Ethics

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Despite the importance and acceptance of research ethics consultation as an entity in many medical research areas, little is known about its status in nursing research. Focusing on inquiries from nurse researchers, we retrospectively analyzed records of integrated clinical research consultation, provided by members of the Clinical Research Center independently of the research ethics committee, at a Japanese university hospital during 2018–2019. Among various consultations in nursing studies ( n = 101), 43 were related to research ethics. The main issues in research ethics consultation were compatibility with guidelines ( n = 28; 65%) and application of ethics review ( n = 12; 28%). Future studies should investigate international settings and address the relevance of research ethics consultation to promote proper nursing studies.

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“…Arnold et al (2018) and Paquette and Ross (2018) raise related questions about how consultants should do their job in cases of conflicting recommendations from REC services and regulatory bodies such as IRBs, particularly situations where the IRB has approved a protocol as permissible from a regulatory standpoint that a REC service “finds impermissible based on their ethical analysis” (Paquette and Ross 2018). We acknowledge that the IRB does have regulatory authority, and consultations are advisory.…”

Section: Role and Scopementioning

confidence: 99%

“…Arnold et al (2018), Paquette and Ross (2018), and Fost (2018) raise questions and concerns about how clinical research ethics consultants should be trained. This is a fundamental question that needs attention.…”

Section: Training and Qualitymentioning

confidence: 99%

Defining the Scope and Improving the Quality of Clinical Research Ethics Consultation: Response to Open Peer Commentaries About the National Collaborative

Porter¹,

Danis

Taylor

et al. 2018

The American Journal of Bioethics

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The Open Peer Commentaries on “The Emergence of Clinical Research Ethics Consultation: Insights from a National Collaborative201D highlight the many ways in which the practice of ethics consultation for clinical research can be further advanced. We respond here to a number of key considerations highlighted by commentators, including the role and scope of research ethics consultation (REC), relationships with other institutional services and programs, efforts to ensure the quality of consultations provided, and the feasibility of widespread REC services.

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Clinical and Translational Research Ethics: Training Consultants and Biomedical Research Personnel

Cited by 7 publications

References 8 publications

Creating a Research Ethics Consultation Service: Issues to Consider

Creating a Research Ethics Consultation Service: Issues to Consider

Research Ethics Consultation in Nursing Studies

Defining the Scope and Improving the Quality of Clinical Research Ethics Consultation: Response to Open Peer Commentaries About the National Collaborative

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