Does Community Consultation Matter?

Biros, Michelle H.

doi:10.1111/acem.12044

Cited by 9 publications

(6 citation statements)

References 17 publications

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“…Two types of value for community consultation were frequently emphasized: 1) the ability to clarify impact of trial enrollment on potential enrollees and ways to refine the study and 2) the potential to promote trust, provide transparency, and demonstrate respect 5–13 . There were questions raised about the extent to which community consultation accomplishes these goals, especially identifying changes 14–19 .…”

Section: Resultsmentioning

confidence: 99%

“…There were questions raised about the extent to which community consultation accomplishes these goals, especially identifying changes 14–19 . A key theme was the reiteration that community consultation is not intended to be a “consent” process or vote, although acceptance is relevant 6,9,20,21 . As emphasized in the regulations, the primary purpose of community consultation is to provide an opportunity for public comment and feedback 2…”

Section: Resultsmentioning

confidence: 99%

“…For example, some commentators have argued that the extent and nature of consultation should be scaled to study risks 8,11,31 . Second, commentators emphasized the “two‐way” nature of consultation and the importance of alignment between chosen methods and this goal 6,9,32,33 . There have been explicit arguments against use of quantitatively oriented, less interactive, forms of consultation, emphasizing the ability of more interactive methods to facilitate substantive input and that views change during discussions 5,8–10,34 .…”

Section: Resultsmentioning

confidence: 99%

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Meeting unique requirements: Community consultation and public disclosure for research in emergency setting using exception from informed consent

Dickert

Metz

Fetters

et al. 2021

Academic Emergency Medicine

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Background Exception from informed consent (EFIC) regulations for research in emergency settings contain unique requirements for community consultation and public disclosure. These requirements address ethical challenges intrinsic to this research context. Multiple approaches have evolved to accomplish these activities that may reflect and advance different aims. This scoping review was designed to identify areas of consensus and lingering uncertainty in the literature. Methods Scoping review methodology was used. Conceptual and empirical literature related to community consultation and public disclosure for EFIC research was included and identified through a structured search using Embase, HEIN Online, PubMed, and Web of Science. Data were extracted using a standardized tool with domains for major literature categories. Results Among 84 manuscripts, major domains included conceptual or policy issues, reports of community consultation processes and results, and reports of public disclosure processes and results. Areas of consensus related to community consultation included the need for a two‐way exchange of information and use of multiple methods. Public acceptance of personal EFIC enrollment is commonly 64% to 85%. There is less consensus regarding how to assess attitudes, what “communities” to prioritize, and how to determine adequacy for individual projects. Core goals of public disclosure are less well developed; no metrics exist for assessing adequacy. Conclusions Multiple methods are used to meet community consultation and public disclosure requirements. There remain no settled norms for assessing adequacy of public disclosure, and there is lingering debate about needed breadth and depth of community consultation.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Meeting unique requirements: Community consultation and public disclosure for research in emergency setting using exception from informed consent

Dickert

Metz

Fetters

et al. 2021

Academic Emergency Medicine

View full text Add to dashboard Cite

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“…It is unclear if community consultation does in fact add human subject protection, but it has provided insight into patient populations, and the opportunity to determine how emergency research, with and without consent, is viewed by the population 4 5…”

mentioning

confidence: 99%

“…The concerns that cause uncertainty need to be determined. When non-commitment is due to lack of understanding, researchers must be sure that complex research concepts are carefully explained; describing the concepts in the context of a specific study has been seen to improve understanding 4 5. If the uncertainty is due to concerns about losing the connection to their clinician and care plans, the investigator must delineate the difference between clinical care and research.…”

mentioning

confidence: 99%

Never, always and maybe. Addressing attitudes of patients towards emergency medicine research

Biros

2016

Emerg Med J

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As the clinical specialties of emergency medicine and prehospital medicine developed, patients who otherwise would have died in the field began to survive to reach the ED. It soon became apparent that existing emergent treatments for many critical conditions were unsatisfactory and/or were understudied. However, traditional methods of obtaining prospective informed consent for research participation are not feasible when a devastating pathology deprives patients of meaningful decision-making capacity. With that in mind, a set of regulations was developed by the Federal regulatory agencies in USA; this allows for exception from informed consent (EFIC) in emergency research in specific clinical circumstances 1 and went into effect in 1996. The emergency medicine community was the key driver in the creation of these regulations.

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Learning From Experience: A Systematic Review of Community Consultation Acceptance Data

Fehr

Pentz

Dickert

2015

Annals of Emergency Medicine

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Does Community Consultation Matter?

Cited by 9 publications

References 17 publications

Meeting unique requirements: Community consultation and public disclosure for research in emergency setting using exception from informed consent

Meeting unique requirements: Community consultation and public disclosure for research in emergency setting using exception from informed consent

Never, always and maybe. Addressing attitudes of patients towards emergency medicine research

Learning From Experience: A Systematic Review of Community Consultation Acceptance Data

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