Patient and Surrogate Postenrollment Perspectives on Research Using the Exception From Informed Consent: An Integrated Survey

Scicluna, Victoria M.; Biros, Michelle H.; Harney, Deneil; Jones, Elizabeth B.; Mitchell, Amy L.; Pentz, Rebecca D.; Silbergleit, Robert; Speight, Candace; Wright, David W.; Dickert, Neal W.

doi:10.1016/j.annemergmed.2020.03.017

Cited by 7 publications

(17 citation statements)

References 16 publications

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“…More black participants disagreed with enrolment without prior consent than white, other race and unknown race categories. (35) This nding may re ect other studies that show black participants prefer to give prior permission before their inclusion in research. (37) However, these ndings may lead to numerous assumptions.…”

Section: Acceptability Of Deferred Consentmentioning

confidence: 72%

“…(35) The Established Status Epilepticus Treatment Trial (ESETT) enrolled participants without prospectively provided consent and supported the nding that the phrasing of statements is important. (35) This is supported by studies showing acceptability varies when asked about personal or general enrolment using deferred consent. (36) In the ESETT trial, participants were asked if they were "glad that themselves or their family members were included in the study".…”

Section: Acceptability Of Deferred Consentmentioning

confidence: 98%

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Exploring the Inclusion of Under-Served Groups in Trials Methodology Research: An Example from Ethnic Minority Populations’ Views on Deferred Consent

Raven-Gregg

Shepherd

2021

Preprint

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Background: Deferred consent is used to recruit patients in emergency research, when informed consent cannot be obtained prior to enrolment. This model of consent allows studies to recruit larger numbers of participants, especially where a surrogate-decision maker may be unavailable to provide consent. Whilst deferred consent offers the potential to promote trial diversity by including under-served groups, it is ethically complex and views about its use amongst these populations requires further exploration. The aim of this article is to build upon recent initiatives to improve inclusivity in trials, such as the NIHR INCLUDE project, and consider whether trials methodology research is inclusive, focusing on ethnic minority populations’ attitudes towards the use of deferred consent.Main text: Findings from the literature suggest that research regarding attitudes toward recruitment methods like deferred consent largely fail to adequately represent ethnic minorities. Many studies fail to report the composition of patient samples or conduct analyses on any differences between specific patient groups. In those that do, the categorisation of ethnic groups is ambiguous. Frequently diversely different groups are considered as more homogenous than they are. Whilst deferred consent is deemed generally acceptable, analysis of patient sub-groups shows that this attitude is not universal. Those from racial and ethnic minority backgrounds reported higher levels of unacceptability, which was impacted by previous first or second-hand experience of its use and historical mistrust in research. However, whilst deferred consent was found to increase the numbers of black participants enrolled in some trials, their over-enrolment in other trials may raise further concerns. Conclusions: Inclusivity in clinical trials is important, as highlighted by the COVID-19 pandemic. To improve this, we must ensure that methodological studies such as those exploring attitudes to research are inclusive. More effort is needed to understand the views of under-served groups, such as ethnic minorities, toward research in order to improve participation in clinical trials. Our findings echo those from the INCLUDE project, in that better reporting is needed and increasing the confidence of ethnic minority groups in research requires improving representation throughout the research process. This will involve diversifying research teams and ethics committees.

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Section: Acceptability Of Deferred Consentmentioning

confidence: 72%

Section: Acceptability Of Deferred Consentmentioning

confidence: 98%

Exploring the Inclusion of Under-Served Groups in Trials Methodology Research: An Example from Ethnic Minority Populations’ Views on Deferred Consent

Raven-Gregg

Shepherd

2021

Preprint

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“…This shows that ethnic minorities are more likely to appreciate the importance of deferring consent but experience personal reluctancy toward enrolment regarding themselves. Furthermore, this demonstrates that the wording of statements and the language used when asking opinions of deferred consent may greatly impact the responses generated [35].…”

Section: Attitudes Of Ethnic Minorities Towards Deferred Consentmentioning

confidence: 99%

Exploring the inclusion of under-served groups in trials methodology research: an example from ethnic minority populations’ views on deferred consent

Raven-Gregg

Shepherd

2021

Trials

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Background Deferred consent is used to recruit patients in emergency research, when informed consent cannot be obtained prior to enrolment. This model of consent allows studies to recruit larger numbers of participants, especially where a surrogate-decision maker may be unavailable to provide consent. Whilst deferred consent offers the potential to promote trial diversity by including under-served groups, it is ethically complex and views about its use amongst these populations require further exploration. The aim of this article is to build upon recent initiatives to improve inclusivity in trials, such as the NIHR INCLUDE project, and consider whether trials methodology research is inclusive, focusing on ethnic minority populations’ attitudes towards the use of deferred consent. Main text Findings from the literature suggest that research regarding attitudes toward recruitment methods like deferred consent largely fail to adequately represent ethnic minorities. Many studies fail to report the composition of patient samples or conduct analyses on any differences between specific patient groups. In those that do, the categorisation of ethnic groups is ambiguous. Frequently diversely different groups are considered as more homogenous than they are. Whilst deferred consent is deemed generally acceptable, analysis of patient sub-groups shows that this attitude is not universal. Those from racial and ethnic minority backgrounds reported higher levels of unacceptability, which was impacted by previous first or second-hand experience of its use and historical mistrust in research. However, whilst deferred consent was found to increase the numbers of black participants enrolled in some trials, their over-enrolment in other trials may raise further concerns. Conclusions Inclusivity in clinical trials is important, as highlighted by the COVID-19 pandemic. To improve this, we must ensure that methodological studies such as those exploring attitudes to research are inclusive. More effort is needed to understand the views of under-served groups, such as ethnic minorities, toward research in order to improve participation in clinical trials. Our findings echo those from the INCLUDE project, in that better reporting is needed and increasing the confidence of ethnic minority groups in research requires improving representation throughout the research process. This will involve diversifying research teams and ethics committees.

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“…We chose this model because previous research has demonstrated the difficulties involved in seeking informed consent in emergency medical research. [17][18][19][20][21][22][23][24][25][26] Largent et al provide an alternative to unsatisfactory consent processes used in this context. Furthermore, their model continues to be cited regularly in the emergency research literature.…”

Section: Comparison Of Ethical Framework With the Consent Substitute Modelmentioning

confidence: 99%

“…We compared the five conditions of the consent substitute model with the emergency research provisions within international and national ethical frameworks, to determine whether it could be employed by researchers adhering to these frameworks. We chose this model because previous research has demonstrated the difficulties involved in seeking informed consent in emergency medical research 17–26 . Largent et al provide an alternative to unsatisfactory consent processes used in this context.…”

Section: Comparison Of Ethical Framework With the Consent Substitute Modelmentioning

confidence: 99%

Do National and International Ethics Documents Accord With the Consent Substitute Model for Emergency Research?

Langlois

Armstrong

Siriwardena

2020

Academic Emergency Medicine

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In 2010 Largent, Wendler, and Emanuel proposed the "consent substitute model" for emergency research with incapacitated participants. The model provides a means to enroll participants in emergency research without consent, if five conditions are met: 1) the research addresses the patients' urgent medical needs, 2) the riskbenefit ratio is favorable, 3) there are no known conflicts with patients' values or interests, 4) cumulative net risk is minimal, and 5) consent is given as soon as possible. We review national and international ethics laws, regulations, and guidelines to determine 1) whether they accord with the consent substitute model's five conditions and 2) the level of congruence across these documents. We find that only one document meets all five conditions and that there is significant disparity among the documents, particularly between national and international ones. These differences may have stymied international collaboration in emergency research. We recommend that the two international documents used most, the International Council for Harmonization's Guideline for Good Clinical Practice and the World Medical Association's Declaration of Helsinki, are revised to include more specific provisions on emergency medical research.

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Patient and Surrogate Postenrollment Perspectives on Research Using the Exception From Informed Consent: An Integrated Survey

Cited by 7 publications

References 16 publications

Exploring the Inclusion of Under-Served Groups in Trials Methodology Research: An Example from Ethnic Minority Populations’ Views on Deferred Consent

Exploring the Inclusion of Under-Served Groups in Trials Methodology Research: An Example from Ethnic Minority Populations’ Views on Deferred Consent

Exploring the inclusion of under-served groups in trials methodology research: an example from ethnic minority populations’ views on deferred consent

Do National and International Ethics Documents Accord With the Consent Substitute Model for Emergency Research?

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