A randomized implementation trial to increase adoption of evidence-informed consent practices

Solomon, Erin D.; Goodman, Melody S.; Parsons, Meredith; Baldwin, Kari; Friedrich, Annie B.; Harris, Jenine K.; DuBois, James M.

doi:10.1017/cts.2022.520

Cited by 2 publications

(1 citation statement)

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“…Knowledge, resources, and attitudes are all potentially modifiable, and our online toolkit ( ConsentTools.org ) contains resources to address barriers identified in our study [ 72 ]. For example, we provide education on regulatory definitions and guidance regarding LARs, available empirical data, sample forms to document participant wishes, a tool to assess LARs’ understanding of consent information, and template language to use with IRBs when justifying the decision to involve LARs.…”

Section: Discussionmentioning

confidence: 99%

Barriers to Using Legally Authorized Representatives in Clinical Research with Older Adults

Solomon

Baldwin

Wroblewski

et al. 2023

ADR

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Background: Older adults are at increased risk of cognitive impairments including Alzheimer’s disease dementia. Legally authorized representatives (LARs) can provide informed consent when a participant is no longer able to, but little is known about barriers to incorporating them in research. Objective: Explore reasons for not asking and documenting participant decisions to appoint LARs among researchers conducting clinical intervention trials studying older adults or individuals with cognitive impairments. Methods: Mixed method design consisting of a survey (N = 1,284) and qualitative interviews (N = 40) regarding barriers to incorporating LARs. Participants were principal investigators and clinical research coordinators. Results: 37% (N = 469) had not asked and documented participant decisions about appointing LARs in the prior year. They had significantly lower confidence in resources available to incorporate LARs and lower positive attitudes compared to their counterparts who had done so. The majority (83%) had no trials studying individuals with cognitive impairments and reported LARs were not applicable. A minority (17%) had at least one trial studying individuals with cognitive impairments and reported being unaware of LARs. Qualitative findings indicate discomfort broaching a sensitive topic especially with individuals who are not yet impaired. Conclusion: Resources and education to increase awareness and knowledge of LARs are needed. Researchers studying older adults should, at minimum, have the knowledge and resources to incorporate LARs when necessary. Stigma and discomfort discussing LARs will need to be overcome, as early proactive discussions before a participant loses decisional capacity could enhance participant autonomy and facilitate recruitment and retention of older adults to research.

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Section: Discussionmentioning

confidence: 99%

Barriers to Using Legally Authorized Representatives in Clinical Research with Older Adults

Solomon

Baldwin

Wroblewski

et al. 2023

ADR

Self Cite

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A training protocol compliance of 13% was observed in a research study of clinical research professionals

Solomon,

Mozersky,

Parsons

et al. 2024

BMC Res Notes

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Objective We attempted to conduct a randomized controlled trial of three different informed consent training formats to evaluate their effectiveness. We recruited 503 clinical research professionals, who received $50 for participation. Incidental findings showed unexpectedly low rates of compliance with completing the study training protocols, resulting in insufficient statistical power to test our original hypotheses. In this report, we conducted a secondary analysis of the data in which we characterize and evaluate the observed low compliance. This involved using literature on average reading times, speed-reading times, and video play speeds to calculate the timeframes required to complete the three training formats. Results Only 13% of participants completed the training in a reasonable timeframe. Furthermore, only 46% of participants completed the training in the minimum possible timeframe. These findings lead us to ask whether online research training is effective, since no training can be effective if participants do not actually complete the training. Given extensive requirements for educational training among clinical research professionals, we feel the burden of proof is on training programs to demonstrate that they have positive effects. Supplementary Information The online version contains supplementary material available at 10.1186/s13104-024-06870-0.

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A randomized implementation trial to increase adoption of evidence-informed consent practices

Abstract: This version may be subject to change during the production process.

Cited by 2 publications

References 40 publications

Barriers to Using Legally Authorized Representatives in Clinical Research with Older Adults

Barriers to Using Legally Authorized Representatives in Clinical Research with Older Adults

A training protocol compliance of 13% was observed in a research study of clinical research professionals

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