Partnering With Patients to Bridge Gaps in Consent for Acute Care Research

Dickert, Neal W.; Bernard, A. Michelle; Brabson, JoAnne M.; Hunter, Rodney J.; McLemore, Regina; Mitchell, Amy L.; Palmer, Stephen C. F.; Reed, Barbara D.; Riedford, Michele; Simpson, Raymond T.; Speight, Candace; Steadman, Tracie; Pentz, Rebecca D.

doi:10.1080/15265161.2020.1745931

Cited by 26 publications

(5 citation statements)

References 20 publications

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“…For example, informed decision making is difficult to facilitate when there is a need to make quick decisions to treat severe illness in the context of stressful situations and to communicate with surrogates about complex decisions they have not previously considered. 18 COVID-19 has also highlighted challenges related to coordination between research and clinical staff and to the need to provide interpreters for non-English speaking participants. 19,20 And for many years, there have been prevalent concerns about comprehension in general with the growing complexity and length of consent documents.…”

Section: Informed Consent Practices Prior To the Covid-19 Pandemicmentioning

confidence: 99%

Informed consent: Old and new challenges in the context of the COVID-19 pandemic

Rothwell

Brassil

Barton-Baxter

et al. 2021

J. Clin. Trans. Sci.

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Section: Informed Consent Practices Prior To the Covid-19 Pandemicmentioning

confidence: 99%

Informed consent: Old and new challenges in the context of the COVID-19 pandemic

Rothwell

Brassil

Barton-Baxter

et al. 2021

J. Clin. Trans. Sci.

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“…Although understanding the impact of this novel consent process on participants and research teams requires further evaluation (which is ongoing), we believe that the process described here has important ethical advantages 20 . At the simplest level, it started with engaging the people whom the process is intended to serve and designed materials and strategy around their experiences and needs.…”

Section: Discussionmentioning

confidence: 99%

“…We enlisted a seven‐member PAP, established previously, to develop consent processes for the MOST trial. The PAP was composed of three types of individuals: patients who had experienced stroke or acute myocardial infarction, people who served as a surrogate decision‐maker for a family member with one of those conditions, and individuals from the Emory Patient and Family Advisory Council 8 . (See table 1 for characteristics of the PAP's members.)…”

Section: Study Methodsmentioning

confidence: 99%

“…The ideal approach should advance achievable goals and meet regulatory demands but recognize the unique context in which these decisions are made. We previously partnered with patients and surrogates to develop consent processes for stroke trials 3 . These processes include focused, short forms that are attentive to tone and structure and an information sheet designed to be a resource during the study.…”

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confidence: 99%

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Getting the Most out of Consent: Patient‐Centered Consent for an Acute Stroke Trial

Dickert

Metz

Deeds³

et al. 2022

Ethics & Human Research

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Informed consent for clinical trials in acute stroke is characterized by challenges related to urgency, cognitive impairment, and geographical separation. Context‐appropriate approaches are needed for this setting. We conducted a mixed‐methods project involving focus groups and interviews as well as collaboration with a patient advisory panel and a central institutional review board (CIRB) to design and implement a patient‐driven consent process for a multicenter trial incorporating adaptive randomization. Remote consent was recognized as challenging but acceptable. Adaptive randomization was viewed positively, but significant potential for misunderstanding was appreciated. Collaboration between the patient advisory panel and the CIRB resulted in a shortened, more patient‐centered consent form that was approved at all sites with few modifications. An information sheet was developed as a resource for patients and surrogates after enrollment. Collaboration between investigators, patient partners, and a CIRB can facilitate innovation and implementation of patient‐centered, context‐appropriate consent strategies.

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“…We think that, especially in the acute setting in which the decision-making capacity of critically ill participants is absent or at least very limited, it is important to obtain patient views on topics as informed consent and other relevant issues [ 23 ]. Therefore, in this paper we present our findings based on interviews with Dutch SCA survivors, and their next-of-kin, about the donation of their data to research, with the aim of contributing to an empirically informed, patient-centred ethical framework on data use in emergency care research, as well as to the broader health data privacy debate.…”

Section: Introductionmentioning

confidence: 99%

Health data research on sudden cardiac arrest: perspectives of survivors and their next-of-kin

et al. 2021

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Background Consent for data research in acute and critical care is complex as patients become at least temporarily incapacitated or die. Existing guidelines and regulations in the European Union are of limited help and there is a lack of literature about the use of data from this vulnerable group. To aid the creation of a patient-centred framework for responsible data research in the acute setting, we explored views of patients and next-of-kin about the collection, storage, sharing and use of genetic and health-related data for observational research. Methods We conducted qualitative interviews (n = 19) with Dutch sudden cardiac arrest survivors who donated clinical and socio-economic data and genetic samples to research. We also interviewed their next-of-kin. Topics were informed by ethics literature and we used scenario-sketches to aid discussion of complex issues. Results Sudden cardiac arrest survivors displayed limited awareness of their involvement in health data research and of the content of their given consent. We found that preferences regarding disclosure of clinically actionable genetic findings could change over time. When data collection and use were limited to the medical realm, patients trusted researchers to handle data responsibly without concern for privacy or other risks. There was no consensus as to whether deferred consent should be explicitly asked from survivors. If consent is asked, this would ideally be done a few months after the event when cognitive capacities have been regained. Views were divided about the need to obtain proxy consent for research with deceased patients’ data. However, there was general support for the disclosure of potentially relevant post-mortem genetic findings to relatives. Conclusions Sudden cardiac arrest patients’ donation of data for research was grounded in trust in medicine overall, blurring the boundary between research and care. Our findings also highlight questions about the acceptability of a one-time consent and about responsibilities of patients, researchers and ethics committees. Finally, further normative investigation is needed regarding the (continued) use of participants’ data after death, which is of particular importance in this setting. Our findings are thought to be of relevance for other acute and life-threatening illnesses as well.

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Partnering With Patients to Bridge Gaps in Consent for Acute Care Research

Cited by 26 publications

References 20 publications

Informed consent: Old and new challenges in the context of the COVID-19 pandemic

Informed consent: Old and new challenges in the context of the COVID-19 pandemic

Getting the Most out of Consent: Patient‐Centered Consent for an Acute Stroke Trial

Health data research on sudden cardiac arrest: perspectives of survivors and their next-of-kin

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