A Computer-Based Education Intervention to Enhance Surrogates' Informed Consent for Genomics Research

Shelton, Ann K.; Freeman, Bradley D.; Fish, Anne F.; Bachman, Jean A.; Richardson, Lloyd I.

doi:10.4037/ajcc2015983

Cited by 8 publications

(6 citation statements)

References 35 publications

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“…Five studies used the QuIC instrument (Klima et al, 2014; McCarty et al, 2015; McCarty et al, 2007; Ormond et al, 2009; Simon et al, 2015) and one used the Brief Informed Consent Evaluation Protocol (BICEP; Bickmore et al, 2009). One of the studies that used a self-administered survey also reported the initial reliability (Cronbach’s α of .73) and validity data (content validity) for a newly developed instrument to measure surrogate consent for genetic studies (Shelton, Freeman, Fish, Bachman, & Richardson, 2015).…”

Section: Resultsmentioning

confidence: 99%

“…Studies about computer-based informed consent often involved hypothetical biobanking decisions (Beskow, Lin, et al, 2017; Bickmore et al, 2009; Mahnke et al, 2014; McGraw et al, 2012; Shelton et al, 2015). While computer modules may occasionally lead to small gains in understanding, two authors cautioned that technology should be used as an adjunct to more traditional methods of informed consent including human interaction and reading of paper documents (McGraw et al, 2012; Shelton et al, 2015). Interactivity, in the form of comprehension checks or quizzes, provided an important opportunity to review consent information, clarify confusion, and improve understanding (Beskow, Lin, et al, 2017; Bickmore et al, 2009; Simon et al, 2015).…”

Section: Resultsmentioning

confidence: 99%

“…Variability in the qualifications (e.g., physicians vs. research assistants) and actions of the consenter may have influenced participants’ understanding of informed consent in ways that have yet to be determined. In eight studies (Beskow & Dean, 2008; Beskow, Lin, et al, 2017; Mahnke et al, 2014; McCarty et al, 2008; McGraw et al, 2012; Merz & Sankar, 1998; Rahm, Wrenn, Carroll, & Feigelson, 2013; Shelton et al, 2015), participants only read a consent document and/or viewed a computerized version of the consent, with no human leading a consent discussion. Finally, estimated time to explain consent information varied across included studies, ranging from less than 1 min to 1 hr.…”

Section: Resultsmentioning

confidence: 99%

See 2 more Smart Citations

Participants’ Understanding of Informed Consent for Biobanking: A Systematic Review

et al. 2017

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Nurses are increasingly asked to obtain consent from participants for biobanking studies. Biobanking has added unique complexities to informed consent. The purpose of this systematic review was to evaluate participants' level of understanding of the information presented during the informed consent process unique to the donation of biological specimens for research. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were utilized to conduct the review. PubMed, EMBASE, CINAHL, PsycINFO, Scopus, Web of Science, and ProQuest bibliographic databases were searched. Results indicated that elements of informed consent unique to biobanking were poorly understood. Most studies had authors or funding associated with a biobank. Only one study disclosed and assessed participants' understanding of moral risks. Increased disclosures, values-clarification, and presenting information via multiple modalities may facilitate understanding. There is a need to improve the quality of informed consent for biobanking studies by utilizing standardized instruments, definitions, and encouraging research about informed choice outside the biobanking industry.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Participants’ Understanding of Informed Consent for Biobanking: A Systematic Review

et al. 2017

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“…Finally, the incorporation of computer-based tools to help the informed consent process can also be discussed. 37 …”

Section: Discussionmentioning

confidence: 99%

Impact of the COVID-19 Pandemic on Oncology Clinical Research in Latin America (LACOG 0420)

Gongora

Werutsky²,

Jardim

et al. 2021

JCO Global Oncology

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PURPOSE COVID-19 has affected cancer care worldwide. Clinical trials are an important alternative for the treatment of oncologic patients, especially in Latin America, where trials can be the only opportunity for some of them to access novel and, sometimes, standard treatments. METHODS This was a cross-sectional study, in which a 22-question survey regarding the impact of the COVID-19 pandemic on oncology clinical trials was sent to 350 representatives of research programs in selected Latin American institutions, members of the Latin American Cooperative Oncology Group. RESULTS There were 90 research centers participating in the survey, with 70 of them from Brazil. The majority were partly private or fully private (n = 77; 85.6%) and had confirmed COVID-19 cases at the institution (n = 57; 63.3%). Accruals were suspended at least for some studies in 80% (n = 72) of the responses, mostly because of sponsors' decision. Clinical trials' routine was affected by medical visits cancelation, reduction of patients' attendance, reduction of other specialties' availability, and/or alterations on follow-up processes. Formal COVID-19 mitigation policies were adopted in 96.7% of the centers, including remote monitoring and remote site initiation visits, telemedicine visits, reduction of research team workdays or home office, special consent procedures, shipment of oral drugs directly to patients' home, and increase in outpatient diagnostic studies. Importantly, some of these changes were suggested to be part of future oncology clinical trials' routine, particularly the ones regarding remote methods, such as telemedicine. CONCLUSION To our knowledge, this was the first survey to evaluate the impact of COVID-19 on Latin American oncology clinical trials. The results are consistent with surveys from other world regions. These findings may endorse improvements in clinical trials' processes and management in the postpandemic period.

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“…Several innovative approaches aimed at enhancing comprehension of informed consent have been suggested and can be adapted for genomic research in Uganda. For example, use of visual and audio imageries to explain highly technical and complex language (Nabukenya et al, 2022; Taylor et al, 2021); electronic video consent (Naeim et al, 2021), use of Computer-based education modules (Shelton et al, 2015), and summarizing of consent information and delivering it in a conversational and interactive manner (Nabukenya et al, 2022). The revised common rule also introduced the concept of “key information” (HHS.gov, 2018) where participants should be given focused and concise information presented in a way that facilitates comprehension.…”

Section: Best Practicesmentioning

confidence: 99%

Understanding of Critical Elements of Informed Consent in Genomic Research: A Case of a Paediatric HIV-TB Research Project in Uganda

Amayoa

Nakwagala

Barugahare

et al. 2022

Journal of Empirical Research on Human Research Ethics

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Several studies have reported inadequate comprehension of informed consent for genomic research. This study aimed to assess research participants’ understanding of critical elements of informed consent for genomic research. A cross-sectional survey involving 123 parents/caregivers of children participating in a paediatric genomic TB/HIV study was conducted. Only 47.2% of the participants had adequate understanding of consent information. The mean objective (actual) and subjective (perceived) understanding scores were 78.7% and 91.7% respectively. Participants adequately understood most elements of consent however, some elements were poorly understood including foreseeable risks, protection of confidentiality and compensation for research related injury. Overall there was inadequate comprehension of critical elements of informed consent and there was dissonance between actual and perceived comprehension of informed consent.

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A Computer-Based Education Intervention to Enhance Surrogates' Informed Consent for Genomics Research

Cited by 8 publications

References 35 publications

Participants’ Understanding of Informed Consent for Biobanking: A Systematic Review

Participants’ Understanding of Informed Consent for Biobanking: A Systematic Review

Impact of the COVID-19 Pandemic on Oncology Clinical Research in Latin America (LACOG 0420)

Understanding of Critical Elements of Informed Consent in Genomic Research: A Case of a Paediatric HIV-TB Research Project in Uganda

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