Consent for genetics studies among clinical trial participants: findings from                 Action for Health in Diabetes (Look AHEAD)

Espeland, Mark A.; Dotson, Kathy; Jaramillo, Sarah A.; Kahn, Steven E.; Harrison, Barbara; Montez, Maria G.; Foreyt, John P.; Montgomery, Brenda; Knowler, William C.

doi:10.1177/1740774506070727

Cited by 29 publications

(47 citation statements)

References 29 publications

(40 reference statements)

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“…We, like others, conclude that the level of detail contained within the informed consent and the amount of time spent ensuring that the subject understood the informed consent contributed to the high overall consent rates found in the study 1 8 12–15. This trend may be seen because, during the consent process, the subject develops a sense of confidence in the clinician/researcher.…”

Section: Commentsupporting

confidence: 50%

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Effect of ethnicity, gender and drug use history on achieving high rates of affirmative informed consent for genetics research: impact of sharing with a national repository

Ray

Jackson²,

Ducat³

et al. 2011

J Med Ethics

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Aim Genetic research representative of the population is crucial to understanding the underlying causes of many diseases. In a prospective evaluation of informed consent we assessed the willingness of individuals of different ethnicities, gender and drug dependence history to participate in genetic studies in which their genetic sample could be shared with a repository at the National Institutes of Health. Methods Potential subjects were recruited from the general population through the use of flyers and referrals from previous participants and clinicians with knowledge of our study. They could consent to 11 separate choices so that they could specify how and with whom their genetic sample could be shared. Rates of affirmative consent were then analysed by gender, ethnicity and drug dependence history. Results Of 1416 volunteers enrolled, 99.7% gave affirmative informed consent for studies of addiction conducted in our laboratory. No significant difference was found for participation in genetic studies conducted in our laboratory by gender, ethnicity or drug dependence history. Over all 11 questions, individuals with a history of drug use were more likely to agree to consent to participate in our study than were healthy volunteers. Conclusion A high percentage of each category of gender, ethnicity and drug history, gave affirmative consent at all levels. The level of detail in and the amount of time spent reviewing the informed consent, and a relationship of trust with the clinical investigator may contribute to this outcome.

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Section: Commentsupporting

confidence: 50%

“…It is often thought in the research community that individuals with a stigmatised disease will be less likely to participate in research 1 3 11. These individuals may be concerned that they will suffer social, familial or job discrimination if their disease status became known.…”

Section: Commentmentioning

confidence: 99%

Effect of ethnicity, gender and drug use history on achieving high rates of affirmative informed consent for genetics research: impact of sharing with a national repository

Ray

Jackson²,

Ducat³

et al. 2011

J Med Ethics

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“…As suggested by our study and others [23], providing the option to learn of individual research results may serve as a significant, positive influencing factor in decisions about participation by enhancing trust between participants and researchers [41,42] and showing respect for participants [18,43]. Specifically, enhancing trust between researchers and participants may be particularly important for genetics/genomics research as this type of research may raise additional personal and community concerns, potentially affecting overall participation rates of minorities [44,45,46,47,48,49,50]. In addition, concerns regarding the perceived lack of benefit, to the individual or to the community [51,52], may be ameliorated through the provision of options to access individual or summary results.…”

Section: Discussionmentioning

confidence: 99%

Public Perspectives on Returning Genetics and Genomics Research Results

O’Daniel

Haga²

2011

Public Health Genomics

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Background: The debate about returning research results has revealed different perspectives among researchers, participants and advisory groups with participants generally interested in obtaining their results. Given this preference, policies regarding return of individual research results may affect whether a potential subject chooses to participate in a study. Public attitudes, particularly those of African-Americans, toward this issue have been understudied. Methods: In 2008–2009, we convened 10 focus groups in Durham, N.C. to explore attitudes about returning research results and how different policies might influence their likelihood to participate in genetic/genomic studies. Transcripts were complimented by a short anonymous survey. Of 100 participants, 73% were female and 76% African-American with a median age of 40–49 years. Results: Although there was general interest in obtaining genetics research results, particularly individual results, discussants recognized many potential complexities. The option to obtain research results (individual or summary) was clearly valued and lack thereof was potentially a deterrent for genetic/genomic research enrollment. Conclusions: Providing the option to learn research results may help strengthen relationships between investigators and participants and thereby serve as a positive influencing factor for minority communities. Consideration of the broader implications of returning research results is warranted. Engaging diverse publics is essential to gain a balance between the interests and burdens of participants and investigators.

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“…[5][6][7] Genetic biospecimens are commonly collected in observational studies and as adjuncts to therapeutic trials. 8 Comparable investigations involving acutely ill patients are increasingly commonplace and essential to advancing the fi eld of critical care medicine. 4,9,10 Critically ill patients are frequently incapacitated, requiring that informed consent permitting research participation be obtained from surrogate decisionmakers (eg, family members, guardians, or domestic partners).…”

mentioning

confidence: 99%

Surrogate Receptivity to Participation in Critical Illness Genetic Research

Freeman

Butler

Bolcic‐Jankovic³

et al. 2015

Chest

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Consent for genetics studies among clinical trial participants: findings from Action for Health in Diabetes (Look AHEAD)

Abstract: Background-Increasingly, genetic specimens are collected to expand the value of clinical trials through study of genetic effects on disease incidence, progression, or response to interventions.

Cited by 29 publications

References 29 publications

Effect of ethnicity, gender and drug use history on achieving high rates of affirmative informed consent for genetics research: impact of sharing with a national repository

Effect of ethnicity, gender and drug use history on achieving high rates of affirmative informed consent for genetics research: impact of sharing with a national repository

Public Perspectives on Returning Genetics and Genomics Research Results

Surrogate Receptivity to Participation in Critical Illness Genetic Research

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