Principles of Human Subjects Protections Applied in an Opt‐Out, De‐identified Biobank

Pulley, Jill M.; Clayton, Ellen Wright; Bernard, Gordon R.; Roden, Dan M.; Masys, Daniel R.

doi:10.1111/j.1752-8062.2010.00175.x

Cited by 192 publications

(190 citation statements)

References 19 publications

Supporting

Mentioning

188

Contrasting

Order By: Relevance

“…To improve the process of consent at the time of biospecimen donation, supplemental brochures or educational materials that focus on the biobank could be a source of information for participants. For example, as part of an opt-out consent process, Pulley et al (2010) utilized a brief brochure to answer additional questions. Development of informed consent processes that are informed by potential biobank participants is critical to encourage participation across population subgroups.…”

Section: Discussionmentioning

confidence: 99%

Differences in preferences for models of consent for biobanks between Black and White women

et al. 2015

View full text Add to dashboard Cite

Biobanks are essential resources, and participation by individuals from diverse groups is needed. Various models of consent have been proposed for secondary research use of biospecimens, differing in level of donor control and information received. Data are needed regarding participant preferences for models of consent, particularly among minorities. We conducted qualitative semi-structured interviews with 60 women to examine their attitudes about different models of consent. Recruitment was stratified by race (Black/White) and prior biobank participation (yes/no). Two coders independently coded interview transcripts. Qualitative thematic analysis was conducted using NVivo 10. The majority of Black and White participants preferred Bbroad^consent (i.e., blanket permission for secondary research use of biospecimens), and the second most preferred model for both groups was Bstudyspecific^consent (i.e., consent for each future research study). The qualitative analysis showed that participants selected their most preferred model for 3 major reasons: having enough information, having control over their sample, and being asked for permission. Least preferred was notice model (i.e., participants notified that biospecimens may be used in future research). Attitudes toward models of consent differed somewhat by race and prior biobank participation. Participants preferred models of consent for secondary research use of biospecimens that provided them with both specific and general information, control over their biospecimens, and asked them to give permission for use. Our findings suggest that it will be important for researchers to provide information about future uses of biospecimens to the extent possible and have an explicit permission step for secondary research use.

show abstract

Section: Discussionmentioning

confidence: 99%

Differences in preferences for models of consent for biobanks between Black and White women

et al. 2015

View full text Add to dashboard Cite

show abstract

“…10 The SD consists of de-identified clinical data obtained from patients at Vanderbilt University Medical Center, including all clinics that are part of the hospital system. Clinical data from multiple sources are available, including diagnostic and procedure codes, basic demographics, discharge summaries, progress notes, health history, multidisciplinary assessments, laboratory values, imaging reports, medication orders, and pathology reports.…”

Section: Study Populationmentioning

confidence: 99%

Enhancing Uterine Fibroid Research Through Utilization of Biorepositories Linked to Electronic Medical Record Data

Feingold-LinkLani

EdwardsTodd

JonesSarah

et al. 2014

Journal of Women's Health

View full text Add to dashboard Cite

Background: Uterine leiomyomata (fibroids) affect up to 77% of women by menopause and account for $9.4 billion in yearly healthcare costs. Most studies rely on self-reported diagnosis, which may result in misclassification of controls since as many as 50% of cases are asymptomatic and thus undiagnosed. Our objective was to evaluate the performance and accuracy of a fibroid phenotyping algorithm constructed from electronic medical record (EMR) data, limiting to subjects with pelvic imaging. Methods: Our study population includes women from a clinical population at Vanderbilt University Medical Center (2008)(2009)(2010)(2011)(2012). Analyses were restricted to women 18 years and older with at least one fibroid diagnosis confirmed by imaging for cases or at least two separate pelvic imaging procedures without a diagnosis for controls. We randomly reviewed 218 records to evaluate the accuracy of our algorithm and assess the indications for pelvic imaging. Participant characteristics and indications for imaging were compared between cases and controls in unadjusted and adjusted logistic regression analyses. Results: Our algorithm had a positive predictive value of 96% and negative predictive value of 98%. Increasing age (odds ratio = 1.05, 95% confidence interval 1.03-1.08) and Black race (odds ratio = 2.15, 95% confidence interval 1.18-3.94) were identified as risk factors for fibroids. The most common indications for imaging in both cases and controls were pain, bleeding, and reproductive factors, and the most common imaging modality was a pelvic ultrasound. Conclusions: These data suggest that using biorepositories linked to EMR data is a feasible way to identify populations of imaged women that facilitate investigations of fibroid risk factors.

show abstract

“…In contrast, many SDMs in our study voiced the opinion that collection of genetic samples without explicit consent would be acceptable, analogous to the creation of data repositories in nonacute settings. 37 The tendency to downplay long-term risks associated with genetic data collection might underlie our finding that SDMs perceived genetic data and nongenetic data similarly.…”

Section: Discussionmentioning

confidence: 92%

Perspectives of surrogate decision makers for critically ill patients regarding gene variation research

Iverson

Celious

Kennedy

et al. 2013

Genetics in Medicine

View full text Add to dashboard Cite

about potential misuse of genetic data largely centered on misconduct, paternity, forensic applications, and insurance and employment discrimination. Although surrogate decision makers expressed that their loved ones would have interest in return of results and being recontacted for future use, these interests were secondary to confidentiality concerns. Conclusion:Respondents perceived genetic and nongenetic data as comparable. Informed consent processes that provide clear information regarding confidentiality protections, specimen handling, and parameters for future use may enhance enrollment. 2013:15(5):368-373 Genet Med

show abstract

Principles of Human Subjects Protections Applied in an Opt‐Out, De‐identified Biobank

Cited by 192 publications

References 19 publications

Differences in preferences for models of consent for biobanks between Black and White women

Differences in preferences for models of consent for biobanks between Black and White women

Enhancing Uterine Fibroid Research Through Utilization of Biorepositories Linked to Electronic Medical Record Data

Perspectives of surrogate decision makers for critically ill patients regarding gene variation research

Contact Info

Product

Resources

About