MétaCan
Menu
Back to cohort
Record W2555044821 · doi:10.1186/s12874-016-0263-7

Conducting a large, multi-site survey about patients’ views on broad consent: challenges and solutions

2016· article· en· W2555044821 on OpenAlexfundno aff
Maureen E. Smith, Saskia C. Sanderson, Kyle B. Brothers, Melanie F. Myers, Jennifer B. McCormick, Sharon Aufox, Martha J. Shrubsole, Nanibaa’ A. Garrison, Nathaniel D. Mercaldo, Jonathan S. Schildcrout, Ellen Wright Clayton, Armand H. Matheny Antommaria, Melissa Basford, Murray H. Brilliant, John J. Connolly, Stephanie M. Fullerton, Carol R. Horowitz, Gail P. Jarvik, Dave Kaufman, Terri Kitchner, Rongling Li, Evette Ludman, Catherine A. McCarty, Valerie McManus, Sarah Stallings, Janet L. Williams, Ingrid A. Holm

Bibliographic record

VenueBMC Medical Research Methodology · 2016
Typearticle
Languageen
FieldMedicine
TopicEthics in Clinical Research
Canadian institutionsnot available
FundersNational Center for Advancing Translational SciencesNational Institute of Environmental Health SciencesNational Human Genome Research InstituteCanada Excellence Research Chairs, Government of CanadaNational Institute of Diabetes and Digestive and Kidney DiseasesCincinnati Children's Hospital Medical CenterChildren's Hospital of Philadelphia
KeywordsMEDLINEData scienceInformed consentMedicineFamily medicinePsychologyComputer scienceAlternative medicinePolitical sciencePathologyLaw

Abstract

fetched live from OpenAlex

BACKGROUND: As biobanks play an increasing role in the genomic research that will lead to precision medicine, input from diverse and large populations of patients in a variety of health care settings will be important in order to successfully carry out such studies. One important topic is participants' views towards consent and data sharing, especially since the 2011 Advanced Notice of Proposed Rulemaking (ANPRM), and subsequently the 2015 Notice of Proposed Rulemaking (NPRM) were issued by the Department of Health and Human Services (HHS) and Office of Science and Technology Policy (OSTP). These notices required that participants consent to research uses of their de-identified tissue samples and most clinical data, and allowing such consent be obtained in a one-time, open-ended or "broad" fashion. Conducting a survey across multiple sites provides clear advantages to either a single site survey or using a large online database, and is a potentially powerful way of understanding the views of diverse populations on this topic. METHODS: A workgroup of the Electronic Medical Records and Genomics (eMERGE) Network, a national consortium of 9 sites (13 separate institutions, 11 clinical centers) supported by the National Human Genome Research Institute (NHGRI) that combines DNA biorepositories with electronic medical record (EMR) systems for large-scale genetic research, conducted a survey to understand patients' views on consent, sample and data sharing for future research, biobank governance, data protection, and return of research results. RESULTS: Working across 9 sites to design and conduct a national survey presented challenges in organization, meeting human subjects guidelines at each institution, and survey development and implementation. The challenges were met through a committee structure to address each aspect of the project with representatives from all sites. Each committee's output was integrated into the overall survey plan. A number of site-specific issues were successfully managed allowing the survey to be developed and implemented uniformly across 11 clinical centers. CONCLUSIONS: Conducting a survey across a number of institutions with different cultures and practices is a methodological and logistical challenge. With a clear infrastructure, collaborative attitudes, excellent lines of communication, and the right expertise, this can be accomplished successfully.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.216
metaresearch head score (Gemma)0.889
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch, Science and technology studies, Research integrity, Insufficient payload (model declined to judge)
Consensus categoriesMetaresearch, Research integrity
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: none
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.673
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.2160.889
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.000
Bibliometrics0.0010.000
Science and technology studies0.0000.004
Scholarly communication0.0000.000
Open science0.0010.001
Research integrity0.0010.005
Insufficient payload (model declined to judge)0.0010.001

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.981
GPT teacher head0.730
Teacher spread0.251 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; both teacher heads agree on what is shown here.

Study designObservational
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations11
Published2016
Admission routes1
Has abstractyes

Explore more

Same venueBMC Medical Research MethodologySame topicEthics in Clinical ResearchFrench-language works237,207