Purpose: In 2011, an Advanced Notice of Proposed Rulemaking proposed that de-identified
human data and specimens be included in biobanks only if patients provide consent. The …

BACKGROUND Genetic information is unique among all laboratory data because it not only
informs the current health of the specific person tested but may also be predictive of the …

The increased international sharing of data in research consortia and the introduction of new
technologies for sequencing challenge the informed consent (IC) process, adding …

Background Biobank participants often do not understand much of the information they are
provided as part of the informed consent process, despite numerous attempts at simplifying …

Accurate clinical interpretation of children's whole-genome and whole-exome sequences
relies on comparing the patient's linked genomic and phenotypic data with variant reference …

Background: observational research is increasingly important in clinical decision-making.
Opt-out consent has been proposed as a more practical way to obtain participants' consent …

Aims: To investigate the attitudes of patients toward the return of individual research results
from scientific research with residual tissue. Methods and Findings: We recruited 1319 …

Large-scale biorepositories that couple biologic specimens with electronic health records
containing documentation of phenotypic expression can accelerate scientific research and …

IN “RAW PERSONAL DATA: PROVIDING ACCESS”(POLICY FORUM, 24 January, p. 373),
JE Lunshof and colleagues argue that donors should have access to raw data derived from …

In this article, we report on an effort to study the development and usefulness of a large,
broad-use, opt-in biorepository for genomic research, focusing on three ethical issues …