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The purpose of this study was to establish the technical merit, feasibility, and generalizability of a new measure of understanding of informed consent for use with clinical research participants. A total of 109 teens/young adults at a large, pediatric medical center completed the consenting process of a hypothetical biobanking study. Data were analyzed using a combination of classical and modern theory analytic methods to produce a final set of 19 items referred to as the uConsent scale. A requirement of the scale was that each item mapped directly onto one or more of the Basic Elements of Informed Consent from the 2018 Final Rule. Descriptive statistics were computed for each item as well as the scale as a whole. Partial credit (Rasch) logistic modeling was then used to generate difficulty/endorsability estimates for each item. The final, 19‐item uConsent scale was derived using inferential methods to yield a set of items that ranged across difficulty levels (−3.02 to 3.10 logits) with a range of point‐measure correlations (0.12 to 0.50), within‐range item‐ and model‐fit statistics, varying item types mapped to both Bloom's Taxonomy of Learning and required regulatory components of the 2018 Final Rule. Median coverage rate for the uConsent scale was 95% for the 25 randomly selected studies from ClinicalTrials.gov. The uConsent scale may be used as an effective measure of informed consent when measuring and documenting participant understanding in clinical research studies today.

Little is known about the number of minors enrolled in clinical research today. IRB administrators at leading pediatric medical centers were surveyed regarding studies with minors. Analyses were descriptive in nature with adaptive Bayesian bootstrap imputation used with missing data. Officials from 17/41 (41.5%) pediatric research centers responded: 74,204 active studies were estimated, 29,078 (39%) included minors, and 6574 (23%) were “more than minimal risk.” Minors accounted for 0.7–2.87M research subjects. Pediatric medicine desperately needs a more accurate and reliable reporting system for tracking the recruitment, retention, and involvement of minors in clinical research.

In 2016, the U.S. National Institutes of Health (NIH) announced a new policy requiring single institutional review board (sIRB) review for multisite studies. However, adherence to the new policy requires the separation of regulatory institutional review board (IRB) work per Federal guidance from site-specific local compliance concerns. In particular, genomic research is subject to a wide range of state laws, institutional requirements, and local population preferences. In this qualitative study, we explored the anticipated needs of genomics researchers and IRB administrators around implementing the policy. We observed multiple uncertainties, particularly about intersite communication processes, sIRB selection processes, and roles of the reviewing IRB and local sites regarding local context information relevant to genomics. Optimal implementation of the NIH policy may require additional guidance for researchers and IRB administrators.

With passage and implementation of the Affordable Health Care Act, more vulnerable segments of the U.S. population will now have access to regular health care and increased opportunities to participate in biomedical research. Yet, access to new groups brings with it new responsibilities for investigators, most importantly, reducing burdens for participants. Data collected through this small pilot study suggest several preliminary but potentially important findings when working with adults from low-income populations: First, while all participants read some parts of the consent forms (55%), only a minority reported reading the entire form (45%); second, 73% of participants reported understanding the study very well whereas only 27% reported understanding the study “a little”; third, there was a slight reported advantage of the simplified form over the regular form; however, this difference varied by section. Relatedly, other research has shown a high incidence of persons reading none of the consent form, but signing a statement that they have read and understood the study. Why does this occur? What are we teaching people when we request that they sign a consent form they have chosen not to read? What are the ethical and regulatory implications? Embedded ethics studies such as this one, although pilot and preliminary in nature, offer a number of advantages, such as stimulating additional scientific inquiry as well as challenging established institutional practices.

Clinicians and researchers must contextualize a patient’s genetic variants against population-based references with detailed phenotyping. We sought to establish globally scalable technology, policy, and procedures for sharing biosamples and associated genomic and phenotypic data on broadly consented cohorts, across sites of care. Three of the nation’s leading children’s hospitals launched the Genomic Research and Innovation Network (GRIN), with federated information technology infrastructure, harmonized biobanking protocols, and material transfer agreements. Pilot studies in epilepsy and short stature were completed to design and test the collaboration model. Harmonized, broadly consented institutional review board (IRB) protocols were approved and used for biobank enrollment, creating ever-expanding, compatible biobanks. An open source federated query infrastructure was established over genotype–phenotype databases at the three hospitals. Investigators securely access the GRIN platform for prep to research queries, receiving aggregate counts of patients with particular phenotypes or genotypes in each biobank. With proper approvals, de-identified data is exported to a shared analytic workspace. Investigators at all sites enthusiastically collaborated on the pilot studies, resulting in multiple publications. Investigators have also begun to successfully utilize the infrastructure for grant applications. The GRIN collaboration establishes the technology, policy, and procedures for a scalable genomic research network.

The oversight of research involving human participants is a complex process that requires institutional review board review as well as multiple non-institutional review board institutional reviews. This multifaceted process is particularly challenging for multisite research when each site independently completes all required local reviews. The lack of inter-institutional standardization can result in different review outcomes for the same protocol, which can delay study operations from start-up to study completion. Hence, there have been strong calls to harmonize and thus streamline the research oversight process. Although the institutional review board is only one of the required reviews, it is often identified as the target for harmonization and streamlining. Data regarding variability in decision-making and interpretation of the regulations across institutional review boards have led to a perception that variability among institutional review boards is a primary contributor to the problems with review of multisite research. In response, many researchers and policymakers have proposed the use of a single institutional review board of record, also called a central institutional review board, as an important remedy. While this proposal has merit, the use of a central institutional review board for multisite research does not address the larger problem of completing non-institutional review board institutional review in addition to institutional review board review—and coordinating the interdependence of these reviews. In this article, we describe the overall research oversight process, distinguish between institutional review board and institutional responsibilities, and identify challenges and opportunities for harmonization and streamlining. We focus on procedural and organizational issues and presume that the protection of human subjects remains the paramount concern. Suggested modifications of institutional review board processes that focus on time, efficiency, and consistency of review must also address what effect such changes have on the quality of review. We acknowledge that assessment of quality is difficult in that quality metrics for institutional review board review remain elusive. At best, we may be able to assess the time it takes to review protocols and the consistency across institutions.

PurposeClinicians and researchers must contextualize a patient’s genetic variants against population-based references with detailed phenotyping. We sought to establish globally scalable technology, policy, and procedures for sharing biosamples and associated genomic and phenotypic data on broadly consented cohorts, across sites of care.MethodsThree of the nation’s leading children’s hospitals launched the Genomic Research and Innovation Network (GRIN), with federated information technology infrastructure, harmonized biobanking protocols, and material transfer agreements. Pilot studies in epilepsy and short stature were completed to design and test the collaboration model.ResultsHarmonized, broadly consented institutional review board (IRB) protocols were approved and used for biobank enrollment, creating ever-expanding, compatible biobanks. An open source federated query infrastructure was established over genotype–phenotype databases at the three hospitals. Investigators securely access the GRIN platform for prep to research queries, receiving aggregate counts of patients with particular phenotypes or genotypes in each biobank. With proper approvals, de-identified data is exported to a shared analytic workspace. Investigators at all sites enthusiastically collaborated on the pilot studies, resulting in multiple publications. Investigators have also begun to successfully utilize the infrastructure for grant applications.ConclusionsThe GRIN collaboration establishes the technology, policy, and procedures for a scalable genomic research network.