Kelly Nicole Michelson

Current challenges in the clinical research landscape include insufficient enrollment of study participants, lack of study participant diversity, protracted study progression, and the siloing of research within academic medical centers. Recent advances in technology could minimize barriers to producing effective, timely, and comprehensive clinical research by addressing issues from study design to dissemination of results. Particularly, the Fast Health Interoperability Resources standards and Clinical Decision Support Hooks could support data acquisition, sharing, and expansion of research across organizations and disparate electronic health records. We developed a novel approach, Precision Accelerated Clinically Embedded Research (PACER), that leverages these advances in healthcare technology to integrate very short, minimal-risk research activities into clinical encounters. PACER could enable scalable, efficient, and cost-effective clinical research and has enormous potential. However, PACER also presents potential ethical, sociotechnical, and implementation quandaries. The current study aimed to obtain insights on these matters from relevant individuals. We conducted 47 qualitative semi-structured interviews with patients, clinicians, research experts (individuals involved in developing and conducting research), and bioethicists. We sought participants’ perspectives on the potential ethical, sociotechnical, and implementation issues raised by PACER. We identified five key domains: impacts on clinical research, consent, compensation, impacts on people and organizations, and implementation. We examined interview participants’ views using bioethical principles of autonomy, justice/fairness, beneficence, and nonmaleficence. While participants had diverse views, these insights highlight important considerations for PACER implementation and suggest areas for future empirical work.

Clinical data sharing combined with deep learning, and soon quantum computing, has the potential to radically accelerate research, improve healthcare, and lower costs. Unfortunately, those tools also make it much easier to use the data in ways that can harm patients. This article will argue that the vast amounts of data collected by data brokers, combined with advances in computing, have made reidentification a serious risk for any clinical data that is shared openly. The new NIH data sharing policy acknowledges this new reality by directing researchers to consider controlled access for any individual-level data. The clinical data sharing community will be well-advised to follow the lead of the physics and astronomy communities and create a “walled garden” approach to data sharing. While the investment will be significant, this approach provides the optimal combination of both access and privacy.

Following an unexpected pediatric death, survivors undergo unique trauma. Medical examiners (MEs) evaluate most of these deaths. We evaluated the bereavement support available to survivors in the Chicagoland area following a pediatric death. We had two goals: to characterize the available bereavement support options and compare the locations (by zip code) of support groups with the locations (by zip code) in which pediatric ME cases occurred. We identified 48 organizations that provided bereavement support services at 74 locations in the summer and fall of 2020. Locations by zip codes in which the largest number of ME cases occurred did not have support groups. Locations in which more ME cases occurred generally had lower-income populations and a greater proportion of Black or Hispanic residents. Bereavement support following pediatric death is inadequate and unevenly distributed across the Chicagoland area.

Background: Social workers (SWs) and chaplains are trained to support families facing challenges associated with critical illness and potential end-of-life issues. Little is known about how parents view SW/chaplain involvement in care for critically ill children with cancer. Methods: We studied parent perceptions of SW/chaplain involvement in care for pediatric intensive care unit (PICU) patients with cancer or who had a hematopoietic cell transplant. English- and Spanish-speaking parents completed surveys within 7 days of PICU admission and at discharge. Some parents participated in an optional interview. Results: Twenty-four parents of 18 patients completed both surveys, and six parents were interviewed. Of the survey respondents, 66.7% and 75% interacted with SWs or chaplains, respectively. Most parents described SW/chaplain interactions as helpful (81.3% and 72.2%, respectively), but few reported their help with decision making (18.8% and 12.4%, respectively). Parents described SW/chaplain roles related to emotional, spiritual, instrumental, and holistic support. Few parents expressed awareness about SW/chaplain interactions with other healthcare team members. Conclusions: Future work is needed to determine SWs’/chaplains’ contributions to and impact on parental decision making, improve parent awareness about SW/chaplain roles and engagement with the healthcare team, and understand why some PICU parents do not interact with SWs/chaplains.

This Viewpoint discusses the gap between clinical medical ethics and some business practices related to patient data sharing and secondary use of data by corpor