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The article covers electronic informed consent (eIC) from different dimensions so that practitioners might understand the history, regulation, and current status of eIC. It covers the transition of informed consent to electronic screens and the implications of that transition in terms of design, costs, and data analysis. The article explores the limits of regulation mandating eIC for mobile application research, and addresses some of the broader social context around eIC.

Mobile devices with health apps, direct-to-consumer genetic testing, crowd-sourced information, and other data sources have enabled research by new classes of researchers. Independent researchers, citizen scientists, patient-directed researchers, self-experimenters, and others are not covered by federal research regulations because they are not recipients of federal financial assistance or conducting research in anticipation of a submission to the FDA for approval of a new drug or medical device. This article addresses the difficult policy challenge of promoting the welfare and interests of research participants, as well as the public, in the absence of regulatory requirements and without discouraging independent, innovative scientific inquiry. The article recommends a series of measures, including education, consultation, transparency, self-governance, and regulation to strike the appropriate balance.

Beginning in the 20th century, scientific research came to be dominated by a growing class of credentialed, professional scientists who overwhelmingly displaced the learned amateurs of an earlier time. By the end of the century, however, the exclusive realm of professional scientists conducting research was joined, to a degree, by “citizen scientists.” The term originally encompassed non-professionals assisting professional scientists by contributing observations and measurements to ongoing research enterprises. These collaborations were especially common in the environmental sciences, where citizen scientists participated in counting wildlife and measuring environmental conditions. Later, patient groups began to play a more active role in supporting clinical trials and collecting health records from affected individuals.

The prospect of newly-emerging, technology-enabled, unregulated citizen science health research poses a substantial challenge for traditional research ethics. Unquestionably, a significant amount of research ethics study is needed to prepare for the inevitable, widespread introduction of citizen science health research. Using the case study of mobile health (mHealth) research, this article provides an ethical, legal, and social implications (ELSI) research agenda for citizen science health research conducted outside conventional research institutions. The issues for detailed analysis include the role of IRBs, recruitment, inclusion and exclusion criteria, informed consent, confidentiality and security, vulnerable participants, incidental findings, and publication and data sharing.

Background Apoptosis is disrupted in prostate tumor cells, conferring a survival advantage. p53 is a nuclear protein believed to regulate cancer progression, in part by inducing apoptosis. To test this possibility in future studies, the objective of the present study was to generate a transgenic mouse model expressing mutant p53 in the prostate (PR). Methods Transgene incorporation was tested using Southern analysis. Expression of mutant p53 protein was examined using immunofluorescence microscopy. Apoptosis in the PR was evaluated using the Tunnel method. Results A construct, consisting of the rat probasin promoter and a mutant human p53 fragment, was prepared and used to generate transgenic mice. rPB-mutant p53 transgene incorporation, as well as nuclear accumulation of mutant human p53 protein, was demonstrated. Prostatic intraepithelial neoplasia (PIN) III and IV were found in PR of 52-week old transgenic mice, whereas no pathological changes were found in the other organs examined. PR ability to undergo apoptosis following castration was reduced in rPB-mutant p53 mice as compared to non transgenic littermates. Conclusions Transgenic rPB-mutant p53 mice accumulate mutant p53 protein in PR, resulting in neoplastic lesions and reduced apoptotic potential in the PR. Breeding rPB-mutant p53 mice with mice expressing an oncogene in their PR will be useful in examining interactions of multiple genes that result in progression of slow growing prostate tumors expressing oncogenes alone to metastatic cancer. © 2004 Wiley-Liss, Inc.

We determined the incidence of voiding disorders and upper tract deterioration in children with cervical and upper thoracic level myelomeningocele.We retrospectively reviewed the neurosurgical and urological presentation, evaluation and treatment of 11 patients of whom 8 had cervical and 3 had upper thoracic myelomeningocele. There were 7 female and 4 male patients 10 months to 39 years old (mean age 12 years). All patients were ambulatory and 5 of 11 (45%) had hydrocephalus. Although a voiding history was obtained by a neurosurgeon in all patients, only 9 had undergone a formal urological evaluation, including video urodynamic assessment in 5.No patient had an increased post-void residual and none had ever been placed on intermittent catheterization. Tethered spinal cords from caudal fixation (thickened filum terminale and a lipomyelomeningocele) were present in 2 patients with urinary incontinence of whom 1 had recurrent cystitis. Imaging studies of the upper tracts were normal in all 9 patients and video urodynamics were normal in 3 of 5. No patient has required urological operative intervention.To our knowledge, this study represents the largest reported series of patients with cervical and upper thoracic myelomeningocele who have undergone urological evaluation. Our experience suggests that patients with cervical and upper thoracic myelomeningocele have a low risk of voiding disorders and upper tract deterioration unless other conditions, such as a congenital tethered cord, are present. Additional reports of children with cervical and upper thoracic myelomeningocele are necessary to confirm these findings.