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Digital informed consent may better inform individuals about health research and increase participation. In the United States and elsewhere, minorities and rural populations are underrepresented in health research and may benefit from well-designed electronic informed consent (eIC). Seven focus groups were conducted with 50 Caucasian, African American, and rural patients in the United States. Participants were asked their preferences for a paper versus electronic informed consent document. Participants found the e-version easier to use, more interesting, and better for understanding. Minority participants emphasized limited access, computer literacy, and trust barriers to eIC. Rural participants were concerned about accessibility, connectivity, privacy, and confidentiality. People see value in electronic consenting. Researchers should consider barriers to eIC among underrepresented populations before recruitment. more...

The Russian Radiobiological Human Tissue Repository (RHTR) at the Southern Urals Biophysics Institute in Ozyorsk, Russia, was established to collect and store biospecimens supporting research on health consequences of chronic, low-dose radiation exposures. The purpose of this paper is to describe the RHTR resources and the availability of high-quality biological specimens. RHTR has enrolled two groups of subjects from 1951 to the present time: exposed workers at the Mayak Production Association facilities and residents of Ozyorsk who were never occupationally exposed to ionizing radiation (controls). Biospecimens are collected with informed consent of participants and are annotated with demographic, occupational, dosimetry and medical information. To date, 900 individuals have provided surgical tissues and 1000 have provided autopsy tissues. Blood samples are also collected and stored. Familial DNA is available from parent–offspring triads. Biospecimens and annotated data are available to interested scientists worldwide, via the RHTR website. more...

A pilot study assessed an electronic informed consent model within a randomized controlled trial (RCT). Participants who were recruited for the parent RCT project were randomly selected and randomized to either an electronic consent group ( n = 32) or a simplified paper-based consent group ( n = 30). Results from the electronic consent group reported significantly higher understanding of the purpose of the study, alternatives to participation, and who to contact if they had questions or concerns about the study. However, participants in the paper-based control group reported higher mean scores on some survey items. This research suggests that an electronic informed consent presentation may improve participant understanding for some aspects of a research study. more...

Ethical and legal requirements for healthcare providers in the United States, stipulate that patients sign a consent form prior to undergoing medical treatment or participating in a research study. Currently, the majority of the hospitals obtain these consents using paper-based forms, which makes patient preference data cumbersome to store, search and retrieve. To address these issues, Health Sciences of South Carolina (HSSC), a collaborative of academic medical institutions and research universities in South Carolina, is developing an electronic consenting system, the Research Permissions Management System (RPMS). This article reports the findings of a study conducted to investigate the efficacy of the two proposed interfaces for this system - an iPad-based and touchscreen-based by comparing them to the paper-based and Topaz-based systems currently in use.This study involved 50 participants: 10 hospital admission staff and 40 patients. The four systems were compared with respect to the time taken to complete the consenting process, the number of errors made by the patients, the workload experienced by the hospital staff and the subjective ratings of both patients and staff on post-test questionnaires.The results from the empirical study indicated no significant differences in the time taken to complete the tasks. More importantly, the participants found the new systems more usable than the conventional methods with the registration staff experiencing the least workload in the iPad and touchscreen-based conditions and the patients experiencing more privacy and control during the consenting process with the proposed electronic systems. In addition, they indicated better comprehension and awareness of what they were signing using the new interfaces.The results indicate the two methods proposed for capturing patient consents are at least as effective as the conventional methods, and superior in several important respects. While more research is needed, these findings suggest the viability of cautious adoption of electronic consenting systems, especially because these new systems appear to address the challenge of identifying the participants required for the complex research being conducted as the result of advances in the biomedical sciences. more...

Background and aim: As non-randomised studies have suggested that surgical decompression may reduce mortality in patients with space occupying hemispheric infarction, randomisation may be considered unethical in controlled trials testing this treatment strategy. We studied differences in recall of information and in appreciation of the informed consent procedure between representatives included in the Hemicraniectomy After Middle cerebral artery infarction with Life-threatening Edema Trial (HAMLET) and representatives of patients participating in the randomised trial of Paracetamol (Acetaminophen) In Stroke (PAIS). Methods: 1 year after study inclusion, we contacted 30 consecutive representatives who had given informed consent for participation of their relative in HAMLET, and 30 for PAIS. Recall of trial details and appreciation of the informed consent procedure were investigated using standardised questionnaires and compared between the two groups. Results: All 30 PAIS representatives and 28 HAMLET representatives were interviewed. Participation of their relative in a clinical trial was remembered by 86% of HAMLET and 40% of PAIS representatives (p more...

Aims: This study assessed parent knowledge of newborn screening (NBS) and parent attitudes toward NBS for untreatable conditions, NBS for late-onset disorders and informed consent in NBS. Methods: Seventeen qualitative focus groups were held in Alaska, California, Hawaii, and Washington with mothers of children 10 years old or younger. Results: Most participants did not recall receiving information about NBS, and all wanted this information prenatally. In addition, most felt that the current system of ‘informed dissent’ was adequate, provided they were told about NBS prior to delivery. All women supported NBS for conditions that occur in infancy without a proven treatment. However, they disagreed about NBS for disorders that manifest in late childhood or adulthood. Conclusions: The results show a general consensus among the focus group participants about issues that cause dissent among public health and health care professionals. Parent attitudes differ from those of many professional communities with regard to timing of NBS education, informed consent, NBS for disorders that lack an effective treatment, and predictive testing of children for late-onset disorders. The results highlight the need to further research parent opinions about expanded NBS using new technologies and to include parents in the development of NBS policies. more...

We examined participants' reading and recall of informed consent documents presented via paper or computer. Within each presentation medium, we presented the document as a continuous or paginated document to simulate common computer and paper presentation formats. Participants took slightly longer to read paginated and computer informed consent documents and recalled slightly more information from the paginated documents. We concluded that obtaining informed consent online is not substantially different than obtaining it via paper presentation. We also provide suggestions for improving informed consent--in both face-to-face and online experiments. more...

Objective: To assess communication between vascular neurosurgeons and their patients with unruptured cerebral aneurysms about treatment options and expected outcomes. Methods: Vascular neurosurgeons and their patients with cerebral aneurysms were surveyed immediately following outpatient appointments in a neurosurgery clinic. Data collected included how well the patient understood their aneurysm treatment options, the risks of a poor outcome from various treatments, and the consensus “best” treatment. Patient and neurosurgeon responses were measured using Likert scales, multiple choice questions, and visual analogue scales. Agreement between patient and neurosurgeon was assessed with kappa scores. The Wilcoxon sign rank test was used to compare visual analogue scale responses. Results: Data for 44 patient–neurosurgeon pairs were collected. Only 61% of patient–neurosurgeon pairs agreed on the best treatment plan for the patient’s aneurysm (κ = 0.51, moderate agreement). Among the neurosurgeons, agreement with their patients ranged from 82% (κ = 0.77, almost perfect agreement) to 52% (κ = 0.37, fair agreement). Patients estimated much higher risks of stroke or death from surgical clipping, endovascular embolisation, or no intervention compared with the estimates offered by their neurosurgeons (surgical clipping: patient 36% v neurosurgeon 13%, p v neurosurgeon 19%, p = 0.040; and no intervention: patient 63% v neurosurgeon 25%, p Conclusions: Following consultation with a vascular neurosurgeon, many patients with cerebral aneurysms have an inaccurate understanding of their aneurysm treatment plan and an exaggerated sense of the risks of aneurysmal disease and treatment. more...