Comparing a Multimedia Digital Informed Consent Tool With Traditional Paper-Based Methods: Randomized Controlled Trial.

Background: The traditional informed consent (IC) process rarely emphasizes research participants' comprehension of medical information, leaving them vulnerable to unknown risks and consequences associated with procedures or studies.

Objective: This paper explores how we evaluated the feasibility of a digital health tool called Virtual Multimedia Interactive Informed Consent (VIC) for advancing the IC process and compared the results with traditional paper-based methods of IC.

Methods: Using digital health and web-based coaching, we developed the VIC tool that uses multimedia and other digital features to improve the current IC process.

Kidney Biopsy-Related Complications in Hospitalized Patients with Acute Kidney Disease.

Background And Objectives: Patients are informed of the risk of kidney biopsy-related complications using data from nonhospitalized patients, which may underestimate the risk for hospitalized patients. We evaluated the rate and risk factors of kidney biopsy-related complications in hospitalized patients with acute kidney disease (AKD) to better estimate the risk in this population.

Design, Setting, Participants, & Measurements: We used data from the Yale biopsy cohort to evaluate rates of kidney biopsy-related complications including adjudicated procedure-related bleeding requiring blood transfusions or angiographic interventions, medium- or large-sized hematomas, reimaging after biopsy including abdominal ultrasonography or computed tomography, and death in hospitalized patients with AKD (including AKI).

Building an Informed Consent Tool Starting with the Patient: The Patient-Centered Virtual Multimedia Interactive Informed Consent (VIC).

Patient safety and quality of care are at risk if the informed consent process does not emphasize patient comprehension. In this paper, we describe how we designed, developed, and evaluated an mHealth tool for advancing the informed consent process. Our tool enables the informed consent process to be performed on tablets (e.

A Survey of Patient Attitudes Toward Participation in Biopsy-Based Kidney Research.

Introduction: As part of the precision medicine initiative, the National Institutes of Health/National Institute of Diabetes and Digestive Kidney Diseases has proposed collecting human kidney tissue to discover novel therapeutic targets from patients with kidney diseases. Patient attitudes on participating in kidney biopsy-based research are largely unknown.

Methods: We evaluated attitudes toward donating kidney tissue to research among participants who had experienced a clinically indicated kidney biopsy, through a survey conducted 9 months (interquartile range, 5-13 months) after their biopsy.

Research participant-centered outcomes at NIH-supported clinical research centers.

Background: Although research participation is essential for clinical investigation, few quantitative outcome measures exist to assess participants' experiences. To address this, we developed and deployed a survey at 15 NIH-supported clinical research centers to assess participant-centered outcomes; we report responses from 4,961 participants.

Methods: Survey questions addressed core aspects of the research participants' experience, including their overall rating, motivation, trust, and informed consent.

Conducting research with human subjects in international settings: ethical considerations.

Biomedical research in international settings is undergoing expansive growth and may potentially result in far-reaching benefits, such as direction of research resources toward solving basic health care needs of world populations. However, key ethical concerns surround this expansion and must be carefully considered by international researchers. International research is impacted by differences in language, culture, regulatory structures, financial resources, and possibly ethical standards.