Characterization of key information sections in informed consent forms posted on ClinicalTrials.gov.

Introduction: Recent revisions to the US Federal Common Rule governing human studies funded or conducted by the federal government require the provision of a "concise and focused" key information (KI) section in informed consent forms (ICFs). We performed a systematic study to characterize KI sections of ICFs for federally funded trials available on ClinicalTrials.gov.

Terms and conditions apply: an ethical analysis of mobile health user agreements in research.

Mobile health (mHealth) technologies raise unique risks to user privacy and confidentiality that are often embedded in lengthy and complex Privacy Policies, Terms of Use, and End User License Agreements. We seek to improve the ethical review of these documents ('user agreements') and their risks in research using mHealth technologies by providing a framework for identifying when these risks are research risks, categorizing the key information in these agreements under relevant ethical and regulatory categories, and proposing strategies to mitigate them. MHealth user agreements typically describe the collected by mHealth technologies, user data are collected and shared, to the different types of data collected, and may include The risks raised by data collection and sharing typically increase with the sensitivity and identifiability of the data and vary by whether data are shared with researchers, the technology developer, and/or third-party entities.

Ensuring the Scientific Value and Feasibility of Clinical Trials: A Qualitative Interview Study.

Background: Ethical and scientific principles require that clinical trials address an important question and have the resources needed to complete the study. However, there are no clear standards for review that would ensure that these principles are upheld.

Methods: We conducted semi-structured interviews with a convenience sample of nineteen experts in clinical trial design, conduct, and/or oversight to elucidate current practice and identify areas of need with respect to ensuring the scientific value and feasibility of clinical trials prior to initiation and while ongoing.

The oversight of autonomous artificial intelligence: lessons from nurse practitioners as physician extenders.

The development of autonomous artificial intelligence (A-AI) products in health care raises novel regulatory challenges, including how to ensure their safety and efficacy in real-world settings. Supplementing a device-centered regulatory scheme with a regulatory scheme that considers A-AI products as a 'physician extender' may improve the real-world monitoring of these technologies and produce other benefits, such as increased access to the services offered by these products. In this article, we review the three approaches to the oversight of nurse practitioners, one type of physician extender, in the USA and extrapolate these approaches to produce a framework for the oversight of A-AI products.

When Is a Change Significant? The Update Problem of Apps in Medical and Behavioral Research.

Digital applications (apps) are commonly used across the research ecosystem. While apps are frequently updated in the course of clinical and behavioral research, there is limited guidance as to when an app update should trigger action related to human research participant protections and who should be responsible for monitoring and reviewing these updates. We term this the "update problem" and argue that, while it is the principal investigator's duty to track all relevant updates, the level of involvement and re-review by the institutional review board (IRB) of an approved research protocol should vary depending on whether the update may be classified as minor, not minor, or significant.

Characterization of Informed Consent Forms Posted on ClinicalTrials.gov.

This cross-sectional study examines available forms and posting trends of registered trials as well as the frequency of form posting by funder type for trials initiated since the revised Common Rule was implemented.

Evaluating the frequency of English language requirements in clinical trial eligibility criteria: A systematic analysis using ClinicalTrials.gov.

Background: A number of prior studies have demonstrated that research participants with limited English proficiency in the United States are routinely excluded from clinical trial participation. Systematic exclusion through study eligibility criteria that require trial participants to be able to speak, read, and/or understand English affects access to clinical trials and scientific generalizability. We sought to establish the frequency with which English language proficiency is required and, conversely, when non-English languages are affirmatively accommodated in US interventional clinical trials for adult populations.

Navigating the ethics of remote research data collection.

COVID-19 has accelerated broad trends already in place toward remote research data collection and monitoring. This move implicates novel ethical and regulatory challenges which have not yet received due attention. Existing work is preliminary and does not seek to identify or grapple with the issues in a rigorous and sophisticated way.

Online Research Participant Communication: Balancing Benefits and Risks.

Online communication has emerged as an important vehicle for participant interaction during the course of clinical research. At the same time, such communication has been identified as a source of risks both for participants and the scientific integrity of clinical trials. Although strategies for mitigating these risks have become a focus in the research community, missing from the discussion has been a sustained and sympathetic effort to understand the various benefits of online communication for participants themselves.