From an idea to the marketplace: Identifying and addressing ethical and regulatory considerations across the digital health product-development lifecycle.

Widespread adoption of digital health tools has the potential to improve health and health care for individuals and their communities, but realizing this potential requires anticipating and addressing numerous ethical and regulatory challenges. Here, we help digital health tool developers identify ethical and regulatory considerations - and opportunities to advance desirable outcomes - by organizing them within a general product-development lifecycle that spans generation of ideas to commercialization of a product.

To Counsel or Not to Counsel: Physician Attitudes and Experiences with Do-It-Yourself (DIY) Fecal Microbiota Transplant (FMT).

Background: In the early 2010s, a phenomenon known as do-it-yourself (DIY) fecal microbiota transplant (FMT) emerged as lay individuals began self-administering FMTs at home. Although prior research indicates that many individuals who perform DIY FMT have sought advice from healthcare providers, to date there has been no investigation of physicians' experiences with DIY FMT. The objective of this qualitative study was to examine the attitudes of physicians who offer FMT regarding the practice of DIY FMT and to assess how they navigated the ethical challenges of patient requests for DIY FMT.

Ethical issues in direct-to-consumer healthcare: A scoping review.

An increasing number of health products and services are being offered on a direct-to-consumer (DTC) basis. To date, however, scholarship on DTC healthcare products and services has largely proceeded in a domain-specific fashion, with discussions of relevant ethical challenges occurring within specific medical specialties. The present study therefore aimed to provide a scoping review of ethical issues raised in the academic literature across types of DTC healthcare products and services.

Alzheimer's in the modern age: Ethical challenges in the use of digital monitoring to identify cognitive changes.

Pushes toward earlier detection of Alzheimer's disease (AD)-related cognitive changes are creating interest in leveraging technologies, like cellphones, that are already widespread and well-equipped for data collection to facilitate digital monitoring for AD. Studies are ongoing to identify and validate potential "digital biomarkers" that might indicate someone has or is at risk of developing AD dementia. Digital biomarkers for AD have potential as a tool in aiding more timely diagnosis, though more robust research is needed to support their validity and utility.

Navigating biosafety concerns within COVID-19 do-it-yourself (DIY) science: an ethnographic and interview study.

Unlabelled: Non-establishment or do-it-yourself (DIY) science involves individuals who may not have formal training conducting experiments outside of institutional settings. While prior scholarship has examined the motivations and values of those involved in the subset of DIY science known as "DIY biology," little research has addressed how these individuals navigate ethical issues in practice. The present study therefore aimed to understand how DIY biologists identify, approach, and resolve one particular ethical issue-biosafety-in their work.

Ethical considerations for researchers developing and testing minimal-risk devices.

This comment provides an overview of ethical considerations for researchers developing and testing minimal-risk devices that interact or interface with people, such as electronic wearables and biomedical sensors. We outline the process of independent review, emphasizing that research can undergo different levels of review depending on its design and risk level. Using scenarios drawn from our own experience, we outline salient ethical considerations for research with such minimal-risk devices.

Proceedings of the 10th annual deep brain stimulation think tank: Advances in cutting edge technologies, artificial intelligence, neuromodulation, neuroethics, interventional psychiatry, and women in neuromodulation.

The deep brain stimulation (DBS) Think Tank X was held on August 17-19, 2022 in Orlando FL. The session organizers and moderators were all women with the theme . Dr.

Mapping the Landscape of Do-it-Yourself Medicine.

The practice of medicine is typically conceptualized as remaining within the boundaries of a hospital or clinic. However, in recent years, patients have been able to gain access to information about medical research as it is ongoing. As a result, there has been a rise in do-it-yourself (DIY) medicine, where individuals treat themselves for medical conditions outside of clinical settings, often mimicking experimental therapies that remain inaccessible to the wider public.

Opportunity Cost or Opportunity Lost: An Empirical Assessment of Ethical Concerns and Attitudes of EEG Neurofeedback Users.

Background: Electroencephalography (EEG) neurofeedback is a type of biofeedback that purportedly teaches users how to control their brainwaves. Although neurofeedback is currently offered by thousands of providers worldwide, its provision is contested, as its effectiveness beyond a placebo effect is unproven. While scholars have voiced numerous ethical concerns about neurofeedback-regarding opportunity cost, physical and psychological harms, financial cost, and informed consent-to date these concerns have remained theoretical.

Non-invasive brain stimulation and neuroenhancement.

Attempts to enhance human memory and learning ability have a long tradition in science. This topic has recently gained substantial attention because of the increasing percentage of older individuals worldwide and the predicted rise of age-associated cognitive decline in brain functions. Transcranial brain stimulation methods, such as transcranial magnetic (TMS) and transcranial electric (tES) stimulation, have been extensively used in an effort to improve cognitive functions in humans.

Pregnant at the start of the pandemic: a content analysis of COVID-19-related posts on online pregnancy discussion boards.

Background: A growing body of evidence indicates that the COVID-19 pandemic has had detrimental mental health effects for pregnant women. However, little is known about the specific stressors that increased anxiety for pregnant women at the start of the pandemic. The present study aimed to better understand the concerns of pregnant women during the beginning COVID-19 pandemic by analyzing content posted during the month of March 2020 on online pregnancy message boards hosted on WhatToExpect.

Translational Neuroethics: A Vision for a More Integrated, Inclusive, and Impactful Field.

As early-career neuroethicists, we come to the field of neuroethics at a unique moment: we are well-situated to consider nearly two decades of neuroethics scholarship and identify challenges that have persisted across time. But we are also looking squarely ahead, embarking on the next generation of exciting and productive neuroethics scholarship. In this article, we both reflect backwards and turn our gaze forward.

Trading Vulnerabilities: Living with Parkinson's Disease before and after Deep Brain Stimulation.

Implanted medical devices-for example, cardiac defibrillators, deep brain stimulators, and insulin pumps-offer users the possibility of regaining some control over an increasingly unruly body, the opportunity to become part "cyborg" in service of addressing pressing health needs. We recognize the value and effectiveness of such devices, but call attention to what may be less clear to potential users-that their vulnerabilities may not entirely disappear but instead shift. We explore the kinds of shifting vulnerabilities experienced by people with Parkinson's disease (PD) who receive therapeutic deep brain stimulators to help control their tremors and other symptoms of PD.

Neurofeedback as placebo: a case of unintentional deception?

The use of placebo in clinical practice has been the topic of extensive debate in the bioethics literature, with much scholarship focusing on concerns regarding deception. While considerations of placebo without deception have largely centred on open-label placebo, this paper considers a different kind of ethical quandary regarding placebo without an intent to deceive-one where the provider believes a treatment is effective due to a direct physiological mechanism, even though that belief may not be supported by rigorous scientific evidence. This is often the case with complementary and alternative medicine (CAM) techniques and also with some mainstream therapies that have not proven to be better than sham.

Ethical Issues in Intraoperative Neuroscience Research: Assessing Subjects' Recall of Informed Consent and Motivations for Participation.

An increasing number of studies utilize intracranial electrophysiology in human subjects to advance basic neuroscience knowledge. However, the use of neurosurgical patients as human research subjects raises important ethical considerations, particularly regarding informed consent and undue influence, as well as subjects' motivations for participation. Yet a thorough empirical examination of these issues in a participant population has been lacking.