Group items tagged

"Abstract The digital revolution is disrupting the ways in which health research is conducted, and subsequently, changing healthcare. Direct-to-consumer wellness products and mobile apps, pervasive sensor technologies and access to social network data offer exciting opportunities for researchers to passively observe and/or track patients 'in the wild' and 24/7. The volume of granular personal health data gathered using these technologies is unprecedented, and is increasingly leveraged to inform personalized health promotion and disease treatment interventions. The use of artificial intelligence in the health sector is also increasing. Although rich with potential, the digital health ecosystem presents new ethical challenges for those making decisions about the selection, testing, implementation and evaluation of technologies for use in healthcare. As the 'Wild West' of digital health research unfolds, it is important to recognize who is involved, and identify how each party can and should take responsibility to advance the ethical practices of this work. While not a comprehensive review, we describe the landscape, identify gaps to be addressed, and offer recommendations as to how stakeholders can and should take responsibility to advance socially responsible digital health research."

"Is it ethical to edit your child's DNA - or your own? Does the answer depend on whether you're perfectly healthy or have a condition like vision loss or are dying of a degenerative disease? And does it matter whether you've got a PhD or never set foot in a college classroom?"

"  Presented by the Law and Policy Working Group and Ethics Working Group Date: Friday, November 22, 2019, from 1:00 PM to 2:15 PM EST Presented by the Law and Policy Working Group and Ethics Working Group Date: Friday, November 22, 2019, from 1:00 PM to 2:15 PM EST"

"Prospective consent and governance principles for participant-led research Nine themes emerged from discussions and interviews relating to informed consent in and governance of PLR. As this PLR was driven by people with different backgrounds asking personal questions, we found that ethical reflection needed to be ongoing and tailored to the individual. For this reason, prospective governance principles were drafted rather than codified rules. Many of the themes were expressed over the course of our PLR as an ongoing informed consent. The process, fostered via frequent communication, helped to reinforce trust among participants and organisers.43 44 Transparency: All relevant information about the project should be actively shared among participants and participant-organisers, including the source of research funding, equipment selection, data management protocols, risks and benefits and conflicts of interest. Access to Expertise: Participant-led research (PLR) requires access to experts (eg, in experimental design, data analysis, research ethics) so that participants can rigorously carry out single-subject experiments.45 Data Access & Control: The participant has the right and ability to manage their own data, and has the final say in what they collect about themselves. Right to Withdraw: Participants have a right to reduce or withdraw their participation at any time. Relevance: PLR addresses questions of relevance to the participants. Beneficence: The participant actively reflects on the balance of benefits and risks of participation and freely choose whether to participate. Responsibility: PLR requires that the participant actively consider the potential benefits and harms of the project to both themselves and others. The responsibility to stay informed is an ongoing process, not a one-time decision. Flexibility: Ethical reflection in PLR should be tailored to individual needs and to the specific context, rather than be handled with 'one size fits all�

"Biomedical Ethics Seminar Series: Special Event  End of Life Liberty: Empowering Dying Patients with Choices. An overview of the evolving changes in law and medicine governing patient autonomy at the end of life over the past 2 decades. What has been learned? What changes ought be considered? Can we move to normalize the practice of aid in dying within the practice of medicine? Do some states offer a model for practice governed by standard of care? Do psychedelic medicines offer a new palliative tool for patients with anxiety? What is the status of the research, and federal, state and local law governing psychedelic substances.

"ReCODE Health is here to support technologists, researchers, ethicists, regulators, institutions and participants involved in the digital health research process. Our value proposition is to increase awareness of ethical principles and practices from the earliest stages of technology design to the deployment of digital health research."

Camille Nebeker: I'm writing a paper on mHealth and research ethics across regulated and unregulated sectors. Came across an article that you may appreciate - it's basically saying that people need to be trained when conducting scientific research. It was aimed at clinicians - not citizen scientists:

Camille Nebeker* 11/13

"While citizen science is gaining attention of late, for those of us involved in community-based public health research, community/citizen involvement in research has steadily increased over the past 50 years. Community Health Workers (CHWs), also known as Promotores de Salud in the Latino community, are critical to reaching underserved populations, where health disparities are more prevalent. CHWs/Promotores provide health education and services and may also assist with the development and implementation of community- and clinic-based research studies. Recognizing that CHWs typically have no formal academic training in research design or methods, and considering that rigor in research is critical to obtaining meaningful results, we designed instruction to fill this gap. We call this educational initiative "Building Research Integrity and Capacity" or BRIC. The BRIC training consists of eight modules that can be administered as a self-paced training or incorporated into in-person, professional development geared to a specific health intervention study. While we initially designed this culturally-grounded, applied ethics training for Latino/Hispanic community research facilitators, BRIC training modules have been adapted for and tested with non-Latino novice research facilitators. This paper describes the BRIC core content and instructional design process."

Featuring Camille Nebeker

The link below shows 3 upcoming webinars that may be of interest. The one on June 20 will feature Camille Nebeker and Gary Wolf speaking about the ethical dimensions of participant-lead research. The webinars are free, but please note that the start times are given in EDT. So if you plan to register for their workshop, it will be at 10:00 am that day.

""Biogen should have had a plan in place from the very start about how it would handle expanded access requests that came in at all different points: before, during and after trial enrollment," Holly Fernandez-Lynch, an assistant professor of medical ethics at the Perelman School of Medicine at the University of Pennsylvania, explained."

"Now more than ever, the global mental health community must look to innovative solutions to curtail the 'second epidemic' of mental ill-health sweeping the world. The huge variety of solutions has created a new problem - how can one ensure the disruptive tech they are using is clinically validated, ethical and efficacious? The Forum has partnered with Deloitte to create a set of standards to vet digital mental health solutions called the Global Governance Toolkit for Digital Mental Health."

"Physicians sometimes grouse about Dr. Google - about the way untrained patients search the internet for information, not always reliable, and come to conclusions, not always sound. A few physicians have taken to drinking their coffee from a cup emblazoned with the words "Please do not confuse your Google search with my medical degree." By now, however, most have made the inevitable accommodations; they suppress the eye roll."

he UC San Diego Design Lab works on major societal issues, such as large-scale education, automation, healthcare, visualization of complex phenomena and data, social interactions, citizen science, and the ethical issues that are of ever-increasing importance.

THE QUANTIFIED SELF is about making personally relevant discoveries using our own self-collected data. We call this practice everyday science, a name that emphasizes its nonprofessional character. Lately we've begun organizing small group projects that show how collaboration can make individual projects easier. Sometimes, joining forces with others who share our question can make it possible to create both personal and generalizable health knowledge. Following the scholar Effy Vayena, we use the term "participant-led research" (PLR) to describe this approach.

Camille Nebeker: And another that my colleague, Eleanor wrote entitled the Rise of the New Bio-Citizen speaks to the need for governance and safety considerations when doing DIY research.

Recommended by Megan Sweeney I listened to the article. It gave me a sense of context for self-study. I also found a strong path of hope that this kind of science will grow during the disruption caused by Covid-19

"The topic of placebo effects is distinguished by decades of keen scientific interest1-4 coupled with a general skepticism regarding the ultimate significance of these phenomena. The importance of psychologic factors in mediating these effects may contribute to the attitude that placebo effects are not as substantial as a therapeutic effect produced by a drug. Complementary and alternative therapies have sometimes been dismissed as "mere placebos." However, recent studies have provided compelling evidence that placebo effects are physiologically measurable with condition-specific pathways.5"

Dr. Jake Fleming recently suggested these potent keywords: quantifiable placebo The keywords led to this article. I find it affirming and empowering.

Recommended by DeAunne Denmark, MD. Phd.