Genetic testing, insurance discrimination and medical research: what the United States can learn from peer countries.

While genetic testing may be the gateway to the future of medicine, it also poses challenges for individuals, especially in terms of differentiated treatments on the basis of their genetic characteristics. The fear of unwanted disclosure to insurers and the possibility of genetic discrimination can hamper the recruitment of individuals for clinical research that involves genetic testing. Precision medicine initiatives, such as All of Us, are proliferating in the United States.

Organ donor intervention trials and risk to bystanders: An ethical analysis.

There are two distinct problems about bystander effects raised by organ donor intervention research. The first is the problem of "bystander organs"-sometimes called "non-target organs"-which Kimmelman discusses in his case presentation. How do we treat the recipients of organs that are not the subject of the intervention research but nonetheless might be directly affected by the research? The second problem is not about altering the organ but the pattern of distribution of organs.

Privacy in the age of medical big data.

Big data has become the ubiquitous watch word of medical innovation. The rapid development of machine-learning techniques and artificial intelligence in particular has promised to revolutionize medical practice from the allocation of resources to the diagnosis of complex diseases. But with big data comes big risks and challenges, among them significant questions about patient privacy.

Big data and black-box medical algorithms.

New machine-learning techniques entering medicine present challenges in validation, regulation, and integration into practice.

Beyond financial conflicts of interest: Institutional oversight of faculty consulting agreements at schools of medicine and public health.

Importance: Approximately one-third of U.S. life sciences faculty engage in industry consulting.

Conflicts of interest and the (in)dependence of experts advising government on immunization policies.

There has been increasing attention to financial conflicts of interest (COI) in public health research and policy making, with concerns that some decisions are not in the public interest. One notable problematic area is expert advisory committee (EAC). While COI management has focused on disclosure, it could go further and assess experts' degree of (in)dependence with commercial interests.

Oversight of Patient-Centered Outcomes Research: Recommendations From a Delphi Panel.

A key aim of patient-centered outcomes research (PCOR) is to generate data that are important to patients by deliberately and extensively involving them in all aspects of research, from design to dissemination. However, certain elements of PCOR raise challenging and potentially novel ethical and regulatory issues for institutional review boards and oversight bodies. These challenges stem primarily from the engagement of patients in roles other than research subject, such as advisors, study personnel, and co-investigators, which gives rise to questions about appropriate levels of protection, training, and education, as well as identifying and managing conflicts of interest.

Truth in Advertising: Disclosure of Participant Payment in Research Recruitment Materials.

The practice of paying research participants has received significant attention in the bioethics literature, but the focus has been almost exclusively on consideration of factors relevant to determining acceptable payment amounts. Surprisingly little attention has been paid to what happens once the payment amount is set. What are the ethical parameters around how offers of payment may be advertised to prospective participants? This article seeks to answer this question, focusing on the ethical and practical issues associated with disclosing information about payment, and payment amounts in particular, in recruitment materials.

Preventing Mitochondrial Diseases: Embryo-Sparing Donor-Independent Options.

Mutant mitochondrial DNA gives rise to a broad range of incurable inborn maladies. Prevention may now be possible by replacing the mutation-carrying mitochondria of zygotes or oocytes at risk with donated unaffected counterparts. However, mitochondrial replacement therapy is being held back by theological, ethical, and safety concerns over the loss of human zygotes and the involvement of a donor.

Deciphering the Sunshine Act: Transparency Regulation and Financial Conflicts in Health Care.

The Physician Payments Sunshine Act ("Sunshine Act"), enacted to address financial conflicts in health care, is the first comprehensive federal legislation mandating public reporting of payments between drug companies, device manufacturers, and medicine. This article analyzes the Sunshine Act's uneven record, exploring how the law serves as an intriguing example of the uncertain case for transparency regulation in health care. The Sunshine Act's bumpy rollout demonstrates that commanding transparency through legislation can be arduous because of considerable implementation challenges.

Preventing Mitochondrial Disease: A Path Forward.

In a possible first, the heritable transmission of a fatal mitochondrial DNA disease (Leigh syndrome) may have been prevented by replacing the mutation-bearing mitochondria of oocytes with donated mutation-free counterparts. The procedure, carried out by a U.S.