Should Chatbots Be Used to Obtain Informed Consent for Research?

Chatbots have become increasingly common in diverse settings as a substitute for human conversation. They are being developed and tested for obtaining informed consent for research. An initial study indicated that chatbots saved time and were successful in knowledge transfer, but the informed consent process serves other purposes, such as building trust and respecting the autonomy and dignity of potential research participants. Additional research and possible regulation are necessary before chatbots should be routinely used in health research.

Translational Bioethics and Health Privacy.

Translational bioethics expands the scope of research ethics to include multidisciplinary analyses of the societal implications of new translational science discoveries. Novel health privacy issues are raised by the collection, use, and disclosure of extensive and diverse big data for research on precision medicine. Similar privacy concerns surround the use of artificial intelligence to analyze vast troves of clinical records to improve patient outcomes. Embedding bioethics scholars with translational scientists can improve the technical analyses and timeliness of bioethical inquiries, but they complicate the task of producing independent and rigorous ethical assessments.

Concordance of International Regulation of Pediatric Health Research.

OBJECTIVE: To assess the comparability of international ethics principles and practices used in regulating pediatric research as a first step in determining whether reciprocal deference for international ethics review is feasible. Prior studies by the authors focused on other aspects of international health research, such as biobanks and direct-to-participant genomic research. The unique nature of pediatric research and its distinctive regulation by many countries warranted a separate study. STUDY DESIGN: A representative sample of 21 countries was selected, with geographical, ethnic, cultural, political, and economic diversity. A leading expert on pediatric research ethics and law was selected to summarize the ethics review of pediatric research in each country. To ensure the comparability of the responses, a 5-part summary of pediatric research ethics principles in the US was developed by the investigators and distributed to all country representatives. The international experts were asked to assess and describe whether principles in their country and the US were congruent. Results were obtained and compiled in the spring and summer of 2022. RESULTS: Some of the countries varied in their conceptualization or description of one or more ethical principles for pediatric research, but overall, the countries in the study demonstrated a fundamental concordance. CONCLUSIONS: Similar regulation of pediatric research in 21 countries suggests that international reciprocity is a viable strategy.

Expanding Paid Sick Leave Laws: The Public Health Imperative.

A key public health measure has received far too little attention over the course of the Covid-19 pandemic: paid sick leave policies that encourage people at risk of spreading disease to stay home rather than come to work. The United States is one of the only developed countries that fails to guarantee paid sick leave at the federal level, leaving a patchwork of state and private policies that undersupply time off when people are contagious and protect top wage earners at wildly disproportionate rates compared with what workers with lower incomes experience. Other countries have shown that sick leave mandates are neither unjustified burdens on employers nor gratuitous giveaways to employees. In fact, sick leave saves on health care costs by making employees less likely to infect coworkers, to be absent for longer themselves, or to need treatment in expensive hospital emergency departments. Nationally guaranteed sick leave is urgently needed to promote public health.

The Illusion of Health Privacy in Obstetrics-Gynecology.

Many health professionals and patients erroneously believe that professional ethics and laws protect the privacy of sensitive records in obstetrics-gynecology. The Health Insurance Portability and Accountability Act Privacy Rule permits disclosure of health records without authorization for public health, law enforcement, and other reasons. Individuals also may be compelled to authorize the release of their records in applying for employment, life insurance, or government benefits. Disclosure of sensitive health information has increased because of comprehensive electronic health records, patient-developed data from mobile devices, consolidation of medical practices, and law enforcement interest in reproductive health records attributable to the change in abortion laws.

Expanding the Role of Bioethics in Translational Science.

Translational science attempts to accelerate and increase the significance of research progressing from bench to bedside. Support from the NIH through its institutional grant program has increased the prominence and importance of translational science. The inclusion of a broadly based bioethics component to translational science presents an opportunity for bioethics scholars to address fundamental social issues, including the effects of translational science on public health, health equity, and human flourishing. Large-scale bioethical inquiries could examine research priorities, unintended consequences of research, and access to and uptake of research discoveries.

The OSHA COVID-19 Case and the Scope of the Occupational Safety and Health Act.

The Occupational Safety and Health Administration (OSHA) issued an emergency temporary standard (ETS) for COVID-19 applicable to private sector employers with 100 or more employees. Among other things, the ETS required employers either to mandate employee vaccination or weekly testing and wearing masks.

Physician Liability for Suicide after Negligent Tapering of Opioids.

The precipitous and medically contraindicated reduction or "tapering" of opioids for patients with chronic pain due to serious medical conditions has caused needless suffering and, increasingly, suicide. Physicians could be liable for wrongful death based on negligent tapering of opioids.

Streamlining ethics review for international health research.

Single-site review means protection and efficiency.

Cardiologists' Perspectives on BiDil and the Use of Race in Drug Prescribing.

OBJECTIVES: We explored cardiologists' attitudes and prescribing patterns specific to the use of generic isosorbide dinitrate and hydralazine hydrochloride, and the fixed-dose patented drug, BiDil. BACKGROUND: Since the Food and Drug Administration approved BiDil in 2005 with an indication for self-identified black patients, disagreement about the appropriateness of race-based drugs has intensified and led to calls for providers and researchers to abandon race-based delimitations. This paper reports empirical evidence of cardiologists' views on BiDil's race-based indication and their ongoing inertia with respect to the debate about BiDil. METHODS: We conducted a 2010 cross-sectional online survey of members of the Association of Black Cardiologists. RESULTS: Fifty-nine cardiologists responded to the survey. Most participants (62.7%) prescribed BiDil to their patients. More than 40% of respondents did not prescribe BiDil to any non-African Americans. When considering whether to prescribe BiDil, a patient's race determined by physician assessment was the third most important factor considered by participants. The majority of participants (72.7%) selected symptoms as the most important factor. Most participants (59.2%) perceived race as defining biologically distinct individuals. Respondents prescribed BiDil more often to African American patients than non-African American patients. However, they prescribed the generic components that makeup BiDil to African Americans and non-African American patients similarly. CONCLUSIONS: The survey provides useful findings that, when viewed within the context of ongoing debates about race-based medicine, show little progress toward appropriately utilizing BiDil to maximize health outcomes, yet, might inform the development of practical and effective guidelines concerning the use of race in medicine.

Doctors and Pain Patients Avoid "Ruan" in the Supreme Court.

Physicians' fear of criminal prosecution for prescribing opioid analgesics is a major reason why many chronic pain patients are having an increasingly difficult time obtaining medically appropriate pain relief. In Ruan v. United States, 142 S. Ct. 2370 (2022), the Supreme Court unanimously vacated two federal convictions under the Controlled Substances Act. The Court held that the government must prove that the defendant knowingly or intentionally acted in an unauthorized manner.

Covid Vaccine Mandates and Religious Accommodation in Employment.

Many employers are requiring their employees to be vaccinated for Covid-19 to comply with federal, state, or local laws, or to conform to employers' policies. Some employees object to vaccination on religious grounds. Title VII of the Civil Rights Act of 1964 prohibits discrimination in employment based on religion and requires employers to reasonably accommodate employees' religious beliefs or practices unless doing so would be an undue hardship to the employer's business. Although a religion need not be an established faith with many followers, philosophical or political objections do not count as religious beliefs. If an employee demonstrates a bona fide religious objection, the issue is whether it can be reasonably accommodated. This will depend on the employer's business, including whether close contact with coworkers or customers is required.

Informed Consent for Secondary Research under the New NIH Data Sharing Policy.

The new NIH data sharing policy, effective January 2023, requires researchers to submit a data management and data sharing plan in their grant application. Expanded data sharing, encouraged by NIH to facilitate secondary research, will require informed consent documents to explain data sharing plans, limitations, and procedures.

Employer Liability for "Take-Home" COVID-19.

Workplace exposure to SARS-CoV-2 has sickened workers and, subsequently, their family members. Family members might be able to recover from the employer in a negligence action using "take-home" liability theory.